LIQUFRUTA GARLIC COUGH MEDICINE - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Liqufruta Garlic Cough Medicine

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Guaifenesin               1% w/v

3 PHARMACEUTICAL FORM

Syrup

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Adults and children 12 years and over: Expectorant for the symptomatic relief of acute productive (chesty) cough.

4.2 Posology and method of administration

Route of administration: oral.

Adults and the elderly: 10–15 ml every 4 hours up to 4 times daily.

Children 12 years and over: 10–15 ml every 4 hours up to 4 times daily.

Liquafruta Garlic Cough Medicine is contraindicated in children under 12 years (see section 4.3).

Do not exceed the stated dose.

Keep out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients

Not to be used in children under the age of 12 years

4.4 Special warnings and precautions for use

Not more than four doses should be given in any 24 hours. Do not exceed the stated dose.

Ask a doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack.

Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash, or persistent headache.

Do not take with a cough suppressant.

4.5 Interaction with other medicinal products and other forms of interaction

If urine is collected within 24 hours of a dose of [product] a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

4.6 Pregnancy and lactation

Guaifenesin containing products have been used for many years without apparent ill-consequence. However, as with all medicines, administration during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs any potential risk to the foetus or neonate. Medical advice should be sought.

4.7 Effects on ability to drive and use machines None.

4.8 Undesirable effects

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

4.9 Overdose

Very large overdose may give rise to nausea and vomiting. General supportive treatment is required.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Non-sedative, expectorant preparation with demulcent properties.

5.2 Pharmacokinetic properties

Guaifenesin is absorbed from the gastro-intestinal tract. It is metabolised and excreted in the urine.

5.3 Preclinical safety data

No preclinical safety problems have been reported.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Invert sugar

Sodium benzoate BP Sodium citrate BP Acetic acid (80% pure)

Citric acid monohydrate BP Ethanol 96% BP

Menthol BP

Garlic flavour F/37723

Caramel 15712

Purified Water Ph. Eur.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4 Special precautions for storage None

6.5 Nature and contents of container

75ml and 150ml

White flint glass bottle with aluminium ROPP cap with polyester (PET)/aluminium foil faced expanded polyethylene wad.

100ml and 200ml

White flint glass bottle with LDPE child-resistant closure with polyester (PET)/aluminium foil faced expanded polyethylene wad.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Alston Garrard & Co Ltd,

Modbury House,

New Mills Business Park,

Modbury,

Devon

PL21 0TP, UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 20677/0002