Vaniqa

• Reduces the growth of excessive hair on the face
• For use in women
• Cream for use on the skin
• Do not use while pregnant or breastfeeding

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. Excessive facial hair growth can occur either due to increased production of male sex hormone (such as testosterone) or because the skin has become more sensitive to this type of hormone. This can lead to the growth of thick or dark hair on the chin, cheeks or upper lip. Some medicines can also induce hair growth.

Vaniqa reduces the growth of excessive hair in unwanted areas, but it does not cure the underlying cause.

Vaniqa is a cream for use on the face. The instructions for use are:

• The cream should be applied to clean, dry skin. Apply a thin layer of cream and rub it in thoroughly until no visual residual product remains on the treated areas.
• Do not wash these areas of skin for four hours after applying the cream.
• Wash your hands after applying the cream. Avoid contact with the eyes, nose and mouth. If you should accidentally get Vaniqa into your eyes, mouth or nose, rinse well with water.
• If you have just shaved or used any other hair removal method, wait at least five minutes before using Vaniqa. It may sting or burn if you put this cream on cut or irritated skin.
• Wait at least five minutes before using makeup or sunscreen on the same areas.

It may take eight weeks before you see results. It is important to continue using the cream. If you do not see any improvement after using it for four months contact your doctor.

If Vaniqa is effective, continue using the cream. If you stop using it your original hair growth may return within eight weeks.

Vaniqa cream expires six months after opening. Discard the opened tube with any remaining cream after six months.

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

Dosage

The recommended dose in adults is:

• Appy the cream twice a day, at least eight 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.

Alcohol/driving

Vaniqa does not interact with alcohol and will normally not affect your ability to drive or operate machinery.

If you use too much/forget to use/stop using Vaniqa

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 immediately.

If you forget to use Vaniqa, apply straight away, but wait at least eight hours before using it again.

To maintain the reduction of hair growth keep using Vaniqa continuously as indicated.

Vaniqa is not suitable for everyone. Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Vaniqa contains').

When should this medicine be used with caution?

Tell your doctor of any other medical problems you may be experiencing (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.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medication if you are pregnant, planning to conceive or breastfeeding.

This medicine should not be used by pregnant or breastfeeding women. You should use an alternative method to manage your facial hair if you are pregnant or trying to become pregnant.

Other medicines and Vaniqa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that do not require a prescription.

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

Like all medicines, this medicine can cause side effects, although some people may not experience any. Side effects are usually limited to the skin and mild in intensity. In such cases they normally resolve without discontinuation of Vaniqa.

Very common (may affect more than 1 in 10 people):

• Acne.

Common (may affect up to 10 in 100 people):

• Dry skin.
• Hair loss.
• Inflammation around the hair shaft.
• Itching.
• Skin rash.
• Redness.
• Skin irritation and bumps caused by shaving.
• Skin irritation.
• Stinging, tingling or burning feeling on the skin.

Uncommon (may affect up to 10 in 1,000 people):

• Bumpy rash (papular rash).
• Cold sores.
• Redness and irritation at the site where the cream is applied.
• Eczema.
• Inflamed, dry, cracked or numb lips.
• Ingrowing hairs.
• Pale areas on the skin.
• Skin bleeding.
• Boils.
• Skin flushing.
• Skin inflammation.
• Sore skin.
• Swelling of the mouth or face.
• Unusual hair texture or hair growth.

Rare (may affect up to 10 in 10,000 people):

• 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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet.

The active substance is eflornithine. Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate). Tiny amounts of sodium hydroxide (E524) are sometimes added to keep acidity levels (pH levels) normal.