Poly Tan DM Suspension

Pronunciation: FEN-il-EF-rin/DEX-brome-fen-IR-a-meen/DEX-troe-meth-OR-fan/pir-IL-a-meen
Generic Name: Phenylephrine/Dexbrompheniramine/Dextromethorphan/Pyrilamine
Brand Name: Poly Tan DM

Poly Tan DM Suspension is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Poly Tan DM Suspension is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Poly Tan DM Suspension if:

• you are allergic to any ingredient in Poly Tan DM Suspension


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take droxidopa, sodium oxybate (GHB), or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Poly Tan DM Suspension:

Some medical conditions may interact with Poly Tan DM Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, stroke, glaucoma or increased pressure in the eye, or thyroid problems


• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; trouble urinating; or an enlarged prostate or other prostate problems

Some MEDICINES MAY INTERACT with Poly Tan DM Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Poly Tan DM Suspension's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Poly Tan DM Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Poly Tan DM Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Poly Tan DM Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Poly Tan DM Suspension:

Use Poly Tan DM Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Poly Tan DM Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Poly Tan DM Suspension and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Poly Tan DM Suspension.

Important safety information:

• Poly Tan DM Suspension may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Poly Tan DM Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Poly Tan DM Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Poly Tan DM Suspension without checking with your doctor.


• Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Poly Tan DM Suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days, if they get worse, or if they occur along with a fever, check with your doctor.


• Poly Tan DM Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Poly Tan DM Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Poly Tan DM Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Poly Tan DM Suspension for a few days before the tests.


• Tell your doctor or dentist that you take Poly Tan DM Suspension before you receive any medical or dental care, emergency care, or surgery.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Use Poly Tan DM Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.


• Caution is advised when using Poly Tan DM Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Poly Tan DM Suspension should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Poly Tan DM Suspension while you are pregnant. Some ingredients of Poly Tan DM Suspension are found in breast milk. Do not breast-feed while taking Poly Tan DM Suspension.

Possible side effects of Poly Tan DM Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Poly Tan DM side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; flushing; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Poly Tan DM Suspension:

Store Poly Tan DM Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Poly Tan DM Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Poly Tan DM Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Poly Tan DM Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Poly Tan DM Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Poly Tan DM resources

• Poly Tan DM Side Effects (in more detail)
• Poly Tan DM Use in Pregnancy & Breastfeeding
• Poly Tan DM Drug Interactions
• Poly Tan DM Support Group
• 0 Reviews for Poly Tan DM - Add your own review/rating

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• Cough and Nasal Congestion

Pilocarpine

Pronunciation: pye-loe-KAR-peen
Generic Name: Pilocarpine
Brand Name: Salagen

Pilocarpine is used for:

Treating dry mouth associated with radiation treatment for cancer or Sjogren syndrome. It may also be used for other conditions as determined by your doctor.

Pilocarpine is a cholinergic agent. It works by increasing the secretion of saliva from the salivary glands, which helps to relieve dry mouth.

Do NOT use Pilocarpine if:

• you are allergic to any ingredient in Pilocarpine


• you have glaucoma, a severe eye infection, eye inflammation, or uncontrolled asthma

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pilocarpine:

Some medical conditions may interact with Pilocarpine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a detached retina or an eye infection


• if you have heart disease, asthma, chronic bronchitis, chronic obstructive pulmonary disease, kidney or liver disease, gallstones, or gall bladder problems


• if you have a psychiatric disorder

Some MEDICINES MAY INTERACT with Pilocarpine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Parasympathomimetic agents (eg, bethanecol) because they may increase the risk of Pilocarpine's side effects


• Beta-blockers (eg atenolol) because the risk of heart-related side effects may be increased


• Anticholinergic agents (eg, atropine, ipratropium) because their effectiveness may be decreased by Pilocarpine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pilocarpine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pilocarpine:

Use Pilocarpine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pilocarpine by mouth with or without food.


• Drinking extra fluids while you are taking Pilocarpine is recommended. Check with your doctor for instructions.


• If you miss a dose of Pilocarpine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pilocarpine.

Important safety information:

• Pilocarpine may cause blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pilocarpine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• It may take 12 weeks for Pilocarpine to work.


• Pilocarpine should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pilocarpine while you are pregnant. It is not known if Pilocarpine is found in breast milk. Do not breast-feed while taking Pilocarpine.

