দেশ: সুইডেন
ভাষা: সুইডিশ
সূত্র: Läkemedelsverket (Medical Products Agency)
estradiolvalerat; noretisteronacetat
Dr. Kade Pharmazeutische Fabrik GmbH
G03FA01
estradiol valerate; norethisterone
1 mg/0,5 mg
Tablett
estradiolvalerat 1,31 mg Aktiv substans; noretisteronacetat 0,5 mg Aktiv substans; laktosmonohydrat Hjälpämne
Apotek
Receptbelagt
Noretisteron och östrogen
Förpacknings: Blister, 28 tabletter (PP); Blister, 30 tabletter (PP); Blister, 84 tabletter (PP); Blister, 90 tabletter (PP); Blister, 28 tabletter (plast/Al); Blister, 30 tabletter (plast/Al); Blister, 84 tabletter (plast/Al); Blister, 90 tabletter (plast/Al)
Godkänd
2006-02-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Cliovellan 1 mg/0.5 mg tablets Estradiol/Norethisterone Acetate READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THE LEAFLET 1. What Cliovellan is and what it is used for 2. What you need to know before you take Cliovellan 3. How to take Cliovellan 4. Possible side effects 5. How to store Cliovellan 6. Contents of the pack and other information 1. WHAT CLIOVELLAN IS AND WHAT IT IS USED FOR Cliovellan is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen and a progestogen. Cliovellan is used in postmenopausal women with at least 1 year since their last natural period. Cliovellan 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”). Cliovellan alleviates these symptoms after menopause. You will only be prescribed Cliovellan 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 use Cliovellan to prevent osteoporosis after menopause. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLIOVELLAN MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT carries risks which need to be considered when deciding whether to st সম্পূর্ণ নথি পড়ুন
Produktinformationen för Cliovellan 1mg/0,5 mg tablett, MTnr 20837, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. S U M M A R Y O F P R O D U C T C H A R A C T E R I S T I C S 1. NAME OF THE MEDICINAL PRODUCT Cliovellan 1 mg/0.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains estradiol 1 mg (as estradiol valerate) and norethisterone acetate 0.5 mg. Excipient: lactose 65.78 mg. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablets White, round, flat tablets, 6 mm in diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for estrogen deficiency symptoms in women more than one year after menopause. 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. The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cliovellan is a preparation for the continuous combined hormone replacement treatment of women with an intact uterus. One tablet is taken daily without interruption, preferably at the same time of 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. Changing over to a combination product with a higher dose should be considered if after 3 months the treatment has not resulted in satisfactory symptom relief. Women with amenorrhoea not taking HRT or women transferring from another co সম্পূর্ণ নথি পড়ুন