Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
DROSPIRENONE, ETHINYL ESTRADIOL
Clonmel Healthcare Ltd
G03AA12
DROSPIRENONE, ETHINYL ESTRADIOL
0.03/3 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, fixed combinations
Authorised
2013-08-23
• if you have or have ever had chloasma (a discoloration of the skin especially of the face or neck known as “pregnancy patches”). If so, avoid direct sunlight or ultraviolet light. • if you have hereditary angioedema, products containing oestrogens may cause or worsen symptoms. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or diffi- culty swallowing or hives together with difficulty breathing. CARMEN AND VENOUS AND ARTERIAL BLOOD CLOTS The use of any combination pill, including Carmen, increases a woman’s risk of developing a VENOUS BLOOD CLOT (VENOUS THROMBOSIS) compared with women who do not take any contraceptive pill. The risk of VENOUS BLOOD CLOTS in users of combination pills increases: • with increasing age • if you are overweight • if one of your close relatives ever had a blood clot in the leg, lung (pulmonary embolism), or other organ at a young age • if you have to have surgery, if you have had a serious accident or if you are immo- bilised for a long time. It is important to tell your doctor that you are using Carmen as you may have to stop taking it. Your doctor will tell you when to start again. This is usually about two weeks after you are back on your feet. Your chances of having a blood clot are increased by taking the Pill. – Of 100,000 women who are not on the Pill and not pregnant, about 5 – 10 may have a blood clot in a year. – Of 100,000 women taking a Pill like Carmen, 30 Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carmen 0.03mg/3mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone Excipients with known effects: Lactose monohydrate 62 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow round film-coated tablets of 5.7 mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral use. HOW TO TAKE CARMEN 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 CARMEN 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 Carmen 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 Carmen preferably on the day of removal, but at the latest when the next application would hav Прочитайте повний документ