Famciclovir Mylan Cold Sore Relief famciclovir 500 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

famciclovir, Quantity: 500 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Famciclovir

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

3

Class:

Medicine Registered

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

For the treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients aged 18 years and over.

Product summary:

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

Authorization status:

Registered

Authorization date:

2013-02-04

Patient Information leaflet

FAMCICLOVIR MYLAN
COLD SORE RELIEF
_famciclovir_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FAMCICLOVIR
MYLAN Cold Sore Relief. It does
not contain all the available
information and does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your pharmacist or doctor
have weighed the risks of you taking
FAMCICLOVIR MYLAN Cold Sore
Relief 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 THIS
MEDICINE.
You may need to read it again.
WHAT FAMCICLOVIR
MYLAN COLD SORE
RELIEF IS USED FOR
FAMCICLOVIR MYLAN Cold Sore
Relief is an antiviral medicine that is
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 I
(HSV-1). Cold sores usually begin on
or around the lips, mouth, and nose.
After redness and swelling develop,
the small red bumps turn into fluid-
filled blisters.
The blisters may weep or burst, and
this can be tender and painful. 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.
The infection is most commonly
acquired as a baby or child from
physical contact with parents or
relatives that have a cold sore, often
by kissing. After the initial infection
has healed, the virus becomes
dormant in nerve cells.
Cold sores can be unpredictable.
Even after many years, some people
may experience recurring cold sores
due to viral reactivation. Some
common triggers to a cold sore may
include:
•
sun exposure
•
stress
•
fatigue
•
menstrual periods
•
fever
•
illness
•
dry chapped lips
•
skin trauma
•
a cold
Many people who get cold sores
know when one is coming by a
tingling, burning, itchy or painful
sensatio

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FAMCICLOVIR MYLAN
COLD SORE RELIEF
_Famciclovir _
1
NAME OF THE MEDICINE
Famciclovir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of famciclovir as the active ingredient.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
FAMCICLOVIR MYLAN Cold Sore Relief tablets are white, oval shape,
biconvex, film coated, debossed
with “FAM 500” on one side and “G” on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FAMCICLOVIR MYLAN Cold Sore Relief is indicated for the treatment of
recurrent herpes labialis (cold
sores) in immunocompetent adult patients aged 18 years and over.
4.2
DOSE AND METHOD OF ADMINISTRATION
For adults 18 years of age and over.
RECURRENT HERPES LABIALIS (COLD SORES):
The recommended dosage is 1500 mg as a single dose. Initiate therapy
at the earliest sign or symptom of a
cold sore (e.g. tingling, itching or burning). Treatment was initiated
within 1 hour of symptom onset in the
recurrent herpes labialis clinical study.
Renal Impairment
As reduced clearance of penciclovir is related to reduced renal
function, as measured by creatinine clearance,
patients who have or at-risk of renal impairment should be referred to
their medical practitioner for screening
for renal impairment and any subsequent dosage adjustment if
necessary. Therefore, use of FAMCICLOVIR
MYLAN
Cold Sore Relief in patients with renal impairment should only be
under medical advice. The
following modifications in dosage are recommended:
CREATININE CLEARANCE (ML/MIN/1.73M
2
)
DOSAGE
> 60
No dosage adjustment necessary
40 - 59
750 mg single dose
20 - 39
500 mg single dose
10 - 20
250 mg single dose
for patients on haemodialysis
250 mg single dose
FAMCICLOVIR MYLAN Cold Sore Relief – PRODUCT INFORMATION
2
FAMCICLOVIR MYLAN
Cold Sore Relief is only available as unscored tablets containing 500
mg of
famciclovir.
As these recommendations are not based on repeated dose data,