SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Children’s Cough Balsam Linctus

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Ipecacuanha liquid extract BP    0.005ml

Liquorice liquid extract BP    0.125ml

For excipients see 6.1

3.    PHARMACEUTICAL FORM

Oral solution, brown in colour.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic treatment of productive cough in children.

4.2.    Posology and Method of Administration

Oral administration

Children: 6-10 years. One 5ml spoonful.

Over 10 years two 5ml spoonfuls.

To be taken up to 4 times a day.

Do not give to children under six years of age without medical advice. If symptoms persist consult your doctor.

4.3.    Contra-indications

Known hypersensitivity to the product.

4.4    Special warnings and precautions for use

Caution should be exercised in patients with hepatic and renal impairment, cardiac disorders and a history of drug abuse. The use of this preparation is not generally recommended in children under 6 years of age except on medical advise.

If symptoms persist consult your doctor.

This product contains sucrose. Therefore care should be exercised in diabetics. Use of this product may cause dental caries in children.

4.5    Interaction with other medicinal products and other forms of interaction

Liquorice may counteract the effects of diuretics.

4.6. Pregnancy and Lactation

This medicine is for children, so use in pregnancy and lactation is not applicable.

4.7. Effects on Ability to Drive and Use Machines

None

4.8. Undesirable Effects

Side effects are rare and mild when recommended dose is administered. Large doses may cause nausea, vomiting, diarrhoea, thirst, headache, hyperventilation and may lead to profound acidosis and hypokalaemia. Liquorice liquid extract used in this preparation may cause reversible sodium retention and potassium loss leading to hypertension, water retention and electrolyte imbalance.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

Overdose with ipecacuanha results in nausea, vomiting, bloody diarrhoea, mucoerosions of the gastrointestinal tract. Effects on the heart vary from mild depression to inversion of the T wave to bradycardia or myocardial infarction. Liquorice may cause sodium and water retention and hypokalaemia treatment is symptomatic and supportive. Gastric lavage if vomiting has not occurred. Fluid and electrolyte imbalance should be corrected. Cardiac irregularities if presented should be treated.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The actions of ipecacuanha are mainly those of its major alkaloids, emetine and cephaeline. They act locally by irritating the gastric mucosa and centrally by stimulating the medullary chemoreceptor trigger zone to induce vomiting.

5.2. Pharmacokinetic Properties

The ipecacuanha liquid extract is well absorbed from the gastrointestinal tract. The ipecacuanha alkaloids emetine and cephaeline are eliminated from the body very slowly and may be detected in urine up to 60 days after ipecacuanha use.

5.3. Preclinical Safety Data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cinnamic acid BP Benzoic acid (E210) BP Ethyl cinnamate BP Vanillin BP

Cinnamon oil BP Ethanol BP Syrup BP Purified honey BP Treacle HSE

Nipasept sodium HSE (Sodium salts of methyl, ethyl and propylparabens)

Chloroform BP

Camphor BP

Aniseed oil BP

Potassium citrate (E332) BP

Potable water HSE

6.2. Incompatibilities

None.

6.3. Shelf Life

36 months in unopened container.

6.4. Special Precautions for Storage

Store below 25°C.

Protected from light and moisture. Keep out of the reach of children.

6.5. Nature and Contents of Container

Amber glass bottle with a plastic screw cap. Size: 100ml, 200ml.

6.6. Instructions for Use/Handling None stated.

MARKETING AUTHORISATION HOLDER

Bell, Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside

PR9 9AL

8    MARKETING AUTHORISATION NUMBER(S)

PL 03105/0075

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

07/07/2008

10 DATE OF REVISION OF THE TEXT

07/06/2016