MyTAFF 25mg (TENOFOVIR ALAFENAMIDE TABLETS)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TENOFOVIR ALAFENAMIDE FUMARATE

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

TENOFOVIR ALAFENAMIDE FUMARATE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Mylan Laboratories Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
MYTAFF
25MG (TENOFOVIR
ALAFENAMIDE TABLETS)
TENOFOVIR ALAFENAMIDE 25 MG
WHAT IS IN THIS LEAFLET
1.
What MYTAFF is used for
2.
How MYTAFF works
3.
Before you take MYTAFF
4.
How to take MYTAFF
5.
While you are taking
MYTAFF
6.
Side effects
7.
Storage and disposal of
MYTAFF
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1.
WHAT MYTAFF IS USED FOR
MYTAFF is used to
TREAT
CHRONIC (LONG TERM) HEPATITIS B
in adults and adolescents aged 12
years and older, who weigh at
least 35 kg. Hepatitis B is an
infection affecting the liver,
caused by the hepatitis B virus.
2.
HOW MYTAFF WORKS
MYTAFF contains the active
substance
_tenofovir alafenamide_
.
This is an
_antiviral medicine_
,
known as a
_nucleotide reverse_
_transcriptase inhibitor _
(NtRTI).
In patients with hepatitis B,
MYTAFF controls the infection
by stopping the virus from
multiplying.
3.
BEFORE YOU TAKE MYTAFF
_When you must not use it:_
DO NOT TAKE MYTAFF
•
IF YOU ARE ALLERGIC
to tenofovir
alafenamide or any of the other
ingredients of this medicine
(listed in section 8).
If this applies to you,
DO NOT
TAKE MYTAFF AND TELL YOUR
DOCTOR IMMEDIATELY
.
_Before you start to use it: _
•
TAKE CARE NOT TO PASS ON YOUR
HEPATITIS B TO OTHER PEOPLE.
You can still infect others when
taking this medicine. MYTAFF
does not reduce the risk of
passing on hepatitis B to others
through sexual contact or blood
contamination. You must
continue to take precautions to
avoid this. Discuss with your
doctor the precautions needed to
avoid infecting others.
•
TELL YOUR DOCTOR IF YOU HAVE A
HISTORY OF LIVER DISEASE.
Patients
with liver disease, who are
treated for hepatitis B with
antiviral medicines, have a
higher risk of severe and
potentially fatal liver
complications. Your doctor may
need to carry out blood tests to
monitor your liver function.
•
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE HAD
KIDNEY DISEASE OR IF TESTS HAVE
SHOWN PROBLEMS WITH YOUR
KIDNEYS.
Before starting
treatm

Ciri produk

TENOFOVIR ALAFENAMIDE TABLETS 25 MG
D3. PROPOSED PACKAGE INSERT
Draft of the actual product proposed package insert is attached here.
MYTAFF 25 MG
TENOFOVIR ALAFENAMIDE TABLETS
NAME OF THE MEDICINAL PRODUCT
MYTAFF 25mg (Tenofovir Alafenamide Tablets)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film Coated Tablet contains:
Tenofovir Alafenamide fumarate equivalent to Tenofovir Alafenamide 25
mg
Excipients with known effects:
Each film-coated tablet contains 67.957 mg of lactose monohydrate.
PHARMACEUTICAL FORM
Film-coated tablet;
A white to off-white, film-coated, round, biconvex tablet debossed
with M on one side of the
tablet and TFI on other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Tenofovir Alafenamide is indicated for the treatment of chronic
hepatitis B in adults and
adolescents (aged 12 years and older with body weight at least 35 kg)
(see section
Pharmacodynamic).
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of chronic hepatitis
B.
Posology
Adults and adolescents (aged 12 years and older with body weight at
least 35 kg): one tablet
once daily.
Treatment discontinuation
Treatment
discontinuation
may
be
considered
as
follows
(See
section
Warning
and
Precautions):
•In HBeAg-positive patients without cirrhosis, treatment should be
administered for at least 6-
12
months
after
HBe
seroconversion
(HBeAg
loss
and
HBV
DNA
loss
with
anti-HBe
detection) is confirmed or until HBs seroconversion or until there is
loss of efficacy. (See
section Warning and Precautions). Regular reassessment is recommended
after treatment
discontinuation to detect virological relapse.
•In HBeAg-negative patients without cirrhosis, treatment should be
administered at least until
HBs seroconversion or until there is evidence of loss of efficacy.
With prolonged treatment for
more than 2 years, regular reassessment is recommended to confirm that
continuing the selected
therapy remains appropriate for the patient.
Missed dose
If a dose is missed and less than 18