Mycophenolic acid 360mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mycophenolate sodium

Available from:

Accord-UK Ltd

ATC code:

L04AA06

INN (International Name):

Mycophenolate sodium

Dosage:

360mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020100; GTIN: 5055565734599

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCOPHENOLIC ACID 360 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

Summary of Product characteristics

OBJECT 1
MYCOPHENOLIC ACID 360MG 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
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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 360mg gastro-resistant tablets
2. Qualitative and quantitative composition
Mycophenolic acid 360 mg gastro-resistant tablets:
Each gastro-resistant tablet contains 360 mg mycophenolic acid (as
mycophenolate sodium).
Each tablet contains 27.9 mg (1.21 mmol) sodium
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet
360 MG:
Peach colored, oblong shaped, biconvex, enteric-coated tablets
imprinted with M2 on one side with black ink
and plain on the other side.
Note: Length and Width of the tablet is 17.50 ± 0.2 mm and 10.35 ±
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 p