Emtricitabine 200mg Tenofovir 245mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Tenofovir disoproxil fumarate; Emtricitabine

Dostępny od:

Zentiva

Kod ATC:

J05AR17

INN (International Nazwa):

Tenofovir disoproxil fumarate; Emtricitabine

Dawkowanie:

245mg ; 200mg

Forma farmaceutyczna:

Tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 05030100; GTIN: 5000283659006

Ulotka dla pacjenta

PRODUCT NAME:
TENOFOVIR EMTRI.245/200MG F.TB.TRF(GB)
PM CODE:
11030015289
OLD PM CODE:
11030014636
PM TYPE:
LEAFLET
ARTWORK VERSION:
03
ARTWORK CREATION DATE:
14.03.2017
ARTWORK REVISION DATE:
11.12.2017
REASON OF REVISION:
Text changes.
PLANT NAME:
LULEBURGAZ
ARTWORK BY:
BG
NUMBER OF COLORS:
1
Black
GENERAL INFORMATION
TECHNICAL INFORMATION
FORMAT (size):
165 x 500 ± 0.5 mm
LEATUS (optical code/pharma code):
235
TECHNICAL DRAWING NUMBER:
B10080
MINIMAL SIZE OF TEXT:
9 pt.
FONTS:
Helvetica Neue
Package leaflet: Information for the patient
Emtricitabine/Tenofovir disoproxil Zentiva
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 Zentiva is
and what it is used for
2. What you need to know before you take
Emtricitabine/Tenofovir disoproxil Zentiva
3. How to take Emtricitabine/Tenofovir disoproxil Zentiva
4. Possible side effects
5. How to store Emtricitabine/Tenofovir disoproxil
Zentiva
6. Contents of the pack and other information
1. What Emtricitabine/Tenofovir disoproxil Zentiva
is and what it is used for
Emtricitabine/Tenofovir disoproxil Zentiva
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

Charakterystyka produktu

OBJECT 1
EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA 200
MG / 245 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 06-Nov-2017 | Zentiva
1. Name of the medicinal product
Emtricitabine/Tenofovir disoproxil Zentiva 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 291.5 mg of tenofovir disoproxil phosphate or 136 mg tenofovir).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Blue, oval biconvex film-coated tablet without half-score with
dimensions approx. 19.35 x 9.75 mm.
4. Clinical particulars
4.1 Therapeutic indications
Emtricitabine/Tenofovir disoproxil Zentiva is indicated in
antiretroviral combination therapy for the
treatment of HIV-1 infected adults (see section 5.1).
Emtricitabine/Tenofovir disoproxil Zentiva 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 5.1).
4.2 Posology and method of administration
Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva. Please refer to the
Summary of Product Characteristics for
these medicinal products.
If a dose of Emtricitabine/Tenofovir disoproxil Zentiva is missed
within 12 hours of the time it is usually
taken, Emtricitabine/Tenofovir disoproxil Zentiva should be taken as
soon as possible and the normal
dosing schedule should be resumed. If a dose of
Emtricitabine/Tenofovir disoproxil Zentiva is missed by
more than 12 hours and