Possible side effects of Pilocarpine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; dizziness; flushing; frequent urination; nausea; runny nose; sweating; vision changes (eg, blurred vision); weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal pain; breathing problems; change in heart rate; confusion; excessive sweating; excessive tears; headache; shaking; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal heartbeat; blood pressure changes; confusion; diarrhea; difficulty breathing; headache; tremors; vision changes; vomiting.

Proper storage of Pilocarpine:

Store Pilocarpine at room temperature, up to 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Pilocarpine out of the reach of children and away from pets.

General information:

• If you have any questions about Pilocarpine, please talk with your doctor, pharmacist, or other health care provider.


• Pilocarpine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pilocarpine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pilocarpine resources

• Pilocarpine Dosage
• Pilocarpine Use in Pregnancy & Breastfeeding
• Drug Images
• Pilocarpine Drug Interactions
• Pilocarpine Support Group
• 0 Reviews for Pilocarpine - Add your own review/rating

• Pilocarpine Prescribing Information (FDA)


• Pilocarpine Monograph (AHFS DI)


• Pilocarpine Professional Patient Advice (Wolters Kluwer)


• pilocarpine Concise Consumer Information (Cerner Multum)


• pilocarpine Advanced Consumer (Micromedex) - Includes Dosage Information


• Salagen Prescribing Information (FDA)

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• Xerostomia

Optrex Infected Eye Ointment

1. Name Of The Medicinal Product

Optrex Infected Eye Ointment

When sold by Boots The Chemist, the name will be Boots Pharmacy Antibiotic Eye Ointment

2. Qualitative And Quantitative Composition

Chloramphenicol 1.0% w/w.

Each 1 gram of ointment contains 10mg chloramphenicol

For excipients, see 6.1.

3. Pharmaceutical Form

Eye ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of acute bacterial conjunctivitis.

4.2 Posology And Method Of Administration

Topical administration to the eye only.

Adults, children aged 2 years and over and elderly

The recommended dose is a small amount of ointment (~ 1cm) to be applied to the affected eye(s). The ointment should be applied either at night if eye drops are used during the day, or 3 to 4 times a day if eye ointment is used alone

The pharmacist will advise on the most suitable treatment. Treatment should continue for 5 days even if symptoms improve.

4.3 Contraindications

Chloramphenicol eye ointment must not be administered to:

• Patients who have a history of hypersensitivity to chloramphenicol or to any other ingredient of the ointment.

• Patients who have experienced myelosuppression during previous exposure to chloramphenicol.

• Patients with a family history of blood dyscrasias.

4.4 Special Warnings And Precautions For Use

Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported (see section 4.8).

In severe bacterial conjunctivitis and in cases where infection is not confined to the conjunctivae, the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. Therefore, the patient should be referred to seek medical advice.

The use of topical chloramphenicol may occasionally result in overgrowth of non-susceptible organisms including fungi. If any new infection appears during treatment, the patient should be referred to the doctor.

Prolonged or frequent intermittent topical application of chloramphenicol should be avoided since it may increase the likelihood of sensitisation and emergence of resistant organisms.

Do not use for more than 5 days without consulting your doctor.

The label will state:

• If symptoms do not improve within 48 hours talk to your doctor

• Seek further immediate medical advice at any time if symptoms worsen

• Do not use if you are allergic to chloramphenicol or any of the ingredients

• Discard any remaining eye ointment after the five day course of treatment

For external use only.

Keep all medicines out of the sight and reach of children.

Patients should be referred to a doctor if any of the following apply:

• Disturbed vision

• Any significant pain within the eye

• Photophobia

• Eye inflammation associated with a rash on the scalp or face

• The eye looks cloudy

• The pupil looks unusual

• Suspected foreign body in the eye

Patients should also be referred to their doctor if any of the following in his/her medical history apply:

• Previous conjunctivitis in the recent past

• Glaucoma

• Dry eye syndrome

• Eye surgery or laser treatment in the last 6 months

• Eye injury

• Current use of other eye drops or eye ointment

If you wear contact lenses, seek advice either from your optometrist, contact lens practitioner or doctor before you use this product. You should not wear your contact lenses during the course of treatment. If you wear soft contact lenses do not start wearing them for at least 24 hours after you have finished using the eye ointment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Bone marrow depressant drugs

4.6 Pregnancy And Lactation

The safety of chloramphenicol eye drops during pregnancy and lactation has not been established. As this product is for sale without prescription it is not recommended for use during pregnancy.

