FLOVIR 500 famciclovir 500 mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
famciclovir, Quantity: 500 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Famciclovir
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: titanium dioxide; hyprolose; magnesium stearate; hypromellose; lactose; sodium starch glycollate type A; macrogol 400
Administration route:
Oral
Units in package:
56, 20, 30
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Famciclovir is indicated for the treatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of rash. Greatest benefit occurs if the drug is started within 48 hours. Efficacy has not been demonstrated in patients less than 50 years of age, although the occasional younger patient with severe herpes zoster may benefit from therapy with famciclovir. Herpes zoster infection is generally a milder condition in younger patients. Famciclovir is also indicated for the treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older. Famciclovir is also indicated for suppression of recurrent genital herpes. Famciclovir is also indicated in immunocompromised patients for:- treatment of uncomplicated herpes zoster, - treatment of recurrent herpes simplex, - suppression of recurrent herpes simplex
Product summary:
Visual Identification: White to pale yellow colored, oval film-coated, biconvex tablets, debossed with 'X' on one side and '34' on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-02-19
Patient Information leaflet
FLOVIR
CONSUMER MEDICINE INFORMATION
Ver 1.4
Page 1 of 4
FLOVIR 125, 250 & 500
Famciclovir
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLOVIR.
It does not contain all the available
information.
It
does
not
take
the
place of talking to your pharmacist
or doctor.
All
medicines
have
risks
and
benefits. Your pharmacist or doctor
have weighed the risks of you taking
FLOVIR against the benefits it can
provide.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR PHARMACIST
OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLOVIR IS USED FOR
SHINGLES
FLOVIR
is
an
antiviral
medicine
that is used to treat shingles in adults
and adolescents.
Shingles is a condition that is caused
by
a
herpes
virus
called
varicella
zoster,
the
same
virus
that
causes
chicken pox. The virus can become
active again in the body, even after
many
years,
resulting
in
shingles,
The main symptom is a rash that can
cause pain, burning and blisters.
Although FLOVIR does not cure the
viral infection, it helps to relieve the
symptoms and shorten their duration.
The best results are obtained if the
medicine
is
started
as
soon
as
possible
after
the
first
symptoms
begin to appear.
GENITAL HERPES
FLOVIR is used to treat outbreaks of
genital herpes and also to suppress
(prevent) recurrent outbreaks of the
condition.
Genital
herpes
is
a viral
infection
caused by herpes simplex 1 or herpes
simplex 2. It is usually transmitted
through sexual contact.
Symptoms include tingling, burning
or itching of the genitals, followed
by blisters that may be painful.
People who have frequent episodes
of
genital
herpes
can
also
take
FLOVIR to help prevent the attacks.
Taking
FLOVIR
does
not
prevent
you from spreading the herpes virus
to another person.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
FLOVIR
is
only
available
with
a
doctor's
prescription.
It
is
not
addictive.
FLOVIR
i
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Summary of Product characteristics
Product Information:
FLOVIR (Famciclovir Tablets 125, 250 & 500 mg)
Ver 1.3
Page 1 of 17
PRODUCT INFORMATION
FLOVIR 125 (125 MG FAMCICLOVIR TABLETS)
FLOVIR 250 (250 MG FAMCICLOVIR TABLETS)
FLOVIR 500 (500 MG FAMCICLOVIR TABLETS)
NAME OF THE MEDICINE
Famciclovir
CHEMICAL NAME:
9-(4-acetoxy-3-acetoxymethylbut-1-yl)-2-aminopurine
MOLECULAR FORMULA:
C
14
H
19
N
5
O
4
MOLECULAR WEIGHT:
321.3
CAS REGISTRY NUMBER:
104227-87-4
DESCRIPTION
Famciclovir is a synthetic guanine derivative. It is a white to pale
yellow crystalline solid.
FLOVIR is available as tablets containing 125, 250 & 500 mg of
famciclovir.
FLOVIR tablets contain the following inactive ingredients: Sodium
starch glycollate, lactose
anhydrous,
hydroxypropylcellulose,
magnesium
stearate,
hypromellose,
macrogol
400
and
titanium dioxide.
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: Oral antiviral agent, ATC code: JO5A B09
VIROLOGY
Famciclovir is the oral form of the antiviral compound: penciclovir.
Famciclovir is rapidly
converted
_in vivo_
into penciclovir, which has demonstrable
_in vitro_
activity against herpes
Product Information:
FLOVIR (Famciclovir Tablets 125, 250 & 500 mg)
Ver 1.3
Page 2 of 17
simplex viruses (HSV types 1 and 2) and varicella zoster virus (VZV).
The antiviral effect of
orally administered famciclovir has been demonstrated in several
animal models: this effect is
due to
_in vivo_
conversion to penciclovir.
Penciclovir targets virus-infected cells where it is rapidly converted
into penciclovirtriphosphate
(mediated via virus-induced thymidine kinase). The triphosphate
inhibits viral DNA polymerase
by competition with deoxyguanosine triphosphate and is incorporated
into the extending DNA
chain, preventing significant chain elongation. Consequently, viral
DNA synthesis and, therefore,
viral replication are inhibited.
This triphosphate persists in infected cells in excess of 12 hours.
The long intracellular half-life of
penciclovir triphosphate ensures prolonged antiviral activity, as
demonstrated in cell cultures with
HSV-1 a
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