País: Suecia
Idioma: sueco
Fuente: Läkemedelsverket (Medical Products Agency)
tibolon
Novalon S.A.
G03CX01
tibolone
2,5 mg
Tablett
tibolon 2,5 mg Aktiv substans; laktosmonohydrat Hjälpämne; mannitol Hjälpämne
Receptbelagt
Förpacknings: Blister, 28 tabletter; Blister, 30 tabletter; Blister, 3 x 30 tabletter; Blister, 3 x 28 tabletter; Blister, 6 x 28 tabletter; Blister, 6 x 30 tabletter
Godkänd
2016-03-31
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TIBELIA 2.5 MG TABLETS 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 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 [(Invented) name] is and what it is used for 2. What you need to know before you take [(Invented) name] 3. How to take [(Invented) name] 4. Possible side effects 5. How to store [(Invented) name] 6. Contents of the pack and other information 1. WHAT [(INVENTED) NAME] IS AND WHAT IT IS USED FOR This medicine is a Hormone Replacement Therapy (HRT). It contains tibolone, a substance that has favourable effects on different tissues in the body, such as brain, vagina and bone. This medicine is used in postmenopausal women with at least 12 months since their last natural period. This medicine is used for: RELIEF OF SYMPTOMS OCCURING 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"). [(Invented) name] alleviates these symptoms after menopause. You will only be prescribed [(Invented) name] if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use [(Invented) name] to prevent osteoporosis after menopause. There are three different kinds of HRT: - Oestrogen-only HRT - Leer el documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tibelia 2.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contain contains 2.5 mg tibolone. Excipient(s) with known effect: each tablet contains 43.2 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white round uncoated tablets of 6 mm diameter with bevelled edge without any marking . 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause. • Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (See also Section 5.1) For all women the decision to prescribe {Invented name} 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. The tablets should be swallowed with some water or other drink, preferably at the same time every day. 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 {Invented name} treatment. STARTING {INVENTED NAME} Women experiencing a natural menopause should commence treatment with {Invented name} at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with {Invented name} may commence immediately. Women being treated with gonadotrophin releasing hormone (GnRH) analogues, for example, for endometriosis, may commence treatment with {Invented name} immediately. Any irregular/unscheduled vaginal bleeding, either on or off HRT, should be investigated to exclude malignancy before st Leer el documento completo