Atazanavir Teva Capsules Hard 200mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATAZANAVIR SULFATE

Available from:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

J05AE08

INN (International Name):

ATAZANAVIR SULFATE 200 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

ATAZANAVIR SULFATE 200 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2015-12-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATAZANAVIR TEVA 150 MG CAPSULES, HARD
ATAZANAVIR TEVA 200 MG CAPSULES, HARD
ATAZANAVIR TEVA 300 MG CAPSULES, HARD
atazanavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Atazanavir Teva is and what it is used for
2.
What you need to know before you take Atazanavir Teva
3.
How to take Atazanavir Teva
4.
Possible side effects
5.
How to store Atazanavir Teva
6.
Contents of the pack and other information
1.
WHAT ATAZANAVIR TEVA IS AND WHAT IT IS USED FOR
Atazanavir Teva is an antiviral (or antiretroviral) medicine. It is
one of a group called protease inhibitors.
These medicines control Human Immunodeficiency Virus (HIV) infection
by stopping a protein that the
HIV 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 Atazanavir Teva reduces
the risk of developing illnesses
linked to HIV infection.
Atazanavir Teva capsules may be used by adults and children 6 years of
age and older. Your doctor has
prescribed Atazanavir Teva for you because you are infected by the HIV
that causes Acquired
Immunodeficiency Syndrome (AIDS). It is normally used in combination
with other anti-HIV medicines.
Your doctor will discuss with you which combination of these medicines
with Atazanavir Teva is best for
you.
Atazanavir Teva is not a cure for HIV infection. You may continue to
develop infections or other illnesses
linked to HIV infection. You can still pass on HIV when taki

Summary of Product characteristics

Page 1 of 37
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atazanavir Teva 150 mg Capsules, hard
Atazanavir Teva 200 mg Capsules, hard
Atazanavir Teva 300 mg Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains atazanavir sulfate corresponding to 150 mg, 200
mg and 300 mg of
atazanavir.
Excipient with known effect:
Each 150 mg capsule contains 67.2 mg of lactose monohydrate.
Each 200 mg capsule contains 89.6 mg of lactose monohydrate.
Each 300 mg capsule contains 134.4 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Atazanavir Teva 150 mg hard capsules are non transparent size 1
capsules with overall closed
length 19.4 ± 0.3 mm, with dark blue cap, and black mark 150 on light
blue body. The content of
the capsule is light yellow powder.
Atazanavir Teva 200 mg hard capsules are non transparent size 0
capsules with overall closed
length 21.7 ± 0.3 mm with blue cap, and black mark 200 on blue body.
The content of the capsule is
light yellow powder.
Atazanavir Teva 300 mg hard capsules are non transparent size 00
capsules with overall closed
length 23.3 ± 0.3 mm with red cap, and black mark 300 on blue body.
The content of the capsule is
light yellow powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atazanavir Teva capsules, co-administered with low dose ritonavir, are
indicated for the treatment
of HIV-1 infected adults and paediatric patients 6 years of age and
older in combination with other
antiretroviral medicinal products.
Based on available virological and clinical data from adult patients,
no benefit is expected in
patients with strains resistant to multiple protease inhibitors (≥ 4
PI mutations). There are very
limited data available from children aged 6 to less than 18 years (see
sections 4.4 and 5.1).
2
The choice of Atazanavir Teva in treatment experienced adult and
paediatric patients should be
based on individual viral resistance testing and the patient’s
treatment history (se