Emtricitabine/Tenofovir disoproxil Mylan
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
05-12-2023
Summary of Product characteristics
(SPC)
05-12-2023
Public Assessment Report
(PAR)
12-07-2019
Active ingredient:
emtricitabine, tenofovir disoproxil maleate
Available from:
Mylan Pharmaceuticals Limited
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 infection:Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).Emtricitabine/Tenofovir disoproxil Mylan 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 Mylan 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).
Product summary:
Revision: 14
Authorization status:
Authorised
Authorization date:
2016-12-16
Patient Information leaflet
55
B. PACKAGE LEAFLET
56
Package leaflet: Information for the user
Emtricitabine/Tenofovir disoproxil Mylan 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 Mylan is and what it is used
for
2.
What you need to know before you take Emtricitabine/Tenofovir
disoproxil Mylan
3.
How to take Emtricitabine/Tenofovir disoproxil Mylan
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil Mylan
6.
Contents of the pack and other information
1.
What Emtricitabine/Tenofovir disoproxil Mylan is and what it is used
for
Emtricitabine/Tenofovir disoproxil Mylan 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 Mylan 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/Te
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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 Mylan 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 (as maleate).
Excipient with known effect
Each tablet contains 93.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
A light green, film-coated, capsule shaped, biconvex tablet, of
dimensions 19.80 mm x 9.00 mm, debossed
with ‘M’ on one side of the tablet and ‘ETD’ on the other side
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of HIV-1 infection:
Emtricitabine/Tenofovir disoproxil Mylan is indicated in
antiretroviral combination therapy for the treatment
of HIV-1 infected adults (see section 5.1).
Emtricitabine/Tenofovir disoproxil Mylan 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 Mylan 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 Mylan 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 least35 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
3
Emtricitabine/Tenofovir disoproxil Mylan. Plea
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