البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TIBOLONE
EURODRUG LABORATORIES (M) SDN BHD
TIBOLONE
28tablet Tablets
LABORATORIO LEON FARMA, S.A.
Consumer Medication Information Leaflet (RiMUP) 1 TIBOLEEN TIBOLONE 2.5 MG IN THIS LEAFLET: 1. WHAT TIBOLEEN IS USED FOR 2. HOW TIBOLEEN WORKS 3. BEFORE YOU USE TIBOLEEN 4. HOW TO USE TIBOLEEN 5. WHILE YOU ARE USING IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF TIBOLEEN 8. PRODUCT DESCRIPTION 9. MANUFACTURER 10. PRODUCT REGISTRATION HOLDER 1. WHAT TIBOLEEN IS USED FOR TIBOLEEN belongs to the group of medicines called hormone replacement therapy (HRT). It is used for problems that start affecting women when their body no longer produces certain hormones, for example after the change of life (the menopauses). It is also used to prevent bones becoming brittle (osteoporosis) if you are unable to use other treatments. 2. HOW TIBOLEEN WORKS TIBOLEEN helps restore the hormonal balance to relieve menopausal symptoms like thinning, drying and inflammation of the vagina, loss of bone density and osteoporosis, as well as other symptoms, such as reducing hot flushes and improved libido. 3. BEFORE YOU TAKE TIBOLEEN WHEN YOU MUST NOT USE IT Do not take TIBOLEEN • If you are, or think you are, pregnant • If you have or have had breast cancer, or if breast cancer is suspected • If you have a malignant tumour sensitive to oestrogens or if one is suspected (e.g. endometrial tumour) • If you have vaginal bleeding of unknown cause • If you have abnormal growth of the endometrium (endometrial hyperplasia) and you are not yet receiving treatment for this • If you have had in the past or currently have a blood clot in a vein (deep vein thrombosis or pulmonary embolism) of which the cause is unknown • If you have recently had or currently have a blocked artery, e.g. angina (heart spasm caused by lack of oxygen) or a myocardial infarction • If you have had in the past or you currently have liver disease. You cannot use TIBOLEEN until liver function has been restored. • If you have a blood pigment production defect (porphyria) • If you are allergic (hypersensitive) to tibolone, lactose or to any of the other ingredient اقرأ الوثيقة كاملة
222 x 340 1 mm P030 100% Dimensions: Scale: Material type: Leaflet Drawing #: Date: Version: A xxxxx 29.04.19 - PR TIB TIBOLEEN 2,5MG X28 EXELTIS MY Laetus #: Folded: YES NO Substitutes mat. #: Material #/ Product : LICONSA LEON FARMA X Launch: Internal change: Customer change: X Pantones: 170 X 37 mm die cut black 0000 Signature: Date: With the signed proof of this file you commit to have had reviewed and agreed with the following points as part of your review: - Keyline used. - Free varnish areas. - Colors. - Text. - Prefixes order for variable info (If the order is changed you commint to clearly comunicate this change to Chemo's artworks department, otherwise Chemo will not be responsible). - Any other info included in the file. DRAWED BY: APPROVED BY CUSTOMER (Regulatory Affair or Quality Assurance) FRONT SIDE / ANVERSO EXAMPLE / EJEMPLO Pharma Code Read Directions xxxxx Pharma Code Read Directions Pharma Code Read Directions TIBOLEEN 2.5MG TABLETS QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5mg Tibolone (I.N.N). PHARMACEUTICAL FORM White & round tablet. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS • Treatment of complaints resulting from the natural or artificial menopause. Women above 60 years of age should only start with tibolone treatment when they are intolerant of, or contraindicated for, other medicinal products approved for the treatment of estrogen deficiency symptoms. • 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. POSOLOGY AND METHOD OF ADMINISTRATION The dosage is one tablet per day. The tablets should be swallowed without chewing. Tablets must be taken in the order directed on the package every day at about the same time. One tablet is taken consecutively for 28 days until the pack is empty. Each subsequent pack is started after the completion of the previous pack. Improvement of symptoms generally occurs within a few w اقرأ الوثيقة كاملة