Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mycophenolate sodium
Accord-UK Ltd
L04AA06
Mycophenolate sodium
180mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020100; GTIN: 5055565734582
PACKAGE LEAFLET: INFORMATION FOR THE USER MYCOPHENOLIC ACID 180 MG GASTRO-RESISTANT TABLETS Mycophenolic acid 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 or pharmacist or nurse. - 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What Mycophenolic acid gastro-resistant tablets is and what it is used for 2. What you need to know before you take Mycophenolic acid gastro-resistant tablets 3. How to take Mycophenolic acid gastro-resistant tablets 4. Possible side effects 5. How to store Mycophenolic acid gastro-resistant tablets 6. Contents of the pack and other information 1. WHAT MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS IS AND WHAT IT IS USED FOR Mycophenolic acid gastro-resistant tablets contains a substance called mycophenolic acid. This belongs to a group of medicines called immunosuppressants. Mycophenolic acid gastro-resistant tablets is used to stop the body’s immune system from rejecting a kidney transplant. It is used together with other medicines containing ciclosporin and corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS WARNING Mycophenolic acid causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor will speak to you and give you written information, particularly on the effects of mycophenolic acid on unborn babies. Read the information carefully and follow the instructions. If you do not fully understand these ins Přečtěte si celý dokument
OBJECT 1 MYCOPHENOLIC ACID 180MG GASTRO- RESISTANT TABLETS Summary of Product Characteristics Updated 26-May-2022 | Accord Healthcare Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Mycophenolic acid 180mg gastro-resistant tablets 2. Qualitative and quantitative composition Mycophenolic acid 180 mg gastro-resistant tablets: Each gastro-resistant tablet contains 180 mg mycophenolic acid (as mycophenolate sodium). Each tablet contains 13.9 mg (0.61 mmol) sodium For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant tablet 180 MG: Lime Green colored, round shaped, biconvex bevelled edged enteric-coated tablets imprinted with M1 on one side with black ink and plain on the other side Note: Diameter of the tablet is 10.80 ± 0.2 mm 4. Clinical particulars 4.1 Therapeutic indications Mycophenolic acid is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients rec Přečtěte si celý dokument