Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tibolone
Aristo Pharma Ltd
G03CX01
Tibolone
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101; GTIN: 4251575902374 4251575902381
What is in this leaflet 1. What Tibolone tablets are and what they are used for 2. What you need to know before you take Tibolone tablets 3. How to take Tibolone tablets 4. Possible side effects 5. How to store Tibolone tablets 6. Contents of the pack and other information 1. What Tibolone tablets are and what they are used for Tibolone tablets are a Hormone Replacement Therapy (HRT). They contain tibolone, a synthetic sex hormone. Tibolone is used in postmenopausal women with at least 12 months since their last natural period. Tibolone is used for the relief of symptoms occurring after menopause During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Tibolone alleviates these symptoms after the menopause. You will only be prescribed Tibolone if your symptoms seriously hinder your daily life. 2. What you need to know before you take Tibolone tablets Medical History and regular check-ups The use of HRT or Tibolone 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 have a premature menopause the risks of using HRT or Tibolone may be different. Please talk to your doctor. Before you start taking (or restart) HRT or Tibolone, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and /or an internal examination, if necessary. Once you have started on Tibolone, you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Tibolone. Go for regular breast screening, as recommended by your doctor. Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is importa Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tibolone 2.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tibolone 2.5 mg tablets: each tablet contains 2.5 mg tibolone. Excipient(s) with known effect: lactose monohydrate: Tibolone 2.5 mg tablets: each 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 Posology The dosage is one tablet per day. Method of administration The tablets should be swallowed, with some water or other drink, preferably at the same time every day. Elderly 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 Tibolone 2.5 mg tablets treatment. Starting Tibolone 2.5 mg tablets Women experiencing a natural menopause should commence treatment with Tibolone 2.5 mg tablets at least 12 months after their last natural bleed. Women experiencing a surgical menopause may commence treatment with Tibolone 2.5 mg tablets 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 Tibolone 2.5 mg tablets (see section 4.3). _ _ Switching from a sequential or continuous combined HRT preparation If changing from a sequential HRT preparation, treatment with_ _Tibolone 2.5 mg tablets should start th Belgenin tamamını okuyun