Země: Švédsko
Jazyk: švédština
Zdroj: Läkemedelsverket (Medical Products Agency)
estradiolvalerat; noretisteronacetat
Paranova Läkemedel AB
G03FA01
estradiol valerate; norethisterone
1 mg/0,5 mg
Tablett
laktosmonohydrat Hjälpämne; noretisteronacetat 0,5 mg Aktiv substans; estradiolvalerat 1,31 mg Aktiv substans
Apotek
Receptbelagt
Noretisteron och östrogen
Avregistrerad
2015-05-13
PACKAGE LEAFLET: INFORMATION FOR THE USER CLIOVELLE 1 MG/0.5 MG TABLETS Estradiol/Norethisterone Acetate READ ALL OF 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 THIS LEAFLET 1. What Cliovelle is and what it is used for 2. What you need to know before you take Cliovelle 3. How to take Cliovelle 4. Possible side effects 5. How to store Cliovelle 6. Contents of the pack and other information 1. WHAT CLIOVELLE IS AND WHAT IT IS USED FOR Cliovelle is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. Cliovelle is used in postmenopausal women with at least 1 year since their last natural period. Cliovelle is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Cliovelle alleviates these symptoms after menopause. You will only be prescribed Cliovelle 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 Cliovelle to prevent osteoporosis after menopause. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLIOVELLE MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT carries risks which need to be considered when deciding whether to start taking it, o Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cliovelle 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 with known effect: lactose 65.78 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, round, biconvex 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 (see also section 4.4). The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Cliovelle 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. Method of administration Oral use. Women with amenorrhoea not taking HRT or women transferring from another continuous combined HRT product can start treatment with Cliovelle on any convenient day. For women transferring from sequential preparations the treatment should be started immediately after withdrawal bleeding has stopped. Missed dose If the patient forgets to take a tablet she can take it within 12 hours of the usual time, otherwise the forgotten tablet must be discarded. Missed doses can increase the likelihood of breakthrough bleeding and spotting. 4.3 CONTRAINDICATIONS - Known, past or s Přečtěte si celý dokument