Emtricitabine/Tenofovir disoproxil Krka

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

emtricitabine, tenofovir disoproxil succinate

Available from:

KRKA, d.d., Novo mesto

ATC code:

J05AR03

INN (International Name):

emtricitabine, tenofovir disoproxil

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Treatment of HIV-1 infectionEmtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.Emtricitabine/Tenofovir disoproxil Krka is 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 (see section 5.1Pre-exposure prophylaxis (PrEP)Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Product summary:

Revision: 12

Authorization status:

Authorised

Authorization date:

2016-12-09

Patient Information leaflet

46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA 200 MG/245 MG FILM-COATED
TABLETS
emtricitabine/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 Emtricitabine/Tenofovir disoproxil Krka is and what it is used
for
2.
What you need to know before you take Emtricitabine/Tenofovir
disoproxil Krka
3.
How to take Emtricitabine/Tenofovir disoproxil Krka
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil Krka
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA IS AND WHAT IT IS USED
FOR
EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA CONTAINS TWO ACTIVE
SUBSTANCES, _emtricitabine _and
_tenofovir disoproxil_. Both of these active substances are
_antiretroviral _medicines which are used to
treat HIV infection. Emtricitabine is a _nucleoside reverse
transcriptase inhibitor _and tenofovir is a
_nucleotide reverse transcriptase inhibitor. _However, both are
generally known as NRTIs and they
work by interfering with the normal working of an enzyme (reverse
transcriptase) that is essential for
the virus to reproduce itself.
-
EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA IS USED TO TREAT HUMAN
IMMUNODEFICIENCY VIRUS
1 (HIV-1) INFECTION IN ADULTS.
-
IT IS ALSO USED TO TREAT HIV IN ADOLESCENTS AGED 12 TO LESS THAN 18
YEARS WHO WEIGH AT LEAST
35 KG, and who have already been treated with other HIV medicines that
are no longer effective
or have caused side effects.
-
Emtricitabine/T

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of
tenofovir disoproxil
(equivalent to 300.7 mg of tenofovir disoproxil succinate or 136 mg of
tenofovir).
Excipient(s) with known effect
Each film-coated tablet contains 80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Emtricitabine/Tenofovir disoproxil Krka film-coated tablets are blue,
oval, biconvex tablets, of
dimensions 20 mm x 10 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection_
Emtricitabine/Tenofovir disoproxil Krka is indicated in antiretroviral
combination therapy for the
treatment of HIV-1 infected adults (see section 5.1).
Emtricitabine/Tenofovir disoproxil Krka is also indicated for the
treatment of HIV-1 infected
adolescents, with NRTI resistance or toxicities precluding the use of
first line agents (see sections 4.2,
4.4 and 5.1).
_Pre-exposure prophylaxis (PrEP)_
Emtricitabine/Tenofovir disoproxil Krka is indicated in combination
with safer sex practices for pre-
exposure prophylaxis to reduce the risk of sexually acquired HIV-1
infection in adults and adolescents
at high risk (see sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Emtricitabine/Tenofovir disoproxil Krka should be initiated by a
physician experienced in the
management of HIV infection.
Posology
_Treatment of HIV in adults and adolescents aged 12 years and older,
weighing at least 35 kg:_ One
tablet, once daily.
_Prevention of HIV in adults and adolescents aged 12 years and older,
weighing at least 35 kg:_ One
tablet, once daily.
3
Separate preparations of emtricitabine and tenofovir disoproxil are
available for treatment of HIV-1
infection if it becomes necessary to discontinue or modify the dose of
one of the components of
Emtricitabi