CERTICAN 0.25 MG DISPERSIBLE TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

EVEROLIMUS

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

EVEROLIMUS

Unit dalam pakej:

50Tablet Tablets; 60Tablet Tablets; 100Tablet Tablets; 250Tablet Tablets

Dikeluarkan oleh:

NOVARTIS PHARMA STEIN AG

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
_ _
CERTICAN
®
Everolimus (
0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg Tablet; 0.1mg and 0.25mg Dispersible
Tablet)
1
WHAT IS IN THIS LEAFLET
1.
What Certican is used for
2.
How Certican works
3.
Before you use Certican
4.
How to use Certican
5.
While you are using Certican
6.
Side effects
7.
Storage and Disposal of Certican
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CERTICAN IS USED FOR
Certican is used to help prevent your
body from rejecting a transplanted
kidney, heart or liver. Certican must be
used together with other
immunosuppressant medicines, notably
ciclosporin for microemulsion for kidney
and heart transplantation or tacrolimus
for liver transplantation and
corticosteroids.
HOW CERTICAN WORKS
Certican belongs to a group of medicines
known as immunosuppressants.
BEFORE YOU USE CERTICAN
Certican will only be prescribed for you
by a doctor with experience in
transplantation medicine. Follow your
doctor’s instructions carefully. They may
differ from the general information
contained in this leaflet.
_When you must not use it _
•
If you are allergic (hypersensitive) to
everolimus, sirolimus
_ _
or to any of
the other components of Certican.
•
The ingredients contained in each
tablet are listed at the end of this
leaflet.
Tell your doctor if you suspect you may
have had an allergic reaction to any of
these ingredients in the past.
_PREGNANCY AND BREAST-FEEDING _
Ask your doctor or pharmacist for advice
before taking any medicine.
•
Certican must not be used during
pregnancy unless indicated by your
doctor to be clearly necessary. If you
are pregnant or think that you may
be, tell your doctor who will discuss
with you the potential risk of taking
Certican during pregnancy.
•
Breast-feeding should be
discontinued by patients taking
Certican
_Females of child-bearing potential and _
_male patients _
You should use an effective
contraceptive method during treatment
with Certican and for 8 weeks after
treatm

Ciri produk

Novartis Page 2
Malaysian Package Leaflet 05 Nov 2018 Certican 
Certican 
S elective immunosuppressive agent
DESCRIPTION AND COMPOSITION
Pharmaceutica l forms
Tablets and dispersible tablets.
The tablets and the dispersible tablets are white to yellowish, marbled, round, flat with a
bevelled edge.
Active substance
Tablets
Certican ® tablets contain 0.25 mg, 0.5 mg, 0.75 mg or 1.0 mg everolimus.
Dispersib le Tablets
Certican ® dispersible tablets contain 0.1 mg or 0.25 mg everolimus.
Certain dosage strengths and dosage forms may not be available in all countries.
Active moiety
Everolimus .
Excipients
Tablets
Butylated hydroxytoluene (E321), magnesium stearate , lactose monohydrate, hypromellose,
crospovidone, lactose anhydrous.
Dispersible Tablets
Butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose,
crospovidone, lactose anhydrous, colloidal anhydrous silica.
Pharmaceutical fo rmulations may vary between countries.
INDICATIONS
Kidney and heart transplantation
Certican is indicated for the prophylaxis of organ rejection in adult patients at low to
moderate immunological risk receiving an allogeneic renal or cardiac transplant. In kidney
and heart transplantation, Certican should be used in combination with ciclosporin for
microemulsion and corticosteroids.