Robitussin (guaifenesin)

Robitussin (guaifenesin) Medicine

Overdose

Signs and Symptoms associated with an overdose of Guaifenesin:

Nausea and vomiting

Treatment:

Appropriate supportive therapy dependent upon individual response to the preparation.

Shelf life

100ml bottles: 27 months

250ml bottles: 36 months.

List of excipients

Glycerol

Carmellose Sodium

Sodium Benzoate (E211)

Sodium Cyclamate

Ethanol (96%)

Levomenthol

Maltitol (E965)

Sorbitol Solution 70%

Natural Cherry Flavouring

Citric Acid Anhydrous

Caramel (E150)

Acesulfame Potassium

Purified Water

Undesirable effects

The following side effects may be associated with the use of Guaifenesin:

Gastrointestinal Disorders

Nausea, vomiting

Immune System Disorders

Hypersensitivity reactions

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.

Preclinical safety data

No relevant information additional to that already contained elsewhere in the SPC.

Pharmacotherapeutic group

Expectorant

Pharmacodynamic properties

Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary action and facilitates the removal of mucus. This changes an unproductive cough to a cough that is more productive and less frequent.

Pharmacotherapeutic group: Expectorant

ATC code: RO5CAO3

Pharmacokinetic properties

Guaifenesin is well absorbed from the gastro intestinal tract following oral administration. Guaifenesin has a plasma half-life of approximately 1 hour. It is rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite

Date of revision of the text

January 2014

Marketing authorisation holder

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Special precautions for storage

Do not store above 25°C.

Keep out of the sight and reach of children.

Nature and contents of container

PET bottles containing 100ml or 250ml with PET lined PP/HDPE screw caps.

A clear polypropylene measuring cap is also included.

Marketing authorisation number(s)

PL 00165/0097

Special warnings and precautions for use

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/treated. Stop use and ask a healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash, or persistent headache.

Keep out of the sight and reach of children.

Do not exceed recommended dose.

Excipient warnings:

- Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol.

- This medicinal product contains 2.7% v/v ethanol (alcohol), up to 214 mg per dose, (equivalent to approx 2 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

Effects on ability to drive and use machines

No or negligible influence.

Special precautions for disposal and other handling

No special requirements

Date of first authorisation/renewal of the authorisation

1 September 1993