ted in breast milk in small amounts. There is insufficient information on the effects of Guaifenesin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from this product, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.
4.7 Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive or operate machinery.
4.8 Undesirable effects
The safety of guaifenesin/menthol is based on available data from clinical trials and adverse drug reactions (ADRs) identified during post-marketing experience are included.
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, including isolated reports
Not known (cannot be estimated from the available data)
ADRs are presented for 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
Incidence
Reported adverse event
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
4.9 Overdose
Symptoms and signs
The effects of acute toxicity from guaifenesin may include gastro-intestinal discomfort, nausea and drowsiness.
When taken in excess, guaifenesin may cause renal calculi.
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 decongesta
