Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ETHINYLESTRADIOL GESTODENE
Bayer Limited
ETHINYLESTRADIOL GESTODENE
Transdermal Patch
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER apleek 60 micrograms/24 hours + 13 micrograms/24 hours transdermal patch gestodene/ethinylestradiol 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 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 apleek is and what it is used for .......................................................................................... 2 2. What you need to know before you use apleek ............................................................................ 2 Do not use apleek ......................................................................................................................... 3 Warnings and precautions ............................................................................................................ 4 BLO Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 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 apleek 60 micrograms/24 hours + 13 micrograms/24 hours transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 11 cm 2 transdermal patch contains 2.10 mg gestodene and 550 micrograms ethinylestradiol. Each transdermal patch releases 60 micrograms gestodene per 24 hours and 13 micrograms ethinylestradiol (equal to oral doses of 20 micrograms) per 24 hours. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Thin matrix-type transdermal patch consisting of five layers. The patch is round, transparent, and has a size of 11 cm 2 . On its sticky side the patch is covered by a two-part square- shaped shiny clear protective liner. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Female hormonal contraception. apleek is intended for women of fertile age. Safety and efficacy have been established in women aged 18 to 45 years. The decision to prescribe apleek should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with apleek compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology apleek is used in a 28-day (4-week) cycle: For three consecutive weeks (21 days), one new patch is applied per week and the used patch removed. Week Four is patch-free. Withdrawal bleeding is expected to begin during this time. One week after the last patch is r Read the complete document