Benylin Mucus Cough
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BENYLIN Chesty Coughs (Non-drowsy)
Benylin Mucus Cough
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BENYLIN Chesty Coughs (Non-drowsy) contains 100 mg guaifenesin and
1.1 mg levomenthol in each 5 ml.
3. PHARMACEUTICAL FORM
Clear red syrup
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
BENYLIN Chesty Coughs (Non-drowsy) is indicated for the symptomatic relief of cough.
4.2 Posology and method of administration
Adults and children aged 12 years and over:
Oral. Two 5 ml spoonfuls four times a day.
Children under 12 years:
Benylin Chesty Coughs (Non Drowsy) is contraindicated in children under the age of 12 years (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].
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3 Contraindications
BENYLIN Chesty Coughs (Non-drowsy) 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 12 years.
4.4 Special Warnings and Precautions for Use
BENYLIN Chesty Coughs (Non-drowsy) 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].
4.5 Interaction with other medicinal products and other forms of interaction
If urine is collected within 24 hours of a dose of BENYLIN Chesty Coughs (Non-drowsy) a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid ( 5-HIAA) and vanillylmandelic acid (VMA).
4.6 Pregnancy and Lactation
Insufficient information is available on the effects of administration of BENYLIN Chesty Coughs (Non-drowsy) during human pregnancy. BENYLIN Chesty Coughs (Non-drowsy), 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.
4.7 Effects on Ability to Drive and Use Machines
No special comment - unlikely to produce an effect.
4.8 Undesirable Effects
Side effects resulting from guaifenesin administration are very rare.
Adverse reactions to menthol at the low concentration present in BENYLIN Chesty Coughs (Non-drowsy) are not anticipated.
4.9 Overdose Symptoms and signs
The symptoms and signs of overdose may include gastro-intestinal discomfort, nausea and drowsiness.
Treatment
Treatment should be symptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Cough and cold preparations, Expectorants. ATC Code: R05CA10
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 in reflex 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.
5.2 Pharmacokinetic 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 Cmax was approximately 1.4 ug/ml, with tmax occurring approximately 15 minutes after drug administration.
Menthol is well absorbed from the gastrointestinal tract following oral 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/ 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-methane -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 this product, menthol or guaifenesin in hepatic or renal impairment.
Pharmacokinetics in the Elderly
There have been no specific studies in the use of this product, menthol or guaifenesin in the elderly.
5.3 Pre-clinical Safety Data 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.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sodium benzoate Sucrose Liquid glucose Glycerol
Citric acid monohydrate Sodium citrate Saccharin sodium Ethanol 96%
Caramel T12 Ponceau 4R (E124)
Concentrated raspberry essence double strength Natural sweetness enhancer Carbomer Purified water
6.2. Incompatibilities
None known
6.3
Shelf life
3 years
Do not store above 30°C.
Nature and contents of container
125, 150, 200 or 300ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyterephtalate ethylene faced aluminium/expanded polyethylene laminated wad
6.6.
Instruction for use and handling None applicable.
7
MARKETING AUTHORISATION HOLDER
McNeil Products Limited Foundation Park Roxborough Way Maidenhead Berkshire SL6 3UG United Kingdom
8.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15th December 1997
10 DATE OF REVISION OF THE TEXT
12/12/2014