Tenofovirdisoproxil Medicopharm 245 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TENOFOVIRDISOPROXILFUMARAAT 300 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

Beschikbaar vanaf:

Medicopharm AG Stangenreiterstraße 4 83131 NUßDORF AM INN (DUITSLAND)

ATC-code:

J05AF07

INN (Algemene Internationale Benaming):

TENOFOVIRDISOPROXILFUMARAAT 300 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

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) ; 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); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-05-23

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TENOFOVIRDISOPROXIL MEDICOPHARM 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 Tenofovirdisoproxil Medicopharm is and what it is used for
2.
What you need to know before you take Tenofovirdisoproxil Medicopharm
3.
How to take Tenofovirdisoproxil Medicopharm
4.
Possible side effects
5.
How to store Tenofovirdisoproxil Medicopharm
6.
Contents of the pack and other information
IF TENOFOVIRDISOPROXIL MEDICOPHARM 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 TENOFOVIRDISOPROXIL MEDICOPHARM IS AND WHAT IT IS USED FOR
Tenofovirdisoproxil Medicopharm 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
Tenofovirdisoproxil
Medicopharm should always be used combined with other medicines to
treat HIV infection.
Tenofovirdisoproxil Medicopharm 245 mg film-coated tablets are a
treatment for HIV (Human
Immunodeficiency Virus) infection. The tablets are suitable for:
•
adul

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Tenofovirdisoproxil Medicopharm 245 mg
filmomhulde tabletten
.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
fumarate).
Excipient(s) with known effect:
Each tablet contains 151.730 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, almond shaped, film-coated tablets debossed with a
dimension of approx 16.90 mm in
length and 10.40 mm in width, with “H” on one side and “123”
on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_HIV-1 infection _
Tenofovirdisoproxil Medicopharm 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 Tenofovirdisoproxil
Medicopharm 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 Tenofovirdisoproxil
Medicopharm 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).
Tenofovirdisoproxil Medicopharm 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 Tenofovirdisoproxil Medicopharm 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 _
Tenofovirdisoproxil Medicopharm 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) leve