APO-VALACICLOVIR valaciclovir hydrochloride monohydrate 500mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride monohydrate, Quantity: 584 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Valaciclovir hydrochloride monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; macrogol 8000; hypromellose; titanium dioxide; indigo carmine aluminium lake; stearic acid

Administration route:

Oral

Units in package:

240, 100, 500, 480

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. . For the treatment of ophthalmic zoster. . For the treatment of recurrent herpes labialis (cold sores) . For the treatment of clinical episodes of genital herpes simplex infections. . For the prevention of recurrent genital herpes in immunocompromised patients. . Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Product summary:

Visual Identification: Dark Blue, capsule-shaped, biconvex film coated tablet, engraved "APO" on one side, "VAL 500" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2010-02-26

Patient Information leaflet

APO-VALACICLOVIR
_FOR CYTOMEGALOVIRUS_
_Contains the active ingredient valaciclovir hydrochloride
monohydrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about valaciclovir. 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
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet
•
if you are worried about taking
your medicine
•
to obtain the most up-to-date
information
You can also download the most up
to date leaflet from
www.apotex.com.au.
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Valaciclovir. It contains the active
ingredient valaciclovir hydrochloride
monohydrate.
Valaciclovir belongs to a group of
medicines called antivirals.
It is used to prevent cytomegalovirus
(CMV) infection and disease,
following solid organ transplantation.
CMV is another type of herpes virus.
It can cause symptoms similar to
glandular fever (high temperature,
sore throat and swollen glands).
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
THERE IS NOT ENOUGH INFORMATION TO
RECOMMEND THE USE OF THIS
MEDICINE IN CHILDREN.
BEFORE YOU TAKE THIS
MEDICINE
_W

Summary of Product characteristics

1
AUSTRALIAN PI –
APO-VALACICLOVIR (VALACICLOVIR HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Valaciclovir hydrochloride monohydrate
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Valaciclovir is the L-valine ester of aciclovir. Aciclovir is a purine
nucleoside analogue. The maximum
solubility of valaciclovir hydrochloride monohydrate in water is 174
mg/mL at 25°C.
Each tablet contains 500 mg or 1000 mg of valaciclovir, as the active
ingredient. In addition, each
tablet
contains
the
following
inactive
ingredients:
Stearic
acid,
colloidal
anhydrous
silica,
Hypromellose, Macrogol 8000, titanium dioxide, indigo carmine
aluminium lake (500 mg tablet only).
500 MG TABLETS
Dark blue, capsule-shaped, biconvex film-coated tablets, engraved
“APO” on one side, “VAL 500” on
the other side.
1000 MG TABLETS
White, oval shaped, biconvex film coated-tablet, partially scored and
engraved “APO” on one side, “VAL
1000” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

For the treatment of herpes zoster (shingles) in adult patients who
commence therapy
within 72 hours of the onset of rash.

For the treatment of ophthalmic zoster.

For the treatment of recurrent herpes labialis (cold sores)

For the treatment of clinical episodes of genital herpes simplex
infections.

For the prevention of recurrent genital herpes in immunocompromised
patients.

Prophylaxis
of
cytomegalovirus
(CMV)
infection
and
disease
following
solid
organ
transplantation in patients at risk of CMV disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
For treatment of herpes zoster, 1000 mg of valaciclovir three times a
day for seven days.
2
The recommended dosage of valaciclovir for the treatment of cold sores
is 2000 mg twice daily
for 1 day with the second dose taken about 12 hours (no sooner than 6
hours) after the first dose.
Therapy should be initiated at the earliest symptom of a cold sore
(e.g. tingling, itching, or
burning).
For treatment of first clinical presentation