Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Contraindicated in children under 12 years of age.
Hypersensitivity to guaifenesin or to any of the excipients listed in section 6.1.
Do not take if suffering from porphyria.
Do not exceed the stated dose. Do not take with any other cough and cold medicine.
Seek medical advice if suffering from chronic cough or asthma.
Use with caution in patients with renal impairment.
Not recommended for concomitant use with a cough suppressant.
Do not take if you are pregnant or breast feeding unless recommended by a health care professional (see section 4.6). This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. Contains 3.965 g of sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Also contains 8.452 mg of sodium benzoate and trace amount of benzyl alcohol in each 5 ml. Benzyl alcohol may cause allergic reactions.
If urine is collected within 24 hours of a dose of the medicinal product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Guaifenesin may increase the rate of absorption of paracetamol.
Interaction studies have only been performed in adults.
The product should not be used during pregnancy unless recommended by a healthcare professional. There are limited data on the use of guaifenesin in pregnant women.
The product should be avoided during lactation unless recommended by a healthcare professional. There is insufficient information on the excretion of guaifenesin/metabolites in human milk.
No known effects.
The product has no or negligible influence on the ability to drive and use machines.
Adverse events which have been associated with guaifenesin are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
The list of the following adverse effects relates to those experienced with guaifenesin at OTC doses (maximum 800mg per day), in shortterm use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
| System Organ Class | Frequency | Adverse Events |
|---|---|---|
| Immune System Disorders | Not known | Hypersensitivity |
| Gastrointestinal Disorders | Not known | Abdominal discomfort, nausea, vomiting |
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
Not applicable.
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