EURAX

Patient information leaflet: information for the patient

Eurax 10% cream

crotamitone
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

1. What Eurax is and what it is used for
2. What you need to know before using Eurax
3. How to use Eurax
4. Possible side effects
5. How to store Eurax
6. Contents of the pack and other information

1. What Eurax is and what it is used for

Eurax contains the active substance crotamitone, a compound belonging to a class of medicines known as
antipruritics and acaricides (agents active against mites). When applied to the skin, crotamitone relieves
itching. It also kills the parasite responsible for a skin infection called scabies.
Eurax is indicated for the treatment of itching when not associated with evident skin changes:

• anal itching;
• vulvar itching (external part of the vagina);
• itching due to allergies;
• insect bites;
• urticaria.

Eurax is also used in skin infestations caused by the scabies mite.
Consult your doctor if you do not feel better or if you feel worse after 5 days.

2. What you should know before using Eurax

Do not use Eurax

• if you are allergic to crotamiton or to any of the other ingredients of this medicine (listed in section 6);
• if you have recently suffered from skin diseases associated with irritation and oozing, and in general in cases requiring treatment with dressings.

Warnings and precautions
Talk to your doctor or pharmacist before using Eurax.
Do not use / apply Eurax:

• inside the mouth (mucosa), and avoid contact with the eyes. If this occurs, wash thoroughly with water;
• if you have wounds that are oozing fluid;
• if you have a severe form of eczema, a skin inflammation associated for example with redness and itching;
• if your skin is broken or highly inflamed.

Take particular care with Eurax:

• if you have eczematous scabies, because you must treat the eczema first and only afterwards the scabies;
• because the use, especially if prolonged, of topical skin products may cause irritation and allergic reactions. If this occurs, stop treatment and contact your doctor, who will provide appropriate therapy.

Children
Eurax should be used with caution and under strict medical supervision when used for the treatment of scabies in children under 3 years of age.
Other medicines and Eurax
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
No medicines are known to affect the action of Eurax.
Eurax with food and drinks
No foods are known to affect the action of Eurax.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Eurax during pregnancy, particularly during the first three months.
Breastfeeding
Do not use Eurax during breastfeeding unless advised by your doctor.
Driving and using machines
Eurax does not impair the ability to drive or operate machinery.
Eurax contains propylene glycol and cetostearyl alcohol
This medicine contains propylene glycol, which may cause skin irritation.
This medicine contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Eurax

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Eurax should be applied to the skin. After applying the cream, gently massage it in.
The cream is non-greasy and does not stain clothing.
Do not exceed the recommended doses.

Treatment of itching (pruritus)

• Apply a sufficient amount of Eurax to the areas where you experience itching.
• Use the medicine 2–3 times a day.

Relief from itching occurs rapidly and lasts approximately 6–10 hours. In difficult cases requiring prolonged treatment, continue using the medicine until the itching disappears.

Treatment of scabies
Apply the medicine once daily after a warm bath and when the skin is dry, preferably in the evening. Continue treatment for 3–5 days, depending on the therapeutic response.
Apply a sufficient amount of Eurax over the entire body, except for the face and scalp.
Pay particular attention to areas where the parasite is most commonly found: between the fingers, wrists, armpits, and genital area. At the same time, change bed linen and underwear to prevent re-infestation.
After completing treatment, take a bath to wash the body.
Do not use the medicine for more than 5 days.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.

Use in children under 3 years of age
Eurax should be used with caution and under strict medical supervision when treating scabies. Do not exceed the recommended doses.

If you use more Eurax than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
If you have accidentally ingested Eurax, you may experience:

• nausea;
• vomiting;
• irritation of the mucous membranes inside the mouth, esophagus, and stomach;
• rarely, loss of consciousness and convulsions.

If you forget to use Eurax
Do not use a double dose to make up for the missed dose.

If you stop using Eurax
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Uncommon side effects (may affect up to 1 in 100 people)

• Itching.

Rare side effects (may affect up to 1 in 1,000 people)

• Contact dermatitis (an inflammation of the skin caused by contact with certain substances);
• Skin reactions, including allergic reactions, characterized for example by skin irritation, redness, itching, and swelling.

If you experience a severe form of irritation, discontinue treatment with Eurax.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eurax

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the information about the medicine available; therefore, retain both the carton and the package leaflet.

6. Package contents and other information

What Eurax contains

• The active substance is crotamiton. 100 g of cream contains 10 g of crotamiton.
• The other components are glyceryl monostearate 40-55, propylene glycol, isopropyl myristate, polyoxyl 40 stearate, cetyl stearyl alcohol, liquid paraffin, purified water.

Description of the appearance of Eurax and contents of the pack
Cream for use on the skin (cutaneous use).
Each pack contains one 20 g tube of 10% cream.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito n. 131
Torre Annunziata (NA), Italy
Or
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG,
Barthstraße 4, 80339
Munich, Germany