In view of the fact that chloramphenicol may appear in breast milk, use of the product during lactation should be avoided.

4.7 Effects On Ability To Drive And Use Machines

Blurring of vision can occur with the ointment and patients should be warned not to drive or operate machinery unless their vision is clear.

4.8 Undesirable Effects

Transient burning or stinging sensations may occur with the use of chloramphenicol eye ointment. Serious side effects include hypersensitivity reactions that may manifest as angioneurotic oedema, anaphylaxis, urticaria, fever, and vesicular and maculopapular dermatitis. Treatment must be discontinued immediately in such cases.

Bone marrow depression, including the idiosyncratic type of irreversible and fatal aplastic anaemia that is recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.

4.9 Overdose

In view of the relatively small amount of chloramphenicol in chloramphenicol eye ointment, overdosage with this product is unlikely to constitute a hazard.

If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an opthalmological examination should be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chloramphenicol is a potent inhibitor of bacterial protein synthesis, and exerts its effects by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Escherichia coli, Haemophilus influenzae, Staphyloccus aureus, Streptococcus haemolyticus, Morax anenfeld, Klebsiella/Enterobacter species and others.

Entrobacteriaceae are variably resistant while Pseudomonas and Mycobacteria are usually resistant.

5.2 Pharmacokinetic Properties

Chloramphenicol enters the aqueous humour following topical application.

Chloramphenicol is widely distributed in body tissues and fluids: it enters the CSF, giving concentrations of about 50% of those existing in the blood even in the absence of inflamed meninges; it diffuses across the placenta into the fetal circulation, into breast milk, and into the aqueous and vitreous humour of the eye. Up to about 60% in the circulation is bound to plasma protein. The half-life of chloramphenicol has been reported to range from 1.5 to 4 hours; the half-life is prolonged in patients with severe hepatic impairment and is also much longer in neonates. Renal impairment has relatively little effect on the half-life of the active drug, due to its extensive metabolism, but may lead to accumulation of the inactive metabolites. Chloramphenicol is excreted mainly in urine.

The absorption, metabolism, and excretion of chloramphenicol are subject to considerable interindividual variation, especially in infants and children, making monitoring of plasma concentrations necessary to determine pharmacokinetic in a given patient.

5.3 Preclinical Safety Data

Preclinical safety data does not add anything of further significance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid Paraffin

Polyethylene in Mineral Oil (Plastibase 50W)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

4 years

6.4 Special Precautions For Storage

Do not store above 25°C.

Although the shelf life once opened is 28 days, patients will be advised to discard the medicine after a 5 day course of treatment.

6.5 Nature And Contents Of Container

4 gm laminated tube fitted with an ophthalmic nozzle and screw cap

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Optrex Limited

1 Thane Road West

Nottingham

NG2 3AA

8. Marketing Authorisation Number(S)

PL 00062/0052

9. Date Of First Authorisation/Renewal Of The Authorisation

30/07/2007

10. Date Of Revision Of The Text

23/07/2009

Lemsip Max All Night Cold & Flu Tablets

1. Name Of The Medicinal Product

Lemsip Max All Night Cold & Flu Tablets, or

Lemsip Max All Night Flu Relief Tablets, or

Lemsip Max All Night Flu Relief, or

Nurofen All Night Cold & Flu Tablets or

Nurofen All Night Flu Relief Tablets, or

Nurofen All Night Flu Relief.

2. Qualitative And Quantitative Composition

Active Ingredients	Quantity
Ibuprofen BP	200.0mg
Phenylephrine hydrochloride	5.0mg

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Yellow film coated tablet, printed with an identifying motif (IPE) in black ink.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms of cold and 'flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses.

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Two tablets every 8 hours. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period.

Not to be given to children under 12 years.

4.3 Contraindications

Hypersensitivity to ibuprofen, phenylephrine or any of the excipients in the product. Hypertension and severe coronary heart disease.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes or proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Severe heart failure, renal failure or hepatic failure (see Section 4.4).

