Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
estetrol monohydrate, drospirenone
Estetra SPRL
G03
estetrol, drospirenone
Sex hormones and modulators of the genital system,
Contraceptives, Oral
Oral contraception.The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Revision: 3
Authorised
2021-05-19
23 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE USER LYDISILKA 3 MG/14.2 MG FILM-COATED TABLETS drospirenone/estetrol This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Lydisilka is and what it is used for 2. What you need to know before you take Lydisilka 3. How to take Lydisilka 4. Possible side effects 5. How to store Lydisilka 6. Contents of the pack and other information 1. WHAT LYDISILKA IS AND WHAT IT IS USED FOR Lydisilka is a contraceptive pill that is used to prevent pregnancy. - The 24 pink film-coated tablets are active tablets that contain a small amount of two different female hormones, namely estetrol and drospirenone. - The 4 white film-coated tablets are inactive tablets that do not contain hormones and are called placebo tablets. - Contraceptive pills that contain two different hormones, like Lydisilka, are c Perskaitykite visą dokumentą
23 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Lydisilka 3 mg/14.2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pink active tablet contains 3 mg drospirenone and estetrol monohydrate equivalent to 14.2 mg estetrol. Each white placebo tablet does not contain active substances. Excipient with known effect Each pink active tablet contains 40 mg lactose monohydrate. Each white placebo tablet contains 68 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). The active film-coated tablet is pink, 6 mm diameter, round, biconvex with a drop-shaped logo embossed on one side. The placebo film-coated tablet is white to off-white, 6 mm diameter, round, biconvex with a drop-shaped logo embossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology and method of administration _How to take Lydisilka _ Oral use. 3 One tablet is to be taken daily for 28 consecutive days. 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. Each pack starts with 24 pink active tablets, followed by 4 white placebo tablets. Each subsequent pack is started the day after the last tablet of the previous pack. Stickers marked with the 7 days of the week are provided, and the relevant weekday sticker should be stuck on the Perskaitykite visą dokumentą