Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Mifepristone
Nordic Group B.V.
G03XB01
Mifepristone
600 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
mifepristone
2018-11-30
Mifegyne 600 mg tablets Module 1.3.1.3 Package leaflet Version 2019/07 1 PACKAGE LEAFLET: INFORMATION FOR THE USER MIFEGYNE 600 MG TABLETS MIFEPRISTONE 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. - This medicine has been prescribed for you only. Do not 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Mifegyne is and what it is used for 2. What you need to know before you take Mifegyne 3. How to take Mifegyne 4. Possible side effects 5. How to store Mifegyne 6. Contents of the pack and other information 1. WHAT MIFEGYNE IS AND WHAT IT IS USED FOR Mifegyne tablets contain mifepristone which is an anti-hormone that acts by blocking the effects of progesterone, a hormone which is needed for pregnancy to continue. Mifegyne can therefore cause termination of pregnancy. It can also be used to soften and open the entrance (the cervix) to the womb (uterus)_._ Mifegyne is recommended to be used 1) For the medical termination of a pregnancy: - no later than 63 days after the first day of your last menstrual cycle, - in combination with a second medicine, a prostaglandin (a substance that triggers contractions of the womb and softens the cervix), which you take 36 to 48 hours after taking Mifegyne. 2) As pre-treatment before giving prostaglandin for termination of pregnancy for medical reasons beyond 3 months pregnancy. 3) To induce labour in cases where the foetus has died in the womb and where it is not possible to use other medical treatments (prostaglandin or oxytocin). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIFEGYNE DO NOT TAKE MIFEGYNE • IN ALL CASES, - if you are allergic to mifepristone or any of the other ingredients of Prečítajte si celý dokument
Health Products Regulatory Authority 23 August 2019 CRN008SPP Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mifegyne 600 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg mifepristone. _For the full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Tablet. Biconvex, light yellow, almond shaped tablet with a length of 19 mm and a width of 11 mm, with γ engraved on one side and 600 on the other side. 4 CLINICAL PARTICULARS For termination of pregnancy, the anti-progesterone mifepristone and the prostaglandin analogue can only be prescribed and administered in accordance with the countries national laws and regulations. 4.1 THERAPEUTIC INDICATIONS 1-MEDICAL TERMINATION OF DEVELOPING INTRA-UTERINE PREGNANCY. In sequential use with a prostaglandin analogue, up to 63 days of amenorrhea (see section 4.2). 2-PREPARATION FOR THE ACTION OF PROSTAGLANDIN ANALOGUES IN THE TERMINATION OF PREGNANCY FOR MEDICAL REASONS _(BEYOND _ _THE FIRST TRIMESTER)_. 3-LABOUR INDUCTION IN FOETAL DEATH IN UTERO. In patients where prostaglandin or oxytocin cannot be used. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 1-MEDICAL TERMINATION OF DEVELOPING INTRA-UTERINE PREGNANCY The method of administration will be as follows: - Up to 49 days of amenorrhea: Mifepristone is taken as a single 600 mg (i.e. 1 tablet of 600 mg) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue: misoprostol 400 µg orally, or gemeprost 1 mg per vaginam. - Between 50-63 days of amenorrhea Mifepristone is taken as a single 600 mg (i.e. 1 tablet of 600 mg) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam. Information on the posology of misoprostol or gemeprost can be found in the respective product information. 2-PREPARATION FOR THE ACTION OF PROSTAGLANDIN ANALOGUES IN THE TERMINATION OF PREGNANCY FOR MEDICAL REASONS Mifepristone is taken as a single 600 mg (i.e. 1 tablet of 600 mg) o Prečítajte si celý dokument