VANIQA 11.5% CREAM

Introduction

Package Leaflet: Information for the User

Vaniqa 11.5% Cream

Eflornithine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Vaniqa and what is it used for
2. What you need to know before you use Vaniqa

1. How to use Vaniqa
2. Possible side effects

5 Storage of Vaniqa

1. Contents of the pack and further information

1. What is Vaniqa and what is it used for

Vaniqa contains the active substance eflornithine. Eflornithine delays hair growth by its effect on a specific enzyme (a protein in the body involved in hair formation).

Vaniqa is used to reduce excessive hair growth (hirsutism) on the face in women over 18 years of age.

2. What you need to know before you use Vaniqa

Do not use Vaniqa:

• if you are allergic to eflornithine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Vaniqa

• tell your doctor about any other medical problems you are experiencing (especially those related to your kidneys or liver)

Excessive hair growth can be caused by underlying diseases. Consult your doctor if you have polycystic ovary syndrome (PCOS) or hormone-producing tumors, or if you are taking medications that can induce hair growth, such as cyclosporin (after organ transplantation), glucocorticoids (e.g. for rheumatic or allergic diseases), minoxidil (for hypertension), phenobarbital (for seizures), or phenytoin (for seizures) or hormone replacement therapy with similar effects to male hormones.

Girls and adolescents

Vaniqa is notrecommended for use in persons under 18 years of age.

Other medicines and Vaniqa

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

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

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant or breast-feeding. You should use an alternative method to treat your facial hair if you are pregnant or think you may be pregnant.

Driving and using machines

Vaniqa is not expected to affect your ability to drive or use machines.

Vaniqa contains cetyl alcohol and stearyl alcoholwhich may cause local skin reactions (e.g. contact dermatitis). Vaniqa also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)which may cause allergic reactions (possibly delayed).

3. How to use Vaniqa

Follow exactly the instructions of administration of this medicine indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

• Use it twice a day, leaving a space of at least 8 hours.
• If you experience irritation (e.g. stinging), reduce the use of Vaniqa to once a day until the irritation has passed. If it persists, contact your doctor.

• If you have shaved or used any other hair removal method, you should wait at least 5 minutesbefore using Vaniqa. It may sting or burn if applied to cut or irritated skin.
• Clean and dry the skin areas before applying the cream.
• Apply a thin layer of cream and massage it in until no visible residue of the product remains on the treated areas.

• Whenever possible, do notwash these skin areas during the 4 hours following application of the cream.
• Wash your hands after applying the cream.
• Wait at least 5 minutesbefore using makeup or sunscreens on the same areas.
• When using on the face, avoidcontact with the eyes or the inside of the nose or mouth. If Vaniqa accidentally gets into your eyes, mouth, or nose, rinse well with water.

Vaniqa is nota hair removal cream, so you may need to continue with the method you use to remove hair, such as shaving or depilatory creams.

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

If you use more Vaniqa than you should

If too much cream is applied to the skin, it is unlikely to harm you.

If you or someone else accidentally ingests Vaniqa, tell your doctor.

If you forget to use Vaniqa

Apply it as soon as you remember, but wait at least 8 hours before using it again.

If you interrupt treatment with Vaniqa

To maintain the reduction of hair growth, continue using Vaniqa as directed.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects are usually limited to the skin and are mild. In such cases, they usually resolve without interruption of treatment with 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)

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

Very common (affects more than 1 user in 10)

1. acne

Common (affects 1 to 10 users in 100)

• dry skin
• hair loss
• inflammation around the pore
• itching
• rash
• redness
• skin irritation and bumps caused by shaving
• skin irritation

• burning, itching, or tingling sensation of the skin

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

• papular rash
• cold sore
• redness and irritation at the site of application of the cream
• eczema
• inflamed, numb, cracked, or dry lips
• ingrown hairs
• pale areas of skin
• skin bleeding
• skin furuncles
• skin redness
• skin inflammation
• skin ulcers
• swelling of the mouth or face

1. abnormal hair texture or abnormal hair growth

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

• abnormal skin growth (skin neoplasia)
• excessive hair growth
• facial redness and pimples possibly with pus
• other skin disorders
• inflammation and redness of the skin with scaling and itching (seborrhoeic dermatitis)
• rash with redness, bumps, or blisters
• skin cysts
• skin tightness

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vaniqa

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

Do notuse this medicine after the expiry date which is stated on the carton and on the bottom of the tube after EXP. The expiry date is the last day of the month stated.

Once opened, discard the tube with the remaining cream after 6 months.

Make sure to close the tube cap tightly after each use.

Do notstore above 25°C.

Medicines should notbe disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Vaniqa

The active substance is eflornithine.

Each gram of cream contains 115 mg of eflornithine (as monohydrochloride).

The other ingredients are:

Cetyl alcohol, macrogol cetostearyl ether, dimeticone, glyceryl stearate, macrogol stearate, methyl parahydroxybenzoate (E218), liquid paraffin, phenoxyethanol, propyl parahydroxybenzoate (E216), purified water, and stearyl alcohol. Occasionally, very small amounts of sodium hydroxide (E524) are added to maintain normal acidity levels (pH levels).

Appearance and pack size of the product

Vaniqa is a white to off-white cream. It is available in tubes of 15 g, 30 g, and 60 g, but not all pack sizes may be marketed.

Marketing authorisation holder

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

You can obtain further information on this medicine from the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu