Dry Cough Syrup
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemsip Cough for Dry Cough & Sore Throat Oral Solution Strepsils Sore Throat & Dry Cough Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Active ingredients |
Quantity/dose |
Specification |
|
Glycerol |
0.25 ml |
EP |
|
Honey |
500.00 mg |
HSE |
|
Citric acid monohydrate |
25.00 mg |
EP |
|
Lemon oil terpeneless |
0.0005 ml |
BP |
|
Syrup |
3.75ml |
BP |
3 PHARMACEUTICAL FORM
Oral syrup.
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.
No special dose is required for elderly patients.
Glass bottle
Adults and children 12 years and over: Two 5ml spoonfuls, three or four times daily.
Children 1-12 years: One 5ml spoonful, three or four times daily.
PETE plastic bottle
Adults and children 12 years and over: 10 ml dose (fill measure cup to 10 ml), three to four times daily.
Children aged 1-12 years: 5 ml dose (fill measure cup to 5 ml), three to four times daily.
Rinse the measure cup after use.
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 50 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 Fertility, 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.
5.1 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
Glass bottle - Three years.
PETE bottle - Two 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 (100ml and 200ml).
Transparent blue plastic PETE bottle (180ml).
Translucent yellow graduated polypropylene measuring cup.
Pack sizes: 100ml, 180ml and 200ml.
6.6 Special precautions for disposal
Oral administration.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0038
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/04/1995
10 DATE OF REVISION OF THE TEXT
12/09/2016