TAFICITA (Emtricitabine and Tenofovir Alafenamide Film Coated Tablets 200mg25mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Mylan Laboratories Limited

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TAFICITA
(EMTRICITABINE AND TENOFOVIR
ALAFENAMIDE FILM COATED TABLETS
200MG/25MG)
_EMTRICITABINE (200MG) AND TENOFOVIR ALAFENAMIDE (25MG) _
WHAT IS IN THIS LEAFLET?
1.
What Taficita is used for
2.
How Taficita works
3.
Before you take Taficita
4.
How to use Taficita
5.
While you are using
Taficita
6.
Side effects
7.
Storage and disposal of
Taficita
8.
Product description
9.
Manufacturer
10.
Product Registration
Holder
WHAT TAFICITA IS USED FOR
Taficita in combination with
other medicines is for the
TREATMENT OF HUMAN
IMMUNODEFICIENCY VIRUS 1
(HIV-1) INFECTION
in adults
and adolescents 12 years of age
and older, who weigh at least
35 kg.
HOW TAFICITA WORKS
Taficita contains two active
substances:
•
EMTRICITABINE,
an
antiretroviral medicine of a
type known as a
nucleoside reverse
transcriptase inhibitor
(NRTI)
•
TENOFOVIR ALAFENAMIDE,
an
antiretroviral medicine of a
type known as a nucleotide
reverse transcriptase
inhibitor (NtRTI)
Taficita blocks the action of
the reverse transcriptase
enzyme, which is essential for
the virus to multiply. Taficita
therefore reduces the amount
of HIV in your body.
BEFORE YOU TAKE TAFICITA
_-When you must not use it _
DO NOT TAKE TAFICITA:
•
IF YOU ARE ALLERGIC TO
EMTRICITABINE, TENOFOVIR
ALAFENAMIDE
or any of the
other ingredients of this
medicine (listed in
section 6 of this leaflet).
CHILDREN AND ADOLESCENTS
Do not give this medicine to
children aged 11 years or
under, or weighing less than
35 kg. The use of Taficita in
children aged 11 years or under
has not yet been studied.
_-Before you start to use it _
WARNINGS AND PRECAUTIONS
You must remain under the
care of your doctor while
taking Taficita.
TALK TO YOUR DOCTOR BEFORE
TAKING TAFICITA:
•
IF YOU HAVE LIVER
PROBLEMS OR HAVE
SUFFERED LIVER DISEASE,
INCLUDING HEPATITIS.
Patients with liver disease
including chronic
hepatitis B or C, who are
treated with antiretrovirals,
have a higher risk of
severe and potentially fatal
liver complications. If you
have hepatitis B in

Ciri produk

Note:
Barcodes Should be readable in both the side
of the folded leaflet. It should be scannable.
Position of barcode can be changed by vendor
to meet the above requirement.
.
TAFICITA
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE TABLETS
200 MG/25 MG
1.
NAME OF THE MEDICINAL PRODUCT
TAFICITA (Emtricitabine and Tenofovir Alafenamide Tablets 200 mg/25
mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of Emtricitabine and Tenofovir Alafenamide
Fumarate equivalent to 25 mg of tenofovir alafenamide.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
A blue, film-coated, rectangular, biconvex, beveled edge tablet
debossed with M on one side of the tablet and EAI on the other side.
The film-coated tablet should not be chewed, crushed, or SPLIT
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TAFICITA is indicated in combination with other antiretroviral agents
for the treatment of adults and adolescents (aged 12 years and
older with body weight at least 35 kg) infected with human
immunodeficiency virus type 1 (HIV-1) (see sections 4.2 – Posology &
Method of Administration and 5.1 Pharmacodynamic Properties).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy 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
TAFICITA should be administered as shown in Table 1.
TABLE 1: DOSE OF TAFICITA ACCORDING TO THIRD AGENT IN THE HIV
TREATMENT REGIMEN
DOSE OF TAFICITA
THIRD AGENT IN HIV TREATMENT REGIMEN (SEE SECTION 4.5)
Emtricitabine
and
Tenofovir
Alafenamide
200/10 mg once daily
Atazanavir with ritonavir or cobicistat Darunavir with ritonavir or
cobicistat
1
Lopinavir with ritonavir
Emtricitabine
and
Tenofovir
Alafenamide
200/25 mg once daily
Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine,
raltegravir
1.
Emtricitabine and Tenofovir Alafenamide 200/10 mg in combination with
darunavir 800 mg and cobicistat 150 mg, administered
as a fixed-dose combination tablet, was studied in treatment naive
s