Tenofovirdisoproxil Vocate 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

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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), 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

Autorisatie datum:

2023-09-26

Bijsluiter

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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tenofovirdisoproxil Vocate 245 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
fumarate).
Excipient with known effect
Each tablet contains 151.73 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White coloured, almond shaped, film-coated tablets, of dimensions
16.90 mm x 10.40 mm, debossed
on one side with 'H' and on the other side with ‘123'.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_HIV-1 infection _
Tenofovirdisoproxil Vocate 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
Vocate 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).
Tenofovirdisoproxil Vocate 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 Vocate 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 Vocate 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 infla