ARX-ACICLOVIR aciclovir 200mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aciclovir, Quantity: 200 mg

Available from:

Arrotex Pharmaceuticals 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:

90 tablets, 50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ARX-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: White to off-white, capsule shaped, biconvex tablets, with 'ACV' debossed on one side and '200' 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

ACICLOVIR APOTEX
_Aciclovir_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will 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 THIS MEDICINE IS
USED FOR
Aciclovir belongs to a group of
medicines called anti-virals.
The 200 mg strength is used to:
•
treat genital herpes. It makes an
outbreak of genital herpes shorter
and less severe
•
prevent or reduce the number of
outbreaks and/or severity of
genital herpes in people who
experience them often.
The 800 mg strength is used:
•
to treat shingles, also known as
herpes zoster. Shingles is caused
by the same virus which causes
chicken pox. It usually involves
nerve pain and a blistery rash,
limited to one area of the body. If
taken within 72 hours of first
getting the rash, aciclovir makes
an outbreak of shingles shorter
and less severe
•
as part of the management
program for certain infections in
people who have the human
immunodeficiency virus (HIV).
HIV is the virus that causes
acquired immune deficiency
syndrome (AIDS). Aciclovir does
not cure AIDS or get rid of the
HIV virus from your body, but it
may prevent further damage to
the immune system by stopping
production of the herpes viruses.
_HOW IT WORKS_
Aciclovir works by stopping the
production of the virus that causes
herpes and shingles. It does not get
rid of the virus from your body.
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.
This medicine is available only with
a doctor's prescr

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
ACICLOVIR APOTEX (ACICLOVIR)
1
NAME OF THE MEDICINE
Aciclovir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg or 800 mg aciclovir
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
_200 mg_: capsule shaped, biconvex, white to off-white tablets
embossed “200” on one side and
“ACV” on the other side.
_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 human
immunodeficiency virus
(HIV) disease (CD4+ counts < 150 × 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 (HSV) 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 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 occasional
breakthrough
episodes may, however, continue to occur during suppressive therapy.
2
Suppressive therapy is not considered appropriate for patients in whom
attacks are mild, last
for short periods and/or occur in