Boots Chesty Cough & Congestion Relief Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
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 100
Pseudoephedrine hydrochloride BP 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 drugs (such as TCAs).
Concomitant use with sympathomimetic agents such as decongestants and tricyclic antidepressants may occasionally cause a rise in blood pressure.
Guaifenesin
If urine is collected within 24 hours of a dose of guaifenesin a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, but in view of a possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, the use of the product during pregnancy should be avoided. The amounts of pseudoephedrine and guaifenesin secreted into breast milk are considered too small to be harmful.
4.7. Effects on Ability to Drive and Use Machines
No adverse effects known.
4.8 Undesirable effects
Guaifenesin
The following side effects may be associated with the use of guafenesin: Gastrointestinal disorders: Nausea, vomiting, gastrointestinal discomfort. Immune system disorders: Hypersensitivity reactions.
Pseudoephedrine
Cardiovascular disorders: Tachycardia, palpitations, other cardiac dysrhythmias.
Gastrointestinal disorders: Nausea and/or vomiting.
General disorders and administration site conditions: Irritability.
Immune system disorders: Hypersensitivity reactions, including crosssensitivity that may occur with other sympathomimetics.
Nervous system disorders: Headache, tremor, anxiety, restlessness, excitability, dizziness, insomnia, hallucinations (particularly in children) and paranoid delusions.
Psychiatric disorders: Confusion and sleep disturbance.
Renal and urinary disorders: Difficulty in micturition including urinary retention.
Skin and subcutaneous tissue disorders: Skin reactions including rash. Vascular disorders: Hypertension.
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.
4.9. Overdose
Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken particularly with regard to the cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam.
Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.
PHARMACOLOGICAL PROPERTIES
5.
5.1. Pharmacodynamic Properties
Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.
Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant.
5.2. Pharmacokinetic Properties
Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3L/kg bodyweight.
Guaifenesin is readily absorbed from the gastrointestinal tract. It is rapidly metabolised and excreted in the urine.
5.3. Pre-clinical Safety Data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Liquid sugar
Hydroxyethylcellulose
Glycerin
Flav F menthol E43525 Acesulfame K
Potassium sorbate Citric acid monohydrate Sodium citrate Food flavour 511630E Blackcurrant flavour 17407107 Strawberry 500244E Patent blue V Carmoisine edicol Purified water
6.2. Incompatibilities
None stated.
6.3. Shelf-Life
24 months.
6.4. Special Precautions for Storage
Do not store above 30°C.
6.5 Nature and contents of container
An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.
Pack sizes: 120ml
6.6. Instructions for Use, Handling and Disposal
Not applicable.
7.
MARKETING AUTHORISATON HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
Trading as: BCM
8. MARKETING AUTHORISATION NUMBER(S)
PL 0014/0555
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
Not applicable.
10 DATE OF REVISION OF THE TEXT
13/07/2015