1. Name of the medicinal product
Boots Cough and Decongestant Syrup 6 Years +

2. Qualitative and quantitative composition
Active ingredient
 % w/v
 
Guaifenesin Ph Eur

Pseudoephedrine hydrochloride
 1.0

0.2
 

3. Pharmaceutical form
Syrup

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

4.2 Posology and method of administration
For oral administration.

Children 6 to 12 years: Two 5ml spoonfuls three or four times a day.

Not more than 4 doses should be given in any 24 hours.

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 and carers should seek medical attention if the child's condition deteriorates during treatment.

Warning: Do not exceed the stated dose.

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

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

Severe renal impairment

Cardiovascular disease including hypertension and peripheral vascular disease.

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

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

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

Hallucinations

Restlessness

Sleep disturbances

Caution in moderate to severe renal impairment.

Pseudoephedrine should be used with caution when administered to patients taking antihypertensive agents, tricyclic antidepressants, other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine-like psycho-stimulants. The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

Do not give with any other cough and cold medicine.

If symptoms do not go away, talk to your pharmacist or doctor.

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, diuretics & beta-blockers): pseudoephedrine may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloi