Ictady 245 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

TENOFOVIRDISOPROXILSUCCINAAT SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL

Beschikbaar vanaf:

Double-E Pharma Limited 17 Corrig Road 18 DUBLIN (IERLAND)

ATC-code:

J05AF07

INN (Algemene Internationale Benaming):

TENOFOVIRDISOPROXILSUCCINAAT COMPOSITION corresponding to ; TENOFOVIRDISOPROXIL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tenofovir Disoproxil

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; TITAANDIOXIDE (E 171);

Autorisatie datum:

2016-04-28

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ICTADY 245 MG, FILMOMHULDE TABLETTEN
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
IF 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 IS AND WHAT IT IS USED FOR
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 should always be used
combined with other medicines to treat HIV infection.
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

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Ictady 245 mg, filmomhulde tabletten
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_
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).
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 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_
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).

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