Last trimester of pregnancy.

Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see Section 4.5).

4.4 Special Warnings And Precautions For Use

Ibuprofen

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see gastrointestinal and cardiovascular risks below).

The elderly are at increased risk of consequence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory: Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Other NSAIDs: The use of this product with concomitant NSAIDs, including cyclo-oxygenase-2 selective inhibitors, should be avoided (see Section 4.5).

SLE and mixed connective tissue disease: Systemic lupus erythematosus and mixed connective tissue disease - increased risk of aseptic meningitis (see Section 4.8).

Renal: Renal impairment as renal function may further deteriorate (see Sections 4.3 and 4.8).

Hepatic: Hepatic dysfunction (see Sections 4.3 and 4.8).

Cardiovascular and cerebrovascular effects: Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (

Impaired female fertility: There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastrointestinal: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see Section 4.8).

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see Section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelets agents such as aspirin (see Section 4.5).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological: Serious skin reactions, some of them fatal, including exfoliating dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see Section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. This product should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

The label will include:

Read the enclosed leaflet before taking this product.

Do not take if you:

• Have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding.

• Are allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers.

• Are taking other NSAID painkillers, or aspirin with a daily dose above 75 mg.

Speak to a pharmacist or your doctor before taking if you:

• Have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems.

• Are a smoker.

• Are pregnant.

If symptoms persist or worsen, consult your doctor.

Phenylephrine

Phenylephrine should be used with care in patients with hyperthyroidism, cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen

Ibuprofen should not be used in combination with:

Aspirin: Unless low-dose aspirin (not above 75 mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see Section 4.4).

Other NSAIDs including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse reactions (see Section 4.4).

Ibuprofen should be used with caution in combination with:

Anti-coagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin (see Section 4.4).

Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see Section 4.4).

Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see Section 4.4).

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: There is evidence for potential increase in plasma levels of lithium.

Methotrexate: There is potential for an increase in plasma methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Phenylephrine

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta-blockers.

Phenylephrine is not recommended for patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (MAOIs).

4.6 Pregnancy And Lactation

Ibuprofen

Whilst no teratogenic effects have been demonstrated to in animal experiments, the use of this product should, if possible, be avoided during the first six months of pregnancy.

During the third trimester, ibuprofen is contraindicated as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.3).

In limited studies, ibuprofen appears in the breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.

See Section 4.4 regarding female fertility.

Phenylephrine

The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia. In view of the lack of data on the use of phenylephrine during lactation, this medicine should not be used during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Ibuprofen

Hypersensitivity reactions have been reported following treatment with ibuprofen and these may consist of:

(a) Non-specific allergic reaction and anaphylaxis.

(b) Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm or dyspnoea.

(c) Various skin reactions, e.g. pruritis, urticaria, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional effects may occur.

Hypersensitivity reactions

Uncommon: Hypersensitivity reactions with urticaria and pruritus.

Very rare: Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).

Exacerbation of asthma and bronchospasm.

Gastrointestinal

The most commonly-observed adverse events are gastrointestinal in nature.

Uncommon: Abdominal pain, nausea and dyspepsia.

Rare: Diarrhoea, flatulence, constipation and vomiting.

Very rare: Peptic ulcer, perforation and gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis and mouth ulceration.

Exacerbation of colitis and Crohn's disease (see Section 4.4).

Nervous System

Uncommon: Headache, dizziness and tinnitus.

Very rare: Aseptic meningitis - single cases have been reported very rarely.

Renal

Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

Hepatic

Very rare: Liver disorders.

Haematological

Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Dermatological

Uncommon: Various skin rashes.

Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis, can occur.

Immune System

In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation, have been observed (see Section 4.4).

Cardiovascular and Cerebrovascular

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke) (see Section 4.4).

Phenylephrine

High blood pressure with headache and vomiting, probably only in overdose. Rarely, palpitations.

Also, rare reports of allergic reactions and occasionally urinary retention in males.

4.9 Overdose

Ibuprofen

In children, ingestion of more than 400 mg/kg may cause symptoms. In adults, the dose response rate effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

Phenylephrine

Features of severe overdose of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression.

Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an intravenous alpha-receptor blocking agent.

