Myfortic 180mg gastro-resistant tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Mycophenolate sodium

Fáanlegur frá:

Novartis Pharmaceuticals UK Ltd

ATC númer:

L04AA06

INN (Alþjóðlegt nafn):

Mycophenolate sodium

Skammtar:

180mg

Lyfjaform:

Gastro-resistant tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 08020100; GTIN: 5010678913156

Upplýsingar fylgiseðill

1
Package leaflet: Information for the user
Myfortic
®
180 mg gastro-resistant tablets
Mycophenolic acid (as mycophenolate sodium)
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 Myfortic is and what it is used for
2.
What you need to know before you take Myfortic
3.
How to take Myfortic
4.
Possible side effects
5.
How to store Myfortic
6.
Contents of the pack and other information
1.
What Myfortic is and what it is used for
Myfortic contains a substance called mycophenolic acid. This belongs
to a group of medicines called
immunosuppressants.
Myfortic 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 Myfortic
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
under “Warnings and
precautions” and “Pregnancy and breast-feeding”.
Do not take Myfortic:

if you are allergic to mycopheno

Vara einkenni

OBJECT 1
MYFORTIC 180 MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 10-Jun-2022 | Novartis
Pharmaceuticals 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
Myfortic
®
180 mg gastro-resistant tablets
Myfortic
®
360 mg gastro-resistant tablets
2. Qualitative and quantitative composition
Each gastro-resistant tablet contains 180 mg or 360 mg mycophenolic
acid (as mycophenolate sodium).
Excipients with known effect:
Lactose: 45 mg or 90 mg per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet
180mg: Lime green, film-coated round tablet, with bevelled edges and
the imprint (debossing) “C” on one
side.
360mg: Pale orange red film-coated ovaloid tablet, with imprint
(debossing) “CT” on one side.
4. Clinical particulars
4.1 Therapeutic indications
Myfortic is indicated in combination with ciclosporin and
corticosteroids for the prophylaxis of acute
transplant rejection in adult patien