Ictady 245mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TENOFOVIR DISOPROXIL

Available from:

Rivopharm Limited 17 Corrig Road, Sandyford, Dublin 18,, Ireland

ATC code:

J05AF07

INN (International Name):

TENOFOVIR DISOPROXIL 245 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TENOFOVIR DISOPROXIL 245 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2016-04-22

Patient Information leaflet

Page 1 of 8
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

Summary of Product characteristics

Page 1 of 45
1.
NAME OF THE MEDICINAL PRODUCT
Ictady 245 mg 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 viral 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 film-coated tablets are