Phenylephrine overdose is likely to result in: nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, mydriasis, acute angle closure glaucoma (most likely to occur in those with closed angle glaucoma), tachycardia, palpitations, allergic reactions (e.g. rash, urticaria, allergic dermatitis), dysuria, urinary retention (most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy).

Additional symptoms may include, hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking medicinal products such as phentolamine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

M01AE51 - Ibuprofen, combinations.

Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

The therapeutic effect of ibuprofen in symptoms relating to the common cold and influenza has a duration of up to 8 hours.

Phenylephrine

Phenylephrine is a post-synaptic alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2 Pharmacokinetic Properties

Ibuprofen

Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys.

Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, peak levels are observed after 1-2 hours. These times may vary with different dosage forms.

The half-life of ibuprofen is about 2 hours.

In limited studies, ibuprofen appears in the breast milk in very low concentrations.

Phenylephrine

Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism.

It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of the nasal mucosa.

When taken by mouth as a nasal decongestant, phenylephrine is usually given at intervals of 4-6 hours.

Ibuprofen and Phenylephrine Combination

The ibuprofen component of this fixed combination (ibuprofen 200 mg plus phenylephrine hydrochloride 5 mg) is absorbed faster than standard ibuprofen 200 mg tablets, with therapeutic levels being reached in 26.4 minutes (from the fixed combination) as opposed to 55.2 minutes (for standard ibuprofen).

5.3 Preclinical Safety Data

There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline cellulose

Sodium starch glycolate Type A

Hypromellose

Magnesium stearate

Talc

Water, purified

Industrial methylated spirits

Mastercote yellow FA 0156

Black printing ink

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Store in a dry place.

Store in the original package.

Store below 25°C.

Keep out of reach and sight of children.

6.5 Nature And Contents Of Container

A strip pack consisting of a blister tray of white pigmented 250 μm PVC/40 gsm PVDC laminate heat-sealed to lacquered 20 μm aluminium foil containing 2, 4 or 8 tablets. One or two trays packed in a cardboard carton (i.e. 4, 6, 8, 10, 12, 14 or 16 tablets).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.

8. Marketing Authorisation Number(S)

PL 00063/0556.

9. Date Of First Authorisation/Renewal Of The Authorisation

17/11/2008

10. Date Of Revision Of The Text

08/07/2011

Foille Plus

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Foille Plus (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Foille Plus (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Foille Plus (benzocaine topical)?

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  asthma, bronchitis, emphysema, or other breathing disorder;

  
  


• 
  

  heart disease;

  
  


• 
  

  a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Foille Plus (benzocaine topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Foille Plus (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Foille Plus (benzocaine topical) side effects

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• 
  

  headache, tired feeling, confusion;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  feeling light-headed or short of breath; and

  
  


• 
  

  pale, blue, or gray appearance of your skin, lips, or fingernails.

  
  

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzocaine topical and call your doctor at once if you have any of these other serious side effects:

• 
  

  headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

  
  


• 
  

  severe burning, stinging, or sensitivity where the medicine is applied;

  
  


• 
  

  swelling, warmth, or redness; or

  
  


• 
  

  oozing, blistering, or any signs of infection.

  
  

Less serious side effects may include:

• 
  

  mild stinging, burning, or itching where the medicine is applied;

  
  


• 
  

  skin tenderness or redness; or

  
  


• 
  

  dry white flakes where the medicine was applied.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Foille Plus (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Foille Plus resources

• Foille Plus Side Effects (in more detail)
• Foille Plus Use in Pregnancy & Breastfeeding
• Foille Plus Support Group
• 0 Reviews · Be the first to review/rate this drug

• Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information


• Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information


• Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Where can I get more information?

• Your pharmacist can provide more information about benzocaine topical.

See also: Foille Plus side effects (in more detail)

Prednisol

Generic Name: prednisolone ophthalmic (pred NIS oh lone)

Brand Names: Econopred Plus, Omnipred, Pred Forte, Pred Mild, Prednisol

What is Prednisol (prednisolone ophthalmic)?

Prednisolone is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Prednisolone ophthalmic (for the eyes) is used to treat eye swelling caused by allergy, infection, injury, surgery, or other conditions.

Prednisolone ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Prednisol (prednisolone ophthalmic)?

You should not use this medication if you are allergic to prednisolone or other steroids, or if you have certain types of infection (viral, fungal, or bacterial) that can affect your eyes.

