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

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

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

Excipients with known effect (mg per ml)

Ethanol 39.7mg

Ponceau 4R (E124) 0.05mg

Sodium 1.8mg

Glucose

Fructose

Macrogol glycerol hydroxystearate 40

For the full list of excipients, see section 6.1.

Oral solution

Clear to slightly opalescent red liquid

Benylin Mucus Cough Max Menthol Flavour 100 mg/ 5 ml Oral Solution is indicated to help loosen phlegm and thin bronchial secretions associated with productive cough, for use in adults and adolescents over 12 years.

Posology

Adults and adolescents over 12 years:

10 ml (200mg guaifenesin) 4 times a day.

Maximum daily dose: 40ml (800mg guaifenesin)

Paediatric population

The safety and efficacy of Benylin Mucus Cough Max Menthol Flavour 100 mg/5 ml Oral Solution in children under 12 years of age has not yet been established.

No data are available.

Elderly:

As per adults.

Hepatic/renal impairment

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.

Method of administration

Oral

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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.

No interaction studies have been performed which revealed an interaction with guaifenesin.

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 Max Menthol Flavour 100 mg/5 ml Oral Solution is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feedingGuaifenesin 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 Max Menthol flavour 100 mg/5 ml Oral Solution therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

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

Guaifenesin has no or negligible influence on the ability to drive and use machines.

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

Immune System Disorders: Hypersensitivity reactions including pruritus and urticaria, rash (frequency – not known).

Gastrointestinal disorders: Abdominal pain upper, diarrhoea, nausea, vomiting (frequency – not known).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms and signs

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

When taken in excess, guaifenesin may cause renal calculi.

Management

Treatment should be symptomatic and supportive.

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

Mechanism of action

This product 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.

There is no information available on the pharmacokinetics of guaifenesin in special populations.

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.

Biotransformation 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.

Any unused medicinal product should be disposed of in accordance with local requirements.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

PL 15513/0165

5 May 2010 / 02 Aug 2018

02-Aug-2018