Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Tibolone
PCO Manufacturing Ltd.
G03CX; G03CX01
Tibolone
2.5 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Other estrogens; tibolone
Authorised
2001-09-07
_ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LIVIAL ® 2.5 MG TABLETS tibolone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE Keep this leaflet. You may need to read it again. If you have any further questions or need more advice, ask your doctor, family planning nurse or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them. If any of the side effects gets severe, or if you notice any not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT LIVIAL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIVIAL 3. HOW TO TAKE LIVIAL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LIVIAL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT LIVIAL IS AND WHAT IT IS USED FOR Livial is a Hormone Replacement Therapy (HRT). Livial contains tibolone, and is used in postmenopausal women with at least 12 months since their last natural period. 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. If indicated: 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. In section 6 “Contents of the pack and other information” you can find more information about Livial and what it is used for. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIVIAL MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT or Livial carries risks which need to be considered when deciding whether to start taking it, or whether to carry on ta Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 09 June 2022 CRN00CZ44 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Livial 2.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of tibolone. Excipients: also includes lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from Greece, Spain, the United Kingdom and Czech Republic:_ White, circular, flat tablet with bevelled edges, coded ‘MK’ above ‘2’ on one side and ‘Organon’ and a star on the reverse side. 4 CLINICAL PARTICULARS As per PA23198/021/001 5 PHARMACOLOGICAL PROPERTIES As per PA23198/021/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Potato starch Magnesium stearate Ascorbyl palmitate Lactose monohydrate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package in order to protect from light and moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Blisters of 28 or 30 tablets in a carton. Not all pack sizes may be marketed. Health Products Regulatory Authority 09 June 2022 CRN00CZ44 Page 2 of 2 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 MARKETING AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 MARKETING AUTHORISATION NUMBER PPA0465/081/001 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/081/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07 September 2001 Date of last renewal: 07 September 2006 Last updated: October 2016 La Lesen Sie das vollständige Dokument