Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
oestrogens conjugated, bazedoxifene
Pfizer Europe MA EEIG
G03CC07
oestrogens conjugated, bazedoxifene
conjugated estrogens and bazedoxifene
Postmenopause
Duavive is indicated for:Treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.The experience treating women older than 65 years is limited.
Revision: 15
Authorised
2014-12-16
31 B. PACKAGE LEAFLET 32 Package leaflet: Information for the patient DUAVIVE 0.45 mg/20 mg modified-release tablets conjugated oestrogens/bazedoxifene 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 DUAVIVE is and what it is used for 2. What you need to know before you take DUAVIVE 3. How to take DUAVIVE 4. Possible side effects 5. How to store DUAVIVE 6. Contents of the pack and other information 1. What DUAVIVE is and what it is used for DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and bazedoxifene. Conjugated oestrogens is a medicine that belongs to a group of medicines called hormone replacement therapy (HRT). Bazedoxifene belongs to a group of non-hormonal medicines called selective oestrogen receptor modulators (SERMs). DUAVIVE is used in postmenopausal women who still have their uterus (womb) and have not had a natural period in the last 12 months. DUAVIVE is used for: Relief of symptoms occurring after menopause During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). DUAVIVE alleviates these symptoms after menopause. You will only be prescribed this medicine if your symptoms seriously hinder your daily life and your doctor determines that other types of HRT are not appropriate for you. 2. What you need to know before you take DUAVIVE Medical history and regular check-ups The use of DUAVIVE carries risks, which need to be considered when decidi Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT DUAVIVE 0.45 mg/20 mg modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene. Excipients with known effect Each modified-release tablet contains 96.9 mg sucrose (includes 0.7 mg sucrose as sucrose monopalmitate), 62.9 mg lactose (as monohydrate), 0.2 mg maltitol liquid, 0.0176 mg glucose, and 0.0088 mg sorbitol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablet. Pink, oval-shaped, modified-release tablet of 12 mm printed on one side with “0.45/20”. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications DUAVIVE is indicated for the treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate. The experience treating women older than 65 years is limited. 4.2 Posology and method of administration Posology For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used (see section 4.4). The recommended dose is 0.45 mg conjugated oestrogens (CE) and 20 mg bazedoxifene (BZA) taken as a single oral tablet, once daily. If a tablet is forgotten, it should be taken as soon as the patient remembers. Therapy should then be continued as before. If more than one tablet has been forgotten, only the most recent tablet should be taken, the patient should not take double the usual dose to make up for missed tablets. Special populations Elderly CE/BZA has not been studied in women over 75 years of age. Based on available data no dosage adjustment is necessary based on age (see section 5.2). The experience treating women older than 65 years is limited. 3 Renal impairment The pharmacokinetics of CE/BZA have not been evaluated in patients with renal impairm Aqra d-dokument sħiħ