Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Tibolone 2.5mg;
Organon (New Zealand) Limited
Tibolone 2.5 mg
2.5 mg
Tablet
Active: Tibolone 2.5mg Excipient: Ascorbyl palmitate Lactose monohydrate Magnesium stearate Potato starch
Blister pack, 28 tablets
Prescription
Prescription
Aspen Oss B.V
· Treatment of symptoms resulting from the natural or surgical menopause in post-menopausal women. Women above 60 years of age should only start with LIVIAL treatment when they are intolerant of or contraindicated for other medicinal products approved for the treatment of oestrogen deficiency symptoms. · 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.
Package - Contents - Shelf Life: Blister pack, - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, - 84 tablets - 24 months from date of manufacture stored at or below 25°C
1988-11-08
LIVIAL ® TABLETS 1 LIVIAL ® TABLETS _Tibolone 2.5 mg _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Livial. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Livial against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS INFORMATION WITH THE PACK. You may wish to read it again. WHAT LIVIAL IS USED FOR Livial tablets contain the active these symptoms after menopause. You will only be prescribed Livial 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 Livial to prevent osteoporosis after menopause. Livial is not a contraceptive. Livial has no effect on alertness and concentration as far as is known. A doctor's prescription is required to obtain this medicine. BEFORE YOU USE LIVIAL • you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated • you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) • you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) • you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina • you have or have ever had liver disease and your liver function tests have not returned to normal • you have a rare blood problem called porphyria which is passed down in families (inherited) • you are allergic (hypersensitive) to tibolone or any of the ingredient tibolone, which is a Läs hela dokumentet
Page 1 of 14 NEW ZEALAND DATA SHEET 1 LIVIAL ® 2.5 MG TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of the steroid tibolone. Excipient with known effect: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM LIVIAL tablets 2.5 mg are 6 mm in diameter, white, round and flat with bevelled edges, coded "MK" above "2" on one side and "Organon" and a star on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of symptoms resulting from the natural or surgical menopause in post menopausal women. Women above 60 years of age should only start with LIVIAL treatment when they are intolerant of or contraindicated for other medicinal products approved for the treatment of oestrogen deficiency symptoms. • 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, LIVIAL 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 that moment (including cardiovascular disease and breast cancer, see SECTION 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL SAFETY AND EFFICACY and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). LIVIAL 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 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. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE) should be used Läs hela dokumentet