ZELITREX valaciclovir 500mg (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

INN (International Name):

valaciclovir hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

2 tablets starter pack, 10 tablets, 100 tablets, 30 tablets, 42 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 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 Zelitrex, 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:

2007-02-28

Patient Information leaflet

ZELITREX
®
TABLETS
1
ZELITREX
® 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 Zelitrex 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 Zelitrex
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 ZELITREX TABLETS
ARE USED FOR
_HOW ZELITREX TABLETS WORK _
Zelitrex 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).
Zelitrex 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. Zelitrex 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 blisters from developing,
or help the blisters to heal more
quickly.
Zelit

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ZELITREX (VALACICLOVIR AS
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Valaciclovir as hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZELITREX tablets 500mg contain 500mg of valaciclovir as hydrochloride.
3
PHARMACEUTICAL FORM
ZELITREX 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.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS
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 ZELITREX, it is recommended that patients use
safer sex practices. (SEE
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
Prophylaxis of cytomegalovirus (CMV) infection and disease following
solid organ transplantation in
patients at risk of CMV disease.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
FOR THE TREATMENT OF HERPES ZOSTER (SHINGLES)
For treatment of herpes zoster, 1000 mg of ZELITREX three times a day
for seven days.
FOR THE TREATMENT OF HERPES LABIALIS (COLD SORES)
The recommended dosage of ZELITREX 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)
GENITAL HERPES
_For the treatment of genital herpes _
For treatment of first clinical presentation of genital herpes, 500 mg
of ZELITREX twice a day for 5 to
10 days. For recurrent episodes of genital herpes, 500 mg twice