Atazanavir Teva 200 mg Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atazanavir sulfate

Available from:

Teva B.V.

ATC code:

J05AE; J05AE08

INN (International Name):

Atazanavir sulfate

Dosage:

200 milligram(s)

Pharmaceutical form:

Capsule, hard

Administration route:

oral use

Units in package:

. Pack size of 60 and 60 x 1 capsules.

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic group:

protease inhibitor

Therapeutic area:

Protease inhibitors; atazanavir

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

Authorization status:

Not marketed

Authorization date:

2015-10-30

Patient Information leaflet

PACKAGE LEAFLET
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATAZANAVIR TEVA
DO NOT TAKE ATAZANAVIR TEVA

IF YOU ARE ALLERGIC
to atazanavir or any of the other ingredient

Summary of Product characteristics

Health Products Regulatory Authority
29 October 2020
CRN00C066
Page 1 of 32
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atazanavir Teva 200 mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains atazanavir sulfate corresponding to 200 mg of
atazanavir.
Excipient with known effect:
Each 200 mg capsule contains 89.6 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
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.
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 (see section 4.2).
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).
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 (see sections
4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Adults_
The recommended dose of Atazanavir Teva is 300 mg once daily taken
with ritonavir 100 mg once daily and with food.
Ritonavir is used as a booster of atazanavir pharmacokinetics (see
sections 4.5 and 5.1). (See also section 4.4 Withdrawal of
ritonavir only under restrictive conditions).
_Paediatric patients (6 years to less than 18 years of age and
weighing at least 15 kg)_
The dose of Atazanavir Teva for paediatric patients is based on body
weight as shown in Table 1 and should not exceed the
recommended ad