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Reckitt Benckiser Healthcare (UK) Ltd

Freepost, RSBU-TEBT-GSTU, Reckitt Benckiser, Kingston Upon Thames, KT2 6LZ, UK
Telephone: +44 (0)500 455 456
WWW: http://www.reckittbenckiser.com
Medical Information Direct Line: +44 (0)500 455 456
Customer Care direct line: +44 (0)500 455 456

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Summary of Product Characteristics last updated on the eMC: 08/08/2011
SPC Lemsip Cough Dry


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1. NAME OF THE MEDICINAL PRODUCT

Lemsip Cough Dry


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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


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3. PHARMACEUTICAL FORM

Linctus.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of dry tickly coughs and sore throats.


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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.


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4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

Do not give to children under 1 year.


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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).


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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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.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

None known.


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4.9 Overdose

Overdosage is unlikely but if it does occur then treatment consists of general supportive therapy and may include gastric lavage.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

No preclinical findings of relevance have been reported.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Ethanol (96%), Nipasept sodium and water.


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6.2 Incompatibilities

None known.


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6.3 Shelf life

Three years.


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6.4 Special precautions for storage

Store below 25°C.


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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).


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6.6 Special precautions for disposal and other handling

Oral administration.


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ADMINISTRATIVE DATA

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7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.


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8. MARKETING AUTHORISATION NUMBER(S)

PL 0063/0038.


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24th April, 1995.


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10. DATE OF REVISION OF THE TEXT

08/07/2011



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/23400/SPC/


Active Ingredients/Generics

 
   glycerol
   sucrose
   citric acid monohydrate
   honey
   lemon oil terpeneless