Fabiflu 200mg Tablets

Country: Малезија

Језик: Енглески

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

Активни састојак:

Favipiravir

Доступно од:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Међународно име):

Favipiravir

Јединице у пакету:

1 X 34s Tablets; 5 X 1 X 34s Tablets

Произведен од:

Glenmark Pharmaceuticals Limited

Информативни летак

Consumer Medication Information Leaflet (RiMUP)
FABIFLU 200MG TABLETS
Favipiravir 200mg Tablets
1
What is in this leaflet
1. What Fabiflu is used for
2. How Fabiflu works
3. Before you use Fabiflu
4. How to use Fabiflu
5. While you are using it
6. Side effects
7. Storage and Disposal of Fabiflu
8. Product Description
9.Manufacturer
and
Product
Registration Holder
10. Date of revision
What Fabiflu is used for
Fabiflu is used for
the treatment
of
mild to moderate COVID-19 patients.
From
the
clinical
trial,
limited
efficacy
data
for
Fabiflu
200mg
Tablets
in the age group 18 to 30
years old,
and >60 years old for the
treatment
of
patients
with mild to
moderate COVID-19 disease.
How Fabiflu works
Fabiflu
contains
a
medicine
called
Favipiravir.
This belongs to a group
of
medicines
called
antivirals.
It
works
by
stopping
the
growth
of
viruses
Before you use Fabiflu
- When you must not use it
Do not use Fabiflu:
• if you are allergic (hypersensitive)
to Favipiravir or any of the other
ingredients of this medicine.
• if you are pregnant or suspected to
be pregnant
• if you are lactating/ breastfeeding
• if
you
have
severe
liver
impairment
• if
you
have
severe
kidney
impairment
• in children
Talk to your doctor if this applies to
you.
- Before you start to use it
Before you take Fabiflu,
make sure
the prescribing doctor knows

if you are a woman of child-
bearing age

if
you are a man and your
female
partner
is
of
childbearing age

if
you are allergic to other
medicines

if you have gout or a history
of gout

if
you have hyperuricaemia
(increased
blood
uric
acid
level
and symptoms may be
aggravated).

if
you
have
severe
liver
problems
If
you are a woman of
childbearing
age,
you
must
have
a
negative
pregnancy
test
before
starting
treatment with Fabiflu.
You or
your
partner
must
use
an
effective
contraceptive
during
the
time you are taking the treatment and
for
7 days
after
stopping treatment.
This
can
be
discussed
with
your
doctor.
-Use in Pregnancy and Lactation
Fabiflu is not
to be used in wo

Карактеристике производа

SAME SIZE ARTWORK
LEAFLET SIZE : 300 x 450 mm
150 mm
450 mm
300 mm
_For the use only of a Registered Medical Practitioner or a Hospital
or a Laboratory_
DRUGS
SIGNS, SYMPTOMS, AND TREATMENT
MECHANISM AND RISK FACTORS
Pyrazinamide
Reabsorption of uric acid in the renal tubule is additively
enhanced.
Repaglinide
Inhibition of CYP2C8 increases blood level of repaglinide.
Theophylline
Interaction with XO may increase blood level of favipiravir.
Inhibition of AO by favipiravir may decrease blood level of
active forms of these drugs.
Blood uric acid level increases.
When pyrazinamide 1.5g once daily and favipiravir 1200 mg /400 mg BID
were administered, the blood uric acid level was 11.6 mg/dL when
pyrazinamide was administered alone, and 13.9 mg/dL in
combination with favipiravir.
Blood level of repaglinide may increase, and adverse reactions to
repaglinide
may occur.
Blood level of favipiravir may increase, and adverse reactions to
favipiravir
may occur.
Efficacy of these drugs may be reduced
Famciclovir Sulindac
PE58502 MY
LABEL CLAIM
Each film-coated tablet contains
Favipiravir 200 mg
Excipient(s) q.s.
Colours: Titanium Dioxide USP NF & Ferric oxide yellow USP NF
For the full refer list of excipients,
PHARMACEUTICAL FORM
Film-coated tablet
PRODUCT DESCRIPTION
Yellow coloured, film coated round shaped, tablets plain on both
sides.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
For the treatment of patients with mild to moderate COVID-19 disease.
From the clinical trial, limited efficacy data for Fabiflu 200mg
Tablets in the age group 18 to 30 years old, and >60 years old for the
treatment of patients with mild to
moderate COVID-19 disease.
POSOLOGY AND METHOD OF ADMINISTRATION
st
The recommended dosage of favipiravir for adults is 1800 mg orally
twice daily on 1 day followed by 800 mg orally twice daily, up to
maximum of 14 days.
Note: Use only as directed by a physician.
_USE IN THE ELDERLY_
Since the elderly often have reduced physiological functions,
favipiravir should be administered with care to them by monitorin