Benylin Mucus Cough Menthol flavour 100 mg/5 ml Oral Solution

This product contains 20 mg guaifenesin in each ml (100mg in 5ml).

Each ml also contains:

Ethanol 39.7mg

Ponceau 4R (E124) 0.05mg

Sodium 1.8mg

Glucose

Fructose

For a full list of excipients, see section 6.1.

Oral solution

Clear to slightly opalescent red liquid

This product is indicated to help loosen phlegm and thin bronchial secretions associated with productive cough, for use in adults and adolescents over 12 years.

Adults and adolescents over 12 years:

For oral administration: 10 ml (200mg guaifenesin) 4 times a day.

Maximum daily dose: 40ml (800mg 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.

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

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 7 days, 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 or glucose galactose malabsorption should not take this medicine.

This 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 or kidney disease or epilepsy.

This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.

This product contains 17.6mg sodium per 10ml dose. This should be taken into consideration by those on a controlled sodium diet.

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.

Insufficient information is available on the effects of administration of this product during human pregnancy. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus.

It is not certain whether guaifenesin is excreted in breast milk.

Based on its pharmacodynamic profile, guaifenesin has no influence on the ability to drive or use machines.

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

Immune System Disorders: Hypersensitivity reactions (frequency – not known).

Gastrointestinal disorders: Gastrointestinal discomfort, nausea,vomiting (frequency – not known).

Symptoms and signs

The symptoms and signs of overdose may include gastro-intestinal discomfort, nausea and drowsiness.

Treatment

Treatment should be symptomatic and supportive.

ATC Code: R05CA03; Pharmacotherapeutic Group: Cough and Cold Preparations, Expectorants

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.

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 t½ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours.

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.

Xanthan gum

Sodium chloride

Saccharin sodium

Ammonium glycyrrhizate

Sodium benzoate (E211)

Citric acid anhydrous

Sodium citrate

Macrogol glycerol hydroxystearate 40

Levomenthol

Raspberry flavour F2126 (includes ethanol, glucose and fructose)

Caramel (E150) (includes glucose)

Ponceau 4R (E124)

Glycerol

Macrogol 1500

Propylene glycol

Ethanol 96%

Purified water

Not applicable.

3 years

In-use: 4 weeks

Do not store above 25°C

Store in the original container to protect from light

Type III, Amber glass bottle, containing 150ml, fitted with:

A plastic child resistant cap fitted with a PET-faced wad.

No special requirements.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required (these should be disposed of in line with local requirements). These measures will help to protect the environment.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

PL 15513/0165

5 May 2010

24 January 2012