McNeil Healthcare (Ireland) Ltd

BENYLIN Non-drowsy for Chesty Coughs Syrup

Guaifenesin 100mg/5ml

Levomenthol 1.1mg/5ml

Each 5 mls contains 100 mg guaifenesin and 1.1 mg levomenthol

Excipients: Also includes glucose liquid 34.9g per 5ml, sucrose 1g per 5ml, Ponceau 4R (E124) 0.25mg per 5ml and sodium 16.4mg per 5ml.

For a full list of excipients, see section 6.1

Syrup

Clear red syrup having a characteristic odour.

BENYLIN Non-drowsy for Chesty Coughs is indicated for the symptomatic relief of productive cough.

Adults and children over 12 years:

Oral. Two 5 ml spoonfuls four times a day.

Children under 12 years:

Not recommended (see section 4.3).

The Elderly:

As for adults.

Hepatic/renal dysfunction

Experience with the use of this product suggests that normal adult dosage is appropriate for mild to moderate dysfunction. Caution should be exercised in severe hepatic and severe renal impairment. [See Pharmacokinetics].

BENYLIN Non-drowsy for Chesty Coughs is contra-indicated in individuals with known hypersensitivity to the product, or any of its components.

BENYLIN Non-drowsy for 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 when using the product in the presence of severe renal or severe hepatic impairment, [See Pharmacokinetics].

Benylin Non Drowsy for Chesty Coughs should not be used in children under the age of 12 years.

If urine is collected within 24 hours of a dose of BENYLIN Non-drowsy for 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 ).

Insufficient information is available on the effects of administration of BENYLIN Non-drowsy for Chesty Coughs during human pregnancy. BENYLIN Non-drowsy for 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.

No special comment - unlikely to produce an effect

Side effects resulting from guaifenesin administration are very rare.

Adverse reactions to menthol at the low concentration present in BENYLIN Non-drowsy for Chesty Coughs are not anticipated.

Symptoms and signs

The symptoms and signs of overdose may include gastro-intestinal 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.

Menthol has mild local anaesthetic and decongestant properties.

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 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 t_½ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours.

Menthol is hydroxylated in the liver by microsomal enzymes to p- menthane -3,8 diol. This is then conjugated with glucuronide and excreted both in urine and bile as the glucuronide.

Pharmacokinetics in Renal/Hepatic Impairment

There have been no specific studies of BENYLIN Non-drowsy for Chesty Coughs, menthol or guaifenesin in hepatic or renal impairment .

Pharmacokinetics in the Elderly

There have been no specific studies in the use of BENYLIN Non-drowsy for Chesty Coughs, menthol or guaifenesin in the elderly.

Carcinogenicity

There is insufficient information available to determine whether guaifenesin or menthol have carcinogenic potential.

Mutagenicity

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

The results of a range of tests suggest that menthol does not have a mutagenic potential.

Teratogenicity

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

The results of a number of studies suggest that the administration of menthol does not produce any statistically significant teratogenic effects in rats, rabbits and mice.

Fertility

There is insufficient information available to determine whether guaifenesin or menthol have the potential to impair fertility.

Sodium benzoate (E211)

Sucrose

Liquid Glucose

Glycerol

Citric acid monohydrate

Sodium citrate

Saccharin sodium

Ethanol 96%

Caramel T12 (E150)

Ponceau 4R (E124)

Concentrated raspberry essence double strength

Natural sweetness enhancer

Carbomer

Purified water

None known

3 years.

Do not store above 30°C. Keep bottle tightly closed.

Amber glass bottles (pharmacopoeial grade III) with an aluminium ROPP cap with melinex-faced pulpboard wad or with a 3 piece plastic child resistant, tamper evident closure fitted with a PE-Alu-PET or polyethylene/ expanded polyethylene laminated wad or with a plastic HDPE cap fitted with a PE-Alu-PET wad..

Pack sizes: 30 ml, 125 ml or 300 ml.

Not all pack sizes may be marketed.

No special requirements.

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/20/1

20.10.1997 / 20.10.2008

June 2009