VALACICLOVIR SANDOZ valaciclovir (as hydrochloride) 500 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride, Quantity: 556.275 mg (Equivalent: valaciclovir, Qty 500 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

valaciclovir hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 400

Administration route:

Oral

Units in package:

20, 42, 10, 30, 100

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 valaciclovir, 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.

Product summary:

Visual Identification: White to off-white capsule shaped film coated tablets with "500" debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2010-03-05

Patient Information leaflet

VALACICLOVIR SANDOZ
1
VALACICLOVIR SANDOZ
®
_FOR HERPES ZOSTER, HERPES LABIALIS, HERPES SIMPLEX AND
CYTOMEGALOVIRUS _
_Valaciclovir hydrochloride film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Valaciclovir Sandoz.
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 taking 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 need to read it again.
WHAT VALACICLOVIR
SANDOZ IS USED FOR
_HOW VALACICLOVIR SANDOZ WORKS _
This medicine belongs to a group of
medicines called antivirals.
Valaciclovir Sandoz tablets 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).
Valaciclovir Sandoz works by
stopping the multiplication of the
viruses which causes herpes, shingles
and cold sores. It can reduce the
length and severity of an outbreak of
shingles and cold sores and the
duration of pain, and shorten the
healing time of crusts, associated
with shingles and cold sores.
Valaciclovir Sandoz 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

Summary of Product characteristics

200914-Valaciclovir Sandoz-pi
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
VALACICLOVIR SANDOZ
® (VALACICLOVIR HYDROCHLORIDE) FILM-
COATED TABLETS
1
NAME OF THE MEDICINE
Valaciclovir hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valaciclovir Sandoz tablets contain the active ingredient valaciclovir
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Valaciclovir Sandoz 500 mg capsule shaped film coated tablets - White
to off-white capsule
shaped film coated tablets with ‘500’ debossed on one side and
plain on other side.
Valaciclovir Sandoz 1000 mg capsule shaped film coated tablets
*
- White to off-white, capsule
shaped film coated tablets with “1000” debossed on one side and
plain on other side.
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 valaciclovir, 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
_Herpes Zoster_
:
_ _
1000 mg of valaciclovir three times a day for seven days.
_Cold sores: _
Recommended dosage is 2000 mg of valaciclovir 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_
:
_ _
First clinical presentation, 500 mg of valaciclovi