ETILTOX 200 mg Tabletki

Treść ulotki

1. ETILTOX 200 mg tablets
   1. What is ETILTOX and what is it used for
   2. What you need to know before taking ETILTOX
   3. How to take ETILTOX
   4. Possible side effects
   5. How to store ETILTOX
   6. Contents of the pack and other information

ETILTOX 200 mg tablets

Disulfiram

Read this leaflet carefully before 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 ETILTOX is and what it is used for
• 2. What you need to know before you take ETILTOX
• 3. How to take ETILTOX
• 4. Possible side effects
• 5. How to store ETILTOX
• 6. Contents of the pack and other information

1. What is ETILTOX and what is it used for

ETILTOX contains the active ingredient disulfiram which belongs to a group of medicines used in
alcohol dependence that act on the process of transforming alcohol in the body (inhibition
of aldehyde dehydrogenase). In particular, disulfiram determines an accumulation of a substance, called
acetaldehyde, which causes a condition (acetaldehyde syndrome), characterized by symptoms such as: feeling
of warmth, headache, difficulty breathing, increased awareness of heartbeats (palpitations),
increased heart rate (tachycardia), decreased blood pressure
(hypotension), pronounced anxiety, weakness, dizziness and mental confusion. All these unpleasant
symptoms dissuade the alcoholic from continuing to consume alcoholic substances.
ETILTOX is indicated for the treatment of alcohol dependence (detoxification from chronic alcoholism).

2. What you need to know before taking ETILTOX

Do not take ETILTOX

• if you are allergic to disulfiram or to any of the other ingredients of this medicine (listed in section 6);
• if you are under 18 years of age (See section “Children and adolescents”);
• if you suffer from serious heart problems (heart failure, coronary artery disease);
• if you have serious problems with blood circulation to the brain (cerebrovascular events);
• if you suffer from high blood pressure and are not taking medicines to treat this condition (untreated hypertension);
• if you suffer from mental health problems (serious personality disorder, psychosis, risk of suicide);
• if you consume alcoholic beverages or if you have recently undergone therapy with medicines that contain alcohol such as some cough syrups, drops, tonics or other similar medicines (See sections “Warnings and precautions”, “Other medicines and ETILTOX” and “ETILTOX with food, beverages and alcohol”);
• if you are exposed to a chemical substance called ethylene dibromide and its vapors;
• if you are breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking ETILTOX.
This medicine should never be administered without the patient’s knowledge, to unconscious people or
who have consumed alcohol in the last 24 hours (See section “ETILTOX with food, beverages and alcohol”).
Take this medicine only under the direct supervision of a doctor experienced in the treatment of
alcohol dependence and only if you are genuinely willing to embark on a detoxification course
(selected and cooperative patients).
Before starting therapy, your doctor will subject you to appropriate tests to determine if you are a
suitable patient for treatment with this medicine.
In addition, your doctor will inform you about the alcohol content in the liquid form of syrups, drops, toiletries,
mouthwashes that may contain amounts of alcohol sufficient to cause serious adverse effects
(See section “Other medicines and ETILTOX”).
Take this medicine with caution and under the direct supervision of your doctor:

• if you suffer from serious kidney and liver problems (renal, hepatic insufficiency);
• if you suffer from respiratory diseases (chronic respiratory conditions);
• if you suffer from diabetes (diabetes mellitus);
• if you have problems with thyroid function (hypothyroidism, hyperthyroidism);
• if you suffer from epilepsy;
• if you have suffered brain damage (cerebral damage);
• if you experience an allergic skin reaction due to contact with rubber (contact dermatitis).

During treatment with this medicine, turn to your family and a specialist doctor
(psychotherapeutic treatment) for adequate support to help you avoid alcohol consumption.
This medicine can cause serious liver damage (hepatic), especially after 1-3 months of treatment.
Therefore, during and after treatment, your doctor must check blood coagulation (coagulation factors) and
liver function (amino transferase and phosphatase analysis) through
specific blood tests. If you experience an alteration in the results of these tests (transaminase values 3 times higher than the reference value), your doctor must immediately stop therapy with
ETILTOX.

Children and adolescents
This medicine is contraindicated in children under 18 years of age (See section “Do not take
ETILTOX”).

Other medicines and ETILTOX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not take ETILTOX together with the following medicines, as they increase the effects of disulfiram:

• sulfonamides, used for the treatment of diabetes;
• phenylbutazone, aminopyrine, used for the treatment of inflammation;
• moxalactam, cefamandole and cefoperazone, used for the treatment of infections.

Do not take this medicine if you have undergone therapy with syrups or drops that contain alcohol because
they may cause an alcohol-disulfiram reaction (See section “Possible side effects”).
Take ETILTOX with caution and tell your doctor if you are taking the following medicines:

• amitriptyline, used for the treatment of depression and chlorpromazine, used for the treatment of some mental disorders, because they can increase the intensity of the alcohol-disulfiram reaction;
• benzodiazepines such as chlordiazepoxide and diazepam, used for the treatment of anxiety and sleep disorders, as disulfiram increases their sedative effect;
• oral anticoagulants (warfarin), used to thin the blood, oral hypoglycemic agents, used to reduce blood sugar levels, hypnotics and sedatives (e.g. theophylline), used for the treatment of sleep and breathing disorders, pethidine and morphine, used for the treatment of pain, amphetamines, used as central nervous system stimulants, phenytoin, used for the treatment of epilepsy, antipyrine, used for the treatment of inflammation, rifampicin, used for the treatment of infections caused by bacteria. Disulfiram increases the effects and toxicity of these medicines, therefore it may be necessary to reduce the dose;
• metronidazole and isoniazid, used for the treatment of infections caused by bacteria, paraldehyde, used for the treatment of epilepsy as, if you take these medicines together with ETILTOX, the risk of side effects affecting the brain is greater;
• pimozide, used for the treatment of some mental disorders, as a condition called organic cerebral syndrome may occur, characterized by a reduction in mental functions;
• beta-blockers, vasodilators, used for the treatment of various heart disorders and for the treatment of high blood pressure, medicines whose actions on the central nervous system are mediated by norepinephrine, dopamine or MAO inhibitors (phenelzine, tranylcypromine), used for the treatment of depression, as serious side effects may occur.