Before using prednisolone ophthalmic, tell your doctor if you have glaucoma, herpes, or if you have recently had cataract surgery.

Do not use prednisolone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using prednisolone before putting your contact lenses in. Shake the eye drops gently before each use.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

If you still have pain or swelling after 2 days of treatment, stop using this medication and call your doctor. Do not stop using prednisolone ophthalmic suddenly after long-term use without first talking to your doctor. You may need to use less and less before you stop the medication completely.

What should I discuss with my healthcare provider before using Prednisol (prednisolone ophthalmic)?

You should not use this medication if you are allergic to prednisolone or other steroids, or if you have certain types of infection (viral, fungal, or bacterial) that can affect your eyes.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use prednisolone ophthalmic:

• 
  

  glaucoma;

  
  


• 
  

  recent cataract surgery; or

  
  


• 
  

  herpes simplex.

  
  

FDA pregnancy category C. It is not known whether prednisolone ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether prednisolone ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Prednisol (prednisolone ophthalmic)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using prednisolone ophthalmic.

To apply the eye drops:

• Shake the bottle gently before each use to be sure the medicine is well mixed.


• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  


• 
  

  Use only the number of drops your doctor has prescribed.

  
  


• 
  

  Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

  
  

If you still have pain or swelling after 2 days of treatment, stop using this medication and call your doctor. Do not stop using prednisolone ophthalmic suddenly after long-term use without first talking to your doctor. You may need to use less and less before you stop the medication completely.

If you use prednisolone ophthalmic for longer than 10 days, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

Store this medication at room temperature away from moisture and heat. Keep the bottle or tube tightly capped. Do not allow this medicine to freeze.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of prednisolone ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while using Prednisol (prednisolone ophthalmic)?

Do not wear any contact lens that has not been approved by your doctor.

Do not use prednisolone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using prednisolone ophthalmic before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

Prednisolone ophthalmic can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to see clearly.

Prednisol (prednisolone ophthalmic) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  pain behind your eyes, sudden vision changes, severe headache;

  
  


• 
  

  sudden eye irritation;

  
  


• 
  

  blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

  
  


• 
  

  signs of new eye infection, such as swelling, draining, or crusting of your eyes.

  
  

Less serious side effects may include:

• 
  

  temporary cloudy vision;

  
  


• 
  

  increased sensitivity to light; or

  
  


• 
  

  mild stinging, burning, itching, or irritation in your eyes.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Prednisol (prednisolone ophthalmic)?

It is not likely that other drugs you take orally or inject will have an effect on prednisolone used in the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Prednisol resources

• Prednisol Side Effects (in more detail)
• Prednisol Use in Pregnancy & Breastfeeding
• Prednisol Drug Interactions
• Prednisol Support Group
• 0 Reviews for Prednisol - Add your own review/rating

• AK-Pred Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Econopred Prescribing Information (FDA)


• Econopred Plus Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Econopred Plus Prescribing Information (FDA)


• Omnipred Prescribing Information (FDA)


• Pred Forte Prescribing Information (FDA)


• Prednisolone Monograph (AHFS DI)


• Prednisolone Acetate eent Monograph (AHFS DI)

Compare Prednisol with other medications

• Postoperative Ocular Inflammation

Where can I get more information?

• Your pharmacist can provide more information about prednisolone ophthalmic.

See also: Prednisol side effects (in more detail)

Methylphen Tablets

Dosage Form: tablet
Methylphen

DESCRIPTION:

Each tablet for oral administration contains:

Hyoscyamine Sulfate . . . . . . . . . . . . . 0.12 mg

Methenamine . . . . . . . . . . . . . . . . . . . 81.6 mg

Phenyl Salicylate . . . . . . . . . . . . . . . . 36.2 mg

Benzoic Acid . . . . . . . . . . . . . . . . . . . . 9.0 mg

Methylene Blue . . . . . . . . . . . . . . . . . . 10.8 mg


Inactive Ingredients: Cetyl Alcohol, Coarse Rice Starch, Crospovidone, Ethylcellulose, FDC Blue 2 Aluminum Lake, Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate, Silicon Dioxide, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide, Triacetin, Yellow Iron Oxide.


