Antabuse 400 mg Effervescent Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Disulfiram

Available from:

Actavis Group hf

ATC code:

N07BB; N07BB01

INN (International Name):

Disulfiram

Dosage:

400 milligram(s)

Pharmaceutical form:

Effervescent tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Drugs used in alcohol dependence; disulfiram

Authorization status:

Marketed

Authorization date:

1985-02-06

Patient Information leaflet

PARTICULARS TO APPEAR ON THE INTERNAL FOLDS OF THE LABEL/LEAFLET
FIX-A-FORM
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANTABUSE
®
400 MG EFFERVESCENT TABLETS
Disulfiram
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Antabuse® is and what it is used for
2. What you need to know before you take Antabuse®
3. How to take Antabuse®
4. Possible side effects
5. How to store Antabuse®
6. Contents of the pack and other information
1.
WHAT
ANTABUSE®
IS AND WHAT IT IS USED FOR
Disulfiram (Antabuse’s active ingredient) is used as a supportive
agent in the treatment of alcoholism.
When you drink alcohol it is changed in the body into acetaldehyde.
Disulfiram blocks the enzyme
which breaks down acetaldehyde. This leads to an increased level of
acetaldehyde in the blood
causing unpleasant physical reactions.
Antabuse® is used in the treatment of people with drinking problems.
If you are treated with
Antabuse® and drink alcohol you will experience a series of
unpleasant physical reactions, which
may stop you from drinking further alcohol.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANTABUSE®
DO NOT TAKE
Antabuse® and
TELL
your doctor if you have:
• an
ALLERGY
(hypersensitivity) to the active substance or any of the other
ingredients of this medicine
listed in section 6.
• SEVERE HEART
disease or heart failure
•
had a
STROKE
• HIGH BLOOD PRESSURE
• SEVERE PSYCHIATRIC
or
PERSONALITY DISORDER
• ANY THOUGHTS OF HARMING OR KILLING YOURSELF
or
PSYCHOSIS
•
current
LIVER DISEASE

Summary of Product characteristics

Health Products Regulatory Authority
07 June 2022
CRN00CXRY
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Antabuse 400 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tablet contains 400mg Disulfiram.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablets
White, flat, circular effervescent tablets, 15 mm in diameter, with a
cross-score on one side and coded ‘CJ’.
The cross-score allows the product to be divided into equal quarters.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antabuse is indicated as an adjuvant for the treatment of co-operative
chronic alcoholic dependents. It should be used in
conjunction with appropriate psychiatric treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
On the first day of treatment the patient should be given 800 mg
Antabuse in one dose and told on no account to take any
alcohol. The next day the patient is to take 600 mg and on the third
day 400 mg. On the fourth and fifth day the patient should
take 200 mg and subsequently 200 mg or 100 mg daily or 2-3 times
weekly, the dosage continuing until, in the opinion of the
physician, the patient is restored to the social order.
The physician, bearing in mind the potential severity, may feel that
in individual cases an alcohol challenge is necessary. This
may be performed from the fifth day of dosage onwards. Alcohol
challenge consists initially of the administration of 5 ml
ethanol (approximately 12 ml of brandy) on an empty stomach.
If there is no reaction after 20 minutes, patients may receive a
further 10 ml of ethanol. At this dosage of alcohol a positive
result rarely consists of more than a noticeable flushing with
tachycardia and sometimes a slight fall in blood pressure. If there
is no reaction the dosage of Antabuse may be increased, and the test
repeated a week later until a positive result is obtained.
Method of administration
For oral use.
Disperse the tablet in water and stir immediately before intake.
4.3 CON