VACLOVIR 500 valaciclovir (as hydrochloride) 500 mg tablet bottle pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

valaciclovir hydrochloride, Quantity: 611.22 mg (Equivalent: valaciclovir, Qty 500 mg)

Verfügbar ab:

Alphapharm Pty Ltd

INN (Internationale Bezeichnung):

valaciclovir hydrochloride

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; macrogol 400

Verabreichungsweg:

Oral

Einheiten im Paket:

240, 100, 480, 8, 42, 10, 500, 30

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

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 VACLOVIR, it is recommended that patients use safer sex practices (see section 4.4). Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Produktbesonderheiten:

Visual Identification: White coloured, oval shaped, biconvex film coated tablet with a breakline on one side and plain on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2010-11-04

Gebrauchsinformation

VACLOVIR®
1
VACLOVIR®
FOR CYTOMEGALOVIRUS
_valaciclovir (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VACLOVIR.
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 benefits and
risks. Your doctor has weighed the
risks of you taking VACLOVIR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT VACLOVIR IS
USED FOR
VACLOVIR belongs to a group of
medicines called antivirals.
VACLOVIR is 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). VACLOVIR can
help prevent CMV infection and
herpes simplex infections.
Ask your doctor if you have any
questions about why VACLOVIR
has been prescribed for you.
VACLOVIR is not addictive.
BEFORE YOU TAKE
VACLOVIR
_WHEN YOU MUST NOT TAKE IT _
Do not take VACLOVIR if you have
an allergy to:
•
any medicine containing
(valaciclovir, aciclovir)
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT OR ARE TRYING TO
BECOME PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE
TAKING THIS MEDICINE.
Your doctor will discuss the risks and
benefits of using VACLOVIR tablets
when pregnant and during
breastfeeding.
DO NOT GIVE THIS MEDICINE TO
CHILDREN.
There is not enough information to
recommend the use of VACLOVIR
in children.
DO NOT TAKE THIS MEDICINE AFTER

Fachinformation

AUSTRALIAN PRODUCT INFORMATION
VACLOVIR
®
_Valaciclovir (as hydrochloride) _
1
NAME OF THE MEDICINE
Valaciclovir (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valaciclovir is the L-valine ester of acyclovir. Aciclovir is a purine
nucleoside analogue.
VACLOVIR tablets contain 250, 500 or 1000 mg of valaciclovir (as
valaciclovir hydrochloride).
For the full list of excipients see Section 6.1
LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Dosage form: film coated tablet
250 mg tablets: white coloured, oval shaped, biconvex film coated
tablet
500 mg tablets: white coloured, oval shaped, biconvex film coated
tablet with break line on one side and plain
on the other side
1000 mg tablets: white coloured, oval shaped, biconvex film coated
tablet with a break line on one side and
plain on the other side
4
CLINICAL PARTICULARS
4.1
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 VACLOVIR, 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
DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
For the treatment of herpes zoster: 1000 mg of VACLOVIR three times a
day for 7 days.
The recommended dosage of VACLOVIR 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).
VACLOVIR
®