TENOFOVIR DISOPROXIL ACTAVIS 245 Milligram Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

TENOFOVIR DISOPROXIL SUCCINATE

Tilgjengelig fra:

Actavis Group PTC ehf

ATC-kode:

J05AF07

INN (International Name):

TENOFOVIR DISOPROXIL SUCCINATE

Dosering :

245 Milligram

Legemiddelform:

Tablets

Resept typen:

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

Terapeutisk område:

Nucleoside and nucleotide reverse transcriptase inhibitors

Autorisasjon status:

Authorised

Autorisasjon dato:

2016-07-01

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ICTADY 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 Ictady is and what it is used for
2.
What you need to know before you take Ictady
3.
How to take Ictady
4.
Possible side effects
5.
How to store Ictady
6.
Contents of the pack and other information
IF ICTADY 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 ICTADY IS AND WHAT IT IS USED FOR
Ictady contains the active substance _tenofovir disoproxil succinate_.
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
Ictady should always be used combined with other medicines to treat
HIV infection.
ICTADY 245 MG 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 no longer fully effective due to development
of resistance, or
have caused side effects.
ICTADY 245 MG TABLETS ARE ALSO A TREATMENT FOR

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ictady 245mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
succinate).
Excipient with known effect:
Each tablet contains 105 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light blue, almond-shaped, film-coated tablets, with dimensions of
approximately 17.0 mm x 10.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_HIV-1 infection_
Ictady 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 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 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).
Ictady 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 Ictady to treat antiretroviral-experienced patients with
HIV-1 infection should be based on individual vira
resistance testing and/or treatment history of patients.
_Hepatitis B infection_
Ictady 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
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).
Ictady 245 mg f