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Vaniqa 11.5% cream Eflornithine,Hydrochloride
2015-01-05 23:49:08 来源: 作者: 【 】 浏览:423次 评论:0

For doctors

 

What is it and how is it used?

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.

What do you have to consider before using it?

Do NOT use Vaniqa:

Take special care with Vaniqa:

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 is it used?

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.

What are 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 (
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 should it be stored?

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).

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For doctors

What is it?

Vaniqa is a white cream that contains 11.5% of the active substance eflornithine.

What is it used for?

Vaniqa is used for the treatment of facial hirsutism in women. Facial hirsutism is excessive growth on the face of coarse hair, often in a male pattern.
The medicine can only be obtained with a prescription.

How is it used?

Vaniqa is applied in a thin layer to clean and dry affected areas twice daily (at least eight hours apart) and rubbed in. A benefit may be noticed within eight weeks of starting treatment. Continued treatment may give further improvement and is necessary to maintain beneficial effects. Vaniqa should be stopped if no beneficial effects are noticed within four months of starting treatment. Women using Vaniqa may still need to use other means to remove hair (plucking, shaving).

How does it work?

Vaniqa contains the active substance eflornithine. Eflornithine blocks the action of an enzyme, ornithine decarboxylase. This enzyme is found in the bulb of the hair follicle where it controls hair production. When this enzyme is blocked, the growth of hair is slowed down.

How has it been studied?

The effectiveness of Vaniqa has been studied in two clinical trials including 596 women treated for up to 24 weeks with Vaniqa, or with a placebo (a dummy treatment, in this case the cream without any active substance). The effectiveness of the treatment was assessed by the doctor at the end of the study who graded the hirsutism as: ‘clear/almost clear’, ‘marked improvement’, ‘improved’ or ‘no improvement/worse’, 48 hours after women had shaved the treated areas of the face and under the chin.

What benefits has it shown during the studies?

Improvement was seen as early as 8 weeks after the start of treatment. Significant improvement for Vaniqa versus placebo was seen in both studies. When the results were combined, a successful outcome (graded as ‘clear/almost clear’ or ‘marked improvement’) was seen in 35% of women treated with Vaniqa, against 9% of those treated with placebo.

What is the risk associated?

The most common side effect (seen in more than 1 patient in 10) is acne. Other common side effects are pseudofolliculitis barbae (ingrown hairs), alopecia (hair loss), stinging skin, burning skin, dry skin, pruritus (itching), erythema (redness), tingling skin, irritated skin, rash, and folliculitis (infected hair follicles). For the full list of all the side effects reported with Vaniqa, please see the Package Leaflet. Vaniqa should not be used in people who may be hypersensitive (allergic) to eflornithine or to any of the other ingredients.

Why has it been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Vaniqa’s benefits are greater than its risks for the treatment of facial hirsutism in women. They recommended that Vaniqa be given marketing authorisation (made available to doctors).

Further information

The European Commission granted a marketing authorisation valid throughout the European Union, for Vaniqa in on 20 March 2001. The marketing authorisation holder is Laboratorios Almirall, S.A.

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Name

 

Vaniqa 11.5% cream

 

Composition

 

Each gram of Vaniqa 11.5% w/w cream contains 115 mg eflornithine (as hydrochloride monohydrate).

Excipients:
Cetostearyl alcohol
Stearyl alcohol.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Cream.

White to off white cream

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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