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.
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.
None known
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
Body system (SOC) | Incidence | Adverse Event Preferred Term |
Immune system disorders | Not known | Hypersensitivity reactions (hypersensitivity, pruritus and urticaria) Rash |
Gastrointestinal disorders | Not known | Abdominal pain upper Diarrhoea Nausea Vomiting |
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
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.
BENYLIN Children's Chesty Coughs is an expectorant for the symptomatic relief of acute productive (chesty) coughs.
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 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.
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.
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.
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.
Any unused product or waste material should be disposed of in accordance with local requirements
Administrative data
