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Novartis Consumer Health

Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK
Telephone: +44 (0)1276 687300
Fax: +44 (0)1276 687284
Medical Information Direct Line: +44 (0)1276 687202
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1276 687290
Medical Information Facsimile: +44 (0)1276 687288


Summary of Product Characteristics last updated on medicines.ie: 25/04/2014
SPC Eurax 10% w/w Cream



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1. NAME OF THE MEDICINAL PRODUCT

Eurax® 10% w/w Cream


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Crotamiton 10% w/w.

Excipients also include

Methyl parahydroxybenzoate (E218)

0.15 %w/w

Stearyl alcohol

0.75 %w/w

Perfume (containing benzyl benzoate)

< 0.125 % w/w

For full list of excipients see section 6.1.


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3. PHARMACEUTICAL FORM

Cream.

A white to cream coloured cream, giving a homogenous smear, apart from trapped air bubbles; odour characteristic of perfume.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

As an antipruritic and sarcopticide for use in the management of pruritus of any aetiology and in the treatment of scabies.


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4.2 Posology and method of administration

Pruritus

Apply to the affected area 2 to 3 times daily. Eurax will provide relief from irritation for 6-10 hours after each application. Eurax can be used in children.

There are no special dosage recommendations in the elderly.

Scabies

After a thorough bath, Eurax should be applied to all areas below the chin with particular attention to interdigital areas. It is advisable to repeat the treatment 24 hours later. A bath should be taken a day after with a change of clothes and bedding.

All contacts should be treated simultaneously in scabatic patients.

Method of administration: For cutaneous use.


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4.3 Contraindications

Use in patients hypersensitive to any of the ingredients or suffering from acute exudative dermatoses.


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4.4 Special warnings and precautions for use

If symptoms persist consult the doctor.

Eurax can be used for children, although it is advised that you consult your doctor before use on infants.

For external use only.

Eurax should not be used near the eyes or on broken skin, or for weeping skin conditions.

Consult your doctor before using Eurax if you are pregnant or breast feeding.

If you suffer from genital itching, consult your doctor or pharmacist before using Eurax.


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4.5 Interaction with other medicinal products and other forms of interaction

None stated.


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4.6 Pregnancy and lactation

There is no evidence of risk during pregnancy. When breast feeding, application should not be made to the nipples.


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4.7 Effects on ability to drive and use machines

None stated.


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4.8 Undesirable effects

Use near the eyes may produce inflammation of conjunctiva. Local irritation of skin may occur.


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4.9 Overdose

Symptomatic treatment.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

None stated.


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5.2 Pharmacokinetic properties

None stated.


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5.3 Preclinical safety data

None stated.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Methyl parahydroxybenzoate (E218)

Phenylethyl Alcohol

Glycerol

Triethanolamine

Sodium Laurilsulfate

Ethylene Glycol Monopalmitostearate

Stearyl Alcohol

Concentrated Ammonia Solution

Stearic Acid

Hard Paraffin

White Beeswax

Perfume Givaudan No 45 (containing benzyl benzoate)

Purified Water


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

30 months.


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

Internally lacquered aluminium tubes.

Pack sizes: 30 and 100g


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6.6 Special precautions for disposal and other handling

No special requirements.


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ADMINISTRATIVE DATA

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7. MARKETING AUTHORISATION HOLDER

Novartis Consumer Health UK Ltd

Park View, Riverside Way

Watchmoor Park, Camberley

Surrey

GU15 3YL

UK

Trading as: Novartis Consumer Health


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8. MARKETING AUTHORISATION NUMBER(S)

PA 30/23/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1 April 1978/11 April 2008


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10. DATE OF REVISION OF THE TEXT

16 April 2014


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Legal Category

Retail sale through pharmacies only



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Active Ingredients

 
   Crotamiton