देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
ULIPRISTAL ACETATE
Sumar Pharma ehf Haukahlijð 5 102 Reykjavik, Iceland
G03XB02
ULIPRISTAL ACETATE 5 mg
TABLET
ULIPRISTAL ACETATE 5 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2019-04-30
1 PACKAGE LEAFLET Page 2 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KAREVONAL 5 MG TABLETS Ulipristal acetate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Karevonal 5mg tablets is and what it is used for 2. What you need to know before you take Karevonal 5mg tablets 3. How to take Karevonal 5mg tablets 4. Possible side effects 5. How to store Karevonal 5mg tablets 6. Contents of the pack and other information 1. WHAT KAREVONAL 5MG TABLETSIS AND WHAT IT IS USED FOR Karevonal 5mg tabletscontains the active substance ulipristal acetate. It is used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb). Karevonal 5mg tabletsis used in adult women (over 18 years of age) before they reach the menopause. In some women, uterine fibroids may cause heavy menstrual bleeding (your ‘period’), pelvic pain (discomfort in the belly) and create pressure on other organs. This medicine acts by modifying the activity of progesterone, a naturally occuring hormone in the body. It is used either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KAREVONAL 5MG TABLETS You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards. DO NOT TAKE KAREVONAL 5MG TABLETS: - if you are allergic to ulipristal पूरा दस्तावेज़ पढ़ें
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 14 1.NAME OF THE MEDICINAL PRODUCT Karevonal 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of ulipristal acetate. Excipient with known effect: Each tablet contains 118 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White or almost white, round biconvex tablet of 7 mm, engraved with “149” on one side and “LP” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Karevonal 5 mg tablets treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids. Posology The treatment consists of one tablet of 5 mg to be taken once daily for treatment courses of up to 3 months each. Tablets may be taken with or without food. Treatments should only be initiated when menstruation has occurred: - The first treatment course should start during the first week of menstruation. - Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion. The treating physician should explain to the patient the requirement for treatment free intervals. Repeated intermittent treatment has been studied up to 4 intermittent courses. If a patient misses a dose, the patient should take ulipristal acetate as soon as possible. If the dose was missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. _Special population _ _Renal impairment _ Page 3 of 14 No dose adjustment is recommended in p पूरा दस्तावेज़ पढ़ें