देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
DROSPIRENONE, ETHINYLESTRADIOL
Clonmel Healthcare Ltd
G03AA12
DROSPIRENONE, ETHINYLESTRADIOL
0.02/3 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, fixed combinations
Authorised
2013-08-23
NL/H/2631/001/IB/003 1 PACKAGE LEAFLET: INFORMATION FOR THE USER CARMENELLE 0.02 MG/3 MG FILM-COATED TABLETS ETHINYLESTRADIOL/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, pharmacist or nurse. This medicine has been prescribed for you only. Do no 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 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”) WHAT IS IN THIS LEAFLET: 1. WHAT CARMENELLE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARMENELLE When you should not use Carmenelle Warnings and precautions Carmenelle and venous and arterial blood clots Carmenelle and cancer Bleeding between periods What to do if no bleeding occurs during the gap week Other medicines and Carmenelle Taking Carmenelle with food, drink and alcohol Laboratory tests Pregnancy, breast-feeding and fertility Driving and using machines Carmenelle contains lactose 3. HOW TO TAKE CARMENELLE When can you start with the first strip? If you take more Carmenelle than you should If you forget to take Carmenelle What to do in the case of vomiting or severe diarrhoea NL/H/2631/001/IB/003 2 Delaying your period: what you need to kno पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carmenelle 0.02mg/3mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone Excipients with known effect: Lactose monohydrate 44 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, round film-coated tablets of 5.7 mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Carmenelle should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Carmenelle compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral use. HOW TO TAKE CARMENELLE 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 CARMENELLE 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 Carmenelle 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 Carmenelle preferably on the day of removal, but at the latest when the next पूरा दस्तावेज़ पढ़ें