Robitussin Mucus Cough and Congestion Relief

Robitussin Chesty Cough with Congestion

Robitussin Mucus Cough and Congestion Relief 20mg, 6mg/ml Oral Solution

Guaifenesin, 100mg per 5ml

Pseudoephedrine Hydrochloride, 30mg per 5ml

Pale pink clear liquid for oral administration.

Nasal decongestant and expectorant for the symptomatic relief of respiratory tract disorders.

Oral Administration.

Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.

Children under 12 years: Do not use.

Hypersensitivity to any of the ingredients.

Use in patients with ischaemic heart disease, thyrotoxicosis, glaucoma, diabetes, enlargement of the prostate or urinary retention.

Patients taking a prescription monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI drug..

Use in children under 12 years of age.

Sympathomimetics (such as pseudoephedrine hydrochloride) may occasionally cause an increase in blood pressure when used in combination with other sympathomimetics and tricyclic antidepressants (TCAs) and therefore special care is advisable in patients receiving antihypertensive therapy.

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 your 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 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 25.2 mg sodium per 10ml dose. This should be taken into consideration by patients on a controlled sodium diet.

- This product contains Amaranth (E123), which may cause allergic reactions.

- This medicinal product contains 2.7 % w/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.

No or negligible influence.

The following side effects may be associated with the use of guaifenesin and pseudoephedrine:

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.

Symptoms:

Guaifenesin overdose: nausea and vomiting.

Pseudoephedrine overdose: Bradycardia, palpitation, tachycardia, nausea, vomiting, convulsion (seizure), dizziness, tremor, agitation, anxiety, insomnia, irritability, nervousness, restlessness, hypertension, increased blood pressure.

Treatment: Appropriate supportive therapy dependent upon individual response to the preparation.

Guaifenesin

Pharmacotherapeutic group: Expectorant

ATC code: RO5CAO3

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 secretion promotes ciliary action and facilitates the removal of mucus. This changes a dry unproductive cough to a cough that is more productive and less frequent.

Pseudoephedrine Hydrochloride

Pharmacotherapeutic group: Sympathomimetic

ATC code: R01BA02

Pseudoephedrine is a stereoisomer of ephedrine and has a similar action, but has been stated to have less pressor activity and central nervous system effects.

It is a sympathomimetic agent with indirect and direct effects on adrenergic receptors and is an orally effective upper respiratory tract decongestant. It has alpha- and beta-Adrenergic activity and has pronounced stimulating effects on the central nervous system. In therapeutic doses it raises the blood pressure by increasing cardiac output and also by inducing peripheral vasoconstriction.

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.

Pseudoephedrine is absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged (55-75%) in the urine together with small amounts of its hepatic metabolite. It has a half-life of several hours; elimination is enhanced and half-life accordingly shorter in acid urine.

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

Glycerol

Carmellose Sodium

Disodium Edetate

Sodium Benzoate (E211)

Sodium Cyclamate

Amaranth (E123)

Ethanol

Levomenthol

Maltitol (E965)

Sorbitol Solution 70%

Natural Cherry Flavouring

Citric Acid Anhydrous

Caramel (E150)

Acesulfame Potassium

Purified Water.

Not applicable

24 months

Do not store above 25°C.

Keep out of the sight and reach of children.

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

A clear polypropylene measuring cap also included.

No special requirements.

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

PL 00165/0098

1 September 1993

February 2014