SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Lemsip Cough Dry

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	3.75 ml	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.

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. Pre-clinical 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 Content 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.    Instructions for Use, Handling and 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

AUTHORISATION

24th April, 1995.

10 DATE OF REVISION OF THE TEXT

21/11/2011