McNeil Healthcare (Ireland) Ltd

Benylin Children's Chesty Cough 50mg/5ml Syrup

Each 5ml contains 50 mg guaifenesin.

Excipients: Also include: 2.525g sorbital liquid (E420) per 5ml.

For a full list of excipients, see section 6.1.

Syrup

A colourless to slightly yellow clear syrup

BENYLIN Children's Chesty Coughs is indicated for the symptomatic relief of productive coughs.

Adults and children over 12 years:

Not applicable.

Children aged 6 to 12 years:

Oral. 10 ml syrup four times daily.

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

Use only when simple measures have failed to bring adequate relief.

Use for more than five consecutive days is not recommended

Children under 6 years:

BENYLIN Children's Chesty Coughs is not recommended for administration to children under 6 years of age. [See section 4.3]

The Elderly

Not applicable.

Hepatic/renal dysfunction

Guaifenesin is extensively metabolised, however, no data are available on the use of guaifenesin in patients with hepatic or renal failure. [See Pharmacokinetics].

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

BENYLIN Children's Chesty Coughs is contra-indicated in children under 6 years.

BENYLIN Children's Chesty Coughs should be not used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

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

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

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.

Consult a pharmacist or other healthcare professional before use in children aged 6 to 12 years.

If urine is collected within 24 hours of a dose of BENYLIN Children's Chesty Coughs a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

This product has been formulated specifically for children, and would therefore not normally be taken during pregnancy and lactation.

Insufficient information is available on the effects of administration of BENYLIN Children's Chesty Coughs during human pregnancy. BENYLIN Children's Chesty Coughs, like most medicines, should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus.

Guaifenesin is excreted in breast milk in small amounts with no effect expected on the infant.

Not applicable.

Side effects resulting from guaifenesin administration are very rare.

Symptoms and signs

The effects of acute toxicity from guaifenesin may include gastrointestinal discomfort, nausea and drowsiness.

Treatment

Treatment should be symptomatic and supportive.

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 or menthol 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 or menthol have 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 or menthol have the potential to impair fertility.

Glycerol (E422)

Sorbitol, liquid (non-crystallising) (E420)

Sodium citrate (E331)

Citric acid monohydrate

Sodium saccharin

Sodium benzoate (E211)

Carmellose Sodium

Strawberry 580.193/T

Purified water

Not applicable

3 years.

Do not store above 25°C.

Store in original container.

Keep the bottle tightly closed in order to protect from moisture.

30 ml, 125 ml and 300 ml amber glass bottles with a polyester wadded white aluminium ROPP cap or a 3 piece plastic child resistant, tamper evident closure fitted with a polyester faced wad, or polyethylene/expanded polyethylene laminated wad. Or 2 piece plastic child resistant, tamper evident closure fitted with a PVDC wad.

Not all pack sizes may be marketed.

Do not used if bottle seal is broken when purchased.

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/31/1

Date of first authorisation: 27 July 1998

Date of last renewal: 27 July 2008

April 2011