VALACOR 500 valaciclovir 500 mg (as valaciclovir hydrochloride) tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

valaciclovir, Quantity: 500 mg

Dostupné z:

Sun Pharma ANZ Pty Ltd

INN (Medzinárodný Name):

Valaciclovir

Forma lieku:

Tablet, film coated

Zloženie:

Excipient Ingredients: microcrystalline cellulose; povidone; crospovidone; magnesium stearate; indigo carmine aluminium lake; titanium dioxide; hypromellose; polysorbate 80; macrogol 6000; macrogol 400

Spôsob podávania:

Oral

Počet v balení:

42 tablets per pack, 10 tablets per pack, 30 tablets per pack, 100 tablets per pack

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. Treatment of ophthalmic zoster. Treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of > 15 ml/min. For the 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 PRECAUTIONS). For prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Prehľad produktov:

Visual Identification: Blue, capsule shaped, biconvex, film coated, tablets, debossed with 'V' AND '5' on either side of breakline on one side, notched on either side along with the breakline and plain 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

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2011-02-22

Príbalový leták

VALACOR 500 CMI V3 March 2020
Page 1 of 11
VALACOR 500
_VALACICLOVIR TABLETS_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
VALACOR 500
(valaciclovir).
It does not contain all the available information.
It does not take the place of talking to your doctor or
pharmacist.
This leaflet was last updated on the date at the end of this
leaflet. More recent information may be available. The latest
Consumer
Medicine
Information
is
available
from
https://www.ebs.tga.gov.au/
and may contain important information
about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed
the risks of you taking
VALACOR 500
against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with this medicine. You may need to read it
again.
WHAT VALACOR 500 TABLET IS USED FOR
VALACOR 500
tablets contain valaciclovir (as hydrochloride).
VALACOR 500
tablets belong to a group of medicines called anti-
virals.
VALACOR 500
tablets are used for one or more of the following in
adults:
•
_TREATMENT OF HERPES ZOSTER (SHINGLES): _
Valaciclovir works by
stopping the multiplication of the virus which causes shingles.
It can reduce the length and severity of an outbreak of shingles
and the duration of pain associated with shingles. It
is
important the treatment is started within the first three
days of the shingles attack.
VALACOR 500 CMI V3 March 2020
Page 2 of 11
•
_TREATMENT OF OPHTHALMIC ZOSTER (SHINGLES AFFECTING THE EYE _
_REGION)_
_ _
•
_TREATMENT OF GENITAL HERPES INFECTION: _
Valaciclovir works by
stopping the multiplication of the virus which causes herpes.
It can reduce the length and severity of an outbreak of
herpes, the duration of pain and shorten the time to healing
of crusts associated with herpes. They do not eliminate the
herpes virus from the body. The herpes virus is also known as
the Herpes Simplex Virus, or HSV

Súhrn charakteristických

VALACOR 500 PI V4 29/JUN/2020
1
AUSTRALIAN PRODUCT INFORMATION
VALACOR 500
VALACICLOVIR
1
NAME OF THE MEDICINE
Valaciclovir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VALACOR 500 film-coated tablet contains 500 mg valaciclovir (as
hydrochloride).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet.
Blue coloured, capsule shaped, biconvex, film coated tablets, debossed
with ‘V’ and ‘5’ on either side
of the breakline on one side, notched on either side along with the
breakline and plain on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC PARTICULARS
VALACOR 500 is indicated:
•
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
in
immunocompromised
patients
with
creatinine clearance of >15 mL/min.
•
For reduction of transmission of genital herpes in patients suffering
from recurrent genital
herpes. In addition to therapy with VALACOR 500 (valaciclovir), it is
recommended that
patients use safer sex practices. (see SECTION 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE).
•
For
prophylaxis
of
cytomegalovirus
(CMV)
infection
and
disease
following
solid
organ
transplantation in patients at risk of CMV disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
For treatment of herpes zoster, 1000 mg of valaciclovir (2 tablets of
VALACOR 500) three times a day
for seven days.
For treatment of first clinical presentation of genital herpes, 500 mg
of valaciclovir (1 tablet of
VALACOR 500) twice a day for 5 to 10 days.
For recurrent episodes of genital herpes, 500 mg of valaciclovir (1
tablet of VALACOR 500) twice daily
for 5 days.
VALACOR 500 PI V4 29/JUN/2020
2
Dosing should begin as early as possible. For recurrent episodes of
genital herpes, this should ideally
be during the prodromal period or immediately fo