FAMCICLOVIR MYLAN famciclovir 500 mg tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

famciclovir, Quantity: 500 mg

Beszerezhető a:

Alphapharm Pty Ltd

INN (nemzetközi neve):

Famciclovir

Gyógyszerészeti forma:

Tablet, film coated

Összetétel:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; hyprolose; silicon dioxide; magnesium stearate; purified water; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000

Az alkalmazás módja:

Oral

db csomag:

3 tablets, 14 tablets, 56 tablets, 30 tablets

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

FAMCICLOVIR MYLAN 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 is generally a milder condition in younger patients.. FAMCICLOVIR MYLAN is also indicated for the treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older.. FAMCICLOVIR MYLAN is also indicated for suppression of recurrent genital herpes.. FAMCICLOVIR MYLAN is also indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients.. FAMCICLOVIR MYLAN is also indicated in immunocompromised patients for:. - treatment of uncomplicated herpes zoster. - treatment of recurrent herpes simplex. - suppression of recurrent herpes simplex.

Termék összefoglaló:

Visual Identification: White, oval shape, biconvex, film coated tablet, debossed with ,"FAM 500" on one side and "G" on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2010-03-10

Betegtájékoztató

EZOVIR FOR SHINGLES
_famciclovir_
CONSUMER MEDICINE INFORMATION
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 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 EZOVIR
against the benefits it can provide.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EZOVIR
IS USED
FOR
EZOVIR
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 EZOVIR
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 FOR YOU.
Your doctor may have prescribed it
for another reason.
EZOVIR
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 TAKING EZOVIR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EZOVIR
IF YOU HAVE
AN ALLERGY TO:
•
famciclovir, the active ingredient
•
penciclovir, a related antiviral
medicine
•
a

Termékjellemzők

AUSTRALIAN PRODUCT INFORMATION
FAMCICLOVIR MYLAN
_Famciclovir _
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.
Famciclovir Mylan tablets contain lactose monohydrate. For the full
list of excipients, see
SECTION 6.1 LIST
OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Famciclovir Mylan 125 mg - white, oval shape, biconvex, film coated
tablet, debossed with “FAM 125” on
one side and “G” on other side.
Famciclovir Mylan 250 mg - white, oval shape, biconvex, film coated
tablet, debossed with “FAM 250” on
one side and “G” on other side.
Famciclovir Mylan 500 mg - white, oval shape, biconvex, film coated
tablet, debossed with “FAM 500” on
one side and “G” on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FAMCICLOVIR MYLAN 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.
FAMCICLOVIR MYLAN 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
METHOD OF ADMINISTRATION
Famciclovir Mylan is intended for oral administration.
Famciclovir can be taken without regard to meals (see
SECTION 5.2 PHARMACOKINETIC PROPERTIES - EFFECT OF
FOOD
).
Famciclovir – PRODUCT INFORM