1. Name Of The Medicinal Product
Children's 6 Month Plus Cough and Congestion Syrup or Children's Cough and Cold Syrup or Infant Sugar Free Cough & Congestion Syrup
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Liquid
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of coughs and nasal congestion associated with colds and for bronchial coughs.
4.2 Posology And Method Of Administration
Infants 6-12 months: 2.5ml.
Children 1-4 years: 5ml.
Children 4-5 years: 10ml.
The dose may be repeated every 4 hours if necessary, but not more than four doses to be given in 24 hours.
For oral administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment. Should be avoided in patients with cardiovascular disease, hyperthyroidism, diabetes mellitus, hypertension, renal impairment, prostatic enlargement, phaeochromocytoma, angle closure glaucoma.
4.4 Special Warnings And Precautions For Use
Not recommended for children under 6 months.
The elderly should consult their doctor before taking this product.
Caution in patients suffering from asthma.
Do not exceed the stated dose.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment (see also Section 4.3). Coadministration may cause a hypertensive crisis with marked headache, severe hypertension and possibly subarachnoid haemorrhage..
Ephedrine should be avoided in patients undergoing anaesthesia with cyclopropane, halothane or other volatile anaesthetics. An increased risk of arrhythmias may occur if given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Ephedrine may antagonise the effects of some antihypertensives in particular adrenergic neurone blockers, beta blockers and alpha blockers. Ephedrine has been shown to increase the clearance and reduce the half life of dexamethasone.
4.6 Pregnancy And Lactation
The safety of Children's 6 Months Plus Cough and Congestion Syrup during pregnancy and lactation has not been established. It is not known whether ephedrine can cause foetal abnormalities when taken during pregnancy.
The use of ephedrine during lactation has been associated with irritability and disturbed sleep in the breast fed infant.
There is no specific information available on the use of ipecacuanha during pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
Undesirable effects may include giddiness, headache, nausea, vomiting, tachycardia, palpitations, tremors and insomnia.
4.9 Overdose
Symptoms of overdosage may include those undesirable effects under 4.8. In addition paranoid psychosis, delusions and hallucinations may also occur. Treatment of overdosage in general requires symptomatic and supportive therapy. Vomiting may be controlled by intramuscular injection of chlorpromazine or other phenothiazine. Fluid and electrolyte balance should be corrected. Diazepam may be given to control central nervous system stimulation and convulsions. A beta blocker may be required to control cardiac arrhythmias.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic alpha and beta receptors. As a result ephedrine causes bronchodilatation.
Ipecacuanha has expectorant properties.
5.2 Pharmacokinetic Properties
Ephedrine is readily and completely 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 metabolites produced by hepatic metabolism. Ephedrine has a plasma elimination half life of 3 to 6 hours depending on urinary pH.
There is no information available on ipecacuanha.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Maltitol Liquid
Glycerol
Hydroxyethylcellulose
Citric Acid
Sodium Citrate
Sodium Chloride
Saccharin Sodium Gran
Sorbic Acid
Alcohol 96%
Blackcurrant Flavour – IFFH
Water Purified
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
An amber coloured polyethylene terephthalate bottle with a polypropylene child resistant closure fitted with an expanded polyethylene liner, packed in a cardboard carton.
Pack size: 150 ml.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
8. Marketing Authorisation Number(S)
PL 00014/0388
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of First Authorisation: 9 October 1989
Date of Last Renewal: 4 March 1996
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