MYFORTIC GASTRO-RESISTANT TABLET 180 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MYCOPHENOLATE SODIUM 192.4mg Eqv MYCOPHENOLIC ACID

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

L04AA06

Dosage:

192.4mg

Pharmaceutical form:

ENTERIC COATED TABLET

Composition:

MYCOPHENOLATE SODIUM 192.4mg Eqv MYCOPHENOLIC ACID 180mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Produktions GmbH

Authorization status:

ACTIVE

Authorization date:

2003-08-01

Patient Information leaflet

MYFORTIC


Immunosuppressant 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Gastro-resistant tablets 
ACTIVE SUBSTANCE 
Each gastro-resistant tablet contains 180 mg or 360 mg mycophenolic acid (MPA) equivalent 
to 192.4 and 384.4 mycophenolate sodium. 
The two dosage strengths may not be available
in all countries. 
ACTIVE MOIETY 
Mycophenolate sodium is the sodium salt
of the active moiety, mycophenolic acid. 
EXCIPIENTS 
Maize starch; povidone (K-30); crospovidone; lactose; colloidal silicon dioxide; magnesium 
stearate. 
The  gastro  resistant  tablet  coating  of  Myfortic  180  mg  consists  of  hypromellose  phthalate/ 
hydroxypropylmethylcellulose phthalate; titanum dioxide;
iron oxide yellow; indigotin. 
The  gastro  resistant  tablet  coating  of  Myfortic  360  mg  consists  of  hypromellose  phthalate/ 
hydroxypropylmethylcellulose phthalate; titanum dioxide;
iron oxide yellow; iron oxide red. 
180mg Myfortic tablet comes as a lime green, film coated, round tablet, with beveled edges 
and the imprint (debossing) “C” on one side. 
360mg Myfortic tablet comes as a pale orange-red, film coated, ovaloid tablet with imprint 
(debossing) “CT” on one side. 
Pharmaceutical formulations may vary between countries. 

INDICATIONS 
Myfortic is indicated in combination with ciclosporin for microemulsion  and corticosteroids 
for  the  prophylaxis  of  acute  transplant  rejection  in  adult  patients  receiving  allogeneic  renal 
transplants. 

DOSAGE AND ADMINISTRATION 
DOSAGE 
The  recommended  dose  is  720  mg  (four  180  mg  or  two  360  mg  Myfortic  gastro-resistant 
tablets) administered twice daily (1440 mg daily dose).  Myfortic delayed-release tablets and 
mycophenolate  mofetil  tablets  and  capsules

Summary of Product characteristics

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MYFORTIC

Immunosuppressant
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Gastro-resistant tablets
ACTIVE SUBSTANCE
Each gastro-resistant tablet contains 180 mg or 360 mg mycophenolic
acid (MPA) equivalent to
192.4 mg and 384.8 mg mycophenolate sodium.
The two dosage strengths may not be available in all countries.
EXCIPIENTS
Maize starch; povidone (K-30); crospovidone; lactose; colloidal
silicon dioxide; magnesium
stearate.
The gastro resistant tablet coating of 180 mg Myfortic consists of
hypromellose phthalate/
hydroxypropylmethylcellulose phthalate; titanium dioxide; iron oxide
yellow; indigotin.
The gastro resistant tablet coating of 360 mg Myfortic consists of
hypromellose phthalate/
hydroxypropylmethylcellulose phthalate; titanium dioxide; iron oxide
yellow; iron oxide red.
180mg Myfortic tablet comes as a lime green, film coated, round
tablet, with beveled edges and
the imprint (debossing) “C” on one side.
360mg Myfortic tablet comes as a pale orange-red, film coated, ovaloid
tablet with imprint
(debossing) “CT” on one side.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Myfortic is indicated in combination with ciclosporin for
microemulsion and corticosteroids for
the
prophylaxis
of
acute
transplant
rejection
in
adult
patients
receiving
allogeneic
renal
transplants.
Myfortic is indicated for induction and maintenance treatment of adult
patients with ISN/RPS
Class III, IV or V lupus nephritis.
The evidence for efficacy was based on surrogate endpoints in studies
where the majority of
patients with lupus nephritis were ISN/RPS (2003) Class IV (see
Clinical Studies section).
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic
gastro-resistant tablets)
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twice daily (1440 mg daily dose). Myfortic delayed-release tablets and
mycophenolate mofetil
tablets and capsules should not be used interchangeably without
physician supervision because
the rat