Tenofovir disoproxil Mylan

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

tenofovir disoproxil

Saatavilla:

Mylan Pharmaceuticals Limited

ATC-koodi:

J05AF07

INN (Kansainvälinen yleisnimi):

tenofovir disoproxil

Terapeuttinen ryhmä:

Antivirals for systemic use

Terapeuttinen alue:

HIV Infections

Käyttöaiheet:

HIV-1 infectionTenofovir disoproxil 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 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 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 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 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 infectionTenofovir disoproxil 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.evidence of lamivudine-resistant hepatitis B virus.decompensated liver disease.Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.

Tuoteyhteenveto:

Revision: 18

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2016-12-08

Pakkausseloste

62
B. PACKAGE LEAFLET
63
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENOFOVIR DISOPROXIL MYLAN 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 Tenofovir disoproxil Mylan is and what it is used for
2.
What you need to know before you take Tenofovir disoproxil Mylan
3.
How to take Tenofovir disoproxil Mylan
4.
Possible side effects
5.
How to store Tenofovir disoproxil Mylan
6.
Contents of the pack and other information
IF THIS MEDICINE 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 MYLAN IS AND WHAT IT IS USED FOR
Tenofovir disoproxil Mylan 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
Mylan should always be used combined with other medicines to treat HIV
infection.
TENOFOVIR DISOPROXIL MYLAN 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

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tenofovir disoproxil Mylan 245 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
maleate).
Excipient with known effect
Each tablet contains 155 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light blue, round, biconvex, film-coated tablets, 12.20 ± 0.20 mm in
diameter, debossed with
‘TN245’ on one side and ‘M’ on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HIV-1 infection
Tenofovir disoproxil 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 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 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 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 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 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)