מדינה: גרמניה
שפה: גרמנית
מקור: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
Tibolon
Aristo Pharma GmbH (3082323)
G03CX01
tibolone
Tablette
Tibolon (22718) 2,5 Milligramm
zum Einnehmen
erloschen
2014-02-17
SANDOZ Business use only Page 1 of 9 1.3.1 spc-label-pl - common-pl - 5,418 (ES/H/0224/001 ChangeID 145814) 20150115 TIBOLONE 2.5 MG TABLET 722-1613.00 PACKAGE LEAFLET: INFORMATION FOR THE USER2.5 MG TABLETS For adult use Active substance: Tibolone 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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What קרא את המסמך השלםis and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR 2.5 mg tablet The active substance is: tibolone. is a Hormone Replacement Therapy (HRT). is used in postmenopausal women with at least 12 months since their last natural period. is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). alleviates these symptoms after menopause. You will only be prescribed if your symptoms seriously hinder your daily life. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT or carries risks that need to be considered when deciding whether to start taking it, or whether to carry on taking it. The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you hav
SANDOZ Business use only Page 1 of 11 1.3.1 spc-label-pl - common-spc - 5,002 (ES/H/0224/001 ChangeID 145814) 20141211 TIBOLONE 2.5 MG TABLET 722-1613.00 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT2.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: 2.5 mg tibolone. Excipient: One tablet contains approximately 75 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to whitish, flat round tablets of approximately 6 mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of oestrogen deficiency symptoms in women more than one year after the menopause. For all women the decision to prescribe tibolone should be based on an assessment of the individual patient´s overall risks and, particularly in the over 60s, should include consideration of the risk of stroke (see sections 4.4 and 4.8). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use Posology _Adults and the elderly _ The dosage is one tablet per day without interruption. No dose adjustment is necessary for the elderly. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used. A separate progestogen should not be added with קרא את המסמך השלםtreatment. _Starting _ • Women experiencing a natural menopause should commence treatment with at least 12 months after their last natural bleed. • Women experiencing a surgical menopause may commence treatment with immediately. Any irregular/unscheduled vaginal bleeding, either on or off HRT, for which there is no obvious cause, should be investigated to exclude malignancy before starting (see section 4.3). Method of administration The tablets should be swallowed without chewing, with some water or other drink, preferably at the same time every day. SANDOZ Business use only Page 2 of 11 1.3.1 spc-label-pl - common-spc - 5,002 (ES/H/022