Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
tibolone, Quantity: 2.5 mg
Southern Cross Pharma Pty Ltd
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; potato starch; ascorbyl palmitate; magnesium stearate; mannitol
Oral
84 Tablets, 28 Tablets
(S4) Prescription Only Medicine
- Short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.,- Second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.
Visual Identification: White to off-white round uncoated tablets without any markings.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-04-03
TIBOLONE SCP/032017/CMI-00 1 TIBOLONE SANDOZ _contains the active ingredient tibolone _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about TIBOLONE SANDOZ. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking TIBOLONE SANDOZ against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. What TIBOLONE SANDOZ is used for TIBOLONE SANDOZ tablets contain the active ingredient tibolone, which is a synthetic steroid medicine used for hormone replacement therapy (HRT). It mimics the activity of the female sex hormones in the body. TIBOLONE SANDOZ contains tibolone, a substance that has a favourable effects on different tissues in the body, such as brain, vagina and bone. TIBOLONE SANDOZ is used in postmenopausal women at least 12 months since their last natural period. TIBOLONE SANDOZ is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of estrogen 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 menopause. You will only be prescribed TIBOLONE SANDOZ 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 take TIBOLONE SANDOZ to prevent osteoporosis after menopause. TIBOLONE SANDOZ is not a contraceptive. TIBOLONE SANDOZ has no effect on alertness and concentration as far as is known. TIBOLONE SANDOZ is available only with a doctor's prescription. Before you us Přečtěte si celý dokument
AUSTRALIAN PRODUCT INFORMATION TIBOLONE SANDOZ, (TIBOLONE), TABLETS _ _ 1. NAME OF THE MEDICINE Tibolone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tibolone SANDOZ tablets contain the active tibolone. Excipient with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tibolone SANDOZ 2.5 mg tablet is white to off-white round uncoated tablets without any markings. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS TIBOLONE SANODZ is indicated for: • Short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women. • Second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. After careful selection of users, TIBOLONE SANDOZ should be prescribed for the shortest duration consistent with treatment goals. Review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at the moment (including cardiovascular disease and breast cancer, see Section 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). TIBOLONE SANDOZ should only be continued for as long as the benefit outweighs the risks. 4.2. DOSE AND METHOD OF ADMINISTRATION TREATMENT OF SYMPTOMS RESULTING FROM THE NATURAL OR SURGICAL MENOPAUSE, MORE THAN ONE YEAR AFTER MENOPAUSE. The recommended dose is 2.5 mg once daily. PREVENTION OF POST-MENOPAUSAL BONE MINERAL DENSITY LOSS: The recommended dose is 2.5 mg once daily. No dose adjustment is necessary for the elderly. The tablets should be swallowed with some water or other drink, preferably at the same time of day. Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months. For initiation and Přečtěte si celý dokument