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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.com

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Summary of Product Characteristics last updated on the eMC: 12/05/2011
SPC Meggezones


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1. NAME OF THE MEDICINAL PRODUCT

Meggezones


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pastille contains menthol 16.0mg BP


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3. PHARMACEUTICAL FORM

Pastille.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Symptomatic relief of sore throats, coughs, colds, catarrh and nasal congestion.


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4.2 Posology and method of administration

Allow one pastille to dissolve slowly in the mouth as required.

Maximum daily dose : Adults - 15 pastilles; children aged 6 to 12 years - 10 pastilles; children aged under 6 years - 5 pastilles.


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4.3 Contraindications

None known.


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4.4 Special warnings and precautions for use

Hypersensitivity to the product is a possible side effect. Contact dermatitis may occur with menthol products.


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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

Safety in pregnancy and lactation has not been established. However menthol-containing products have been used for many years with no ill effect.


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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 stated.


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4.9 Overdose

Systemic effects due to overdosage are most unlikely.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Menthol in pastille formulation relieves catarrh and other symptoms associated with colds.


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5.2 Pharmacokinetic properties

Menthol is excreted in the urine and bile as a glucuronide.


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5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Modified starch, antifoam 1510, sucrose, liquorice extract powder, liquid glucose (80%) solid (1963); peppermint oil; benzoin; water.


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6.2 Incompatibilities

None known.


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6.3 Shelf life

24 months.


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6.4 Special precautions for storage

Once opened keep in a cool dry place.


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6.5 Nature and contents of container

PVC blister packs with aluminium seal in a cardboard box. Packs contain 3, 8, 24, 36 or 48 pastilles.


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00025/0576


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

5 May 1988 / 5 May 1993


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10. DATE OF REVISION OF THE TEXT

4 March 2011


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11. LEGAL STATUS

GSL

© Merck Sharp & Dohme Limited 2011. All rights reserved.

Meggezones/UK/02-11/2



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/22775/SPC/


Active Ingredients/Generics

 
  menthol