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Lemsip Cough for Dry Cough & Sore Throat Oral Solution

Company:  
Reckitt Benckiser Healthcare (UK) Ltd See contact details
ATC code: 
R05X
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About Medicine
{healthcare_pro_orange} This information is for use by healthcare professionals
Last updated on emc: 21 Mar 2024
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.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms and a healthcare professional should be consulted if symptoms persist or worsen.

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.

The product may contain sufficient amounts of sugar to affect the control of diabetes.

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).

Citrates should not be taken together with aluminium hydroxide or aluminium-containing antacids in patients with-end stage renal disease unless consulted with health care professional (see section 4.5).

Duration of treatment should be limited to a maximum of 3 days for adults and children aged 1 year and over. The patient should consult a doctor if symptoms persist or worsen.

4.5 Interaction with other medicinal products and other forms of interaction

Intestinal absorption of aluminium ions may be enhanced by oral doses of citrates, increasing the toxicity of aluminium.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or a limited amount of data from the use of glycerol, honey, citric acid monohydrate, terpeneless lemon oil and syrup in pregnant women. As a precautionary measure, it is preferable to avoid the use of the product during pregnancy unless clearly necessary. Consult a healthcare professional before use.

Breast-feeding

There is insufficient information on the excretion of glycerol, honey, citric acid monohydrate, terpeneless lemon oil and syrup or metabolites in human milk. A risk to newborns/infants cannot be excluded. Consult a healthcare professional before use.

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.

When taken orally large doses of glycerol may cause headache, nausea, and vomiting. Diarrhoea, thirst, dizziness, and mental confusion may occur less frequently. Cardiac arrhythmias have been reported.

Citric acid ingested frequently or in large quantities may cause erosion of the teeth and have a local irritant action or cause diarrhoea.

Overconsumption of sucrose is associated with the formation of dental caries.

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

12/03/2024

Reckitt Benckiser Healthcare (UK) Ltd
Company image
Address
RB Consumer Relations, PO Box 4644, SLOUGH, SL1 0NS, UK
Telephone
0333 2005 345
Medical Information Direct Line
0333 2005 345
Customer Care direct line
0333 2005 345