Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
norelgestromin, Ethinyl estradiol
Gedeon Richter Plc.
G03AA13
norelgestromin, ethinyl estradiol
Sex hormones and modulators of the genital system,
Contraception
Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
Revision: 25
Authorised
2002-08-22
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER EVRA 203 MICROGRAMS/24 HOURS + 33.9 MICROGRAMS/24 HOURS TRANSDERMAL PATCH norelgestromin/ethinyl estradiol 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 get symptoms of a blood clot (see section 2 “Blood clots”). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What EVRA is and what it is used for 2. What you need to know before you use EVRA 3. How to use EVRA 4. Possible side effects 5. How to store EVRA 6. Contents of the pack and other information 1. WHAT EVRA IS AND WHAT IS IT USED FOR EVRA contains two types of sex hormones, a progestogen called norelgestromin and an oestrogen called ethinyl estradiol. Because it contains two hormones, EVRA is called a ‘combined hormonal contraceptive’. It is used to prevent pregnancy. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EVRA GENERAL NOTES Before you start using EVRA you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”. WHEN YOU SHOULD NOT USE EVRA You should not use EVRA if you have any of the conditions listed below. If you do have any of the conditions liste Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 cm 2 transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE). Each transdermal patch releases an average of 203 micrograms of NGMN and 33.9 micrograms of EE per 24 hours. Medicinal product exposure is more appropriately characterised by the pharmacokinetic profile (see section 5.2). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal patch. Thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and heat-stamped “EVRA”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Female contraception EVRA is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years. The decision to prescribe EVRA should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with EVRA compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology To achieve maximum contraceptive effectiveness, patients must be advised to use EVRA exactly as directed. For initiation instructions see ‘How to start EVRA’ below. Only one transdermal patch is to be worn at a time. Each used transdermal patch is removed and immediately replaced with a new one on the same day of the week (Change Day) on Day 8 and Day 15 of the cycle. Transdermal patch changes may occur at any time on the scheduled Change Day. The fourth week is transdermal patch-free starting on Day 22. A new contraceptive cycle begins on the next day following transdermal patch-free week; the next EVRA transdermal patch should be applied even if there has been no withdrawal bleeding or if withdrawal bleeding has not yet stopped. Under no circumstances should there be more than a 7-da Izlasiet visu dokumentu