Krajina: Južná Afrika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Bayer (Pty) Ltd û Isando
See ingredients
TABLET
EACH TABLET CONTAINS DROSPIRENONE 2,0 mg OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL 1,0 mg
Registered
2006-04-05
APPLICANT/PHRC: Bayer (Pty) Ltd DOSAGE FORM AND STRENGTH: Estradiol 1,0 mg plus drospirenone 2,0 mg per tablet PRODUCT PROPRIETARY NAME: ANGELIQ CCDS11/0715/SA2/0922 Page 1 of 9 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S4 ANGELIQ 1 MG/2 MG FILM-COATED TABLET ESTRADIOL (AS ESTRADIOL HEMIHYDRATE)/DROSPIRENONE CONTAINS SUGAR (LACTOSE MONOHYDRATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ANGELIQ • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse, or other health care provider. • ANGELIQ has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What ANGELIQ is and what it is used for 2. What you need to know before you take ANGELIQ 3. How to take ANGELIQ 4. Possible side effects 5. How to store ANGELIQ 6. Contents of the pack and other information 1. WHAT ANGELIQ IS AND WHAT IT IS USED FOR ANGELIQ is for hormone replacement therapy. ANGELIQ provides hormone replacement therapy for the treatment of climacteric complaints in postmenopausal women, such as hot flushes and sweating attacks, sleep disorders, depressed moods, nervousness and signs of involution of the bladder and genital organs. It is also used for treating complaints that are due to greatly decreased activity of the sexual organs (hypogonadism), following the removal of the ovaries or when the ovaries do not work (primary ovarian failure). ANGELIQ is suitable for women who still have a womb (intact uterus). Some women are more likely than others to develop osteoporosis in later life depending on their medical history and lifestyle. If it is appropriate you may be prescribed ANGELIQ to prevent osteoporosis. Your doctor will be able to advise you further. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGELIQ Your doctor will carry out gynaecological, breast, blood pressure and other examinations as appropriate. If you are known to h Prečítajte si celý dokument
APPLICANT/PHRC: Bayer (Pty) Ltd DOSAGE FORM AND STRENGTH: Estradiol 1,0 mg plus drospirenone 2,0 mg per tablet PRODUCT PROPRIETARY NAME: ANGELIQ CCDS11/0715/SA2/0922 Page 1 of 14 SCHEDULING STATUS S4 1. NAME OF THE MEDICINE ANGELIQ Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The pack contains 28 hormonal red film-coated tablets each with estradiol 1,0 mg (as estradiol hemihydrate 1,033 mg) and drospirenone 2,0 mg. Contains sugar (48,2 mg lactose monohydrate per tablet). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Medium red, round film-coated tablets with convex faces, one side marked with the letters DL in a regular hexagon. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Hormone replacement therapy for the treatment of symptoms associated with the climacteric syndrome including vasomotor symptoms (such as hot flushes and sweating attacks), and atrophic urogenital conditions. To reduce the risk of postmenopausal osteoporosis in women with an intact uterus. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY One tablet is taken daily. Each blister pack is for 28 days of treatment. _How to start ANGELIQ _ Women who do not take estrogens or women who change from a continuous combination product may start treatment at any time. Patients changing from a sequential combined hormone replacement therapy should start treatment at the end of the scheduled bleeding. _Administration _ The tablets are to be swallowed whole with some liquid irrespective of food intake. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets should preferably be taken at the same time every day. APPLICANT/PHRC: Bayer (Pty) Ltd DOSAGE FORM AND STRENGTH: Estradiol 1,0 mg plus drospirenone 2,0 mg per tablet PRODUCT PROPRIETARY NAME: ANGELIQ CCDS11/0715/SA2/0922 Page 2 of 14 _Missed tablets _ If a tablet is forgotten it should be taken as soon as possible. If more than 24 hours have elapsed, no extra tablet needs to be taken. If several tablets are Prečítajte si celý dokument