Dyphacol

BENYLIN Children's Chesty Coughs is an expectorant for the symptomatic relief of acute productive (chesty) coughs.

Posology

Adults and children aged 12 years and over:

Not applicable.

Children aged 6 to 12 years:

10 ml syrup four times daily.

Maximum daily dose: 40 ml syrup (400 mg guaifenesin)

Not to be used for more than 5 days without the advice of a doctor. Parents and carers should seek medical attention if the child's condition deteriorates during treatment.

Children under 6 years:

Benylin Children's Chesty Coughs is contraindicated in children under the age of 6 years.

Method of administration

For oral use

Do not exceed the stated dose.

Keep out of the sight and reach of children.

BENYLIN Children's Chesty Coughs is contraindicated in individuals with known hypersensitivity to the product, or any of its components.

Not to be used in children under the age of 6 years.

Ask a doctor before use if your child suffers from chronic cough, if he/she has asthma or is suffering from an acute asthma attack.

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

Do not give with a cough suppressant.

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

Not more than 4 doses should be given in any 24 hours.

Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Guaifenesin has no or negligible influence on the ability to drive or operate machinery.

The safety of guaifenesin is based on available data from clinical trials and adverse drug reactions (ADRs) identified during post-marketing experience.

The frequencies are provided according to the following convention:

Very common >1/10

Common >1/100 and < 1/10

Uncommon >1/1,000 and <1/100

Rare >1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.

Adverse Drug Reactions Identified during Clinical Trials, Epidemiology studies and Post-Marketing Experience with Guaifenesin. Frequency Category estimated from Clinical Trials or Epidemiology Studies

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

Symptoms

The effects of acute toxicity from guaifenesin may include gastrointestinal discomfort, nausea and drowsiness. When taken in excess, guaifenesin may cause renal calculi.

Management

Treatment should be symptomatic and supportive.

Pharmacotherapeutic group: 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.

Absorption

Guaifenesin is well absorbed from the gastro-intestinal tract following oral administration, although limited information regarding its pharmacokinetics is available. 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.

Pharmacokinetics in Renal/Hepatic Impairment

There have been no specific studies of BENYLIN Children's Chesty Coughs or guaifenesin in subjects with renal or hepatic impairment.

Caution is therefore recommended when administering this product to subjects with severe renal or hepatic impairment.

Pharmacokinetics in the Elderly

Not applicable.

Mutagenicity

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

Carcinogenicity

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

None known

Any unused product or waste material should be disposed of in accordance with local requirements