EURAX 10% CREAM 40G TUBE

NOTICE

ANSM - Last updated: 20/04/2017

Name of the medicinal product

EURAX 10 PER CENT, cream

crotamiton

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

Do not use this medication for children.

What is in this leaflet?

1. What is EURAX 10 PERCENT, cream and in which cases is it used?

2. What should I know before using EURAX 10 PERCENT, cream?

3. How to use EURAX 10 PERCENT, cream?

4. What are the possible side effects?

5. How to keep EURAX 10 PER CENT, cream?

6. Package contents and other information.

1. WHAT IS EURAX 10 PERCENT, cream AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group: ANTI-PRURIGINOUS - ATC code: D04AX

This medicine is recommended in case of itching, especially in case of insect bites.

2. BEFORE YOU USE EURAX 10 PER CENT, cream?

Never use EURAX 10 PERCENT, cream in the following cases:

· antecedent of allergy to one of the constituents,

· infected or irritated skin lesions,

· oozing skin lesions.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Warnings and Precautions

Pay attention with EURAX 10 PER CENT, cream:

Itching is only a symptom that can have multiple causes requiring the advice of your doctor especially if persistence or aggravation of the disorders.

Do not apply on a large surface, under occlusive dressing, on injured skin or in infants due to the risk of the active ingredient passing through the blood.

Reserve for external use. Do not apply to the oral mucosa, in or around the eyes, on a soot or eczema.

Wash hands after use of Eurax.

In case of accidental contact with the eyes or oral mucosa, rinse thoroughly with water.

This specialty contains propylene glycol and may cause skin irritation. This medicinal product contains cetostearyl alcohol and may cause local skin reactions (eg eczema).

children

Not applicable.

Other medicines and EURAX 10 PER CENT, cream

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

EURAX 10 PER CENT, cream with food and drink

Not applicable.

Pregnancy and breast feeding

This medication is not recommended during pregnancy, especially during the first 3 months. The use of Eurax is not recommended during breast-feeding unless recommended by a doctor.

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Not applicable.

EURAX 10 PER CENT, cream contains

· propylene glycol and may cause skin irritation.

· of cetostearyl alcohol and may cause local skin reactions (eg eczema).

3. HOW TO USE EURAX 10 PER CENT, cream?

Always use this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

1 application 2 to 3 times a day on the itching area followed by a gentle massage.

In young children, a single application is usually sufficient .

Method and route of administration

Dermal.

Duration of treatment

If symptoms persist, consult your doctor.

If you used more than EURAX 10 PER CENT, cream you should not have

If accidentally swallowed, call your doctor.

If you forget to use EURAX 10 PER CENT, cream

Apply this cream as soon as you notice it. If this is the case for the next application, use the usual dosage.

Do not apply more cream to compensate for the application you have forgotten.

If you stop using EURAX 10 PER CENT, cream

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Stop using Eurax Cream and immediately consult a doctor if you have any of the following signs that may be related to an allergic reaction:

Difficulty breathing or swallowing

Swelling of face, lips, tongue or throat

Severe itching of the skin with redness or pimples

Some side effects are uncommon (≥1 / 1000 to <1/100):

- itching

Other side effects are rare (≥1 / 10,000 to <1/1000):

Eruption, itching, redness of the skin, eczema, angioedema.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE EURAX 10 PER CENT, cream?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.

This medication should be stored at a temperature below 30 ° C.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What EURAX contains 10 PERCENT, cream

· The active substance is:

Crotamiton ................................................. .................................................. .......................... 10.0 g

For 100 g of cream.

· The other components are:

Glycerol stearate, isopropyl myristate, cetostearyl alcohol (Lanette O), macrogol stearate 2000 (Myrj 52), liquid paraffin, propylene glycol, purified water.

What is EURAX 10 PERCENT, cream and contents of the pack

This medication is in the form of a cream.

Tube of 40 or 60 g.

Marketing Authorization Holder

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

CS 80001

78164 MARLY LE ROI CEDEX

Marketing Authorization Operator

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

CS 80001

78164 MARLY LE ROI CEDEX

Maker

NOVARTIS PHARMA SAS

26, RUE DE LA CHAPELLE

68330 HUNINGUE

Or

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

CS 80001

78164 MARLY LE ROI CEDEX

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

<{MM / YYYY}> <{YYYY month}.>

Other

Detailed information on this medicine is available on the ANSM website (France).

VIDAL OF THE FAMILY

EURAX