CellCept 250mg capsules

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Mycophenolate mofetil

Disponible des:

DE Pharmaceuticals

Codi ATC:

L04AA06

Designació comuna internacional (DCI):

Mycophenolate mofetil

Dosis:

250mg

formulario farmacéutico:

Capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 08020100

Informació per a l'usuari

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

Fitxa tècnica

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