FAMVIR famciclovir 500mg tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

famciclovir, Quantity: 500 mg

Available from:

Atnahs Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate; hyprolose; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000; macrogol 4000

Administration route:

Oral

Units in package:

56 tablets, 16 tablets, 4 tablets, 20 tablets, 12 tablets, 30 tablets, 3 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Famvir is indicated for the treatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of the 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 is generally a milder condition in younger patients. Famvir is also indicated in the treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older. Famvir is also indicated for suppression of recurrent genital herpes. Famvir is also indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent patients Famvir 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, oval, film-coated tablet, bi-convex, bevelled edges, debossed with 'FV 500" on one side and plain on the reverse side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

1999-01-06

Patient Information leaflet

FAMVIR
®
(FAM-VEER)
_FOR SHINGLES_
_famciclovir (fam-SYE-klo-veer)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FAMVIR.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
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.
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 doctor has weighed
the risks of you taking FAMVIR
against the benefits it can provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FAMVIR IS USED
FOR
FAMVIR 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 FAMVIR 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
Your doctor may have prescribed it
for another reason.
FAMVIR is only available with a
doctor's prescription. It is not
addictive.
This medicine is not recommended
for use in children under 12 years of
age.
BEFORE YOU TAKE
FAMVIR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE FAMVIR IF YOU HAVE
AN ALLERGY TO:
•
famciclovir, the active ingredient
•
penciclovir, a related

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - FAMVIR
®
(FAMCICLOVIR)
1. NAME OF THE MEDICINE
famciclovir
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Famvir tablets contain 125, 250 or 500 mg of famciclovir.
Excipients of known effects: sugars as lactose (125 and 250 mg tablets
only). See also Section 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Tablets: 125 mg (white, round, film coated, biconvex) debossed with
“FV” on one side and 125 on the
reverse side.
Tablets: 250 mg (white, round, film coated, biconvex) debossed with
“FV” on one side and 250 on the
reverse side.
Tablets: 500 mg (white, oval, film coated, biconvex) debossed with
“FV 500” on one side and no markings on
the reverse side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Famvir 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.
Famvir is also indicated for the treatment of recurrent episodes of
genital herpes in adults and adolescents
12 years of age and older.
Famvir is also indicated for suppression of recurrent genital herpes.
Famvir is also indicated for the treatment of recurrent herpes
labialis (cold sores) in immunocompetent adult
patients.
Famvir is also indicated in immunocompromised patients for:
•
treatment of uncomplicated herpes zoster
•
treatment of recurrent herpes simplex
•
suppression of recurrent herpes simplex
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_IMMUNOCOMPETENT _
_Herpes zoster: _
The recommended dosage of Famvir is 250 mg three times daily for seven
days. Treatment should be
initiated as soon as possible after he