Pays: Malte
Langue: anglais
Source: Medicines Authority
DROSPIRENONE, ESTRADIOL HEMIHYDRATE
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
G03FA17
DROSPIRENONE 2 mg ESTRADIOL HEMIHYDRATE 1 mg
FILM-COATED TABLET
DROSPIRENONE 2 mg ESTRADIOL HEMIHYDRATE 1 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2005-10-05
BP23029_REC31756 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ANGELIQ 1 MG / 2 MG FILM-COATED TABLETS Oestradiol / Drospirenone 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 : For the LEAFLET version of the Angeliq package insert the table of content contains only the major headings 1 to 6: 1. What Angeliq is and what it is used for ..................................................................................................................1 2. What you need to know before you take Angeliq ...................................................................................................2 3. How to take Angeliq ..............................................................................................................................................7 4. Possible side effects ...............................................................................................................................................7 5. How to store Angeliq .............................................................................................................................................9 6. Contents of the pack and other information .......................................................................................................... 10 1. WHAT ANGELIQ IS AND WHAT IT IS USED FOR Angeliq is a Hormone Replacement Therapy (HRT). It contains two types of female hormone, an oestrogen and a progestogen. Angeliq is used in postmenopausal women with at least 1 year since their last natural period. Lire le document complet
1 BP23029_REC31756 SUMMARY OF PRODUCT CHARACTERISTICS 2 BP23029_REC31756 1. NAME OF THE MEDICINAL PRODUCT Angeliq 1 mg/2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 1 mg oestradiol (as oestradiol hemihydrate) and 2 mg drospirenone. Excipient with known effect: 46 mg lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet Medium red, round tablet with convex faces, one side embossed with the letters DL in a regular hexagon. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women more than 1 year post 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 treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Women who do not take hormone replacement therapy (HRT) or women who change from another continuous combined product may start treatment at any time. Women changing from a cyclic, sequential combined HRT regimen, treatment should begin the day following completion of the prior regimen. Posology One tablet is taken daily. Each blister is for 28 days of treatment. Method of 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. If a tablet is forgotten it should be taken as soon as possible. If more than 3 BP23029_REC31756 24 hours have elapsed no extra tablet needs to be taken. If several tablets are forgotten, vaginal bleeding may occur. For treatment of post menopausal symptoms, the lowest effective dose should be used. For initiation and continuation of treatment of postmenopausal symptoms, the lowest eff Lire le document complet