APO-ACAMPROSATE acamprosate calcium 333 mg enteric coated tablets blister

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

acamprosate calcium, Quantity: 333 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

formulario farmacéutico:

Tablet, enteric coated

Composición:

Excipient Ingredients: methylcellulose; methacrylic acid copolymer; sodium hydroxide; purified talc; crospovidone; magnesium stearate; triethyl citrate; hyprolose

Vía de administración:

Oral

Unidades en paquete:

180

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

APO-ACAMPROSATE is indicated as therapy to maintain abstinence in alcohol dependent patients. It should be combined with counselling

Resumen del producto:

Visual Identification: White to off-white, round-shaped, biconvex, enteric coated tablets, engraved with "APO" on one side and "300" on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Registered

Fecha de autorización:

2017-12-21

Información para el usuario

APO-ACAMPROSATE
_Contains the active ingredient acamprosate (as acamprosate calcium)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about acamprosate. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Acamprosate Enteric Coated Tablets.
It contains the active ingredient
acamprosate calcium.
It is used to treat alcohol dependence.
It helps people who are dependent on
alcohol to abstain from drinking
alcoholic beverages.
Alcohol dependence is an illness that
can and should be treated. Drinking
too much alcohol may harm your
health and cause physical,
psychological and social problems. If
this happens to you, your doctor may
advise you to stop drinking alcohol
altogether.
If you drink too much alcohol, your
body and nervous system adapt to its
effects. When you suddenly stop
drinking, you may experience some
unpleasant symptoms (known as
alcohol withdrawal syndrome or the
"shakes"), which can last up to 2
weeks.
During alcohol withdrawal, you may
feel shaky, have an upset stomach, a
fast heart beat and high blood
p

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION
APO-ACAMPROSATE (ACAMPROSATE CALCIUM)
ENTERIC COATED TABLETS
1
NAME OF THE MEDICINE
Acamprosate Calcium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains 333 mg acamprosate calcium as the
active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White to off-white coloured, round-shaped, biconvex, enteric coated
tablets, engraved with
“APO” on one side and “300” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-Acamprosate is indicated as therapy to maintain abstinence in
alcohol dependent
patients. It should be combined with counselling.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Acamprosate Tablets are intended for oral administration.
DOSAGE
Treatment with acamprosate calcium should be initiated as soon as
possible after the
withdrawal period and should be maintained if the patient relapses.
The recommended period
of treatment is 1 year.
Acamprosate calcium enteric coated tablets should be taken with meals,
and swallowed whole.
Based on the clinical results the daily dose is fixed according to
body weight:
For adults weighing 60 kg or more, the dose is 2 tablets taken three
times daily (i.e. 2 tablets
in the morning, at midday and at night).
In adults weighing less than 60 kg, the dose is 2 tablets in the
morning, 1 tablet at midday and
1 tablet at night.
Lower doses might be ineffective. The efficacy and safety of higher
doses have not been
established.
2
4.3
CONTRAINDICATIONS
Acamprosate calcium enteric coated tablets are contraindicated in:
•
patients with a known hypersensitivity to the medicine
•
pregnant or breastfeeding women
•
renal insufficiency (serum creatinine > 120 micromol/L)
•
severe hepatic failure (Childs-Pugh Classification C)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Acamprosate does not constitute treatment for the withdrawal period.
Because the interrelationship between alcohol dependence, depression
and suicidality is well
recognised a