Eurax Cream with Crotamiton

1.What Eurax Cream is and what it is used for

Eurax Cream contains the active ingredient crotamiton which provides quick relief from itching and skin irritation for up to 6 to 10 hours after each application. It is suitable for itchy and irritated skin caused by, for example, sunburn, dry eczema, itchy dermatitis, allergic rashes, hives, nettle rash, chickenpox, insect bites and stings, heat rashes and personal itching.

Eurax Cream is also used for the treatment of scabies.

2.What you need to know before you use Eurax Cream

Do not use Eurax Cream:

- if you are allergic to crotamiton or any of the other ingredients of this medicine (listed in section 6).

- if you have a weeping skin condition (acute exudative dermatoses)

Warnings and precautions

- Eurax Cream is for external use only. Do not use in or around the eyes, or on broken skin.

- Consult your doctor if you are pregnant, breast-feeding or are suffering from genital itching.

- Eurax Cream can be used for children; However, for children under three years of age it should only be used under medical supervision.

- Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc.) that has been in contact with this product burns more easily and is a serious fire hazard.Washing clothing and bedding may reduce product build-up but not totally remove it.

- Eurax contains stearyl alcohol and Methyl hydroxybenzoates thatmaycauselocalskin reactions (e.g. contact dermatitis) or allergic reactions (possibly delayed). Eurax also contains fragrances with geraniol, citronellol, coumarin, benzyl alcohol (0.0187%), benzyl benzoate (0.0047%), citral, d-limonene, eugenol and linalool which may cause allergic reactions.

- You may experience discomfort if you have sensitive skin.

- Stop using this cream if you experience irritation or other unwanted side effects.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask yourdoctororpharmacistforadvicebeforetaking this medicine.

3. How to use Eurax Cream

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are notsure.

With clean hands, gently apply cream to the affected area. Wash your hands immediately after use. Do not use on the eyes or ears.

Adults (including the elderly):

For Itchy & Irritated Skin:

Apply to the affected area 2-3 times daily.

For treatment of Scabies:

After taking a warm bath, the skin should be well dried, and Eurax Cream rubbed into the entire body surface (excluding the face and scalp) until no traces of the cream remain visible.The application should be repeated once daily, preferably in the evening, for a total of 3-5 days.

Children:

Eurax Cream can be used in children however, for children under three years of age, consult a doctor before use and do not apply the cream more than once a day.

If you or a child accidentally swallows some of this Cream, you should contact your doctor or local accident and emergency department immediately.

4. Possible Side-Effects

Like all medicines, Eurax Cream can cause side-effects, although not everybody gets them. If you experience any of these or other side effects, stop using the Cream and seek medical advice:

• Difficulty breathing

• Swelling of the face, tongue or throat,

• Skin rash and irritation

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eurax Cream

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

Do not store above 25°C. Use within 12 months of opening.

Do not use after the expiry date shown on the end of the tube.

6. Contents of the pack and other information

What Eurax Cream contains

Active Ingredient: Crotamiton 10%w/w

Other ingredients: Methyl hydroxybenzoate (E218), phenylethyl alcohol, glycerol, triethanolamine, sodium lauryl sulphate, ethylene glycol monostearate, stearyl alcohol, strong ammonia solution, stearic acid, hard paraffin, white beeswax, purified water and perfume (contains: geraniol, citronellol, coumarin, benzyl alcohol (0.0187%), benzyl benzoate (0.0047%), citral, d-limonene, eugenol, linalool).

What Eurax Cream looks like and the contents of the pack

This medicine is a white to cream coloured cream, available in Internally lacquered aluminium tube of 20, 30 and 100g Not all pack sizes may be marketed.