Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mycophenolate mofetil
DE Pharmaceuticals
L04AA06
Mycophenolate mofetil
250mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020100
1 uk-ie-mt-pil-cellcept-clean-180809-250mg-caps PACKAGE LEAFLET: INFORMATION FOR THE USER CELLCEPT 250 MG CAPSULES (mycophenolate mofetil) 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. • 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What CellCept is and what it is used for 2. What you need to know before you take CellCept 3. How to take CellCept 4. Possible side effects 5. How to store CellCept 6. Content of the pack and other information 1. WHAT CELLCEPT IS AND WHAT IT IS USED FOR The full name of your medicine is CellCept 250 mg capsules. • In this leaflet the shorter name CellCept is used. CellCept contains mycophenolate mofetil. • This belongs to a group of medicines called “immunosuppressants”. CellCept is used to prevent your body rejecting a transplanted organ. • A kidney, heart or liver. CellCept should be used together with other medicines: • Ciclosporin and corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELLCEPT WARNING Mycophenolate 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 mycophenolate on unborn babies. Read the information carefully and follow the instructions. If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section Lees het volledige document
OBJECT 1 CELLCEPT 250MG CAPSULES Summary of Product Characteristics Updated 16-Mar-2018 | Roche Products 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 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 CellCept 250 mg capsules. 2. Qualitative and quantitative composition Each capsule contains 250 mg mycophenolate mofetil. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsules, hard. CellCept capsules: oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" name on the capsule body. 4. Clinical particulars 4.1 Therapeutic indications CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. 4.2 Posology and method of administration Treatment with CellCept should be initiated and maintained by appropriately qualified transplant specialists. Posology _Use in renal transplant _ Adults Oral CellCept should be initiated within 72 hours f Lees het volledige document