Tenofovir Disoproxil Teva 245 mg Film-coated Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Tenofovir disoproxil

Dostupno od:

Teva B.V.

ATC koda:

J05AF; J05AF07

INN (International ime):

Tenofovir disoproxil

Doziranje:

245 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

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

Područje terapije:

Nucleoside and nucleotide reverse transcriptase inhibitors; tenofovir disoproxil

Status autorizacije:

Marketed

Datum autorizacije:

2015-08-21

Uputa o lijeku

MODULE 1.3.1
PATIENT INFORMATION LEAFLET TEXT
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENOFOVIR DISOPROXIL TEVA 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 Teva
is and what it is used for
2.
What you need to know before you take Tenofovir Disoproxil Teva
3.
How to take Tenofovir Disoproxil Teva
4.
Possible side effects
5.
How to store Tenofovir Disoproxil Teva
6.
Contents of the pack and other information
IF TENOFOVIR DISOPROXIL TEVA 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 TEVA IS AND WHAT IT IS USED FOR
Tenofovir Disoproxil Teva
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 Teva
should always be
used combined with other medicines to treat HIV infection.
TENOFOVIR DISOPROXIL TEVA TABLETS ARE A TREATMENT FOR HIV
(Human Immunodeficiency Virus)
infection. The tablets are suitable for:
•
ADULTS
•
ADOLESCENTS AGED 12 TO LESS T

Svojstava lijeka

Health Products Regulatory Authority
03 October 2023
CRN00DLSG
Page 1 of 33
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tenofovir Disoproxil Teva 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 100.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light blue to blue, film coated, oval shaped tablet, 16.6 mm long and
8.9 mm wide, debossed with “T” on one side of the tablet
and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_HIV-1 infection _
Tenofovir Disoproxil Teva 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 Teva 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 Teva 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 Teva 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 activ