Monday, October 17, 2016

Vaniqa 11.5% cream






Vaniqa 11.5% cream



(eflornithine)



Read All Of This Leaflet Carefully Before You Start Using This Medicine.


Keep this leaflet. You may need to read it again.


If you have any further questions, ask your doctor or pharmacist.


This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


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




In this leaflet:


  • 1. What Vaniqa is and what it is used for

  • 2. Before you use Vaniqa

  • 3. How to use Vaniqa

  • 4. Possible side effects

  • 5. How to store Vaniqa

  • 6. Further information




WHAT Vaniqa IS AND WHAT IT IS USED FOR


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.





BEFORE YOU USE Vaniqa



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).





HOW TO USE Vaniqa


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.





Possible Side Effects


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 (<0.1%), rosacea (inflammation and flushing of the skin, and can also cause pus under the skin), a red, scaly, itchy dermatitis, abnormal skin growth, red bumpy rash, skin cysts, blistering rash, excessive hair growth, skin tightness, other skin disorders.


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.




HOW TO STORE Vaniqa


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).




Further Information



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



Laboratorios 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:









Ireland / United Kingdom

Almirall Limited

Pinewood

Chineham Business Park

Crockford Lane

Chineham

Basingstoke
RG24 8AL

United Kingdom

Tel.:+44 (0) 1256 698037






This leaflet was last approved in November 2009






No comments:

Post a Comment