Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Misoprostol
EXELGYN
G02AD06
Misoprostol
400 microgram(s)
Tablet
misoprostol
2019-11-08
Module 1.3.1.1 Package Leaflet IE – version 2021/12 Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER MISOONE 400 MICROGRAM TABLETS Misoprostol 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 MisoOne is and what it is used for 2. What you need to know before you take MisoOne 3. How to take MisoOne 4. Possible side effects 5. How to store MisoOne 6. Contents of the pack and other information 1. WHAT MISOONE IS AND WHAT IT IS USED FOR MisoOne tablets contain misoprostol, which is similar to a chemical substance called ‘prostaglandin’ that your body produces naturally. Misoprostol triggers contractions of the womb and softens the cervix. For medical termination of pregnancy: MisoOne is used after taking another medicine called mifepristone. It should be taken no later than 49 days after the first day of your last menstrual period. For surgical termination of pregnancy: MisoOne is taken on its own prior to surgical termination of pregnancy during the first trimester of pregnancy (within 12 weeks after the first day of your menstruation). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MISOONE DO NOT TAKE MISOONE - if you are allergic to misoprostol, any other prostaglandin or any of the other ingredients of this medicine (listed in section 6). - if the pregnancy has not been confirmed by ultrasound scan or biological tests. - if your doctor suspects an ectopic pregnancy (the egg is implanted outside the womb). - if you cannot take mifepristone (when mifepristone is used in combination with MisoOne). - for medical terminatio Lees het volledige document
Health Products Regulatory Authority 30 October 2020 CRN009K05 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MisoOne 400 microgram tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 400 microgram misoprostol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, flat tablets, with a diameter of 11 mm and thickness of 4.5 mm, with a break line on each side and double "M" engraved on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS For termination of pregnancy, the anti-progesteronemifepristone and the prostaglandin analogue misoprostol can only be prescribedand administered in accordance with the countries national laws and regulations. 4.1 THERAPEUTIC INDICATIONS Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea (see section 4.2). Cervix uteri preparation prior to surgical termination of pregnancy during the first trimester. Misoprostol is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology - Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea: Misoprostol is taken as a single 400 microgram oral dose 36 to 48 hours after taking a single 600 mg oral dose of mifepristone. Information on the posology of mifepristone can be found in the product information of mifepristone. Vomiting within 30 minutes after the intake could lead to a decrease in misoprostol efficacy: oral intake of a new misoprostol 400 microgram tablet is recommended in this case. - Cervix uteri preparation prior to surgical termination of pregnancy during the first trimester: Misoprostol is taken as a single 400 microgram oral dose 3 to 4 hours before surgical operation. Vomiting within 30 minutes after the intake could lead to a decrease in misoprostol efficacy: oral intake of a new misoprostol 400 microgram tablet is recommended in this case. Paediatric population Lees het volledige document