Tenofovir disoproxil Hetero 245 mg filmomhulde tabletten

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

TENOFOVIRDISOPROXIL

Tilgængelig fra:

Hetero Europe S.L.

ATC-kode:

J05AF07

INN (International Name):

TENOFOVIRDISOPROXIL

Lægemiddelform:

Filmomhulde tablet

Sammensætning:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Tenofovir Disoproxil

Produkt oversigt:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Autorisation dato:

2017-04-24

Indlægsseddel

Tenofovir disoproxil Hetero 245 mg filmomhulde tabletten, 245 mg,
film-coated tablet – NL/H/3598/001/DC
NL pl
NL/p/007/17/5
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TENOFOVIR DISOPROXIL HETERO 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 Tenofovir disoproxil Hetero is and what it is used for
2.
What you need to know before you take Tenofovir disoproxil Hetero
3.
How to take Tenofovir disoproxil Hetero
4.
Possible side effects
5.
How to store Tenofovir disoproxil Hetero
6.
Contents of the pack and other information
IF TENOFOVIR DISOPROXIL HETERO 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 HETERO IS AND WHAT IT IS USED FOR
Tenofovir disoproxil Hetero 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
Hetero should always be used combined with other medicines to treat
HIV infection.
TENOFOVIR DISOPROXIL HETERO 245 MG FILM-COATED TABLETS ARE A TREATMENT
FOR H

Produktets egenskaber

Tenofovir disoproxil Hetero 245 mg filmomhulde tabletten, 245 mg,
film-coated tablet – NL/H/3598/001/DC
NL SmPC
NL/s/004/17/3
1
1.
NAME OF THE MEDICINAL PRODUCT
Tenofovir disoproxil Hetero 245 mg filmomhulde tabletten
_ _
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 Hetero 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
Hetero 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 Hetero
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 Hetero 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 Hetero 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 Hetero 245 mg film-coated tablets are indicated
for the treatment of chronic
hepatitis B in adults with:

compensated liver disease, with evidence of ac