PACKAGE LEAFLET:

INFORMATION FOR THE USER

Anthisan® 2%w/w Cream

Mepyramine maleate

SANOFI^

Bis this leaflet hard to see or read? Phone 01483 505515 for help

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Anthisan Cream carefully to get the best results from it.

• Keep this leaflet. You may need to read it again • Ask your pharmacist if you need more information or advice • You should contact a doctor if your symptoms worsen or do not improve after 3 days

• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

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

2. Before you use Anthisan Cream

3. How to use Anthisan Cream

4. Possible side effects

5. How to store Anthisan Cream

6. Further Information

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

2. Before you use Anthisan Cream

H Do not use this medicine and tell your doctor or pharmacist if:

X You are allergic (hypersensitive) to mepyramine maleate or any of the other ingredients of Anthisan Cream (listed in Section 6 below)

The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Do not apply the cream on:

X Eczema

X Extensively broken skin

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Anthisan Cream.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines.

Pregnancy and breast-feeding

Talk to your doctor before using this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel drowsy or sleepy while using this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Anthisan Cream

This medicine contains:

•    Ceto-stearyl alcohol and castor oil. These may cause local skin reactions (such as ‘‘contact dermatitis” which may include the following symptoms: skin redness, swelling and itching, pain or burning sensation).

•    Methyl hydroxybenzoate. This may cause an allergic reaction. This allergy may happen some time after starting the medicine

Anthisan Cream contains a medicine called mepyramine maleate. This belongs to a group of medicines called antihistamines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction.

Anthisan Cream may be provided directly by a pharmacist for use in the following situation:

• Pain, itching and inflammation caused by insect stings, bites and nettle rash

3. How to use Anthisan Cream

Using this medicine (adults, elderly and children)

•    Apply the cream directly to the affected areas of skin

•    Do not apply the cream on eczema and badly broken skin

•    Apply the cream two to three times a day for up to three days

•    For best results, use as soon as possible after the bite or sting

•    Repeated use of the cream for periods longer than a few days is not recommended

•    If your symptoms worsen or do not improve after 3 days talk to your doctor or pharmacist

If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor or pharmacist.

If you use more Anthisan Cream than you should

If you use more Anthisan Cream than you should or it is accidentally swallowed, seek immediate medical attention particularly in young children. Tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you or the child has taken.

The following effects may happen: loss of consciousness and fits (seizures). If you forget to use Anthisan Cream

Do not apply a double amount of cream to make up for a forgotten application. Apply the cream as soon as you remember, then carry on as before.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Anthisan Cream can cause side effects, although not everybody gets them.

Stop using Anthisan Cream and see a doctor or go to a hospital straight away if you notice any of the following side effects:

•    An allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Stop using Anthisan Cream and tell a pharmacist if you notice the following side effect:

•    An increase in skin redness, swelling and itching in the area where you have used the cream. This might be due to a mild allergic reaction

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Malta

ADR Reporting, The Medicines Authority, Post-Licensing Directorate,

203 Level 3, Rue D’Argens, GZR-1368 Gzira Website: www.medicinesauthority.gov.mt email: postlicensing.medicinesauthority@gov.mt

5. How to store Anthisan Cream

•    Keep out of the sight and reach of children

•    Do not use Anthisan Cream after the expiry date which is stated on the carton flap or tube after EXP. The expiry date refers to the last day of that month

•    Do not store above 30°C

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further Information

What Anthisan Cream contains:

•    Each 1g of cream contains 20mg of the active substance, mepyramine maleate

•    The other ingredients are ceto-stearyl alcohol, polyethylene glycol 600 monostearate, castor oil, methyl hydroxybenzoate, foin coupe (fragrance), silicon antifoam and purified water

What Anthisan Cream looks like and contents of the pack

A smooth off-white cream contained within a collapsible aluminium tube with extended nozzle and polypropylene cap. The tube contains 25 grams of cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sanofi

One Onslow Street Guildford Surrey GU1 4YS UK

Tel: 01483 505515 Fax: 01483 535432

email: uk-medicalinformation@sanofi.com

Manufacturer

Sanofi Winthrop Industrie

196, Rue du Marechal Juin

45200 Amilly

France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 06/2013

© Sanofi 1973-2013

518759_NPA 25g Anthisan_GB.indd 2 09/07/13 16:27