ETILTOX with food, beverages and alcohol
During treatment and for 14 days after stopping therapy, do not consume alcoholic substances and foods
that contain alcohol in liquid form, because an alcohol-disulfiram reaction may occur, characterized
by unpleasant, unpredictable and sometimes fatal side effects. Also, pay particular attention to
the consumption of “non-alcoholic” or “alcohol-free” beverages, such as beer or low-alcohol wine, as
if taken in excessive quantities, they can still cause the alcohol-disulfiram reaction (See the
section “Possible side effects”).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
This medicine is not recommended during the first three months (first trimester) of pregnancy.
ETILTOX is not recommended during pregnancy, except in cases of absolute necessity and under the direct
supervision of a doctor.
Do not take ETILTOX if you are breastfeeding (See section “Do not take ETILTOX”).

Driving and operating machinery
ETILTOX can cause drowsiness and fatigue. If you experience these symptoms, avoid driving vehicles and
operating machinery.

3. How to take ETILTOX

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment with ETILTOX is indicated only for adults and must be accompanied by psychological support (psychotherapeutic).
The doctor will establish with appropriate tests if you are suitable to start treatment with ETILTOX.
You can only take this medicine if you have not consumed alcohol for at least 24 hours.
The recommended dose is 4-6 tablets per day, to be taken orally (orally), in a single
administration for 3-4 consecutive days. The doctor will gradually reduce the dose to 1-2 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.

If you take more ETILTOX 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, hallucinations, feeling of tiredness (lethargy);
• increased heart rate (tachycardia);
• increased breathing rate (tachypnea);
• increased body temperature (hyperthermia);
• lowering of blood pressure (hypotension);
• reduction of muscle tone (hypotonia), especially in children;
• joint problems (reduced tendon reflexes);
• increased blood sugar levels (hyperglycemia);
• reduction in the number of white blood cells in the blood (leukocytosis);
• alteration of fat metabolism (ketosis often disproportionate to the degree of dehydration);
• blood problems (metahemoglobinemia);
• serious circulatory problems (cardiovascular collapse), deep state of unconsciousness (coma) and convulsions, in the most severe cases;
• numbness or weakness of the arms and legs (sensorimotor neuropathy);
• alteration of heart activity (electrocardiogram changes, ECG);
• brain problems (encephalopathy);
• mental disorders (psychosis, catatonia);
• movement disorders (dysarthria, myoclonus, ataxia, dystonia, akinesia). 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 ETILTOX, immediately notify your
doctor or go to the nearest hospital.

If you forget to take ETILTOX
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, bad breath (halitosis), stomach (gastric) pain, diarrhea;
• feeling of weakness (asthenia), at the beginning of treatment.

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• skin irritations (allergic dermatitis with rash, acne-like eruption) and itching;
• sexual disorders (decreased libido, sexual dysfunction).

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

• mental disorders (psychotic reactions, paranoia, schizophrenia, mania), depression;
• numbness, tingling, sensitivity and weakness in the arms and legs (peripheral neuropathy), inflammation of the optic nerve (optic neuritis);
• yellowing of the skin and eyes (jaundice), changes in the values of some blood tests (elevated ASAT, ALAT, bilirubin). Very rare(may affect up to 1 in 10,000 people)
• liver problems (liver damage, fulminant hepatitis, liver necrosis). Frequency not known(the frequency of which cannot be estimated based on available data)
• brain problems (encephalopathy).

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

• increased blood flow (vasodilation) to the face and neck with a feeling of warmth (“flushing”), redness, increased body temperature, sweating, nausea, vomiting, itching, skin irritation (urticaria), anxiety, dizziness, headache, blurred vision, increased awareness of heartbeat (palpitations) and breathing problems (hyperventilation);
• increased heart rate (tachycardia), low blood pressure (hypotension), severe breathing problems (respiratory depression), chest pain, changes in heart rhythm (QT prolongation, ST depression, arrhythmias), deep unconsciousness (coma) and convulsions;
• increased blood pressure (hypertension), difficulty breathing (bronchospasm) and blood problems (metahemoglobinemia). The doctor will adopt appropriate therapy based on the severity of the symptoms (oxygen administration and fluid replenishment).

5. How to store ETILTOX

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 “Scad.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 ETILTOX contains

• The active ingredient is disulfiram. Each tablet contains 200 mg of disulfiram.
• The other ingredients are: microcrystalline cellulose, magnesium stearate.

Description of the appearance of ETILTOX and contents of the pack
Pack of 30 tablets.

Marketing Authorisation Holder
Manufacturer
Istituto De Angeli S.r.l. Loc. Prulli n. 103/c – 50066 Reggello (FI) – Italy