ACICLOVIR SANDOZ aciclovir 200mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aciclovir, Quantity: 200 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type A; copovidone; magnesium stearate

Administration route:

Oral

Units in package:

90 tablets, 25 tablets

Prescription type:

(S4) Prescription Only Medicine

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 or 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. Suppressive therapy is not considered appropriate for patients in whom attacks are mild, last short periods and/or occur infrequently (e.g. less frequently than once a month). Aciclovir is effective only during the period of intake and has no residual beneficial effect. It does not eradicate the body viral pool. Following cessation of therapy, the time to onset of recurrences, their frequency, severity and duration remain generally unaffected. Some patients may experience increased severity of the first episode following cessation of therapy. The risk of inducing viral resistance and of potential long-term adverse effects (see Precautions, Carcinogenesis, mutagenesis and impairment of fertility) should be weighed carefully before initiating suppressive therapy. Asymptomatic cases of genital herpes are known to shed the virus with a high frequency. However, at present only limited data are available on the extent and frequency of viral shedding in patients receiving suppressive therapy. Therefore, if therapy with Aciclovir tablets is being used in prenatal period (See Precautions, Use in pregnancy), it should not be assumed that viral shedding has ceased. Pregnancy should be managed according to considerations normally applicable to patients with genital herpes. In view of the complex and variable natural history of genital herpes, suppressive therapy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see Dosage and Administration). Intermittent treatment. For certain patients, intermittent short-term treatment of recurrences is effective. Although the average patients would derive limited benefits from such treatment, a minority of patients who have experienced severe, prolonged recurrent episodes or recurrences complicated by eczema, burns or immunosuppression may experience more appreciable benefits. In those patients, intermittent treatment may be more appropriate than suppressive therapy when recurrences are infrequent. Herpes zoster. In controlled trials aciclovir tablets were shown to reduce acute pain and rash progression in adult patients of all ages with herpes zoster in whom the duration of rash was less than 72 hours. Aciclovir tablets appeared to be relatively less effective in younger adults, in whom Herpes zoster is generally a milder disease. In ophthalmic zoster, oral aciclovir has been shown to reduce the incidence of stromal keratitis and both the incidence and severity of anterior uveitis, but not other ocular complications or acute pain. Note. In immunocompetent patients with very severe Herpes zoster, immunocompromised patients, or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. Advanced symptomatic HIV disease. Studies have shown that oral aciclovir reduced mortality in patients with advanced HIV disease (CD4+ count < 150 x 10 6/L). In addition, oral aciclovir provided effective prophylaxis for herpes virus disease. No significant effect was seen on the prophylaxis of cytomegalovirus (CMV) disease or Epstein-Barr virus (EBV) disease.

Product summary:

Visual Identification: White, round, uncoated, biconvex tablets with break-line on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2004-02-03

Patient Information leaflet

ACICLOVIR SANDOZ
®
1
ACICLOVIR SANDOZ
®
_aciclovir tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about ACICLOVIR
SANDOZ tablets. 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 risks and
benefits. Your doctor has weighed
the risks of you taking ACICLOVIR
SANDOZ 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 THE MEDICINE.
You may want to read it again.
WHAT ACICLOVIR
SANDOZ IS USED
FOR
ACICLOVIR SANDOZ is used for
the treatment of genital herpes.
ACICLOVIR SANDOZ is used for
the treatment of shingles (herpes
zoster). Shingles is caused by the
same virus that causes chicken pox.
Your doctor may, however, have
prescribed ACICLOVIR SANDOZ
for another reason.
IF YOU HAVE ANY QUESTIONS ABOUT
WHY YOU ARE TAKING ACICLOVIR
SANDOZ ASK YOUR DOCTOR OR
PHARMACIST.
ACICLOVIR SANDOZ contains the
active ingredient aciclovir. Aciclovir
belongs to a group of medicines
called "anti-virals".
ACICLOVIR SANDOZ works by
stopping the multiplication of the
virus that causes herpes. It can
reduce the length and severity of an
outbreak of herpes or alternatively
may be used to reduce the number of
outbreaks in someone who has
frequent recurrences. It does not
eliminate the herpes virus from the
body.
BEFORE YOU TAKE
ACICLOVIR SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
aciclovir, the active ingredient, or
to any of the other ingredients
listed at the end of this leaflet
under Product Description
•
any other similar medicines such
as valaciclovir.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT, OR BECOME PREGNANT
WHILE USING ACICLOVIR
SANDOZ.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREASTFEED IF YOU ARE TAKING
THIS MEDICINE.
The active ingredient in
ACICLOVIR SANDOZ passes into
breast mi

Summary of Product characteristics

181224-Aciclovir Sandoz-pi
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
ACICLOVIR SANDOZ
® TABLETS (ACICLOVIR)
1
NAME OF THE MEDICINE
Aciclovir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Aciclovir 200 mg tablets contains 200 mg aciclovir.
Each Aciclovir 800 mg tablets contains 800 mg aciclovir.
The active ingredient of Aciclovir Sandoz 200 mg and 800 mg tablets is
aciclovir. Aciclovir is
a white to off-white crystalline powder, which is slightly soluble in
water.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Aciclovir Sandoz 200 mg Tablets, are white, round tablets with a break
score on one side.
Aciclovir Sandoz 800 mg Tablets, are white, oblong, biconvex tablets
with a break score on
both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 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 episo