APX-VALACICLOVIR valaciclovir 500 mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride, Quantity: 556 mg (Equivalent: valaciclovir, Qty 500 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; crospovidone; colloidal anhydrous silica; Carnauba Wax; magnesium stearate; microcrystalline cellulose; Colour

Administration route:

Oral

Units in package:

30 tablets, 42 tablets, 60 tablets, 90 tablets, 100 tablets, 2 tablets starter pack, 10 tablets, 20 tablets, 4 tablets, 6 tablets, 240 tablets, 480 tablets, 80 tablets, 8 x 500 mg tablet blister pack

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. Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with Valtrex, it is recommended that patients use safer sex practices. (See PRECAUTIONS). Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Product summary:

Visual Identification: White, film coated tablet, white to off-white core, biconvex, elongated, unscored engraved with "500" on one side and plain on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-07-02

Patient Information leaflet

APX-VALACICLOVIR
®
TABLETS
1
APX-VALACICLOVIR
TABLETS
_FOR HERPES ZOSTER, HERPES LABIALIS, HERPES SIMPLEX AND
CYTOMEGALOVIRUS _
_valaciclovir _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-
VALACICLOVIR tablets. It does
not contain all of 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 taking APX-
VALACICLOVIR tablets against the
benefits this medicine is expected to
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 need to read it again.
WHAT APX-
VALACICLOVIR
TABLETS ARE USED FOR
_HOW APX-VALACICLOVIR _
_TABLETS WORK _
APX-VALACICLOVIR tablets
belong to a group of medicines called
antivirals. They are used for the
treatment of genital herpes, shingles
(herpes zoster), ophthalmic zoster
(shingles affecting the eye region)
and cold sores (herpes labialis). It
also used to prevent cytomegalovirus
(CMV) infection and disease
following solid organ transplantation.
CMV is another type of herpes virus
that can cause symptoms similar to
glandular fever (high temperature,
sore throat and swollen glands).
APX-VALACICLOVIR tablets work
by stopping the multiplication of the
virus which causes herpes, shingles
and cold sores. It can reduce the
length and severity of an outbreak
and duration of pain, and shorten the
healing time of crusts, associated
with herpes, shingles and cold sores.
APX-VALACICLOVIR does not
eliminate the herpes virus (Herpes
Simplex Virus or HSV) from the
body.
It is important the 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).
For the treatment of herpes simplex,
start taking the tablets as soon as you
feel an outbreak starting, as you may
prevent the

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APX-VALACICLOVIR
(VALACICLOVIR AS HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Valaciclovir as hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-VALACICLOVIR tablets 500mg contain 500mg of valaciclovir as
hydrochloride.
APX-VALACICLOVIR tablets 1000mg contain 1000mg of valaciclovir as
hydrochloride.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APX-VALACICLOVIR tablets 500mg: White, film coated tablet, white to
off-white core, biconvex,
elongated, unscored engraved with “500” on one side and plain on
the other.
APX-VALACICLOVIR tablets 1000mg: White, film coated tablet, white to
off-white core, biconvex,
elongated, unscored engraved with “1000” on one side and plain on
the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
Reduction of transmission of genital herpes in patients suffering from
recurrent genital herpes. In
addition to therapy with APX-VALACICLOVIR, it is recommended that
patients use safer sex practices.
(SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
2
Prophylaxis of cytomegalovirus (CMV) infection and disease following
solid organ transplantation in
patients at risk of CMV disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
For the treatment of herpes zoster (shingles), 1000 mg of
APX-VALACICLOVIR three times a day for
seven days.
The recommended dosage of APX-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
burnin