Tenofovirdisoproxil STADA 245 mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

TENOFOVIRDISOPROXILSUCCINAAT SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL

Available from:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC code:

J05AF07

INN (International Name):

TENOFOVIRDISOPROXILSUCCINAAT COMPOSITION corresponding to ; TENOFOVIRDISOPROXIL

Pharmaceutical form:

Filmomhulde tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 0-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), 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),

Administration route:

Oraal gebruik

Therapeutic area:

Tenofovir Disoproxil

Product summary:

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);

Authorization date:

2016-04-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENOFOVIRDISOPROXIL STADA 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 STADA 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 TENOFOVIRDISOPROXIL STADA 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 STADA IS AND WHAT IT IS USED FOR
Tenofovirdisoproxil STADA 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 Tenofovirdisoproxil STADA should always be used
combined with other
medicines to treat HIV infection.
TENOFOVIRDISOPROXIL
STADA
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 o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tenofovirdisoproxil STADA 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_
Tenofovirdisoproxil STADA 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).
Tenofovirdisoproxil STADA 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 STADA 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 STADA 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 s