How does it work?

Vaniqa cream contains the active ingredient eflornithine, whichis a type of medicine known as an antiprotozoal. Eflornithine works by blockingthe action of an enzyme called ornithine decarboxylase. This is an enzyme foundin hair follicles and is needed for hair to grow.

The cream is applied to the skin to reduce the growth ofunwanted hair. It is used to treat unwanted facial hair growth in women,usually around the lips or under the chin.

Eflornithine only slows down the growth of unwanted hair. Itdoes not actually remove hair so another method for hair removal such asplucking or shaving may need to be continued whilst using Vaniqacream.

The benefit of using Vaniqa cream may be seen within two monthsafter starting the treatment. If no improvement is seen after four months thentreatment may be stopped by the doctor.

Vaniqa cream needs to be used continually once the benefits ofreduced hair growth on the face have been seen. If treatment is stopped thenre-growth is likely to occur within two months.

What is it used for?

• Treatment of excessive hair growth on the face (facial hirsutism) in women.

Warning!

• Vaniqa should only be used on the face and under the chin.
• Avoid contact of this medicine with the eyes and the moist membranes lining the inside of certain parts of the body, eg mouth, nasal passages (mucous membranes). Rinse with cold water if accidental contact occurs.
• Avoid using on broken or irritated skin.
• Do not use on skin immediately after using any other hair removal method. It is necessary to wait for at least five minutes.
• Wash your hands after applying the cream.
• For maximum effect, you should not clean the treated area of skin within four hours of applying the cream. You can use cosmetics (including sunscreens) on the treated areas, but don’t apply them sooner than five minutes after applying the cream.
• If your skin becomes irritated by the cream you should try using it less frequently. If the irritation persists, stop using the cream and consult your doctor.
• Excessive hair growth due to underlying diseases needs to be investigated and treated before using Vaniqa.

Use with caution in

• Decreased liver function.

Not to be used in

• Males.
• Girls aged under 12 years.
• Pregnancy.
• Breastfeeding.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. It should not be used by pregnant women or by those planning pregnancy. An alternative method of hair removal should be used.
• It is not known if this medicine passes into breast milk, but it is possible that it may. As a result, it should not be used by mothers who are breastfeeding.

Label warnings

• For external use only.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

• Acne.
• Skin irritation – burning, stinging.
• Redness of the skin.
• Rash.
• Ingrown hair.
• Flushing of skin.
• Skin bleeding or blistering.
• Cold sores.
• Dry or numb lips.
• Dry skin.
• Abnormal hair texture and growth.
• Changes in skin pigmentation.
• Itchy dermatitis.
• Skin cysts.

The side effects listed above may not include all of the sideeffects reported by the drug's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already using, including those bought without a prescription and herbalmedicines, before you start treatment with this medicine. Similarly, check withyour doctor or pharmacist before using any new medicines while using this one,to ensure that thecombination is safe.

You can apply cosmetics (including sunscreens) to the areas ofskin treated with this medicine, but don’t apply them sooner than five minutesafter applying Vaniqa cream.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain eflornithine as the active ingredient.