1. Name of the medicinal product
Almus Chesty Cough Linctus with Decongestant
Boots Chesty Cough & Congestion Relief Oral Solution
2. Qualitative and quantitative composition
Active ingredient
mg/5ml
Guaifenesin Ph Eur
Pseudoephedrine hydrochloride BP
100
30
3. Pharmaceutical form
Oral solution
4. Clinical particulars
4.1 Therapeutic indications
A combination expectorant and decongestant for the relief of catarrh associated with acute productive (chesty) cough, nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold without causing drowsiness.
4.2 Posology and method of administration
For oral administration.
Adults and children over 12 years: 10ml (2 teaspoonfuls) four times a day.
Elderly: There is no need for dosage reduction in the elderly.
Children 6-12 years: 5ml (1 teaspoonful) 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.
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.
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 (see section 4.5).
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
If symptoms do not go away talk to your 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 & beta-blockers): this medicine may block the hypotensive effects.
Cardiac glycosides: increased risk of dysrythmias.
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