Apo-Famciclovir

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Famciclovir 125mg

Available from:

Apotex NZ Ltd

INN (International Name):

Famciclovir 125 mg

Dosage:

125 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Famciclovir 125mg Excipient: Hypromellose Macrogol 8000 Poloxamer Purified water Stearic acid Titanium dioxide

Units in package:

Blister pack, Al/Al, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Signa SA de CV

Therapeutic indications:

Apo-Famciclovir is indicated for: · the treatment of acute herpes zoster, including ophthalmic zoster and decreases the duration of associated post-herpetic neuralgia (PHN). · the acute treatment of first episode and recurrences of genital herpes infections, and for the suppression of recurrent genital herpes. · the treatment of recurrent herpes labialis (cold sores) in immunocompromised adults aged 18 years and over. · in immunocompromised patients with herpes zoster or herpes simplex infections.

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al - 40 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP cap and desiccant - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP cap and desiccant - 40 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP cap and desiccant - 56 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2013-03-25

Patient Information leaflet

APOHEALTH FAMCICLOVIR ONCE
1
APOHEALTH
FAMCICLOVIR ONCE
_FOR COLD SORES _
_Famciclovir _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about famciclovir. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Famciclovir is used to treat recurrent
outbreaks of cold sores in adults who
have a normal immune system (the
body system which fights against
infection).
It belongs to a group of medicines
called antivirals.
_HOW IT WORKS _
Cold sores are an infection caused by
a virus called herpes simplex type 1
(HSV-1), commonly acquired as a
child from contact with parents or
relatives. Cold sores usually begin on
or around the lips, mouth, and nose
as small red bumps that turn into
painful fluid-filled blisters.
Famciclovir works by stopping the
production of the virus causing the
cold sore. It does not cure the viral
infection, but it helps to relieve the
symptoms and shorten the duration
of an outbreak.
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. As
the cold sore dries, a shallow ulcer
and yellow crust forms which will
eventually fall off to expose new
pink-coloured skin. Generally, the
sores heal without scarring. After the
initial infection has healed, the virus
becomes dormant in nerve cells.
Cold sores can be unpredictable. The
virus can become active again in the
body, even after many years,
res

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APOHEALTH FAMCICLOVIR ONCE
1. PRODUCT NAME
APO-FAMCICLOVIR (125mg, 250mg and 500mg film- coated tablets)
APOHEALTH FAMCICLOVIR ONCE (500mg film- coated tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
APOHEALTH FAMCICLOVIR ONCE Tablets contain famciclovir 500mg
EXCIPIENT(S) WITH KNOWN EFFECT
None
APOHEALTH FAMCICLOVIR ONCE tablets are gluten free and lactose free.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
APOHEALTH FAMCICLOVIR ONCE 500mg are white, oval, biconvex film-coated
tablets
engraved "APO" on one side and "FAM500” on the other side. Each
tablet typically weighs
549mg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APOHEALTH FAMCICLOVIR ONCE is indicated:
•
for the treatment of recurrent herpes labialis (cold sores) in
immunocompetent adults
aged 18 years and over.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
RECURRENT HERPES LABIALIS (COLD SORES)
1500mg as a single dose for one day. Initiation of treatment is
recommended at the
earliest sign or symptom of a cold sore (e.g. tingling, itching or
burning).
DOSAGE IN RENALLY IMPAIRED PATIENTS
Famciclovir should only be used in patients with or who are at-risk of
renal impairment under
medical advice. Because reduced clearance of penciclovir, the
antivirally active metabolite of
famciclovir (see section 5.2 Pharmacokinetic properties), is related
to reduced renal function,
as measured by creatinine clearance, special attention should be given
to dosages in
patients with impaired renal function.
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 17
APOHEALTH FAMCICLOVIR ONCE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 17
Patients who are at higher risk of renal impairment include those who:
•
are over 50 years of age
•
are smokers
•
have diabetes mellitus, hypertension or established cardiovascular
disease
•
are obese
•
have a family history of chronic kidney disease
•
are of Aboriginal or Torre