Vaniqa 11.5% cream

eflornithine

Vaniqa contains the active substance eflornithine. Eflornithine slows down the growth of hair through its effect on a specific enzyme (a protein in the body involved in the production of hair).

Vaniqa is used to reduce the growth of excessive hair (Hirsutism) on the face of women older than 18 years of age.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Use twice a day, at least 8 hours apart.
• If you experience irritation (e.g. stinging burning), reduce the use of Vaniqa to once daily until the irritation has gone. If it persists contact your doctor.
• If you have just shaved or used any other hair removal method, wait at least 5 minutes before using Vaniqa. It may sting or burn if you put this cream on cut or irritated skin.
• Clean and dry the areas of the skin where you will be using the cream.
• Apply a thin layer of cream and rub it in thoroughly until no visual residual product remains on the treated areas.
• If possible, do not wash these areas of skin for 4 hours after applying the cream
• Wash your hands after applying the cream.
• Wait at least 5 minutes before using make-up or sunscreen on the same areas.
• When using on the face, avoid contact with your eyes or the inside of your nose or mouth. If you should accidentally get Vaniqa into your eyes, mouth or nose, rinse well with water.

Vaniqa is not a depilatory cream, so you may need to continue with your hair removal method, for example by shaving or plucking.

It may take 8 weeks before you see results. It is important to continue using the cream. If you do not see any improvement after using it for 4 months contact your doctor. If you stop using it your original hair growth may return within 8 weeks.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are usually limited to the skin and mild in intensity. In such cases they normally resolve without discontinuation of Vaniqa.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data).

Very common (affects more than 1 user in 10)

• acne

Common (affects 1 to 10 users in 100)

• dry skin
• hair loss
• inflammation around the hair shaft
• itching
• rash
• redness
• skin irritation and bumps caused by shaving
• skin irritation
• stinging, tingling or burning feeling on the skin

Uncommon (affects 1 to 10 users in 1,000)

• bumpy rash (papular rash)
• cold sores
• redness and irritation at the site where the cream is applied
• eczema
• inflammed, dry, cracked or numb lips
• ingrowing hairs
• pale areas on the skin
• skin bleeding
• skin boils
• skin flushing
• skin inflammation
• sore skin
• swelling of the mouth or face
• unusual hair texture or hair growth

Rare (affects 1 to 10 users in 10,000)

• abnormal skin growth (skin neoplasm)
• excessive hair growth
• flushing, facial redness and pimples possibly with pus
• other skin disorders
• red, scaly and itchy skin inflammation (seborrhoeic dermatitis)
• red, bumpy or blistering rash
• skin cysts
• skin tightness

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the box and on the bottom of the tube after EXP. The expiry date refers to the last day of that month.

Discard the opened tube with any remaining cream after 6 months.

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

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.