RICOVIR-EM 200mg300mg Tablets

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Tilgjengelig fra:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Enheter i pakken:

30tablet Tablets

Produsert av:

Mylan Laboratories Limited

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RICOVIR-EM 200MG/300MG TABLETS
Tenofovir Disoproxil Fumarate/Emtricitabine (300mg/200mg)
1
WHAT IS IN THIS LEAFLET
1. What
_Ricovir-EM _
is used for
2. How
_Ricovir-EM _
works
3. Before you use
_Ricovir-EM_
4. How to use
_Ricovir-EM_
5. While you are using it
6. Side Effects
7. Storage and Disposal of
_Ricovir-_
_EM_
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial number
WHAT _RICOVIR-EM _IS USED FOR
_Ricovir-EM _
is indicated in
combination with other
antiretroviral agents for the
treatment of HIV-1 in adults.
_ _
HOW _RICOVIR-EM _WORKS
_Ricovir-EM _
tablet 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.
BEFORE YOU USE _RICOVIR-EM _
-
_When you must not use it_
Do not take
_Ricovir-EM_
If you are allergic (hypersensitive)
to emtricitabine, tenofovir,
tenofovir disoproxil fumarate, or
any of the other ingredients of
_Ricovir-EM _
listed at the end of this
leaflet. If this applies to you, tell
your doctor immediately.
-
_Before you start use it_
Tell your doctor if you have had
kidney disease, or if tests have
shown problems with your
kidneys.
_Ricovir-EM _
may affect
your kidneys. Before starting
treatment, your doctor may order
blood tests to assess kidney
function. Your doctor may also
order blood tests during treatment to
monitor your kidneys and may
advise you to take the tablets less
often.
_Ricovir-EM _
is not
recommended if you have severe
kidney disease or are receiving
haemodialysis.
_Ricovir-EM _
is not
usually taken with other medicines
that can damage your kidneys (see
T

Preparatomtale

RICOVIR-EM 200MG/300MG TABLETS
LABEL CLAIM
Each film coated tablet contains
Emtricitabine 200mg
Tenofovir disoproxil fumarate 300 mg
is equivalent to 245 mg of Tenofovir Disoproxil.
EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE TABLETS 200MG/ 300MG
:
PRODUCT DESCRIPTION
: Blue colored, oval shaped, film coated tablets debossed with
“M117”
on one side and plain on other side
THERAPEUTIC INDICATIONS
RICOVIR-EM is indicated in combination with other antiretroviral
agents (such as non-
nucleoside reverse transcriptase inhibitors or protease inhibitors)
for the treatment of HIV-1
infection in adults.
The following points should be considered when initiating therapy with
RICOVIR EM for the
treatment of HIV-1 infection:
-
It is not recommended that RICOVIR EM be used as a component of a
triple nucleoside
regimen.
-
RICOVIR EM should not be co-administered with Lamivudine + Tenofovir
Disoproxil
Fumarate + Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate or
Lamivudine-
containing products. In treatment experienced patients, the use of
RICOVIR EM should
be guided by laboratory testing and treatment history.
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
POSOLOGY
The dosage of RICOVIR EM is one tablet (containing 200 mg of
Emtricitabine and 300 mg of
Tenofovir Disoproxil Fumarate) once daily taken orally with or without
food. Dose adjustment
for renal impairment significantly increased drug exposures occurred
when Emtricitabine or
Tenofovir Disoproxil Fumarate were administered to patients with
moderate to severe renal
impairment. Therefore, the dosing interval of RICOVIR EM should be
adjusted in patients with
baseline creatinine clearance of 30-49mL/min using the recommendations
in Table 1.
The safety and effectiveness of these dosing interval adjustment
recommendations have not
been clinically evaluated; therefore, clinical response to treatment
and renal function should be
closely monitored in these patients.
No dose adjustment i