This information is intended for use by health professionals

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

Honey

Citric acid monohydrate

Lemon oil terpeneless

Syrup

0.25 ml

500.00 mg

25.00 mg

0.0005 ml

3.75ml

EP

HSE

EP

BP

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. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Respiratory System; Cough and Cold Preparations; Other Cold Preparations ATC Code: R05X

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

Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism, mainly in the liver; it may be used in the synthesis of lipids, metabolised to glucose or glycogen, or oxidised to carbon dioxide and water. It is also excreted in the urine unchanged.

Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose, which are then absorbed.

No relevant pharmacokinetic data are available for citric acid monohydrate, honey or terpeneless lemon oil.

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.

Transparent blue plastic PETE bottle - Two years.

Transparent green plastic 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).

Transparent green plastic PETE bottle (180ml).

Translucent yellow graduated polypropylene measuring cup.

Pack sizes: 100ml, 180ml and 200ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

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

01/12/2017