Vaniqa
eflornithine
Eflornithine
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.
What Vaniqa is and what it is used for
What you need to know before you use Vaniqa
How to use Vaniqa
Possible side effects
How to store Vaniqa
Contents of the pack and other information
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.
if you are allergic to eflornithine or any of the other ingredients of this medicine listed in section 6.
Talk to your doctor of pharmacist before using Vaniqa
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.
Excessive growth of hair may be a result of underlying diseases. Talk to your doctor if you suffer from polycystic ovary syndrome (PCOS) or specific hormone producing tumours, or if you take medicines that can induce hair growth, e.g. cyclosporine (following organ transplants), glucocorticoids (e.g. against rheumatic or allergic diseases), minoxidil (against high blood pressure), phenobarbitone (against seizures), phenytoin (against seizures) or hormone replacement therapy with male hormone like effects.
Vaniqa is not recommended for use in anyone younger than 18 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Talk to your doctor if you need to use other medicines on the areas of skin where you are using the cream.
Vaniqa is not expected to have any effect on your ability to drive or use machines.
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 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 8 hours before using it again.
To maintain the reduction of hair growth keep using Vaniqa continuously as indicated.
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).
acne
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
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
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 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
Keep this medicine out of the sight and reach of children.
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 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.
The active substance is eflornithine.
Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate).
The other ingredients are:
cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate
(E216); purified water and stearyl alcohol. Tiny amounts of sodium hydroxide (E524) are sometimes
added to keep acidity levels (pH levels) normal.
Vaniqa is a cream which is white to off white in colour. It is supplied in tubes of 15 g, 30 g and 60 g but not all pack sizes may be marketed.
Almirall, S.A.
Ronda General Mitre, 151 08022 Barcelona
Spain.
Tel: + 34 93 291 30 00
Almirall Hermal GmbH Scholtzstrasse 3
D-21465 Reinbek Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Almirall N.V.
Tél/Tel: +32 (0)2 771 86 37
Almirall ApS
Tel.: +45 70 25 75 75
Almirall, S.A.
Teл/Tel/Tlf/Tηλ/Sími: +34 93 291 30 00
Almirall BV
Tel.: +31 (0) 307991155
Almirall GmbH
Tel.: +43 01/595 39 60
Almirall ApS
Tel./Puh.: +45 70 25 75 75
Almirall Sp. z o.o.
Tel.: +48 22 330 02 57
Almirall SAS
Tél.: +33(0)1 46 46 19 20
Almirall SpA
Tel.: +39 02 346181
Almirall - Produtos Farmacêuticos, Lda.
Tel.: +351 21 415 57 50
Almirall Limited
Tel: +44 (0) 800 0087399