Mycophenolate mofetil 500mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Mycophenolate mofetil

Dostupné s:

Actavis UK Ltd

ATC kód:

L04AA06

INN (Mezinárodní Name):

Mycophenolate mofetil

Dávkování:

500mg

Léková forma:

Tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 08020100; GTIN: 5012617018168

Informace pro uživatele

BBBA1802
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Details
MYCOPHENOLATE MOFETIL 500MG TABLETS PIL UK
Black
BBBA1802
C.Grant
13/03/18
14/03/18
C.Grant
170x550mm
9pt
IL/ Intas Pharmaceuti-
cals, Ltd.
13/03/18
14/03/18
02
Version 2
01.11.2017
MYCOPHENOLATE MOFETIL 500MG TABLETS
_continued over page_
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
TABLETS ARE AND WHAT THEY ARE USED
FOR
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE MYCOPHENOLATE MOFETIL
TABLETS
3
HOW TO TAKE MYCOPHENOLATE
MOFETIL TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE MYCOPHENOLATE
MOFETIL TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT MYCOPHENOLATE MOFETIL
TABLETS ARE AND WHAT THEY ARE USED
FOR
Mycophenolate mofetil tablets contain
mycophenolate mofetil.
•
This belongs to a group of medicines called
“immunosuppressants”.
Mycophenolate mofetil tablets are used to
prevent your body rejecting a transplanted
organ.
•
A kidney, heart or liver.
Mycophenolate mofetil is used to

Charakteristika produktu

OBJECT 1
MYCOPHENOLATE MOFETIL 500MG TABLETS
Summary of Product Characteristics Updated 21-May-2018 | Accord-UK Ltd
•
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
Mycophenolate mofetil 500mg Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 500mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Purple coloured capsule shaped, biconvex film coated tablet, engraved
'AHI' on one side and '500' on the
other, 18.0 mm in length, 9.0 mm in width and 7.00 mm in thickness.
4. Clinical particulars
4.1 Therapeutic indications
Mycophenolate mofetil 500mg Tablets 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
Treatment with Mycophenolate mofetil 500mg Tablets should be initiated
and maintained by
appropr