1. Name of the medicinal product
Boots Catarrh Cough Syrup

2. Qualitative and quantitative composition

Active ingredient
 mg/5ml
 
Guaifenesin Ph Eur
 100
 
Pseudoephedrine Hydrochloride B.P.
 30
 

3. Pharmaceutical form
Oral Solution

4. Clinical particulars
4.1 Therapeutic indications
A non-drowsy expectorant for the symptomatic relief of acute productive (chesty) cough, nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold.

4.2 Posology and method of administration
Adults and children over 12 years

10ml (Two 5ml spoonfuls) four times a day.

Elderly

There is no need for dosage reduction in the elderly.

Children 6-12 years

5ml (One 5ml spoonful) three times a day.

This medicine is contraindicated in children under 6 years of age (see section 4.3).

Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

4.3 Contraindications
Hypersensitivity to the active substances or any of the excipients.

Severe renal impairment.

Cardiovascular disease including hypertension and peripheral vascular disease.

Diabetes mellitus.

Phaeochromocytoma.

Hyperthyroidism.

Closed angle glaucoma.

Should be avoided in patients with prostatic enlargement.

Concomitant use of other sympathomimetic decongestants.

Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5).

Beta-blockers – (see section 4.5).

Not to be used in children under the age of 6 years.

4.4 Special warnings and precautions for use
Guaifenesin

Ask a doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack.

Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache.

Do not take with a cough suppressant.

Pseudoephedrine

Caution in moderate to severe renal impairment.

If any of the following occur, this medicine should be stopped

Hallucinations

Restlessness

Sleep disturbances

Warning. Do not exceed the stated dose.

If symptoms do not go away talk to your doctor.

Keep all medicines out of the sight and reach of children.

4.5 Interaction with other medicinal products and other forms of interaction
Pseudoephedrine

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Antihypertensives: (including adrenergic neurone blockers & beta-blockers): this product may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloids: (ergotamine & methysergide): increased risk of ergotism.

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Oxytocin: risk of hypertension.

Enhances effects of anticholinergic drugs (such as TCAs).

May increase the possibility of arrhythmias in those taking quinidine or tricyclic antidepressants.

Guaifen