VITRAVIR TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Mylan Pharmaceuticals (Pty) Ltd

Dosage:

400,0 mg & 50,0 mg

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS DARUNAVIR 400,0 mg RITONAVIR 50,0 mg

Authorization status:

Registered

Patient Information leaflet

Mylan (Pty) Ltd
VITRAVIR (duplicate 2)
20 SEPTEMBER 2022
SIGNATURE: PAGE 1 OF 15
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S4
VITRAVIR
FILM COATED TABLETS
DARUNAVIR 400 MG AND RITONAVIR 50 MG
WARNING:
If you are taking VITRAVIR with some medicines
•
used to treat ALLERGIES,
•
used to relieve anxiety and/or trouble sleeping,
•
used to correct irregular heart beat,
•
used to treat migraine headache,
they may cause serious adverse events
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING VITRAVIR
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider.
•
VITRAVIR 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 VITRAVIR is and what it is used for
2.
What you need to know before you take VITRAVIR
Mylan (Pty) Ltd
VITRAVIR (duplicate 2)
20 SEPTEMBER 2022
SIGNATURE: PAGE 2 OF 15
3.
How to take VITRAVIR
4.
Possible side effects
5.
How to store VITRAVIR
6.
Contents of the pack and other information.
1.
WHAT VITRAVIR IS AND WHAT IT IS USED FOR
VITRAVIR contains two active substances.
Darunavir, a HIV-1 protease inhibitor (PI)
Ritonavir, a HIV-1 and HIV-2 protease inhibitor (PI)
Each of these active substances, is also known as an antiretroviral
medicine,
works by inhibiting the proteases enzymes.
VITRAVIR is used for the treatment of Human Immunodeficiency Virus
(HIV)
infection. It belongs to a group of HIV medicines called protease
inhibitors (PIs).
VITRAVIR works by reducing the amount of HIV in your body. This will
improve
your immune system and reduces the risk of developing illnesses linked
to HIV
infection.
IT IS IMPORTANT THAT YOU SEE YOUR HEALTHCARE PROFESSIONAL REGULARLY
WHILE YOU
ARE TAKING VITRAVIR.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITRAVIR
DO NOT TAKE VITRAVIR:
•
If you previously suffered an allergic reaction to any of the act

Summary of Product characteristics

Mylan (Pty) Ltd
MODULE 1.3.1.1
VITRAVIR (replica 2)
Each tablet contains darunavir / ritonavir 400 mg / 50 mg
20 September 2022
Signature
Page 1 of 78
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1
NAME OF THE MEDICINE
VITRAVIR 400 mg/50 mg Film coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains darunavir ethanolate equivalent to
darunavir 400
mg and ritonavir 50 mg.
EXCIPIENTS: Colloidal silicon dioxide; copovidone; crospovidone;
microcrystalline
cellulose; ferric oxide yellow, sodium chloride; sodium stearyl
fumarate; sorbitan
monolaurate; coating: Opadry Yellow 20C520058.
Sugar free.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablets.
A light yellow film-coated ovaloid, biconvex, bevelled edge tablet
debossed with
“M” on one side of the tablet and “DRL” on the other side.
Mylan (Pty) Ltd
MODULE 1.3.1.1
VITRAVIR (replica 2)
Each tablet contains darunavir / ritonavir 400 mg / 50 mg
20 September 2022
Signature
Page 2 of 78
WARNING:
CO-ADMINISTRATION OF VITRAVIR WITH CERTAIN NON-SEDATING
ANTIHISTAMINES,
SEDATIVE HYPNOTICS, ANTI-DYSRHYTHMICS OR ERGOT ALKALOID PREPARATIONS
MAY
RESULT IN POTENTIALLY SERIOUS AND OR LIFE-THREATENING ADVERSE EVENTS
DUE TO
POSSIBLE EFFECTS OF RITONAVIR ON THE HEPATIC METABOLISM OF THESE
MEDICINES.
SEE SECTIONS 4.3 AND 4.4.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In combination with other antiretroviral medicines, VITRAVIR is
indicated for the
treatment
of
human
immunodeficiency
virus
(HIV)
infection
in
antiretroviral
treatment experienced adult patients who are protease-inhibitor-naïve
patients or
after exclusion of darunavir resistance associated mutations
(DRV-RAMs: V11I,
V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V).
Genotypic or
phenotypic testing, should guide the use of VITRAVIR.
There is no information on the use of darunavir in combination with
ritonavir in the
paediatric population _ (less than 18 years of age) _ for the once
daily dose (see
Section 4.2, 5.2 and 5.