1. Name Of The Medicinal Product
Benylin Mucus Cough Menthol 100 mg/5 ml Syrup
2. Qualitative And Quantitative Composition
This product contains 100 mg guaifenesin in each 5 ml.
Also contains:
Ethanol
Glucose
Fructose
Sucrose
Ponceau 4R (E124)
For full list of excipients, see Section 6.1.
3. Pharmaceutical Form
Oral liquid
Clear to slightly opalescent red liquid
4. Clinical Particulars
4.1 Therapeutic Indications
This product is indicated for the symptomatic relief of cough.
4.2 Posology And Method Of Administration
Adults and children over 12 years:
Oral. 10 ml (200mg guaifenesin) 4 times a day.
Maximum daily dose: 40ml (800mg guaifenesin)
Children under 12 years:
Not recommended.
The Elderly:
As for adults.
Hepatic/renal dysfunction
Caution should be exercised in severe hepatic and severe renal impairment.
4.3 Contraindications
This product is contraindicated in individuals with known hypersensitivity to the active substance or to any of the excipients.
4.4 Special Warnings And Precautions For Use
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 one week, 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.
Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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).
4.6 Pregnancy And Lactation
Insufficient information is available on the effects of administration of this product during human pregnancy. This product, 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.
It is not certain whether guaifenesin is excreted in breast milk.
4.7 Effects On Ability To Drive And Use Machines
Based on the pharmacodynamic profile of guaifenesin it is not expected that this product would interfere with the ability to drive or operate machinery.
4.8 Undesirable Effects
The following side effects may be associated with the use of guaifenesin:
Gastrointestinal disorders: Gastrointestinal discomfort, nausea, vomiting.
Immune System Disorders: Hypersensitivity reactions
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
ATC Code: R05CA; Pharmacotherapeutic Group: Expectorants
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.
The guaifenesin in this product is formulated in a thickened vehicle with extra menthol to coat the throat and provide a cooling and soothing demulcent sensation when swallowed.
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.
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.
5.3 Preclinical Safety Data
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.
6. Pharmaceutical Particulars
6.1 List Of Excipients
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, fructose and sucrose)
Caramel (E150) (includes glucose)
Ponceau 4R (E124)
Glycerol
Macrogol 1500
Propylene glycol
Ethanol 96%
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
3 years
In-use: 4 weeks
6.4 Special Precautions For Storage
Do not store above 25ºC
6.5 Nature And Contents Of Container
Type III, Amber glass bottle, containing 150ml, fitted with:
A plastic child resistant cap fitted with a PET-faced wad.
6.6 Special Precautions For Disposal And Other Handling
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0165
9. Date Of First Authorisation/Renewal Of The Authorisation
5 May 2010
10. Date Of Revision Of The Text
5 May 2010
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