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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Emtricitabine; Tenofovir disoproxil

Available from:

Clonmel Healthcare Ltd

ATC code:

J05AR; J05AR03

INN (International Name):

Emtricitabine; Tenofovir disoproxil

Dosage:

200 mg/245 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2016-08-26

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRICITABINE/TENOFOVIR DISOPROXIL CLONMEL 200MG/245MG 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 Clonmel is and what it is
used for
2. What you need to know before you take Emtricitabine/Tenofovir
disoproxil Clonmel
3. How to take Emtricitabine/Tenofovir disoproxil Clonmel
4. Possible side effects
5. How to store Emtricitabine/Tenofovir disoproxil Clonmel
6. Contents of the pack and other information
1. WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL CLONMEL IS AND WHAT IT IS
USED FOR
EMTRICITABINE/TENOFOVIR DISOPROXIL CLONMEL 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 CLONMEL 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 effec

Summary of Product characteristics

Health Products Regulatory Authority
20 September 2023
CRN00DPCC
Page 1 of 31
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil Clonmel 200 mg/245 mg film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine and 300.6 mg
tenofovir disoproxil succinate equivalent to 245 mg of
tenofovir disoproxil.
Excipient with known effect
Each tablet contains 96 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue coloured, capsule shaped film-coated tablets, plain on both
sides. The dimensions of the tablet are 19.3 mm x 8.8 mm ±
5%.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection:_
Emtricitabine/Tenofovir disoproxil Clonmel is indicated in
antiretroviral combination therapy for the treatment of HIV-1
infected adults (see section 5.1).
Emtricitabine/Tenofovir disoproxil Clonmel 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 Clonmel 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 Clonmel 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 HIV-1 infection if it becomes
necessary to discontinue or modify the dose of one of