Hyoscyamine Sulfate. [620-61-1] [3(S)-endo]-_-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1_H,5_H-tropan-3_-ol(-)-tropate (ester) sulfate(2:1)(salt); 3_-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C34H48N2O10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.


Methenamine. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C6H12N4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform.


Phenyl Salicylate. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C13H10O3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43°C. It is very slightly soluble in water and freely soluble in alcohol.


Benzoic Acid [65-85-0] Benzenecarboxylic acid; Benzeneformic acid; Benzenemethanoic acid. C7H6O2; mol. wt. 122.12, C 68.85%, H 4.95%, O 26.20%. Exists as white powder or crystals, scales or needles. It has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether.


Methylene Blue. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C16H18ClN3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

INDICATIONS AND USAGE:

Methylphen is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

DOSAGE AND ADMINISTRATION:

FOR ORAL USE ONLY

Adults: One tablet 4 times per day by mouth, followed by liberal fluid intake.

Older Children: Dosage must be individualized by physician.

This medication is not recommended for use in children up to 12 years of age.

CONTRAINDICATIONS:

Methylphen is contraindicated in patients hypersensitive to any of its ingredients. Risk benefits should be carefully considered when the following medical problems exist: achalasia of esophagus, atony of colon, diseases of cardiovascular system, gastrointestinal hemorrhage; glaucoma; hemolytic anemia from pyruvate kinase and G6PD deficiencies, infected urolithiasis, myasthenia gravis, paralytic ileus, severe ulcerative colitis, toxic megacolon; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

WARNINGS AND PRECAUTIONS:

Do not exceed recommended dosage. This drug may make you dizzy or drowsy or cause blurred vision; use caution while driving, using machinery, or doing any activity that requires alertness or clear vision. Limit alcohol consumption. Cross sensitivity and/or related problems – patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers. There have been no studies to establish the safety of prolonged use of this product in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.


Pregnancy: Teratogenic Effects. Pregnancy Category C: Hyoscyamine Sulfate and Methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether Methylphen Tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.Methylphen Tablets should be given to a pregnant woman only if clearly needed.


Nursing Mothers: Problems in humans have not been documented; however, Methenamine and traces of Hyoscyamine Sulfate are excreted in breast milk. Accordingly, Methylphen Tablets should be given to a lactating woman only if clearly needed. Discuss the risks and benefits with your doctor.


Pediatric Use: Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids (Hyoscyamine Sulfate). This product contains salicylate, which is related to aspirin. Children and teenagers should not take aspirin, aspirin-containing or aspirin-related medications if they have chickenpox, influenza, or any undiagnosed illness without first consulting a doctor. A rare but serious illness known as Reye’s syndrome may occur. This medication is not recommended for use in children up to 12 years of age.


Geriatric Use: Kidney function becomes impaired with age. This medication is removed by the kidneys. Therefore, use with caution in elderly patients as they may respond to usual doses of Hyoscyamine Sulfate with excitement, agitation, drowsiness or confusion.

ADVERSE REACTIONS:

Cardiovascular: rapid heartbeat, flushing

Central Nervous System: blurred vision, dizziness, drowsiness

Genitourinary: difficulty urinating, acute urinary retention

Gastrointestinal: dry mouth, nausea and vomiting

Respiratory: shortness of breath or trouble breathing


Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.


This medication can cause urine and sometimes stools to turn blue-green. This effect is harmless and will subside after medication is stopped.


Call your doctor or physician for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

DRUG INTERACTIONS:

This drug should not be used with the following medications because very serious interactions may occur: live influenza virus vaccine, pramlintide. Because of this product’s effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of Methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of Hyoscyamine Sulfate because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of Hyoscyamine Sulfate, concurrent use with antacids may cause urine to become alkaline, reducing effectiveness of Methenamine by inhibiting its conversion to formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of Hyoscyamine Sulfate; antimyasthenics (concurrent use with Hyoscyamine Sulfate may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria). This is not a complete list of all drug interactions. Tell your doctor or pharmacist of all prescription medications prior to use.

DRUG ABUSE AND DEPENDENCE:

A dependence on the use of Methylphen has not been reported nor expected based on the pharmacology of the ingredients contained in Methylphen.

