CAMPRAL acamprosate calcium 333 mg enteric coated tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

acamprosate calcium, Quantity: 333 mg

Disponible des:

Alphapharm Pty Ltd

formulario farmacéutico:

Tablet, enteric coated

Composición:

Excipient Ingredients: magnesium silicate dihydrate; purified talc; propylene glycol; sodium starch glycollate; colloidal anhydrous silica; crospovidone; magnesium stearate; microcrystalline cellulose; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate

Vía de administración:

Oral

Unidades en paquete:

168 tablets, 18, 48 tablets, 54, 60 tablets, 180 tablets, 84, 90 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

For therapy to maintain abstinence in alcohol-dependent patients, to be combined with counselling.

Resumen del producto:

Visual Identification: 10mm round, white, coated tablet, debossed "333" on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

1999-08-06

Informació per a l'usuari

CAMPRAL
_acamprosate calcium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CAMPRAL. 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 CAMPRAL
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 YOUR
MEDICINE.
You may need to read it again.
WHAT CAMPRAL IS
USED FOR
CAMPRAL is used in the treatment
of 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
pressure. You may also feel anxious,
down or be in a bad mood.
Sometimes, you may see things that
are not there, or suffer from a
headache or not be able to sleep.
If these symptoms are severe, you
may need observation in hospital.
After going through this difficult
period, your doctor will encourage
you to live without alcohol through
counselling. CAMPRAL, in
combination with counselling from a
general practitioner, psychiatrist,
psychologist, or a drug and alcohol
counsellor, will help you to stop
yourself from starting to drink again.
CAMPRAL works by acting on
certain chemical changes that have
taken place in your brain over the
time that you have been drinking
alcohol.
CAMPRAL is not recommended

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
CAMPRAL
_Acamprosate calcium_
1. NAME OF THE MEDICINE
Acamprosate calcium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains acamprosate calcium 333 mg as the active
ingredient.
For a full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
Acamprosate calcium is a white, odourless or practically odourless
powder with a bitter taste. It is freely
soluble in water, practically insoluble in absolute ethanol and
dichloromethane.
Acamprosate calcium is presented as enteric coated tablets which are
round, white and, marked "333" on one
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Campral is indicated as therapy to maintain abstinence in alcohol
dependent patients. It should be combined
with counselling.
4.2 DOSE AND METHOD OF ADMINISTRATION
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.
Campral 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.
4.3 CONTRAINDICATIONS
Campral is contraindicated in:
•
patients with a known hypersensitivity to the medicine
•
pregnant or breastfeeding women
•
renal insufficiency (serum creatinine >120 micromol/L)
•
severe hepatic failure (Child-Pugh Classification C)
CAMPRAL – PRODUCT INFORMATION
2
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