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

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Tenofovir disoproxil; Emtricitabine

Sẵn có từ:

Accord Healthcare Limited

Mã ATC:

J05AR; J05AR03

INN (Tên quốc tế):

Tenofovir disoproxil; Emtricitabine

Liều dùng:

200mg/245 milligram(s)

Dạng dược phẩm:

Film-coated tablet

Loại thuốc theo toa:

Product subject to prescription which may not be renewed (A)

Khu trị liệu:

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

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

2017-05-05

Tờ rơi thông tin

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or
nurse.
-
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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.

is used to treat Human Immunodeficiency Virus 1
(HIV-1) infection, in adults
aged 18 years and over.

should always be used combined with other medicines to
treat HIV
infection.

can be administered in place of emtricitabine and
tenofovir disoproxil used
separately at the same doses.
People who are HIV positive can still pass on HIV when taking this
medicine, although the risk is
lowered by effective antiretroviral therapy. Discuss with your doctor
the precautions n

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil 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 136 mg of
tenofovir).
Excipient(s) with known effect: Each tablet contains 227.20 mg Lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue, capsule shaped, film-coated tablets with a dimension of
approximate 19.20 mm in length and approximate 8.70
mm in width debossed with 'H'
on one side and 'E29'
on the other side.
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).
_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 at
high risk (see sections 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 or prevention of HIV in adults: 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.
Please refer to the Summary of Product Characteristics for these
medicinal products.
If dose of Emtricitabine/Tenofovir disoproxil is missed within 12
hours of the time it is usually taken,
Emtricitabine/Tenofovir disoproxil should be taken as soon as possible
and the normal dosing schedule should be
resumed. If a dose of Emtricitabine/Tenofovir disoproxil is missed by
more than 12 hours and it is almost time for the