ANTABUSE 400 mg Эффервесцентная Таблетка

Содержание инструкции

1. ANTABUSE DISPERGETTES 400 mg effervescent tablets
   1. What is ANTABUSE DISPERGETTES and what it is used for
   2. What you need to know before taking ANTABUSE DISPERGETTES
   3. How to take ANTABUSE DISPERGETTES
   4. Possible side effects
   5. How to store ANTABUSE DISPERGETTES
   6. Contents of the pack and other information

ANTABUSE DISPERGETTES 400 mg effervescent tablets

Disulfiram

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ANTABUSE DISPERGETTES is and what it is used for
• 2. What you need to know before you take ANTABUSE DISPERGETTES
• 3. How to take ANTABUSE DISPERGETTES
• 4. Possible side effects
• 5. How to store ANTABUSE DISPERGETTES
• 6. Contents of the pack and other information

1. What is ANTABUSE DISPERGETTES and what it is used for

ANTABUSE DISPERGETTES contains the active ingredient disulfiram which acts on the process of
transforming alcohol in the body. When alcohol is taken during treatment with disulfiram,
this causes unpleasant symptoms such as difficulty breathing, awareness of heartbeats (palpitations),
headache, nausea and vomiting, which discourage continuing to consume alcoholic substances.
ANTABUSE DISPERGETTES is therefore indicated for the treatment of chronic alcoholism (treatment
of alcohol dependence).

2. What you need to know before taking ANTABUSE DISPERGETTES

Do not take ANTABUSE DISPERGETTES

• if you are allergic to disulfiram or any of the other ingredients of this medicine (listed in section 6);
• if you have heart failure (the heart's inability to pump the adequate amount of blood needed by the body) or an obstruction of the blood vessels leading to the heart (coronary artery disease);
• if you have previously suffered brain damage (serious cerebrovascular events);
• if you suffer from high blood pressure and are not taking medication to treat it (untreated hypertension);
• if you suffer from mental problems (serious personality disorder) and alterations in mental balance (psychosis);
• if you have suicidal thoughts and self-harming behaviors;
• if you consume alcoholic beverages or if you have recently followed a therapy with medicines containing alcohol such as some cough syrups, drops, supplements;
• if you are at risk of exposure to a chemical substance called ethylene dibromide and its vapors;
• if you are breastfeeding (see “Pregnancy and breastfeeding”).

ANTABUSE DISPERGETTES is contraindicated in children and adolescents.
Warnings and precautions
Talk to your doctor or pharmacist before taking ANTABUSE DISPERGETTES.
Take this medicine always under the direct control of a doctor experienced in the treatment of
alcohol dependence and only if you are really willing to embark on a detoxification path.
Before starting therapy, the doctor will prescribe you blood tests to establish if you are a
suitable patient for treatment with this medicine and will inform you about the unpleasant, even serious, effects
that this medicine can cause if you consume alcohol during treatment (See “Possible side
effects”).
The doctor will prescribe you check-ups to be done also during and at the end of the treatment.
In addition, the doctor will recommend that you do not use products (syrups, drops, toiletries, mouthwashes and
foods) that contain alcohol and can cause serious side effects (see “ANTABUSE
DISPERGETTES with food, beverages and alcohol”).
Tell your doctor if:

• you suffer from severe kidney and liver problems (renal, hepatic insufficiency);
• you suffer from long-term respiratory diseases (chronic respiratory pathologies);
• you suffer from diabetes mellitus (a disease characterized by high levels of sugar in the blood);
• you have problems with the function of the thyroid gland (a gland at the base of the neck that regulates metabolism) (hypothyroidism, hyperthyroidism);
• you suffer from epilepsy, a disease that causes seizures (sudden and uncontrollable movements) and loss of consciousness;
• you experience an allergic skin reaction, caused by contact with rubber (contact dermatitis).

During treatment with this medicine, turn to your family members and a specialist doctor
(psychotherapeutic treatment) for adequate support to help you avoid alcohol consumption.
This medicine can cause serious liver damage, especially after 1-3 months of treatment.

