GENRX ACICLOVIR aciclovir 800mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

aciclovir, Quantity: 800 mg

Disponível em:

Arrotex Pharmaceuticals Pty Ltd

Forma farmacêutica:

Tablet

Composição:

Excipient Ingredients: colloidal anhydrous silica; brilliant blue FCF; indigo carmine; magnesium stearate; microcrystalline cellulose; croscarmellose sodium

Via de administração:

Oral

Unidades em pacote:

35 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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 10exp6/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 simples virus may influence the degree of benefit from therapy. Intravenous therapy should be considered in patients in whom prostration, central nervous system involvement or inability to tak eoral medication requires hospitalisation and initiationof more aggressive management. Aciclovir does not prevent the establishment of latency in primary episodes. Recurrent episodes: a) 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 patiens in whom attacks are mild, last for short periods and/or occur infrequently (for example, 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 Carcinogenicity, Mutagenicity, Effects on fertility) shoulld 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 vial shedding in patients receiving suppressive therapy. Therefore, if therapy with aciclovir tablets is being used in the prenatal period (see 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 thearpy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see Dosage and Administration). b) Intermittent treatment: For certain patients intermittent short-term treatment of recurrences is effective. Although the average patient 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 was 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. The same treatment On controlled trials, aciclovir was shown to reduce acute pain and rash progression appeared to be relatively less effective in younger patients, 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 oracute pain. Note: In immune-competent patients with very severe herpes zoster, immune-compromised patients or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. Patients with advanced symptomatic HIV disease (CD4+ counts, < 150 x 10exp6/L) Studies have shown that oral aciclovir reduced mortality in patients with advanced HIV disease. In addition, oral aciclovir provided effective prophylaxis for herpes virus disease. No significant effect was seen on prophylaxsis of CMV disease of EB V disease.

Resumo do produto:

Visual Identification: Oval, blue, biconvex tablet. Engraved APO partial bisect 800 on one side, plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2000-08-07

Folheto informativo - Bula

GENRX ACICLOVIR
_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
The name of your medicine is GenRx
Aciclovir. It contains the active
ingredient aciclovir.
The 200mg 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 800mg 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.
It belongs to a group of medicines
called anti-virals.
This medicine works by stopping the
production of the virus that causes
herpes and shingles.
Aciclovir 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 medi

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION – GENRX
ACICLOVIR (ACICLOVIR)
1
NAME OF THE MEDICINE
Aciclovir
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Aciclovir is a synthetic acyclic purine nucleoside analogue. It is a
white crystalline powder
slightly soluble in water and practically insoluble in most organic
solvents.
Each tablet contains 200mg or 800mg of acyclovir as the active
ingredient.
In addition, each tablet contains the following inactive ingredients:
lactose monohydrate
(200mg tablet only), magnesium stearate, colloidal anhydrous silica,
croscarmellose sodium,
–microcrystalline cellulose , brilliant blue FCF (800mg tablet only)
and indigo carmine.
Aciclovir 200mg tablets contains sugars as lactose.
Aciclovir tablets are gluten free.
200mg tablets are round, blue flat faced, bevel-edged tablets,
engraved “APO” over “200” on
one side and the other side plain.
800mg tablets are oval, blue, biconvex tablets, scored. Engraved APO
partial bisect 800 on
one side, plain in the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aciclovir tablets are indicated for use in adult patients for:
o
the
treatment of first episode (primary or non-primary) genital herpes and
the
management of recurrent episodes of genital herpes in certain patients
;
o
the treatment of acute attacks of herpes zoster (shingles), when the
duration of rash
is less than 72 hours;
o
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, central
nervous system involvement or inability to take oral medication
requires hospitalisation
and initiation of more aggressive management.
Aciclo