Vaniqa 11.5% cream

Women use Vaniqa to reduce the growth of excessive hair on their faces.

How it works

Vaniqa slows down the growth of hair through its effect on an enzyme involved in the production of hair. It does not remove hair. It is not a depilatory cream so you may need to continue removing hair, for example by shaving or plucking. Improvement may be seen as early as 2 months after start up of treatment. If you do not see any benefit after using it for 4 months contact your doctor. If you stop using it your original hair growth may return in 2 months.

Do NOT use Vaniqa:

• if you are allergic (hypersensitive) to eflornithine or to any of the other ingredients.

Take special care with Vaniqa:

• Before using Vaniqa, tell your doctor of any other medical problems (especially related to your kidneys or liver).
• If you are unsure whether or not to use this medicine contact your doctor or pharmacist for advice.

What else should I know?

Excessive growth of hair may be a result of underlying diseases or certain medications. Contact your doctor if you have any questions.

Wait at least 5 minutes after shaving or plucking before using this cream. It may sting or burn if you put this medicine on cut or irritated skin.
Do not get it in your eyes or inside your nose or mouth. If this happens accidentally, rinse thoroughly with water.

Using Vaniqa with other medicines

Speak to your doctor if you need to use other medicines on the areas of skin where you are using it.

Pregnancy and Breast-feeding

Do not use Vaniqa if you are pregnant, or trying to become pregnant. You should not use this medicine while breast-feeding.

Important information about some of the ingredients of Vaniqa

This medicine contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Always use Vaniqa exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

1. If you have just shaved or used any other hair removal method, wait at least 5 minutes before using Vaniqa.

2. Clean and dry the areas of the skin where you will be using it.

3. Apply a thin layer of cream and rub it in thoroughly.

4. If possible, do not wash these areas of skin for 4 hours after putting it on.

5. Wash your hands after applying it.

6. Wait at least 5 minutes before using make-up or sunscreen on the same areas.

7. Use it twice a day, at least 8 hours apart.

8. Vaniqa can cause irritation (stinging, burning). If irritation is caused, reduce the use of Vaniqa to once a day until the irritation has gone. If irritation persists contact your doctor.

How long should I use Vaniqa?

It may take up to 2 months before you see results. Continually using it may lead to further improvement. You will need to keep using it to keep the benefit. If you do not see any benefit after using it for 4 months contact your doctor.

If you use more Vaniqa than you should

If you put too much cream on your skin, it is unlikely to harm you.

If you or anyone else accidentally swallows Vaniqa, contact your doctor.

If you forget to use Vaniqa

Apply straight away, but wait at least 8 hours before using it again.

Like all medicines, Vaniqa can cause side effects, although not everybody gets them. The most frequently reported side effect was acne (7-14%). Other side effects commonly (> 1%) reported were skin problems such as skin reactions from ingrowing hair, hair loss, a burning, stinging or tingling feeling, dry skin, itching, redness or rash.
Also reported, but uncommonly (< 1%), were ingrowing hairs, swelling of the face or mouth, skin bleeding, cold sores, dry, cracked or numb lips, pale areas of the skin, sore skin, flushing of the skin, eczema, irritation of the skin, skin boils, abnormal hair texture and abnormal hair growth. Also reported, but rarely (
If you notice these or any other side effects, or if you are not sure about the effect of Vaniqa, contact your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use the cream after its expiry date. There is an expiry date on the box and on the bottom of the tube of Vaniqa.

Make sure the cap of the tube is tightly closed after each use.

Do not store above 25°C (77°F).

What Vaniqa contains

The active substance is Eflornithine. Each gram of Vaniqa 11.5% cream contains 115 mg of eflornithine (as hydrochloride monohydrate).
The other ingredients are Cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water and stearyl alcohol. Tiny amounts of sodium hydroxide (E524) are sometimes added to keep acidity levels (pH levels) normal.

What Vaniqa looks like and the contents of the pack

Vaniqa is a cream which is white to off white in colour. It is supplied in tubes of 15 g, 30 g and 60 g but not all pack sizes may be marketed.

Marketing Authorisation Holder

Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain.
Tel: + 34 93 291 30 00

Manufacturer

Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiqueBelgiëBelgien, Italia

Almirall SpA Via Messina 38, Torre C 20154 Milano Italia Tel. 39 02 346181 Ireland United Kingdom Almirall Limited Pinewood Chineham Business Park Crockford Lane, Chineham Basingstoke, RG24 8AL United Kingdom Tel. 44 0 1256 698037 Almirall N.V. Medialaan 32 B 4 B-1800 Vilvoorde Belgien Belgique TélTel 32 02 257 26 63 eská republika Danmark Eesti España Ísland Latvija Lietuva Magyarország Malta Nederland Norge Polska România Slovenija Slovenská republika SuomiFinland Sverige Almirall, S.A. Ronda General Mitre, 151 08022 Barcelona panlsko Spanien Hispaania España Spánn Spnija Ispanija Spanyolország Spanja Spanje Spania Hiszpania Spania panija panielsko Espanja Spanien TeTelTlfTSímiPuh 34 93 291 30 00 Deutschland LuxembourgLuxemburg Österreich Almirall GmbH Wien Tel. 43 01595 39 60 Almirall Hermal GmbH Scholtzstrasse 3 21465 Reinbek Deutschland Allemagne Tel. Tél 49 040 72704-0

France Almirall SAS 1, boulevard Victor 75015 Paris Tél. 3301 46 46 19 20 Portugal Almirall - Produtos Farmacêuticos, Lda. Rua João Chagas, 53A, 2 andar - escritório 201, 1495-072 Algés Tel. 351 21 415 57 50

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