Tenofovir disoproxil 245 mg film coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Tenofovir disoproxil

Dostupno od:

Accord Healthcare Limited

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:

2017-04-21

Uputa o lijeku

Leaflet Size: 220 x 440 mm
PHARMA CODE
PHARMA CODE
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 tablet is and what it is used for
2. What you need to know before you take Tenofovir disoproxil tablets
3. How to take Tenofovir disoproxil tablets
4. Possible side effects
5. How to store Tenofovir disoproxil tablets
6. Contents of the pack and other information
IF TENOFOVIR DISOPROXIL TABLETS 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 TABLET IS AND WHAT IT IS
USED FOR
Tenofovir disoproxil tablets 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
tablets
should always be used combined with other medicines to treat HIV
infection.
Tenofovir disoproxil 245 mg film-coated tablets are a treatment for
HIV
(Human Immunodeficiency Virus) infection. The tablets are suitable
for:
•
adults
•
adolescents aged 12 to less than 18 years who have already been
treated with other HIV medicines which are

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tenofovir disoproxil 245 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 245 mg of tenofovir disoproxil.
Excipient(s) with known effect:
Each tablet contains 232 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, almond shaped, biconvex film-coated tablets with a
dimension of approx. 16 mm in length and 10 mm
in width, debossed with “H” on one side and “T11” on the other
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_HIV-1 infection_
Tenofovir disoproxil tablets 245 mg film-coated tablets are 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
tablets 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 tablets 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 245 mg film-coated tablets are 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 tablets 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 245 mg film-coated tablets are 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