Simple Linctus Paediatric BP

1. Name Of The Medicinal Product

Simple Linctus Paediatric BP.

2. Qualitative And Quantitative Composition

Citric Acid Monohydrate BP 31.25mg/5ml dose.

Excipients: Sucrose (Syrup) 4.3g per 5ml, Ethanol (Alcohol) 1.5vol%

For full list of excipients see section 6.1

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of non productive (dry) coughs

4.2 Posology And Method Of Administration

Dose

Children:

1 to 5 years: Give one 5ml spoonful.

6 to 12 years: Give two 5ml spoonfuls.

Repeat up to four times a day if necessary.

4.3 Contraindications

Known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep out of the reach of children.

Consult a doctor if symptoms persist for more than 5 days

Contains 1.5vol% ethanol (alcohol) i.e. up to 118mg per 10ml dose, equivalent to 3ml beer and of 1ml wine per dose. Harmful if suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Also contains 8.6g of sucrose per 10ml. This should be taken into account in patients with diabetes

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There are no or limited amount of data from the use of citric acid monohydrate in pregnant women.

Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

There is insufficient information on the excretion of citric acid monohydrate metabolites in human milk.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

There are no known side effects from using this medicine when used as directed, however, if you notice any side effects, stop use and consult a doctor or pharmacist.

4.9 Overdose

Overdose with this preparation is unlikely to occur due to the low concentrations of the ingredients. However, in the event treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Acid Preparations

ATC Code: A09 AB

5.2 Pharmacokinetic Properties

Citric acid is absorbed after oral administration. It is found naturally in the body and is widely distributed. It is metabolised to carbon dioxide and water in Kreb's citric acid cycle. Citric acid is normally excreted in the urine in amounts ranging from 0.4 to 1.5g daily and this amount is not increased unless very large doses are administered.

5.3 Preclinical Safety Data

No data of relevance, which is additional to that included on other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chloroform

Anise Oil

Ethanol (96%)

Glycerol (E422)

Purified Water

Syrup

6.2 Incompatibilities

None.

6.3 Shelf Life

100ml:	36 months unopened, 3 months after first opening.
200ml:	36 months unopened, 3 months after first opening.
500ml:	36 months unopened, 3 months after first opening.
2000ml:	36 months unopened, 3 months after first opening.

6.4 Special Precautions For Storage

Store below 25°C.

The following additional phrases appear on the 2 litre pack:

Do not store part full bottles.

Pre-pack in tightly closed dispensing containers once opened.

6.5 Nature And Contents Of Container

100ml:	Amber glass bottle with plastic cap or white 28mm child resisitant cap with tamper evident band and EPE/Saranex liner or polypropylene child resisitant cap with a saranex-faced EPE liner
200ml:	Amber glass bottle with plastic cap or white 28mm child resisitant cap with tamper evident band and EPE/Saranex liner or polypropylene child resisitant cap with a saranex-faced EPE liner
500ml:	Amber glass bottle with plastic cap or white 28mm child resisitant cap with tamper evident band and EPE/Saranex liner or polypropylene child resisitant cap with a saranex-faced EPE liner
2000ml:	Amber glass bottle with plastic cap or white 28mm child resisitant cap with tamper evident band and EPE/Saranex liner or polypropylene child resisitant cap with a saranex-faced EPE liner

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Thornton & Ross Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8. Marketing Authorisation Number(S)

PL 00240/6427R

9. Date Of First Authorisation/Renewal Of The Authorisation

16 June 1988 / 09 September 1993

10. Date Of Revision Of The Text

29/04/2010