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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Benylin Mucus Cough Honey & Lemon Flavour 20 mg/ml Syrup

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

This product contains 20 mg guaifenesin in each ml.

Also contains:

Ethanol    0.0519 ml/ml

Glucose 698.4 mg/ml Sucrose    199.8 mg/ml

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Syrup

Clear yellow-brown coloured syrup with a characteristic taste of honey and lemon.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

This product is indicated for the symptomatic relief of productive cough in adults and adolescents of 12 years and above.

4.2    Posology and method of administration

Adults and adolescents of 12 years and above:

Oral. 10 ml (200 mg guaifenesin) 4 times a day. Maximum daily dose: 40 ml (800 mg guaifenesin)

Children under 12 years:

Not recommended.

The Elderly:

As for adults.

Hepatic/renal dysfunction

Caution should be exercised in severe hepatic and severe renal impairment.

If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.

4.3 Contraindications

This product is contraindicated in individuals with known hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use

This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.

Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment.

The concomitant use of cough suppressants is not recommended.

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

This medicinal product contains 4.7 vol % ethanol (alcohol), i.e. up to 400 mg per dose, equivalent to approximately 10 ml beer, 4 ml wine per 10 ml dose. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Contains approximately 2 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.

4.5 Interaction with other medicinal products and other forms of interaction

If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid 5-HIAA) and vanillylmandelic acid (VMA). Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination is illogical and patients may be exposed to unnecessary adverse effects.

No interaction studies have been conducted showing an interaction with guaifenesin.

4.6    Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of Guaifenesin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Benylin Mucus Cough Honey and Lemon Flavour 20 mg/ml Syrup is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

Guaifenesin is excreted in breast milk in small amounts. There is insufficient information on the effects of Guaifenesin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Benylin Mucus Cough Honey and Lemon Flavour 20 mg/ml Syrup therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.

4.7    Effects on ability to drive and use machines

Benylin Mucus Cough Honey & Lemon Flavour 20 mg/ml Syrup is not expected to influence the ability to drive and use machines.

4.8 Undesirable effects

The following side effects may be associated with the use of guaifenesin: Gastrointestinal disorders

Abdominal pain upper, diarrhoea, nausea, vomiting (frequency - not known). Immune System Disorders

Hypersensitivity reactions, including pruritus and urticaria, rash (frequency - not known).

Overdose

Symptoms and signs

The symptoms and signs of overdose may include abdominal pain, nausea and drowsiness.

When taken in excess, guaifenesin may cause renal calculi.

Treatment

Treatment should be symptomatic and supportive.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Cough and cold preparations, Expectorants. ATC Code: R05CA03

Guaifenesin is thought to exert its pharmacological action by stimulating receptors in the gastric mucosa. This increases the output from secretory glands of the gastrointestinal system and reflexly increases the flow of fluids from glands lining the respiratory tract. The result is an increase in volume and decrease in viscosity of bronchial secretions. Other actions may include stimulating vagal nerve endings in bronchial secretory glands and stimulating certain centres in the brain, which in turn enhance respiratory fluid flow. Guaifenesin produces its expectorant action within 24 hours.

5.2 Pharmacokinetic properties

Special Populations

No information regarding guaifenesin’s pharmacokinetics in special populations is available.

Absorption

Guaifenesin is well absorbed from the gastro-intestinal tract following oral administration, although limited information is available on its pharmacokinetics. After the administration of 600 mg guaifenesin to healthy adult volunteers, the C_max was approximately 1.4 ug/ml, with t_max occurring approximately 15 minutes after drug administration.

Distribution

No information is available on the distribution of guaifenesin in humans. Metabolism and elimination

Guaifenesin appears to undergo both oxidation and demethylation. Following an oral dose of 600 mg guaifenesin to 3 healthy male volunteers, the t/ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours.

Preclinical safety data

Carcinogenicity

There is insufficient information available to determine whether guaifenesin has carcinogenic potential.

Mutagenicity

There is insufficient information available to determine whether guaifenesin has mutagenic potential.

Teratogenicity

There is insufficient information available to determine whether guaifenesin has teratogenic potential.

Fertility

There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium citrate

Citric acid monohydrate

Carbomer

Glycerol

Ethanol 96%

Glucose, liquid

Sucrose

Sucralose

Sodium benzoate (E211)

Flavours:

Levomenthol

Bitterness blocking flavour 84E260 Honey flavour SN781458 Lemon flavour 557579CW8 Cooling flavour 539692T Tingling flavour 538723 T Hot mix flavour 538842T Non-alcohol enhancer SC008414

(Flavours contain Propylene glycol and other flavouring ingredients) Caramel (E150)

Purified water

6.2 Incompatibilities

Not applicable.

DATE OF REVISION OF THE TEXT

07/01/2014