Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Misoprostol
Nordic Pharma Ltd
G02AD06
Misoprostol
400microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07010100; GTIN: 08718481142301
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER Topogyne 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. What is in this leaflet : 1. What Topogyne is and what it is used for 2. What you need to know before you take Topogyne 3. How to take Topogyne 4. Possible side effects 5. How to store Topogyne 6. Contents of the pack and other information 1. What Topogyne is and what it is used for Topogyne 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. Topogyne is used after taking another medicine called mifepristone for termination of pregnancy. It should be taken no later than 49 days after the first day of your last menstrual period. 2. What you need to know before you take Topogyne Do not take Topogyne - 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 the first day of your last period was more than 49 days (7 weeks) ago - if your doctor suspects an ectopic precnancy (the egg is implanted outside the womb) - if you cannot take mifepristone (mifepristone is used in combination with Topogyne) Warnings and precautions Talk to your doctor before taking Topogyne - if you have liver or kidney disease - if you suffer from anaemia or malnutrition - if you have cardiovascular disease (heart or circulatory disease) - if you are a Izlasiet visu dokumentu
OBJECT 1 TOPOGYNE 400 MICROGRAM TABLETS Summary of Product Characteristics Updated 28-Mar-2014 | Exelgyn 1. Name of the medicinal product Topogyne 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 4.4 mm, with "M400" engraved on one side. 4. Clinical particulars For termination of pregnancy, the anti-progesterone mifepristone and the prostaglandin analogue misoprostol can only be prescribed and 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). Misoprostol is indicated in adults. 4.2 Posology and method of administration Posology 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. Paediatric population Only limited data is available on the use of misoprostol in adolescents. Method of administration Misoprostol tablets are FOR ORAL USE ONLY and should not be administered by any other route of administration. 4.3 Contraindications - Hypersensitivity to misoprostol or other prostaglandins, or to any of the excipients listed in section 6.1 - Pregnancy not confirmed by ultrasound scan or biological tests - Suspected ectopic pregnancy - Contraindication for mifepristone - Pregnancy beyond 49 days of amenorrhea As misoprostol is used in combination with mifepristone, please refer to the contraindications for this mifepristone as well. 4.4 Special warnings and precautions Izlasiet visu dokumentu