Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Emtricitabine; Tenofovir disoproxil fumarate

제공처:

Tillomed Pharma GmbH

ATC 코드:

J05AR; J05AR03

INN (International Name):

Emtricitabine; Tenofovir disoproxil fumarate

복용량:

200/245 milligram(s)

약제 형태:

Film-coated tablet

치료 영역:

Antivirals for treatment of HIV infections, combinations; tenofovir disoproxil and emtricitabine

승인 상태:

Not marketed

승인 날짜:

2020-10-02

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EMTRICITABINE/TENOFOVIR DISOPROXIL TILLOMED 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 is and what it is used for
2.
What you need to know before you take Emtricitabine/Tenofovir
disoproxil
3.
How to take Emtricitabine/Tenofovir disoproxil
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL IS AND WHAT IT IS USED FOR
Emtricitabine/Tenofovir disoproxil
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 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.
o
Emtricitabine/Tenofovir disoproxil should always be used combined with
other

제품 특성 요약

Health Products Regulatory Authority
23 January 2023
CRN00D780
Page 1 of 32
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil Tillomed 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 mg of tenofovir
disoproxil fumarate or 136 mg of tenofovir).
Excipient with known effect: each film-coated tablet contains 0.76 mg
of soya lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, modified capsule shaped, film-coated tablets,
debossed with "EM" on one side and "144" on other side of
the tablet. The dimensions of the tablet are approximately 19.20 mm x
9.70 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection:_
Emtricitabine/Tenofovir disoproxil is indicated in antiretroviral
combination therapy for the treatment of HIV-1 infected adults
(see section 5.1).
Emtricitabine/Tenofovir disoproxil 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 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 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.
Separate preparations of emtricitabine and tenofovir disoproxil are
available for treatment of H