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SSL International plc
Venus, 1 Old Park Lane, Trafford Park, Urmston, Manchester, M41 7HA , UK
Telephone: +44 (0)8701 222 690
Fax: +44 (0)8701 222 696
WWW: http://www.ssl-international.com
Medical Information Direct Line: +44 (0)161 638 2027
Medical Information e-mail: medical.information@ssl-international.com
Customer Care direct line: +44 (0)161 638 2399
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Summary of Product Characteristics last updated on the eMC: 11/09/2008
SPC Junior Meltus Chesty Coughs with Catarrh

On 28 February 2009 the Commission on Human Medicines (CHM) issued additional safety information for over the counter cough and cold medicines for children under 12 years of age.

Further information can be found on the MHRA website.



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1. NAME OF THE MEDICINAL PRODUCT

Junior Meltus Chesty Coughs with Catarrh


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Guaifenesin 50mg

Cetylpyridinium Chloride 2.5mg


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3. PHARMACEUTICAL FORM

Oral liquid.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of coughs and catarrh associated with influenza, colds and mild throat infections.


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4.2 Posology and method of administration

To be taken three to four times daily.

Children over 6 years: Two 5ml spoonfuls.

Children 2-6 years: One 5ml spoonful

Not to be given to children under two years of age.

Not more than 4 doses should be given in any 24 hours


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4.3 Contraindications

This product is contraindicated in patients hypersensitive to any of the ingredients.


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4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Consult a pharmacist or other healthcare professional before use in children under 6 years.


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4.5 Interaction with other medicinal products and other forms of interaction

Can cause transient abnormality in platelet aggregation patterns determined one hour after ingestion.


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4.6 Pregnancy and lactation

Although there are no known contraindications, as with all medicines, caution should be exercised when administering to pregnant or lactating women.


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4.7 Effects on ability to drive and use machines

Mild drowsiness has been reported.


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4.8 Undesirable effects

Some gastrointestinal discomfort and mild drowsiness has been reported. Very large doses can cause nausea and vomiting.


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4.9 Overdose

Very large doses may cause nausea and vomiting. It is, however, rapidly metabolised and excreted in the urine. The patient should be kept under observation and treated symptomatically.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

A cough linctus containing an expectorant and an oral antiseptic in a colour and sugar free demulcent base, specially formulated for children. The expectorant, guaifenesin, is employed to produce a thinning of mucous secretions and thus relief to bronchial catarrh. The antiseptic, cetylpyridinium chloride, is used for the treatment of superficial mouth infections.


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5.2 Pharmacokinetic properties

None stated.


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5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already in other sections of the SPC.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Glycerin

Alcohol 96%

Sorbitol Solution

Menthol

Saccharin Sodium

Sodium Cyclamate

Povidone

Custard Flavour 570514E

Raspberry Flavour 500251E

Blackberry Flavour 500225E

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 at or below 25oC.


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6.5 Nature and contents of container

Amber glass Sirop bottles fitted with tamper evident caps with polycone liner, packed in printed cartons, containing 100ml, 150ml or 200ml linctus.


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6.6 Special precautions for disposal and other handling

Not applicable


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7. MARKETING AUTHORISATION HOLDER

Cupal Ltd

Venus,

1 Old Park Lane,

Trafford Park,

Manchester,

M41 7HA,

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00338/0086.


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/06/95


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10. DATE OF REVISION OF THE TEXT

03/2008



More information about this product

Link to this document from your website: http://emc.medicines.org.uk/medicine/12985/SPC/Junior Meltus Chesty Coughs with Catarrh/


Active Ingredients/Generics

 
  guaifenesin
  cetylpyridinium chloride


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