EZOVIR famciclovir 250 mg tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

famciclovir, Quantity: 250 mg

Verfügbar ab:

Alphapharm Pty Ltd

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: sodium stearylfumarate; silicon dioxide; copovidone; microcrystalline cellulose; crospovidone; titanium dioxide; macrogol 8000; hypromellose; polydextrose; triethyl citrate

Verabreichungsweg:

Oral

Einheiten im Paket:

14 tablets, 21 tablets, 20 tablets, 56 tablets, 5 tablets, 30 tablets, 3 tablets

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

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 for the 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

Produktbesonderheiten:

Visual Identification: White, round, coated tablets debossed with FM on one side and 250 on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2020-10-13

Gebrauchsinformation

EZOVIR – FOR COLD SORES
_ _
_famciclovir_
CONSUMER MEDICINE INFORMATION
1
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
EZOVIR.
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 SPEAK TO YOUR
PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
Those updates may contain
important information about the
medicine and its use of which
you should be aware.
All medicines have risks and
benefits. Your pharmacist or
doctor has weighed the risks of
you taking EZOVIR 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 EZOVIR IS USED
FOR
EZOVIR is an antiviral medicine
used to treat recurrent outbreaks
of cold sores in adults 18 years
of age and over 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 becomes
dorman

Fachinformation

1
Version 01
AUSTRALIAN PRODUCT INFORMATION – EZOVIR
(FAMCICLOVIR) TABLETS
1 NAME OF THE MEDICINE
Famciclovir
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 125 mg, 250 mg or 500 mg of famciclovir as the
active ingredient.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Ezovir famciclovir 125 mg Tablets are white, round, film-coated
tablets, debossed with “FM”
on one side and “125” on the reverse side.
Ezovir famciclovir 250 mg Tablets are white, round, film-coated
tablets, debossed with “FM”
on one side and “250” on the reverse side.
Ezovir famciclovir 500 mg Tablets are white, oval, film-coated
tablets, debossed with “FM” on
one side and “500” on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ezovir
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.
•
the 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.
Ezovir is also indicated in immunocompromised patients for:
•
treatment of uncomplicated herpes zoster
•
treatment of recurrent herpes simplex
•
suppression of recurrent herpes simplex
_ _
2
Version 01
4.2 DOSE AND METHOD OF ADMINISTRATION
Famciclovir can be taken without regard to meals (se Section 5.2
Pharmacokinetic Properties-
Effect of Food.
IMMUNOCOMPETENT
_Herpes zoster:_
The recommended dosage of Ezovir is 250 mg three times daily for seven
days. Treatment
should be initiated as soon as possible afte