1. Name Of The Medicinal Product
Lemsip Cough Dry
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Linctus.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of dry tickly coughs and sore throats.
4.2 Posology And Method Of Administration
Route of administration - oral.
Adults and children over 12: Two 5ml spoonfuls, three or four times daily.
Children 1-12 years: One 5ml spoonful, three or four times daily.
No special dose is required for elderly patients.
4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients.
Do not give to children under 1 year.
4.4 Special Warnings And Precautions For Use
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml.
Contains esters of parahydroxybenzoic acid which may cause allergic reactions (possibly delayed).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
As with many other medicines, this product should be avoided in the first three months of pregnancy and during lactation unless the benefits outweigh any risks; no significant problems have been reported in breast-fed infants from mothers taking this product.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
None known.
4.9 Overdose
Overdosage is unlikely but if it does occur then treatment consists of general supportive therapy and may include gastric lavage.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Glycerol, honey and syrup act as demulcents and provide a soothing medium for an irritated throat.
The citric acid monohydrate and the lemon oil, terpeneless both add to the sharpness of the product and enhance the flavour.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
No preclinical findings of relevance have been reported.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Ethanol (96%), Nipasept sodium and water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Three years.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band with expanded polyethylene wad. Pack sizes: 100 ml and 200 ml (100 ml is currently sold).
6.6 Special Precautions For Disposal And Other Handling
Oral administration.
ADMINISTRATIVE DATA
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS.
8. Marketing Authorisation Number(S)
PL 0063/0038.
9. Date Of First Authorisation/Renewal Of The Authorisation
24th April, 1995.
10. Date Of Revision Of The Text
08/07/2011
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