RICOVIR Tablets 300mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TENOFOVIR DISOPROXIL FUMARATE

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

TENOFOVIR DISOPROXIL FUMARATE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

Mylan Laboratories Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RICOVIR TABLET
Tenofovir Disoproxil Fumarate (300mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_Ricovir tablet _
is used for
2.
How
_Ricovir tablet _
works
_3._
_ _
Before you use
_Ricovir tablet _
_4._
_ _
How to use
_Ricovir tablet _
5.
While you are using it
6.
Side Effects
_7._
_ _
Storage and Disposal of
_Ricovir _
_tablet _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT _RICOVIR TABLET _IS USED FOR
Tenofovir disoproxil fumarate is the
active substance in
_Ricovir tablet_
. This
active substance is an antiretroviral or
antiviral medicine which is used to
treat Human Immunodeficiency
Disease (HIV) infection for adults
over 18 years of age.
HOW _RICOVIR TABLET _WORKS
_Ricovir tablet _
is a nucleotide reverse
transcriptase inhibitor, generally
known as an NRTI and works by
interfering with the normal working of
enzymes reverse transcriptase that are
essential for the viruses to reproduce
themselves.
This medicine is not a cure for HIV
infection.
BEFORE YOU USE _RICOVIR TABLET _
-
_When you must not use it _
If you are allergic to tenofovir,
tenofovir disoproxil fumarate or any
of the other ingredients of this
medicine (listed in inactive
ingredients). Talk to your doctor or
pharmacist before taking
_Ricovir _
_tablet. _
_ _
-
_Before you start to use it _
_ _
-
_Ricovir tablet _
may affect your
kidneys. Before starting treatment,
your doctor may order blood tests
to assess your kidney function and
may advise you to take the tablets
less often. Do not reduce the
prescribed dose, unless your doctor
has told you to do so. Your doctor
may also order blood tests during
treatment to monitor how your
kidneys work.
-
_Ricovir tablet _
is not usually taken
with other medicines that can
damage your kidneys (see Taking
other medicines).
-
If this is unavoidable, your doctor
will monitor your kidney function
once a week.
-
Some people with HIV taking
combination antiretroviral therapy
may develop a bone disease called
osteonecrosis

Ciri produk

TENOFOVIR DISOPROXIL FUMARATE
300 MG TABLETS
[ Page 1 of 2 ]
ARTWORK IMPLEMENTATION SCHEDULE
CHECK (P) WHICHEVER IS APPLICABLE
(APPROVAL IS NOT VALID WITHOUT FOLLOWING DETAILS)
DATE OF ISSUE
ISSUED BY
DATE OF RETURN
MATERIAL CODE
75091542
SUPERSEDES
75065232
MARKET
Malaysia
[ ] New Component
[ ] Immediately (Stock of superseded component to be
destroyed, if applicable.)
[ ] After consumption of existing (superseded) stock.
[ ] Other (Specify)
.....................................................
................................................................................
DESCRIPTION
LIT. RICOVIR TABS 300 mg (36 Months) MY V2
COMPONENT
Printed Literature
ACTUAL SIZE
Flat- 272 x 312 mm; Folded- 34 x 39 mm
SUBSTRATE
60gsm Century Maplitho Paper
DESIGN & STYLE
Supply in Folded form as Proposed Size (with tape)
_Sign. _
_dd/mm/yy_
_Job Function_
_Sign. _
_dd/mm/yy_
_Job Function_
_Sign. _
_dd/mm/yy_
_Job Function_
REASON FOR
ISSUE
Change in Mylan Healthcare address
PRINTING
PANTONE NOS
1
BLACK
2
NA
3
NA
4
NA
5
NA
6
NA
7
NA
8
NA
PROOF NO.
1
2
3
4
5
NON PRINTING
l
Die Line
NA
NA
NA
DATE
01/06/2022
dd/mm/yy
dd/mm/yy
dd/mm/yy
dd/mm/yy
PREPARED BY
CHECKED BY
APPROVED BY
REMARKS
Revised
A/w
x
x
x
x
PACKAGING
DEVELOPMENT
PACKAGING
DEVELOPMENT
PRODUCTION
REGULATORY
AFFAIRS
QUALITY
ASSURANCE
SOP-000565164-FORM-000565208-A01-03-01-20
FINAL DATE
DD/MM/YY
R
ICOVIR
R
ICOVIR
TENOFOVIR DISOPROXIL
FUMARATE 300 MG
TABLETS
75091542
R
ICOVIR
TENOFOVIR DISOPROXIL
FUMARATE 300 MG
TABLETS
75091542
1.
NAME OF THE MEDICINAL PRODUCT
Tenofovir Disoproxil Fumarate Film Coated Tablet 300 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Tenofovir disoproxil fumarate 300 mg
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Light blue colored, round biconvex film-coated tablet debossed with
“153” on one side
and “M” on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For HIV-1 Infection
Tenofovir Disoproxil Fumarate 300 mg Tablets is indicated in
combination with other
antiretroviral agents for the treatment