Patient Information Leaflet

ANTICOL, 500 mg, tablets
Disulfiram
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Anticol is and what it is used for
Important information before taking Anticol
How to take Anticol
Possible side effects
How to store Anticol
Contents of the pack and other information

1. What Anticol is and what it is used for

Anticol contains disulfiram – an inhibitor of aldehyde dehydrogenase, an enzyme that converts acetaldehyde (the main metabolite of ethanol) into acetic acid. Consumption of ethanol during treatment with Anticol leads to increased levels of acetaldehyde in the body and the occurrence of symptoms of intoxication. These symptoms include: nausea, vomiting, tachycardia (palpitations), hypotension, dizziness, and sudden reddening of the face with a sensation of warmth.
Anticol is used in the treatment of alcohol dependence.

2. Important information before using Anticol

When not to use Anticol:

if the patient is allergic to disulfiram or thiocarbamates, or to any of the other ingredients of this medicine (listed in section 6);
if the patient is in a state of alcohol intoxication, drinks beverages containing ethyl alcohol, or has used medications containing alcohol within the previous 24 hours;
if the patient has heart failure, ischemic heart disease, hypertension, or has previously experienced a cerebrovascular incident;
if the patient has severe respiratory insufficiency;
if the patient has severe hepatic insufficiency;
if the patient has renal insufficiency;
if the patient has diabetes;
if the patient has psychiatric disorders, psychoses (except for previously experienced acute alcohol psychoses), or has a history of suicide attempts.

The patient must give consent to treatment with disulfiram. Disulfiram must under no circumstances be administered without the patient's consent.
Warnings and precautions
Before starting treatment with Anticol, discuss this with your doctor or pharmacist.
Particular caution is required when using Anticol:

in patients with respiratory disorders, hypothyroidism, brain damage, or epilepsy. A disulfiram-alcohol reaction may worsen the progression of these conditions.
in patients with kidney and/or liver disease.

During detoxification treatment and for 14 days after its completion, consumption of alcoholic beverages is strictly prohibited. Drinking alcohol during disulfiram therapy may cause life-threatening symptoms. Alcohol intolerance reactions may also occur after using products containing alcohol (e.g. mouthwashes, sauces, vinegar, cough syrups, warming lotions, aftershaves, perfumes, and other cosmetics).
Caution should also be exercised when consuming products containing small amounts of alcohol or alcohol-free beers and wines, as they may trigger a disulfiram-alcohol reaction.

Anticol with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Disulfiram enhances the effects of anticoagulants, antipyrine, phenytoin, chlordiazepoxide, and diazepam. Animal studies indicate a similar effect on the metabolism of pethidine, morphine, and amphetamine.
Amitriptyline may intensify, while diazepam and chlordiazepoxide may reduce, symptoms of the so-called disulfiram reaction.
Chlorpromazine may reduce some symptoms of the disulfiram reaction, but may overall intensify the reaction.
Disulfiram inhibits oxidation reactions and renal excretion of rifampicin.
Concurrent use of isoniazid and disulfiram may affect the central nervous system and cause dizziness, coordination disturbances, irritability, and insomnia.
Simultaneous use of metronidazole and disulfiram may cause disorientation and psychotic states. Concomitant use of these drugs is not recommended.
Exposure to organic solvents containing alcohol, acetaldehyde, or paraldehyde (e.g. used to dilute paints, gasoline) during disulfiram treatment may trigger a disulfiram reaction.
Disulfiram may prolong the effect of alfentanil.

