FAMCICLOVIR GENERICHEALTH

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

famciclovir

Fáanlegur frá:

Southern Cross Pharma Pty Ltd

INN (Alþjóðlegt nafn):

Famciclovir

Leyfisstaða:

Registered

Upplýsingar fylgiseðill

Famciclovir generichealth CMI v3
Page 1 of 5
CONSUMER MEDICINE INFORMATION
FAMCICLOVIR GENERICHEALTH
famciclovir
What is in this leaflet
This leaflet answers some
common questions about
FAMCICLOVIR
GENERICHEALTH for cold
sores.
It does not contain all the
available information. It does
not take the place of talking
to your pharmacist or doctor.
The information in this leaflet
was last updated on the date
listed on the final page. Some
more recent information on
the medicine may be
available.
You should ensure that you
speak to your pharmacist
or doctor to obtain the
most up to date information
on the medicine.
All medicines have risks and
benefits. Your pharmacist or
doctor has weighed the risks
of you taking FAMCICLOVIR
GENERICHEALTH 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
GENERICHEALTH is
used for
FAMCICLOVIR
GENERICHEALTH is an
antiviral medicine used to
treat recurrent outbreaks of
cold sores in adults who have
a normal immune system (the
body system which fights
against harmful bacteria,
viruses and fungi).
Cold sores are an infection
caused by a virus called
herpes simplex type 1 (HSV-
1). The infection is most
commonly acquired as a
baby or child from contact
with parents or relatives,
often from kissing.
Cold sores usually begin on
or around the lips, mouth,
and nose as small red bumps
that turn into fluid-filled
blisters. Cold sores can be
tender and painful. Many
people who get cold sores
know when one is coming by
a tingling, burning, itchy or
painful sensation or redness
in the area. This can happen
very rapidly.
After redness and swelling
develop, blisters form. The
blisters may weep or burst
and this can be painful. Then
a shallow ulcer and yellow
crust form as the cold sore
dries. The crust eventually
falls off, exposing new pink-
coloured skin. Generally the
sores heal without scarring.
After the initial infection has
healed, the virus becom

Vara einkenni

AUSTRALIAN PRODUCT INFORMATION – FAMCICLOVIR GENERICHEALTH
(FAMCICLOVIR) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Famciclovir.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 125 mg, 250 mg or 500 mg famciclovir.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Famciclovir generichealth 125 mg tablets are white round film coated
tablets with ‘FM’ on one side and
‘125’ on the other side.
Famciclovir generichealth 250 mg tablets are white round film coated
tablets with ‘FM’ on one side and
‘250’ on the other side.
Famciclovir generichealth 500 mg tablets are white oval film coated
tablets with ‘FM’ on one side and
‘500’ on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Famciclovir is indicated for:
•
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.
•
Treatment of recurrent episodes of genital herpes in adults and
adolescents 12 years of age and
older.
•
Suppression of recurrent genital herpes.
•
Treatment of recurrent _herpes labialis_ (cold sores) in
immunocompetent adult patients.
Famciclovir is also indicated in immunocompromised patients for:
•
Treatment of uncomplicated _herpes zoster_.
•
Treatment of recurrent _herpes simplex_.
•
Suppression of recurrent _herpes simplex_.
Famciclovir generichealth v1.1
Page 2 of 19
(famciclovir) film-coated tablet
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Immunocompetent Patients
_Herpes Zoster _
The recommended dosage of famciclovir is 250 mg three times daily for
seven days. Treatment should
be initiated as soon as possible after _herpes zoster_ is diagnosed.
Studi