Emtricitabine/Tenofovir disoproxil Krka d.d.
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
22-06-2023
Summary of Product characteristics
(SPC)
22-06-2023
Public Assessment Report
(PAR)
26-09-2019
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:
Emtricitabine/Tenofovir disoproxil Krka d.d. is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.Emtricitabine/Tenofovir disoproxil Krka d.d. 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.
Product summary:
Revision: 10
Authorization status:
Authorised
Authorization date:
2017-04-28
Patient Information leaflet
41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA D.D. 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 d.d. is and what it is
used for
2.
What you need to know before you take Emtricitabine/Tenofovir
disoproxil Krka d.d.
3.
How to take Emtricitabine/Tenofovir disoproxil Krka d.d.
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil Krka d.d.
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA D.D. IS AND WHAT IT IS
USED FOR
EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA D.D. 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 D.D. 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 hav
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil Krka d.d. 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 d.d. film-coated tablets are
blue, oval, biconvex tablets, of
dimensions 20 mm x 10 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emtricitabine/Tenofovir disoproxil Krka d.d. is indicated in
antiretroviral combination therapy for the
treatment of HIV-1 infected adults (see section 5.1).
Emtricitabine/Tenofovir disoproxil Krka d.d. is also indicated for the
treatment of HIV-1 infected
adolescents, with NRTI resistance or toxicities precluding the use of
first line agents (see section 4.2,
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Emtricitabine/Tenofovir disoproxil Krka d.d. should be initiated by a
physician experienced in the
management of HIV infection.
Posology
_Adults and adolescents aged 12 years and older, weighing at least 35
kg:_ One tablet, once daily.
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
Emtricitabine/Tenofovir disoproxil Krka d.d.. Please refer to the
Summary of Product Characteristics
for these medicinal products.
If a dose of Emtricitabine/Tenofovir disoproxil Krka d.d. is missed
within 12 hours of the time it is
usually taken, Emtricitabine/Tenofovir disoproxil Krka d.d. should be
taken as soon as possible and
the normal dosing schedule should be resumed. If a dose of
Emtricitabine/Tenofovir disoproxil Krka
d.d. is misse
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