Anticol

Package Leaflet: Information for the Patient

ANTICOL, 500 mg, tablets

Disulfiram

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet

• 1. What is Anticol and what is it used for
• 2. Important information before taking Anticol
• 3. How to take Anticol
• 4. Possible side effects
• 5. How to store Anticol
• 6. Contents of the pack and other information

1. What is Anticol and what is it used for

Anticol contains disulfiram - an aldehyde dehydrogenase inhibitor, an enzyme that converts acetaldehyde (the main metabolite of ethyl alcohol) to acetic acid. Consuming ethyl alcohol during Anticol treatment leads to an increase in acetaldehyde levels in the body and the occurrence of poisoning symptoms. These symptoms include: nausea, vomiting, tachycardia (feeling of palpitations), hypotension, dizziness, sudden flushing of the face with a feeling of heat. Anticol is used to treat alcohol dependence.

2. Important information before taking Anticol

When not to take Anticol:

• if you are allergic to disulfiram and thiocarbamates or any of the other ingredients of this medicine (listed in section 6);
• if you are in a state of alcohol intoxication, drinking beverages containing ethyl alcohol or have taken medicines containing alcohol in the last 24 hours;
• if you have heart failure, coronary heart disease, hypertension, have had a cerebrovascular incident;
• if you have severe respiratory failure;
• if you have severe liver failure;
• if you have kidney failure;
• if you have diabetes;
• if you have mental disorders, psychoses (except for past acute alcohol psychoses), have had suicidal attempts.

The patient must give consent to disulfiram treatment. Under no circumstances should disulfiram be administered without the patient's consent.

Warnings and precautions

Before starting Anticol, discuss it with your doctor or pharmacist. Be particularly cautious when taking Anticol:

• in patients with respiratory diseases, hypothyroidism, brain damage, epilepsy. The occurrence of a disulfiram-alcohol reaction may worsen the degree of these diseases.
• in patients with kidney and/or liver diseases.

During detoxification treatment and for 14 days after its completion, there is a ban on drinking alcoholic beverages. Drinking alcohol during disulfiram therapy can cause life-threatening symptoms.Alcohol intolerance symptoms may also occur after using liquids containing alcohol (e.g., mouthwashes, sauces, vinegar, cough syrups, warming agents, aftershave lotions, perfumes, and other cosmetics). You should also be cautious when consuming products containing small amounts of alcohol or non-alcoholic beers and wines, as they may cause a disulfiram-alcohol reaction.

Anticol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Disulfiram enhances the effect of: anticoagulants, antipyrine, phenytoin, chlordiazepoxide, and diazepam. Animal studies indicate a similar effect on the metabolism of pethidine, morphine, and amphetamine.
• Amitriptyline may enhance, and diazepam and chlordiazepoxide may weaken the symptoms of the so-called disulfiram reaction.
• Chlorpromazine may weaken some symptoms of the disulfiram reaction, but overall may enhance it.
• Disulfiram inhibits the oxidation and excretion of rifampicin by the kidneys.
• Concomitant use of isoniazid and disulfiram may affect the central nervous system and cause dizziness, coordination disorders, irritability, and insomnia.
• Metronidazole and disulfiram used concomitantly may cause disorientation and psychotic states. Concomitant use of these medicines is not recommended.
• Contact with organic solvents containing alcohol, acetaldehyde, paraldehyde (e.g., used for thinning paints, gasoline) during disulfiram treatment may cause a disulfiram reaction.
• Disulfiram may prolong the duration of action of alfentanil.

Anticol and alcohol

During disulfiram treatment and for 14 days after its completion, there is an absolute ban on drinking alcoholic beverages. Drinking alcohol during disulfiram treatment can cause a disulfiram-alcohol reaction. Disulfiram-alcohol reactions often occur within 15 minutes after ethanol consumption; symptoms usually reach their maximum within 30 minutes to 1 hour and then gradually subside within the next few hours. Symptoms can be severe and life-threatening. The following symptoms of a disulfiram-alcohol reaction may occur:

• intensive vasodilation on the face and neck, causing flushing, increased body temperature, sweating, nausea, vomiting, itching, urticaria, anxiety, dizziness, headache, vision disturbances, dyspnea, palpitations, and hyperventilation;
• in severe cases, tachycardia, hypotension, respiratory depression, chest pain, changes in the ECG record (QT interval prolongation, ST segment depression), arrhythmias, coma, and convulsions;
• rarely, hypertension, bronchospasm, and methemoglobinemia.

If the above symptoms occur, you should contact your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. The medicine should not be used during pregnancy. The medicine should not be used during breastfeeding. There is no available data on whether disulfiram passes into breast milk. Its use during breastfeeding is not recommended, especially if there is a possibility of interaction with medicines that may be used in the child.

Driving and using machines

Disulfiram may cause side effects such as drowsiness or fatigue. Patients should be sure that it does not affect their ability to drive or operate machinery.

3. How to take Anticol

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Treatment with Anticol can be started after at least a 24-hour period of abstinence. The initial dose is usually 500 mg per day (1 tablet). The tablet is taken once a day in the morning or, in the case of significant sedative effects, in the evening. This dose should be taken for 1 to 2 weeks. Then, a maintenance dose is given, which is 250 mg per day (125 to 500 mg per day). The maximum oral dose is 500 mg per day. The duration of disulfiram treatment is determined by your doctor.

Overdose of Anticol

Symptoms from the central and peripheral nervous system have been reported, which subsided completely. Although in the case of poisoning, most patients experience symptoms within the first 12 hours, cases of worsening clinical condition many days after overdose have been reported, with slow recovery and long-term consequences. Overdose symptoms:

• nausea, vomiting, abdominal pain, diarrhea, drowsiness, delirium, hallucinations, and lethargy.
• tachycardia, accelerated breathing, hyperthermia, and hypotension. Hypotonia may occur, especially in children, and tendon reflexes may be reduced. Hyperglycemia, leukocytosis, ketosis (often disproportionate to the degree of dehydration), and methemoglobinemia have been reported.
• in severe cases, circulatory collapse, coma, and convulsions may occur.
• rarely, sensory-motor neuropathy, EEG abnormalities, encephalopathy, psychoses, and catatonia may occur, which may appear several days after overdose. Speech disorders, clonic muscle convulsions, ataxia, dystonia, and immobility may also occur.

Treatment: Your doctor will provide symptomatic treatment and monitor your condition. In the case of disulfiram overdose, gastric lavage and/or activated charcoal administration may be considered. In the case of intense vomiting, intravenous fluids should be administered.

4. Possible side effects

Like all medicines, Anticol can cause side effects, although not everybody gets them. The frequency of side effects is unknown (frequency cannot be estimated from the available data). The following side effects may occur:

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anticol

Store below 25°C. Store the container tightly closed to protect from light and moisture. Keep the medicine out of the 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 month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 round, biconvex tablet, cream-colored, with beveled edges and dividing lines on one side. Anticol is packaged in 30 tablets in a polyethylene container with a polyethylene cap and a guarantee ring, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Production Plant in Nowa Dęba, ul. Metalowca 2, 39-460 Nowa Dęba, Date of last revision of the leaflet:December 2024