Mycophenolate mofetil 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mycophenolate mofetil

Available from:

Icarus Pharmaceuticals Ltd

ATC code:

L04AA06

INN (International Name):

Mycophenolate mofetil

Dosage:

250mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ACCORD LOGO
MYCOPHENOLATE MOFETIL 250MG CAPSULES
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 MYCOPHENOLATE MOFETIL CAPSULES ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE MOFETIL
CAPSULES
3. HOW TO TAKE MYCOPHENOLATE MOFETIL CAPSULES
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MYCOPHENOLATE MOFETIL CAPSULES
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT MYCOPHENOLATE MOFETIL CAPSULES ARE AND WHAT THEY ARE USED FOR
Mycophenolate mofetil capsules contain mycophenolate mofetil.
-
This belongs to a group of medicines called “immunosuppressants”.
Mycophenolate mofetil capsules are used to prevent your body rejecting
a transplanted organ.
-
A kidney, heart or liver.
Mycophenolate mofetil capsules are used together with other medicines
-
ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE MOFETIL CAPSULES
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 inf

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mycophenolate mofetil 250mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Light blue/peach size 1 hard capsule, 18.9 mm ± 0.5 mm in length,
imprinted with
MMF on cap and 250 on body containing white to off-white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mycophenolate mofetil 250mg Capsules are 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
Posology
Treatment with Mycophenolate mofetil 250mg Capsules should be
initiated and
maintained by appropriately qualified transplant specialists.
_Use in renal transplant _
_Adults _
Oral Mycophenolate mofetil 250mg Capsules should be initiated within
72 hours
following transplantation. The recommended dose in renal transplant
patients is 1g
administered twice daily (2g daily dose).
_Paediatric population aged 2 to 18 years _
The recommended dose of mycophenolate mofetil is 600mg/m
2
administered orally
twice daily (up to a maximum of 2g daily). Mycophenolate mofetil 250mg
Capsules
should only be prescribed to patients with a body surface area of at
least 1.25m
2
.
Patients with a body surface area of 1.25 to 1.5m
2
may be prescribed Mycophenolate
mofetil 250mg Capsules at a dose of 750mg twice daily (1.5g daily
dose). Patients
with a body surface area greater than 1.5 m
2
may be prescribed Mycophenolate
mofetil 250mg Capsules at a dose of 1g twice daily (2g daily dose). As
some adverse
reactions occur with greater frequency in this age group (see section
4.8) compared
with adults, temporary dose reduction or interruption may be required;
these will need
to take into account relevant clinical factors including severity of
reaction.
_Paediatric population <2 years _
There are l