Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
ETHINYLESTRADIOL DROSPIRENONE
Bayer Limited
ETHINYLESTRADIOL DROSPIRENONE
0.03/3 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER Palandra 0.03 mg / 3 mg film-coated tablets Ethinylestradiol / Drospirenone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. _ _ _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, do not pass it on to others. It may harm _ _them. _ _ _ _If any of the side effects gets serious, or if you notice any side effects not listed in this _ _leaflet, please tell your doctor or pharmacist_._ _ 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”). IN THIS LEAFLET 1. WHAT PALANDRA IS AND WHAT IT IS USED FOR ......................... 3 2. BEFORE YOU TAKE PALANDRA ...................................................... 3 When you should not use Palandra .................................................... 3 When do you need to take special care with Palandra ........................ 4 Palandra and thrombosis ..................... ERROR! BOOKMARK NOT DEFINED. Palandra and cancer ........................................................................ 10 Bleeding between periods ................................................................ 10 What you must do if no bleeding occurs in the gap week ................. 10 Palandra and using other read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Palandra 0.03 mg / 3 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.030 mg ethinylestradiol and 3 mg drospirenone Excipient: lactose 46 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Light yellow, round tablet with convex faces, one side embossed with the letters "DO" in a regular hexagon 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Palandra should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Palandra compares with other combined hormonal contraceptives (CHCs), see sections 4.3 and 4.4. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral use HOW TO TAKE PALANDRA 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 PALANDRA • 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 Palandra preferably on the day after the last active tablet (the last tablet containing the active substances) of her read_full_document