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Active substance(s): MEPYRAMINE MALEATE

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V4 - 09/07/2013

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For Sanofi-Aventis use only


V1 - 29/05/2013: New regulatory text
V2 - 07/06/2013: Text modifications
V3 - 14/06/2013: Text modifications
V4 - 09/07/2013: Text modifications



Anthisan® 2%w/w Cream
Mepyramine maleate

2. Before you use Anthisan Cream
Do not use this medicine and tell your doctor or pharmacist if:
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:

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Phone 01483 505515 for help

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

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

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.

3. How to use Anthisan Cream

Important information about some of the ingredients of Anthisan

4. Possible side effects

This medicine contains:

5. How to store Anthisan Cream

• 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).

6. Further Information

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

518759_NPA 25g Anthisan_GB.indd 1

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

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

09/07/13 16:27


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

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:

If you forget to use Anthisan Cream

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

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.

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

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:
ADR Reporting, The Medicines Authority, Post-Licensing Directorate,
203 Level 3, Rue D’Argens, GŻR-1368 Gżira

518759_NPA 25g Anthisan_GB.indd 2

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
One Onslow Street
Surrey GU1 4YS
Tel: 01483 505515
Fax: 01483 535432
Sanofi Winthrop Industrie
196, Rue du Maréchal Juin
45200 Amilly
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

09/07/13 16:27

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.