1. Name Of The Medicinal Product
Boots Cough and Decongestant Syrup 6 Years +
2. Qualitative And Quantitative Composition
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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 alkaloids (ergotamine & methysergide): increased risk of ergotism.
Appetite suppressants and amphetamine-like psycho-stimulants: risk of hypertension.
Oxytocin: risk of hypertension.
Enhances effects of anticholinergic drugs (such as TCAs).
Should not be given with other sympathomimetics such as decongestants, and thyroid hormones. Should not be given to patients undergoing general anaesthesia as them may induce ventricular arrhythmias.
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 Pregnancy And Lactation
Since the product is intended only for use in children, information on its use in pregnancy and lactation is not relevant.
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 guaifenesin:
Gastrointestinal disorders: nausea, vomiting, gastrointestinal discomfort.
Immune system disorders: hypersensitivity reactions.
Pseudoephedrine
Cardiovascular disorders: tachycardia, palpitations, other cardiac dysrythmias.
Gastrointestinal disorders: nausea and/or vomiting, dry mouth.
General disorders and administration site conditions: irritability, thirst, tolerance with dependence has been reported with prolonged administration of pseudoephedrine-containing preparations.
Immune system disorders: hypersensitivity reactions, including cross-sensitivity that may occur with other sympathomimetics.
Musculoskeletal and connective tissue disorders: muscular weakness.
Nervous system disorders: headache, giddiness, tremor, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in children) and paranoid delusions.
Psychiatric disorders: sleep disturbance.
Renal and urinary disorders: difficulty in micturition including urinary retention.
Skin and subcutaneous tissue disorders: skin reactions including rash, sweating.
Vascular disorders: hypertension.
4.9 Overdose
Symptoms of overdosage include headache, nausea, vomiting, tachycardia, urinary retention, hallucinations, coma, tremor, excitement, convulsions, respiratory depression, hypertension and arrhythmias.
Initial treatment consists of either emesis or gastric lavage, if appropriate. Otherwise treatment should be symptomatic and supportive, including the administration of a beta blocker if supraventricular tachycardia supervenes.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pseudoephedrine acts directly on both alpha and to a lesser extent beta adrenergic receptors. It is believed that the alpha adrenergic effects result from inhibition of the production of cyclic AMP by inhibition of the enzyme adenyl cyclase, whereas beta adrenergic effects result from stimulation of adenyl cyclase activity. Pseudoephedrine also has an indirect effect by releasing noradrenaline from its storage sites.
Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant.
5.2 Pharmacokinetic Properties
Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has an elimination half-life of several hours.
Guaifenesin is readily absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Maltitol solution
Hydroxyethyl cellulose
Glycerin
Purified water
Potassium sorbate
Acesulfame K
Sodium citrate
Citric acid monohydrate
Levomenthol
Alcohol 96%
Blackcurrant flavour
Vanilla bean extract
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
Amber PET bottle with polypropylene child resistant closure fitted with an expanded polyethylene liner.
Pack sizes: 100ml, 125ml, 150ml, 200ml
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
England
ML 00014/01
8. Marketing Authorisation Number(S)
PL 00014/0545
9. Date Of First Authorisation/Renewal Of The Authorisation
31 January 1997 / 30 January 2002
10. Date Of Revision Of The Text
May 2009
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