VALACICLOVIR SZ 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

Available from:

Sandoz Pty Ltd

INN (International Name):

valaciclovir hydrochloride

Authorization status:

Registered

Patient Information leaflet

VALACICLOVIR SZ
1
VALACICLOVIR SZ
_Valaciclovir hydrochloride film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Valaciclovir SZ.
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 SZ
IS USED FOR
This medicine is used to treat:
•
genital herpes infections (Herpes
Simplex Virus, or HSV)
•
shingles (herpes zoster) and
ophthalmic zoster (shingles
affecting the eye region).
This medicine is also 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).
It contains the active ingredient
valaciclovir hydrochloride.
Valaciclovir hydrochloride belongs
to a group of medicines called
antivirals.
It works by stopping the
multiplication of the viruses which
cause these infections.
FOR GENITAL HERPES INFECTIONS:
Although Valaciclovir SZ does not
cure the infection, it can reduce the
length and severity of an outbreak of
herpes, the duration of pain and
shorten the time to healing. It also
helps blisters to heal more quickly. If
you start taking them as soon as you
feel an outbreak starting, you may
prevent the blisters from developing.
Valaciclovir SZ tablets can be taken
long term to prevent the HSV
infection coming back. It can also
reduce the risk of transmitting the
virus that causes genital herpes in
patients who are taking it
continuously to prevent or reduce
recurrent outbreaks.
This medicine (or any other antiviral)
does not cure genital herpes or
completely eliminates the risk

Summary of Product characteristics

190206-Valaciclovir SZ-pi
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
VALACICLOVIR SZ
® (VALACICLOVIR HYDROCHLORIDE) FILM-
COATED TABLETS
1
NAME OF THE MEDICINE
Valaciclovir Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valaciclovir SZ tablets contain the active ingredient valaciclovir
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Valaciclovir SZ 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 SZ 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.
*
Not currently marketed in Australia
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 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.
_ _
_Genital Herpes: _
First clinical presentation, 500 mg of valaciclovir twice a day for 5
to 10 days.
For recurrent episodes of genital herpes, 500 mg twice daily for 5
days.
Dosing should begin as early as possible. For recurrent episodes of
genital herpes, this should
ideally be during the prodromal period or immediately following the
appearance of the first
signs or symptoms.
19020