Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Eflornithine monohydrate chloride
DE Pharmaceuticals
P01CX03
Eflornithine monohydrate chloride
115mg/1gram
Cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13090000
1 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 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 press Læs hele dokumentet
OBJECT 1 VANIQA 11.5% CREAM Summary of Product Characteristics Updated 10-Aug-2017 | Almirall Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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 0.32mg 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 do Læs hele dokumentet