Anticol and alcohol
During disulfiram treatment and for 14 days after its discontinuation, absolute abstinence from alcoholic beverages is required. Drinking alcohol during disulfiram therapy may cause a disulfiram-alcohol reaction.
Disulfiram-alcohol reactions often appear within 15 minutes after ethanol ingestion; symptoms usually peak within 30 minutes to 1 hour, then gradually subside over the next few hours. Symptoms may be severe and life-threatening.
The following symptoms of disulfiram-alcohol reaction may occur:

intense vasodilation of the face and neck causing flushing, increased body temperature, sweating, nausea, vomiting, itching, urticaria, anxiety, dizziness, headache, visual disturbances, shortness of breath, palpitations, and hyperventilation;
in severe cases: tachycardia, hypotension, respiratory depression, chest pain, ECG changes (QT interval prolongation, ST segment depression), cardiac arrhythmias, coma, and convulsions;
rarely: hypertension, bronchospasm, and methemoglobinemia.

If any of the above symptoms occur, contact a doctor immediately.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The medicine should not be used in pregnant women.
The medicine should not be used during breastfeeding. There are no available data on whether disulfiram passes into breast milk. Its use during breastfeeding is not recommended, especially when there is a possibility of interaction with medicines that may be used in the infant.
Driving and operating machinery
Disulfiram may cause adverse effects such as drowsiness or fatigue. Patients should ensure that these effects do not impair their ability to drive or operate machinery.

3. How to use Anticol

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Treatment may be initiated after at least a 24-hour period of abstinence. The usual starting dose
is 500 mg daily (1 tablet). The tablet should be taken once daily in the morning, or in case of
pronounced sedative effect, in the evening. This dose is usually administered for 1 to 2 weeks.
Subsequently, a maintenance dose of 250 mg daily (125 to 500 mg daily) is given. The maximum
oral dose is 500 mg daily.
The duration of disulfiram treatment is determined by the physician.
Use of a higher than recommended dose of Anticol
Symptoms affecting the central and peripheral nervous system have been reported, which resolved
completely. Although in cases of poisoning, symptoms usually appear within the first 12 hours in
most patients, there have been reports of clinical deterioration occurring several days after
overdose, with slow recovery and long-term consequences.
Symptoms of overdose:

nausea, vomiting, abdominal pain, diarrhoea, drowsiness, delirium, hallucinations and lethargy.
tachycardia, tachypnoea, hyperthermia and hypotension. Hypotonia may occur, especially in children, and tendon reflexes may be diminished. Hyperglycaemia, leucocytosis, ketosis (often disproportionate to the degree of dehydration) and methaemoglobinaemia have been reported.
in severe cases, circulatory collapse, coma and convulsions may occur.
rarely, sensorimotor neuropathy, EEG abnormalities, encephalopathy, psychoses and catatonia may occur, appearing several days after overdose. Speech disturbances, clonic muscle convulsions, ataxia, dystonia and akinesia may also occur.

Treatment:
The physician will provide symptomatic treatment and monitor the patient's condition.
In case of disulfiram overdose, gastric lavage and/or administration of activated charcoal may be
considered. In the event of severe vomiting, intravenous fluids should be administered.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is unknown (frequency cannot be determined
from the available data).
The following adverse reactions may occur:

psychotic reactions, depression, paranoia, schizophrenia, mania, decreased libido;
drowsiness (at the beginning of treatment), peripheral neuritis, optic neuritis, encephalopathy, metallic taste or garlic taste in the mouth;
nausea, vomiting;
liver cell damage;
allergic dermatitis;
transient impotence;
fatigue (at the beginning of treatment), foul breath.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Anticol

Store below 25°C.
Keep the container tightly closed to protect from light and moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container and carton.
The expiry date refers to the last day of the stated month.
The marking on the packaging: EXP indicates the expiry date, and Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Anticol contains

The active substance is disulfiram. Each tablet contains 500 mg of disulfiram.
The other ingredients are: potato starch, polysorbate 80.

What Anticol looks like and contents of the pack
Anticol is a cream-coloured, round, biconvex tablet with bevelled edges and score lines on one side enabling division into four parts.
Anticol is packed in polyethylene containers with polyethylene caps and tamper-evident rings, containing 30 tablets, placed in a cardboard box.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska Street 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Nowa Dęba Production Site
Metalowca Street 2, 39-460 Nowa Dęba