ACICLOVIR GH

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aciclovir, Quantity: 200 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Aciclovir

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica

Administration route:

Oral

Units in package:

25 tablets, 90 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aciclovir tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advanced symptomatic HIV disease (CD4 + counts < 150 x 10(6)/L). In accordance with details specified in the "Indications" and the "Dosage and Adminsitration" sections of the approved product information provided as Attachment 1.

Product summary:

Visual Identification: Capsule shaped biconvex uncoated white to off-white tablets with 200 debossed on one side and ACV 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:

Licence status A

Authorization date:

2011-08-09

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ACICLOVIR GH
(ACICLOVIR) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Aciclovir GH. 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 it is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT ACICLOVIR GH IS
USED FOR
Aciclovir GH contains aciclovir, a
compound that belongs to a
group of medicines called
antivirals.
Aciclovir GH is used for the
treatment of shingles (herpes
zoster), impaired immunity and
genital herpes.
In the case of shingles, Aciclovir
GH works by stopping the
multiplication of the virus which
causes shingles. It can reduce
the length and severity of an
outbreak of shingles but it will
not get rid of the virus from your
body.
Aciclovir at high strength is used
as part of the management
program in people who have
human immunodeficiency virus
disease (HIV). It acts by
preventing further damage to the
immune system. In these
people, Aciclovir GH also guards
against the herpes virus
disease. Aciclovir does not get
rid of the virus from your body.
Your doctor may have
prescribed Aciclovir GH for
another purpose.
Aciclovir GH is not
recommended for use in
children as there have been no
studies of its effects in children.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
ACICLOVIR GH HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available
with a doctor's prescription.
BEFORE YOU TAKE
ACICLOVIR GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ACICLOVIR GH IF
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
ACICLOVIR (THE ACTIVE
INGREDIENT IN ACICLOVIR GH);
•
ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET.
Some of the symptoms of an
allergic reaction may include:
•
skin rash similar to hives,
itchines

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ACICLOVIR GH
(ACICLOVIR) UNCOATED TABLET
1
NAME OF THE MEDICINE
Aciclovir.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg, 400 mg or 800 mg aciclovir.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Aciclovir GH 200 mg: capsule shaped, biconvex, white to off-white
tablets embossed “200” on one side
and “ACV” on the other side.
Aciclovir GH 400 mg: capsule shaped, biconvex, white to off-white
tablets embossed “400” on one side
and “ACV” on the other side.
Aciclovir GH 800 mg_:_ capsule shaped, biconvex, white to off-white
tablets embossed “800” on one side
and “ACV” on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Treatment of first episode (primary or nonprimary) genital herpes and
the management of recurrent
episodes of genital herpes in certain patients.
Treatment of acute attacks of _Herpes zoster_ (shingles) when the
duration of rash is less than 72 hours.
The management of patients with advanced symptomatic HIV disease (CD4+
counts < 150 x 10
6
/L).
Genital herpes
_ _
_Initial episodes _
The duration of viral shedding is reduced very significantly; the
duration of pain and time to healing are
also reduced. The promptness of initiation of therapy and/or the
patient’s prior exposure to _ Herpes _
_simplex_ virus may influence the degree of benefit from therapy.
Intravenous aciclovir should be considered in patients in whom
prostration, CNS involvement or inability
to take oral medication requires hospitalisation and initiation of
more aggressive management.
Aciclovir GH v3.0
Page 2 of 12
(aciclovir) uncoated tablet
Aciclovir does not prevent the establishment of latency in initial
episodes.
_Recurrent episodes _
_ _
_SUPPRESSION: _ In patients with frequent recurrences, suppressive
therapy prevents or reduces the
frequency and/or severity of recurrences in a high proportion of
patients. Abortive episodes (prodromal
symptoms without vesicle formation) and oc