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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

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

Tilgængelig fra:

Alphapharm Pty Ltd

INN (International Name):

valaciclovir hydrochloride

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

6, 20, 10, 80, 42, 60, 30, 2, 4, 480, 8, 90, 240, 100

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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.

Produkt oversigt:

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

Autorisation status:

Licence status A

Autorisation dato:

2010-11-04

Indlægsseddel

VACLOVIR
®
FOR HERPES ZOSTER AND HERPES LABIALIS
_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 for the treatment
of shingles (herpes zoster) and
ophthalmic zoster (shingles affecting
the eye region) and cold sores
(herpes labialis).
VACLOVIR works by stopping the
multiplication of the virus which
causes shingles and cold sores. It can
reduce the length and severity of an
outbreak of shingles or cold sores
and the duration of pain associated
with shingles and cold sores. It is
important the treatment for shingles
is started within the first 3 days of the
shingles attack.
For the treatment of cold sores,
VACLOVIR should be taken at the
earliest symptom of a cold sore (e.g.
tingling, itching or burning).
VACLOVIR is more effective in
patients 50 years of age and older.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine 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 or 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 TH

Produktets egenskaber

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
®