Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Drospirenone; Ethinylestradiol
Actavis UK Ltd
G03AA12
Drospirenone; Ethinylestradiol
3mg ; 30microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030100; GTIN: 5012617024565
Drospirenone Ethinylestradiol 3mg 30mcg Tablets PIL UK item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. 2. 3. 4. 5. 6. 1. 2. 3. date sent: supplier: approved: min pt size: TECHNICAL APPROVAL black AAAI0410 5 22.6.15 db 8.9.15 db León Farma 222 x 510 7 pt 22.6.15 8.9.15 * Please note that only Actavis Global Artwork Studios are permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): • They are one of the most reliable reversible methods of contraception if used correctly. • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks. • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”). 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. • 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 Cleosensa is and what it is used for 2. What you need to know before you take Cleosensa 3. How to take Cleosensa 4. Possible side effects 5. How to store Cleosensa 6. Contents of the pack and other information 1. WHAT CLEOSENSA IS AND WHAT IT IS USED FOR Cleosensa is a contraceptive pill and is used to prevent pregnancy. Each tablet contains a small amount of two different female hormones, namely drospirenone and et Leggi il documento completo
OBJECT 1 CLEOSENSA 0.03MG/3MG FILM-COATED TABLETS Summary of Product Characteristics Updated 20-Nov-2015 | Accord-UK Ltd 1. Name of the medicinal product Cleosensa 0.03mg/3mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone. Excipient with known effect: Each film-coated tablet contains 62 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Yellow, round, plain, 5.7x3.5 mm, film-coated tablets. 4. Clinical particulars 4.1 Therapeutic indications Oral contraception The decision to prescribe Cleosensa should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Cleosensa compares with other CHCs (see sections 4.3 and 4.4). 4.2 Posology and method of administration Posology The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the blister pack. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. How to start Cleosensa - No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). - Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start with Cleosensa preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using Cleosensa Leggi il documento completo