CERTICAN 0.5 MG TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EVEROLIMUS

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L04AA18

Pharmaceutical form:

TABLETS

Composition:

EVEROLIMUS 0.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Therapeutic group:

EVEROLIMUS

Therapeutic area:

EVEROLIMUS

Therapeutic indications:

Kidney and heart transplantationCertican ® 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.Liver transplantationCertican is indicated for the prophylaxis of organ rejection in adult patients receiving a hepatic transplant. In liver transplantation, Certican should be used in combination with tacrolimus and corticosteroids.

Authorization date:

2015-02-28

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed with a doctor’s prescription only
CERTICAN
® 0.25 MG TABLETS
Each tablet contains:
Everolimus 0.25 mg
CERTICAN
® 0.5 MG TABLETS
Each tablet contains:
Everolimus 0.5 mg
CERTICAN
® 0.75 MG TABLETS
Each tablet contains:
Everolimus 0.75 mg
INACTIVE AND ALLERGENIC INGREDIENTS IN THE PREPARATION: See
section 2 ”Important information about some of the ingredients
of the medicine“ and section 6 ”Further Information“.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information about
the medicine. If you have further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them, even
if it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Certican is used to prevent implant rejection in adult kidney,
heart and liver transplant recipients. For kidney and heart
transplant recipients, Certican must be taken together with
ciclosporin in microemulsion and corticosteroids and for liver
transplant recipients, Certican must be taken together with
tacrolimus and corticosteroids.
Therapeutic Group: Certican belongs to a group of medicines
called immunosuppressants.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
If you are sensitive )allergic( to everolimus or any of the
other ingredients of the medicine. See section 6 ”Further
Information“.
If you are sensitive )allergic( to sirolimus.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
BEFORE USING CERTICAN, TELL YOUR DOCTOR IF:
∙ Medicines that suppress the immune system, like Certican,
reduce your body’s ability to fight against infections.
It is advisable to consult your doctor or transplant centre if
you have a fever or generally feel unwell, or have symptoms
such as coughing or a burning sensation when urinating that
are severe or persistent over several

Summary of Product characteristics

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CERTICAN
®
(Everolimus)
0.25 mg, 0.5 mg, 0.75 mg tablets
Prescribing Information
1
NAME OF THE MEDICINAL PRODUCT
CERTICAN
®
0.25 mg tablets
CERTICAN
®
0.5 mg tablets
CERTICAN
®
0.75 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is everolimus.
0.25 mg tablets
Each tablet contains 0.25 mg everolimus.
0.5 mg tablets
Each tablet contains 0.5 mg everolimus.
0.75 mg tablets
Each tablet contains 0.75 mg everolimus.
The estimated lactose content per tablet of Certican 0.25 mg is 53 mg.
The estimated lactose content per tablet of Certican 0.5 mg is 79 mg.
The estimated lactose content per tablet of Certican 0.75 mg is 118
mg.
For a full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
The tablets are white to yellowish, marbled, round, flat with a
bevelled edge.
0.25 mg: engraved with “C” on one side and “NVR” on the other.
0.5 mg: engraved with “CH” on one side and “NVR” on the other.
0.75 mg: engraved with “CL” on one side and “NVR” on the
other.
4.
CLINICAL PARTICULARS
4.1
Therapeutic 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.
Liver transplantation
Certican
®
is indicated for the prophylaxis of organ rejection in adult patients
receiving a hepatic
transplant. In liver transplantation, Certican should be used in
combination with tacrolimus and
corticosteroids.
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4.2
Posology and method of administration
Treatment with Certican should only be initiated and maintained by
physicians who are experienced in
immunosuppressive therapy following organ transplantation and who have
access to everolimus whole
blood concentration monitoring.
Posology
_Adults _
An initial dose regimen of