Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TIBOLONE
ORGANON MALAYSIA SDN. BHD.
TIBOLONE
28Tablet Tablets; 28 Tablets
N.V. ORGANON
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LIVIAL TABLET ® Tibolone (2.5 mg) 1 Copyright 2022 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET: 1. What _LIVIAL _ is used for 2. How _LIVIAL _ works 3. Before you take _LIVIAL _ 4. How to take _LIVIAL _ 5. While you are taking _LIVIAL _ 6. Side effects 7. Storage and Disposal of _LIVIAL _ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _LIVIAL _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”). _LIVIAL _ alleviates these symptoms after menopause. You will only be prescribed _LIVIAL _ if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS To prevent osteoporosis (fragile bones) in women who are at high risk of fractures after menopause. You can take _LIVIAL _ if other medicines are not suitable for you. HOW _LIVIAL _WORKS _LIVIAL _ is a Hormone Replacement Therapy (HRT). _LIVIAL _ contains tibolone, a substance that has favorable effects on different tissues in the body, such as brain, vagina and bone. _LIVIAL _ is used in postmenopausal women with at least 12 months since their last natural period. This results in the relief of climacteric symptoms such as hot flushes and night sweats, a beneficial effect on the lining of the vagina and a favorable effect on mood and sexual desire. _LIVIAL _ can also stop the process of bone loss that occurs after the menopause in your spine, hip and wrists. Unlike some hormone replacement therapies, _LIVIAL _ does not stimulate the lining of the womb. Treatment with _LIVIAL _ therefore does not lead to monthly vaginal bleeding. BEFORE YOU TAKE _LIVIAL _ _ _ _-_ _ _ _When you must not take it _ DO NOT TAKE _LIVIAL _ If any of the following applies to you. If you are not sure about any of the points below, TALK TO YOUR DOCTOR before taking _LIVIAL_ . Do not take _LIVIA Lees het volledige document
LOCAL PRODUCT CIRCULAR LIVIAL RA 1850 CCDS 1850 12 (12.0A) TIBOLONE, 2.5 MG 1. NAME OF THE MEDICINAL PRODUCT Livial 2.5 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of tibolone. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet. White, round and flat tablets with beveled edges and a diameter of 6 mm and coded “MK” above “2” on one side and “Organon ” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of complaints resulting from the natural or artificial menopause. 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 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage is one tablet per day. No dose adjustment is necessary for the elderly. 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 Livial treatment. STARTING LIVIAL Women experiencing a natural menopause should commence treatment with Livial at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Livial may commence immediately. SWITCHING FROM A SEQUENTIAL OR CONTINUOUS COMBINED HRT PREPARATION If changing from a sequential HRT preparation, treatment with Livial should start the day following completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time. MISSED DOSE A missed dose should be taken as soon as remembered, unless it is more than 12 hours over Lees het volledige document