País: Sudáfrica
Idioma: inglés
Fuente: South African Health Products Regulatory Authority (SAHPRA)
Ranbaxy (SA) (Pty) Ltd
See ingredients
TABLET
EACH COMBIPACK CONTAINS MIFEPRISTONE 200,0 mg (ORAL TAB) MISOPROSTOL 0,2 mg (VAGINAL TAB)
Registered
Ranbaxy Pharmaceuticals (Pty) Ltd Medabon Co, oral and vaginal tablets Response to Clinical Evaluation Queries (dated 3 June 2021) Date submitted: 17 June 2021 Date of CC approval: 07 September 2021 1.3.2 Initials: Page 1 of 11 PROPOSED PATIENT INFORMATION LEAFLET FOR MEDABON CO PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 MEDABON CO ORAL AND VAGINAL TABLETS MIFEPRISTONE MISOPROSTOL Sugar free READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING MEDABON CO: Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. MEDABON CO has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET: 1. What MEDABON CO is and what it is used for 2. What you need to know before you use MEDABON CO 3. How to use MEDABON CO 4. Possible side effects 5. How to store MEDABON CO 6. Contents of the pack and other information Ranbaxy Pharmaceuticals (Pty) Ltd Medabon Co, oral and vaginal tablets Response to Clinical Evaluation Queries (dated 3 June 2021) Date submitted: 17 June 2021 Date of CC approval: 07 September 2021 1.3.2 Initials: Page 2 of 11 1. WHAT MEDABON CO IS AND WHAT IT IS USED FOR MEDABON CO is a combination therapy containing two medicines called mifepristone and misoprostol. MEDABON CO is recommended for the medical termination of a pregnancy no later than 63 days after the first day of your last menstrual period. Mifepristone is an anti-hormone that acts by blocking the effects of progesterone, a hormone which is needed for pregnancy to continue. Misoprostol is a prostaglandin, which is a substance that increases contraction of the womb that will help expel the pregnancy. The two medicines can therefore cause termination of pregnancy and must be used one after the other to give the best possible chance for the treatment to work. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEDABON CO DO NO Leer el documento completo
Ranbaxy Pharmaceuticals (Pty) Ltd Medabon Co, oral and vaginal tablets Response to Clinical Evaluation Queries1 (dated 3 June 2021) Date submitted: 17 June 2021 Date of CC Approval: 07-Sept-2021 1.3.1.1 Initials: Page 1 of 18 PROPOSED PROFESSIONAL INFORMATION FOR MEDABON CO SCHEDULING STATUS S4 1. NAME OF THE MEDICINE MEDABON CO ORAL AND VAGINAL TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each combipack of MEDABON CO contains one mifepristone oral tablet and four misoprostol vaginal tablets. Each mifepristone oral tablet contains 200 mg mifepristone. Each misoprostol vaginal tablet contains 0,2 mg misoprostol. Sugar free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORMS _MIFEPRISTONE: _ Tablet (for oral use). Light yellow, circular, biconvex, uncoated tablet, debossed with “S” on one side and plain on the other side. Diameter: 11,0 mm. _MISOPROSTOL: _ Vaginal tablet. White to off-white, rectangular shaped, uncoated tablet, debossed with a square on either side of the break line on one side and plain on the other side. Diameter: 11,6 mm x 6,3 mm. 4. CLINICAL PARTICULARS Ranbaxy Pharmaceuticals (Pty) Ltd Medabon Co, oral and vaginal tablets Response to Clinical Evaluation Queries1 (dated 3 June 2021) Date submitted: 17 June 2021 Date of CC Approval: 07-Sept-2021 1.3.1.1 Initials: Page 2 of 18 4.1 THERAPEUTIC INDICATIONS MEDABON CO is indicated for medical termination of developing intra-uterine pregnancy of up to 63 days of amenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY 200 mg of mifepristone (one tablet) is taken in a single oral dose, followed 36 to 48 hours later by the administration of misoprostol 0,8 mg (i.e. 4 vaginal tablets of 0,2 mg each) vaginally in a single dose. If the patient vomits shortly after administration of mifepristone, she should inform the doctor. MEDABON CO has only been studied in women over the age of 18. MEDABON CO has not been evaluated for use in children and adolescents._ _ METHOD OF ADMINISTRATION:_ _ The mifepristone tablet is f Leer el documento completo