Tenofovir disoproxil Zentiva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

tenofovir disoproxil phosphate

Available from:

Zentiva k.s.

ATC code:

J05AF07

INN (International Name):

tenofovir disoproxil

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

HIV‑1 infectionTenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV‑1 infected adults.In adults, the demonstration of the benefit of tenofovir disoproxil in HIV‑1 infection is based on results of one study in treatment‑naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre‑treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV‑1 infected adolescents, with NRTI (nucleotide reverse transcriptase inhibitor) resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.The choice of Tenofovir disoproxil Zentiva to treat antiretroviral‑experienced patients with HIV‑1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infectionTenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1);evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1);decompensated liver disease (see sections 4.4, 4.8 and 5.1).Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2016-09-15

Patient Information leaflet

58
B. PACKAGE LEAFLET
59
PACKAGE LEAFLET: INFORMATION FOR THE USER
TENOFOVIR DISOPROXIL ZENTIVA 245 MG FILM-COATED TABLETS
tenofovir disoproxil
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 Tenofovir disoproxil Zentiva is and what it is used for
2.
What you need to know before you take Tenofovir disoproxil Zentiva
3.
How to take Tenofovir disoproxil Zentiva
4.
Possible side effects
5.
How to store Tenofovir disoproxil Zentiva
6.
Contents of the pack and other information
If Tenofovir disoproxil Zentiva has been prescribed for your child,
please note that all the information in
this leaflet is addressed to your child (in this case please read
“your child” instead of “you”).
1.
WHAT TENOFOVIR DISOPROXIL ZENTIVA IS AND WHAT IT IS USED FOR
Tenofovir disoproxil Zentiva contains the active substance tenofovir
disoproxil. This active substance is
an antiretroviral
_ _
or antiviral medicine which is used to treat HIV or HBV infection or
both. Tenofovir is
a nucleotide reverse transcriptase inhibitor, generally known as an
NRTI and works by interfering with
the normal working of enzymes (in HIV reverse transcriptase; in
hepatitis B DNA polymerase) that are
essential for the viruses to reproduce themselves. In HIV Tenofovir
disoproxil Zentiva should always be
used combined with other medicines to treat HIV infection.
TENOFOVIR DISOPROXIL ZENTIVA IS A TREATMENT FOR HIV (HUMAN
IMMUNODEFICIENCY VIRUS)
infection.
The tablets are suitable for:
•
ADULTS
•
ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tenofovir disoproxil Zentiva 245 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains tenofovir disoproxil phosphate
(equivalent to 245 mg of tenofovir
disoproxil).
Excipient with known effect: Each tablet contains 203.7 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Oblong-shaped, light blue colored film-coated tablets with dimensions
approx. 17.2 x 8.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HIV-1 infection
Tenofovir disoproxil Zentiva is indicated in combination with other
antiretroviral medicinal products for
the treatment of HIV-1 infected adults.
In adults, the demonstration of the benefit of tenofovir disoproxil in
HIV-1 infection is based on results
of one study in treatment-naïve patients, including patients with a
high viral load (> 100,000 copies/ml)
and studies in which tenofovir disoproxil was added to stable
background therapy (mainly tritherapy) in
antiretroviral pre-treated patients experiencing early virological
failure (< 10,000 copies/ml, with the
majority of patients having < 5,000 copies/ml).
Tenofovir disoproxil Zentiva is also indicated for the treatment of
HIV-1 infected adolescents, with
NRTI resistance or toxicities precluding the use of first line agents,
aged 12 to < 18 years.
The choice of Tenofovir disoproxil Zentiva to treat
antiretroviral-experienced patients with HIV-1
infection should be based on individual viral resistance testing
and/or treatment history of patients.
Hepatitis B infection
Tenofovir disoproxil Zentiva is indicated for the treatment of chronic
hepatitis B in adults with:
-
compensated liver disease, with evidence of active viral replication,
persistently elevated serum
alanine aminotransferase (ALT) levels and histological evidence of
active inflammation and/or
fibrosis (see section 5.1).
-
evidence of lamivudine-resistant hepatitis B virus (see sec