Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Eflornithine
Almirall, S.A.
D11AX
eflornithine
Other dermatological preparations
Hirsutism
Treatment of facial hirsutism in women.
Revision: 23
Authorised
2001-03-19
15 B. PACKAGE LEAFLET 16 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. WHAT IS IN THIS LEAFLET 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 1. WHAT VANIQA IS AND WHAT IT IS USED FOR 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. 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 Talk to your doctor or 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 Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vaniqa 11.5% cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate). Excipients with known effect: Each gram of cream contains 47.2 mg of cetostearyl alcohol, 14.2 mg of stearyl alcohol, 0.8 mg of methyl parahydroxybenzoate and 0.32 mg of propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. White to off white cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of facial hirsutism in women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Vaniqa cream should be applied to the affected area twice daily, at least eight hours apart. Efficacy has only been demonstrated for affected areas of the face and under the chin. Application should be limited to these areas. Maximal applied doses used safely in clinical trials were up to 30 grams per month. Improvement in the condition may be noticed within eight weeks of starting treatment. Continued treatment may result in further improvement and is necessary to maintain beneficial effects. The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment. Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy. Patients may need to continue to use a hair removal method (e.g. shaving or plucking) in conjunction with Vaniqa. In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur. Special population _Elderly:_ (> 65 years) no dosage adjustment is necessary. _Paediatric population: _ _ _ The safety and efficacy of Vaniqa in children aged 0 to 18 years has not been established. There is no data available to support use in this age group. _Hepatic/renal impairment:_ the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not Przeczytaj cały dokument