FAMCICLOVIR AN famciclovir 250 mg tablets blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Compra

Foglio illustrativo Foglio illustrativo (PIL)
01-12-2017
Scheda tecnica Scheda tecnica (SPC)
01-12-2017

Principio attivo:

famciclovir

Commercializzato da:

Amneal Pharma Australia Pty Ltd

INN (Nome Internazionale):

Famciclovir

Stato dell'autorizzazione:

Registered

Foglio illustrativo

                                _Famciclovir AN – Consumer Medicine Information _
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_Doc ID: 59.AN.M.2.0 _
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_Page 1 _
FAMCICLOVIR AN TABLETS
_Famciclovir _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Famciclovir AN.
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 Famciclovir AN
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 FAMCICLOVIR AN
IS USED FOR
SHINGLES
FAMCICLOVIR AN 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 FAMCICLOVIR AN
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
FAMCICLOVIR AN 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 FAMCICLOVIR AN to
help prevent the attacks.
Taking FAMCICLOVIR AN does
not prevent you from spreading
the herpes virus to another
person.
COLD SORES
FAMCICLOVIR AN is an antiviral
medicine used to treat recurrent
outbreaks of cold sores in adults
who have a normal
                                
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Scheda tecnica

                                _Famciclovir AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Doc ID: 59.AN.P.2.0
Page 1 of 18
FAMCICLOVIR AN
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_(FAMCICLOVIR TABLETS) _
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PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
The name of the medicine is 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.
FAMCICLOVIR AN is available as tablets containing 125, 250 & 500 mg of
famciclovir.
FAMCICLOVIR AN 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
simplex viruses (HSV types 1 and 2) and varicella zoster virus (VZV).
The antiviral effect of
_Famciclovir AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Doc ID: 59.AN.P.2.0
Page 2 of 18
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
                                
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