ZANRIT TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharma Dynamics (Pty) Ltd

Dosage:

100,0 mg & 300,0 mg

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS RITONAVIR 100,0 mg ATAZANAVIR SULPHATE EQUIVALENT TO ATAZANAVIR 300,0 mg

Authorization status:

Registered

Patient Information leaflet

ATAZANAVIR SULPHATE AND RITONAVIR TABLETS_ _
_Each tablet contains 300 mg atazanavir and 100 mg _
_Pharma Dynamics (Pty) Ltd ritonavir _
_ _ Approved: 12 Sept 2023
_ _
_ _
APPROVED PATIENT INFORMATION LEAFLET
_ _
12 September 2023 Page 1 of 24
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
ZANRIT 300/100 mg film coated tablets
Atazanavir sulphate as atazanavir 300 mg and ritonavir 100 mg
ZANRIT contains sugar (lactose 167,292 mg)
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ZANRIT
•
Keep this leaflet. You may need to read it again._ _
•
If you have further questions, please ask your medical practitioner,
pharmacist,
nurse or other healthcare provider._ _
•
ZANRIT has been prescribed for you personally and you should not share
your
medicine with other people. It may harm them, even if their symptoms
are the
same as yours._ _
_ _
WHAT IS IN THIS LEAFLET
1.
What ZANRIT is and what it is used for_ _
2.
What you need to know before you use ZANRIT
3.
How to use ZANRIT_ _
4.
Possible side effects_ _
5.
How to store ZANRIT_ _
ATAZANAVIR SULPHATE AND RITONAVIR TABLETS_ _
_Each tablet contains 300 mg atazanavir and 100 mg _
_Pharma Dynamics (Pty) Ltd ritonavir _
_ _ Approved: 12 Sept 2023
_ _
_ _
APPROVED PATIENT INFORMATION LEAFLET
_ _
12 September 2023 Page 2 of 24
6.
Contents of the pack and other information_ _
_ _
_ _
1.
WHAT ZANRIT IS AND WHAT IT IS USED FOR_ _
ZANRIT is a combination antiviral (or antiretroviral) medicine, used
in combination with
other antiretroviral medicines for the treatment of HIV infection.
It is one of a group called protease inhibitors. These medicines
control Human
Immunodeficiency Virus (HIV) infection by blocking HIV protease, an
enzyme that the
HIV virus needs for its multiplication. They work by reducing the
amount of HIV in your
body and this in turn, strengthens your immune system. In this way
ZANRIT reduces the
risk of developing illnesses linked to HIV infection.
HIV is the virus that causes acquired immune deficiency syndrome
(AIDS).
2.
WHAT YOU NEED TO KN

Summary of Product characteristics

ATAZANAVIR SULPHATE AND RITONAVIR TABLETS_ _
_Each tablet contains 300 mg atazanavir and 100 mg _
_Pharma Dynamics (Pty) Ltd ritonavir _
_ _ Approved: 12 Sept 2023
APPROVED PROFESSIONAL INFORMATION
_ _
12 September 2023 Page 1 of 78
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
ZANRIT 300/100 mg, film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
Atazanavir sulphate equivalent to 300 mg atazanavir and ritonavir 100
mg.
Each tablet contains sugar (lactose monohydrate 167,292 mg).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablets.
WARNING:
CO-ADMINISTRATION
OF
ZANRIT
WITH
CERTAIN
NON-SEDATING
ANTIHISTAMINES,
SEDATIVE
HYPNOTICS,
ANTIDYSRHYTHMICS
OR
ERGOT
ALKALOID PREPARATIONS MAY RESULT IN POTENTIALLY SERIOUS AND/OR
LIFE- THREATENING ADVERSE EVENTS DUE TO POSSIBLE EFFECTS OF ZANRIT
ON THE HEPATIC METABOLISM OF CERTAIN MEDICINES. SEE SECTIONS 4.3 AND
4.5.
ATAZANAVIR SULPHATE AND RITONAVIR TABLETS_ _
_Each tablet contains 300 mg atazanavir and 100 mg _
_Pharma Dynamics (Pty) Ltd ritonavir _
_ _ Approved: 12 Sept 2023
APPROVED PROFESSIONAL INFORMATION
_ _
12 September 2023 Page 2 of 78
ZANRIT is a bilayer, capsule shaped, biconvex, film coated tablet,
having one layer with
white to pale yellow colour and other white to off-white colour, plain
on both the sides. A
thin line on the tablet side may be visible.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZANRIT is indicated in combination with other antiretroviral medicines
for the treatment
of HIV-1 infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose for adults is:
_ _
One tablet, once a day taken orally, with food. The tablet should be
swallowed whole.
SPECIAL POPULATIONS
CONCOMITANT THERAPY
_Efavirenz: _In treatment-naïve patients, it is recommended that
ZANRIT be taken with
efavirenz 600 mg (all once daily).
_Tenofovir: _ When co-administered with tenofovir, it is recommended
that ZANRIT be
given with tenofovir 300 mg, all as a single daily dose with