APO-VALACICLOVIR valaciclovir hydrochloride monohydrate 500mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride monohydrate

Available from:

Apotex Pty Ltd

INN (International Name):

Valaciclovir hydrochloride monohydrate

Authorization status:

Registered

Patient Information leaflet

APO- VALACICLOVIR TABLETS
1
APO- VALACICLOVIR
_FOR HERPES ZOSTER, OPHTHALMIC ZOSTER AND HERPES LABIALIS _
_Valaciclovir hydrochloride monohydrate _
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 valaciclovir. 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 YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Valaciclovir is used to treat:

shingles (herpes zoster)

shingles affecting the eye region
(ophthalmic zoster)

cold sores (herpes labialis)
It belongs to a group of medicines
called antivirals.
_HOW IT WORKS _
Valaciclovir works by stopping the
multiplication of the virus which
causes shingles and cold sores. It can
reduce the length and severity of an
outbreak, as well as reduce the
duration of pain associated with
shingles and cold sores.
It is important that treatment for
shingles is started within the first
three days of the shingles attack.
For the treatment of cold sores, the
tablets should be taken at the earliest
symptom of a cold sore (e.g. tingling,
itching, or burning).
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.
Valaciclovir is more effective in
patients 50 years of age and older.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:

valaciclovir

aciclovir

any of the ingr

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