The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/01/173/001, EU/1/01/173/002, EU/1/01/173/003.
Vaniqa 11.5% cream
Vaniqa 11.5% cream
1. What Vaniqa is and what it is used for
2. What you need to know before you use Vaniqa
3. How to use Vaniqa
4. Possible side effects
5. How to store Vaniqa
6. 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.
Talk to your doctor or pharmacist before using Vaniqa
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.
Do not use Vaniqa if you are pregnant or breast-feeding. You should use an alternative method to manage your facial hair if you are pregnant or trying to become pregnant.
Vaniqa is not expected to have any effect on your ability to drive or use machines.
Vaniqa contains cetostearyl alcohol and stearyl alcohol which 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).
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
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).
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)
If you get 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
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.
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.
Marketing Authorisation Holder
This leaflet was last revised in May 2022