Other medicines and ANTABUSE DISPERGETTES
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Tell your doctor if you are being treated with:

• medicines used for the treatment of diabetes;
• phenylbutazone, aminopyrine and antipyrine, used for the treatment of inflammation;
• moxalactam, cefamandole and cefoperazone, isoniazid, rifampicin and metronidazole (antibiotics), used for the treatment of infections caused by bacteria;
• amitriptyline, phenelzine and tranylcypromine, used for the treatment of low mood (depression);
• pimozide and chlorpromazine, used for the treatment of some mental disorders;
• chlordiazepoxide and diazepam, used for the treatment of anxiety and sleep disorders;
• warfarin, an oral anticoagulant that delays blood clotting;
• theophylline, used for the treatment of respiratory diseases;
• pethidine and morphine, used for the treatment of pain;
• amphetamines, used as stimulants of the nervous system;
• phenytoin and paraldehyde, used for the treatment of epilepsy;
• medicines that have an effect on the heartbeat and on the tone of the arteries and veins, used for the treatment of various heart disorders and for the treatment of high blood pressure;
• antacids, used for disorders related to increased stomach acidity.

ANTABUSE DISPERGETTES with food, beverages and alcohol
During treatment and for 14 days after stopping therapy, do not take alcoholic substances and foods
that contain alcohol in liquid form, because unpleasant, unpredictable and sometimes fatal side effects may occur. For the same reason, pay particular attention to the consumption of “non-alcoholic” or
“alcohol-free” beverages, such as beer or wine with a low alcohol content (see “Possible side
effects”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking this medicine during the first three months of pregnancy.
The doctor will prescribe ANTABUSE DISPERGETTES Only if absolutely necessary.
Do not take ANTABUSE DISPERGETTES if you are breastfeeding (see “Do not take
ANTABUSE DISPERGETTES”).

Driving and operating machinery
ANTABUSE DISPERGETTES can cause drowsiness and fatigue, therefore it can alter the ability to
drive and operate machinery.

3. How to take ANTABUSE DISPERGETTES

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment with ANTABUSE DISPERGETTES is only indicated for adults and must be
accompanied by psychological support (psychotherapeutic).
You can only take this medicine if you have not consumed alcohol for at least 24 hours.
The recommended initial dose is between 2 and 3 tablets per day in a single administration for 3-
4 consecutive days. The doctor will gradually reduce the dose to a maintenance dose between
half a tablet and one and a half tablets per day.
To avoid relapses, the doctor will continue the therapy for several months (not more than 5 months), periodically evaluating
your health conditions.
The tablets can be swallowed normally or dissolved in water or another beverage. In the latter case,
to facilitate the dissolution of the tablet, shake the liquid and drink the resulting suspension immediately in order to
avoid the formation of sediment at the bottom.
To open the container, press on the cap and unscrew. Close the container after use.

If you take more ANTABUSE DISPERGETTES than you should
Following the intake of an excessive dose of this medicine, the following effects may occur:

• nausea, vomiting, abdominal pain, diarrhea;
• drowsiness, delirium (thoughts not corresponding to reality), hallucinations (seeing or hearing things that do not exist), lethargy (deep sleep);
• tachycardia (increased heart rate);
• tachypnea (increased breathing rate);
• hyperthermia (increased body temperature);
• hypotension (low blood pressure);
• hypotonia (reduced muscle tone), especially in children;
• reduced tendon reflexes (altered responses to nervous system stimulation);
• hyperglycemia (increased blood sugar levels);
• leukocytosis (increased number of white blood cells in the blood);
• ketosis (alteration of fat metabolism), often disproportionate to the degree of dehydration;
• metahemoglobinemia (dangerous increase of a protein in the blood);
• cardiovascular collapse (rapid drop in blood pressure), coma (deep state of unconsciousness) and convulsions (sudden and uncontrollable movements), in the most severe cases;
• sensorimotor neuropathy (numbness or weakness of the arms and legs);
• alterations of heart activity seen on electrocardiogram (ECG, the electrical tracing of the heart);
• encephalopathy (brain disease);
• psychosis (alteration of mental balance);
• catatonia (alteration of mental state characterized by immobility, inexpressiveness and inaccessibility);
• dysarthria (difficulty in articulating speech);
• myoclonus (involuntary muscle contractions);
• ataxia (progressive loss of muscle coordination that makes movements difficult);
• dystonia (alteration of muscle tone);
• akinesia (reduction or loss of the ability to perform movements). The doctor will establish the most suitable therapy for you, based on the severity of the symptoms.