OVERDOSAGE:

By exceeding the recommended dosage of Methylphen, symptomology related to the overdose of its individual active ingredients may be expected as follows:


Hyoscyamine Sulfate: Symptoms associated with overdosage of Methylphen will most probably be manifested in the symptoms related to overdosage of alkaloid Hyoscyamine Sulfate. Such symptoms as dryness of mucous membranes; dilation of pupils, hot, dry, flushed skin; hyperpyrexia; tachycardia; palpitations; elevated blood pressure; coma; circulatory collapse and death from respiratory failure can occur due to overdosage of these alkaloids.


Methenamine: If large amounts of the drug (2-8 g daily) are used over extended periods (3-4 weeks), bladder and gastrointestinal irritation, painful and frequent urination, albuminuria and gross hematuria may be expected.


Phenyl Salicylate: Symptoms of Phenyl Salicylate overdosage include burning pain in throat and mouth, white necrotic lesions in the mouth, abdominal pain, vomiting, bloody diarrhea, pallor, sweating, weakness, headache, dizziness and tinnitus. The symptoms, however, are not expected to be discernible from those associated with the other active ingredients in Methylphen.


Benzoic Acid: Symptoms of Benzoic Acid overdosage have not been reported.


Methylene Blue: Symptoms of Methylene Blue overdosage associated with the overdosage of Methylphen are not expected to be discernible from those associated with other active ingredients in Methylphen.


Treatment:

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.


Administration of small doses of diazepam or baclofen to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate re-hydration is required. Symptomatic treatment as determined by a doctor.


If overdose is suspected, contact your local poison center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.

CLINICAL PHARMACOLOGY:

Hyoscyamine Sulfate: Hyoscyamine Sulfate is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. Following oral administration, the drug has an onset of action of 20 to 30 minutes. The half-life is 3.5 hours. Hyoscyamine is distributed throughout the body, crosses the blood-brain barrier, and is approximately 50% bound to plasma proteins. It is metabolized in the liver to tropic acid, tropine, and hyoscyamine glucuronide. Hyoscyamine is excreted primarily unchanged in the urine within 12 hours. Its biotransformation is hepatic.


Methenamine: Methenamine, after oral administration, undergoes hydrolysis and generates formaldehyde, which provides bactericidal or bacteriostatic action. Methenamine is rapidly absorbed from the intestinal tract and is excreted, for the most part, unchanged in the urine at which point it is hydrolyzed if the urine is acidic. It is almost completely excreted (90%) in the urine within 24 hours; of this at a pH of 5, approximately 10-30% is converted to formaldehyde in the stomach.


Phenyl Salicylate: Phenyl Salicylate, a form of salicylic acid, is a mild analgesic for pain relief.


Benzoic Acid: Benzoic Acid helps maintain an acid pH in the urine necessary for the degradation of methenamine.


Methylene Blue: Methylene Blue is a monoamine oxidase inhibitor with weak antiseptic properties. It is well absorbed by the intestinal tract and rapidly reduced to leukomethylene blue, which is stabilized in the urine. Approximately 70-80% is excreted unchanged in the urine.

HOW SUPPLIED:

Methylphen is available as a green tablet, imprinted “334”: bottles of 100 tablets, NDC 49769-334-10. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15°-30°C (59°- 86°F). Keep in a cool, dry place.


WARNING: Keep this and all drugs out of reach of children.

Caution: Rx Only


Manufactured for:

Kylemore Pharmaceuticals

Suwanee, GA 30024

334-10 Iss. 12/09

PACKAGING:

Sample labeling:

METHYLPHEN  hyoscyamine sulfate, methenamine, phenyl salicylate, benzoic acid, methylene blue  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49769-334 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE .12 mg METHENAMINE (METHENAMINE) METHENAMINE 81.6 mg PHENYL SALICYLATE (PHENYL SALICYLATE) PHENYL SALICYLATE 36.2 mg BENZOIC ACID (BENZOIC ACID) BENZOIC ACID 9 mg METHYLENE BLUE (METHYLENE BLUE) METHYLENE BLUE 10.8 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color green Score no score Shape ROUND Size 11mm Flavor Imprint Code KP;334 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49769-334-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/13/2010

Labeler - Kylemore Pharmaceuticals, LLC (831892471)

Revised: 01/2010Kylemore Pharmaceuticals, LLC

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