AURO-VALACICLOVIR valaciclovir (as hydrochloride) 1000mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride, Quantity: 1112 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

valaciclovir hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30, 10

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. ,Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Product summary:

Visual Identification: Blue, film coated, capsule shaped tablets with partial scorebar on both sides containing 'F' on one side and '8' and '3' on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-10-25

Patient Information leaflet

AURO-VALACICLOVIR
CONSUMER MEDICINE INFORMATION
Ver 1.0
Page 1 of 5
AURO-VALACICLOVIR 500 & 1000 TABLETS
_FOR HERPES SIMPLEX, HERPES ZOSTER AND HERPES LABIALIS _
_valaciclovir_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AURO-
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 AURO-
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
AURO-VALACICLOVIR
TABLETS ARE USED FOR
HOW AURO-VALACICLOVIR
TABLETS WORK
AURO-VALACICLOVIR tablets
belong to a group of medicines
called antivirals. AURO-
VALACICLOVIR tablets are used
for the treatment of genital herpes
infection, shingles (infection zoster),
ophthalmic zosters (shingles
affecting the eye region), cold sores
(herpes labialis) and for the
prevention of Cytomegalovirus
(CMV) infection in people following
an organ transplant.
AURO-VALACICLOVIR tablets
work by stopping the multiplication
of the virus which causes herpes,
shingles and cold sores. They can
reduce the length and severity of an
outbreak of herpes, shingles and cold
sores and the duration of pain and
shorten the time to healing of crusts
associated with herpes.
GENITAL HERPES
AURO-VALACICLOVIR tablets do
not eliminate the herpes virus from
the body. The herpes virus is also
known as the Herpes Simplex Virus,
or HSV.
AURO-VALACICLOVIR tablets
help the blisters to heal more
quickly. If you start taking them as
soon as you feel an outbreak starting,
you may actually prevent the blisters
from developing.
AURO-VALACICLOVIR tablets
can also be taken long term to help
prevent the HSV infection coming
back.
AURO-VALACICLOVIR tablets
can also reduce the risk of
transmitting the virus that ca