In case of accidental intake/ingestion of an excessive dose of ANTABUSE DISPERGETTES, immediately
inform your doctor or go to the nearest hospital.

If you forget to take ANTABUSE DISPERGETTES
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur and tend to decrease during therapy or after a
dose adjustment:

Common(may affect up to 1 in 10 people)

• drowsiness, at the beginning of treatment, headache;
• nausea, vomiting, halitosis (bad breath), stomach pain, diarrhea;
• asthenia (feeling of weakness), at the beginning of treatment.

Uncommon(may affect up to 1 in 100 people)

• hypersensitivity (allergy);
• allergic dermatitis with rash (skin irritation with eruption), itching and acne-like rash;
• decreased libido (decreased sexual desire), sexual dysfunction.

Rare(may affect up to 1 in 1,000 people)

• psychotic reactions, mania and schizophrenia (alteration of mental balance), paranoia (seeing or hearing things that do not exist), depression (low mood);
• peripheral neuropathy (numbness, tingling, sensation and weakness in the arms and legs), optic neuritis (inflammation of the optic nerve);
• jaundice, changes in some blood test values (elevated ASAT, ALAT, bilirubin). Very rare(may affect up to 1 in 10,000 people)
• liver damage, fulminant hepatitis, hepatic necrosis (liver problems). Frequency not known(the frequency of which cannot be estimated based on available data)
• encephalopathy (brain problems);
• skin rashes;
• liver damage caused by the medicine (fatal cases have been reported).

Alcohol-disulfiram reaction
If you consume alcohol during treatment with ANTABUSE DISPERGETTES, you may experience an
alcohol-disulfiram reaction with severe and life-threatening symptoms. The reaction occurs within 15 minutes
of consuming alcohol.
The symptoms, which last from 30 minutes to 1 hour and subside within a few hours, are as follows:

• “flushing”, intense increase in blood flow to the face and neck with a feeling of warmth, redness, increased body temperature, sweating, nausea, vomiting, itching, urticaria (skin irritation), anxiety, dizziness, headache, blurred vision, palpitations (increased awareness of heartbeat) and hyperventilation (increased depth of breathing);
• tachycardia (increased heart rate), hypotension (low blood pressure), respiratory depression (decreased breathing activity), chest pain, changes in heart rhythm (prolongation of the QT interval, ST depression, arrhythmias), coma (deep unconsciousness) and convulsions (sudden, uncontrolled movements) in the most severe cases;
• hypertension (high blood pressure), bronchospasm (constriction of the bronchi) and methemoglobinemia (dangerous increase in a blood protein). The doctor will adopt appropriate therapy based on the severity of the symptoms (administration of oxygen and fluid replacement).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store ANTABUSE DISPERGETTES

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ANTABUSE DISPERGETTES contains

• The active ingredient is disulfiram. Each effervescent tablet contains 400 mg of disulfiram.
• The other ingredients are: corn starch, polyvinylpyrrolidone, tartaric acid, sodium bicarbonate, precipitated silica, microgranular cellulose, magnesium stearate, polysorbate 20, talc.

Description of the appearance of ANTABUSE DISPERGETTES and contents of the pack
24 effervescent tablets in a bottle with a screw cap with child-resistant closure.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l. – Via San Giuseppe, 102 – 21047 Saronno (Varese)

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano 43, 24041 Brembate (BG) - Italy