Disulfiram wzf

Package leaflet: Information for the patient

DISULFIRAM WZF, 100 mg, implantation tablets
Disulfiramum
Please read the entire 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Disulfiram WZF is and what it is used for
2. Important information before using Disulfiram WZF
3. How to use Disulfiram WZF
4. Possible side effects
5. How to store Disulfiram WZF
6. Contents of the pack and other information

1. What Disulfiram WZF is and what it is used for

Disulfiram WZF is an inhibitor of aldehyde dehydrogenase, an enzyme that converts acetaldehyde (the main metabolite of ethyl alcohol) into acetic acid. When ethyl alcohol is consumed after implantation of the drug, acetaldehyde concentration increases in the body, leading to symptoms of poisoning by this compound. These symptoms include: nausea, vomiting, tachycardia (rapid heartbeat), hypotension, dizziness, sudden facial flushing with a sensation of warmth.
Disulfiram WZF is used as an adjunct in the treatment of alcohol dependence.

2. Important information before using Disulfiram WZF

When not to use Disulfiram WZF

• if the patient is allergic to disulfiram and 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 last 12 hours before the procedure;
• if the patient has heart failure, ischemic heart disease, hypertension, or a history of circulatory collapse;
• if the patient has psychiatric disorders, psychoses (except for previously experienced acute alcoholic psychoses), or a history of suicide attempts.

Disulfiram-containing medicines must not be used without the patient's informed consent.
Warnings and precautions
Before starting treatment with Disulfiram WZF, discuss this with your doctor or pharmacist.
Particular caution is required when using Disulfiram WZF:

• in patients with respiratory or cardiac diseases, diabetes, or epilepsy. The occurrence of a disulfiram-alcohol reaction may worsen the progression of these diseases.
• in patients with renal and/or hepatic impairment.

Warning
During treatment with disulfiram, it is absolutely forbidden to consume alcoholic beverages.
Consumption of alcohol during disulfiram treatment may cause life-threatening symptoms.
Symptoms of alcohol intolerance may also occur after using products containing alcohol (e.g. mouthwashes, sauces, vinegar, cough syrups, warming preparations, after-shave lotions, and other cosmetics containing alcohol).
Disulfiram WZF and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.

• Disulfiram enhances the effects of anticoagulants, antipyrine, phenytoin, chlordiazepoxide, and diazepam. Animal studies indicate a similar influence on the metabolism of pethidine, morphine, and amphetamine.
• Amitriptyline and chlorpromazine may intensify, while diazepam may reduce, the symptoms of the so-called disulfiram reaction.
• Disulfiram inhibits oxidative 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.
• Metronidazole and disulfiram, when used simultaneously, may cause disorientation and psychotic states. Simultaneous use of these drugs is not recommended.
• Exposure to organic solvents containing alcohol, acetaldehyde, or paraldehyde during disulfiram therapy may trigger a disulfiram-type reaction.
• Disulfiram may prolong the effect of alfentanil.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Disulfiram use is not recommended during the first three months of pregnancy unless otherwise decided by a doctor.
Disulfiram use is not recommended in breastfeeding women unless otherwise decided by a doctor.
Driving and operating machinery
It is unlikely that the medicine affects the ability to drive or operate machinery.
Disulfiram contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Disulfiram WZF

This medicine should always be used as directed by a physician. If in doubt, consult your
doctor or pharmacist.
The tablets for implantation contained in the original packaging are sterile.
The procedure is performed by a physician. The medicine is implanted subcutaneously, arranging 8 to 10
tablets in a star-shaped pattern. The procedure may be repeated after 8 months.
Use of a higher than recommended dose of Disulfiram WZF
Disulfiram has low toxicity. In the event of accidental oral ingestion of a large number
of implantation tablets, medical personnel may perform gastric lavage (if no more than one hour
has passed since ingestion of the medicine), and patient observation is recommended.
If you have any further doubts concerning the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Drowsiness, nausea, vomiting, a metallic or garlic-like taste in the mouth, transient impotence, and easy fatigue may occur.
Psychotic reactions, including depressive states, paranoid states, schizophrenia, and mania, have been reported rarely.
Skin allergic reactions, peripheral neuritis, and hepatocyte damage have also been reported.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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

Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Disulfiram WZF

Store below 25°C. Keep in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation 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 required. This will help protect the environment.

6. Contents of the package and other information

What Disulfiram WZF contains

• The active substance is disulfiram. Each implantation tablet contains 100 mg of disulfiram.
• The other ingredients are: sodium chloride, mannitol, macrogol 6000.

What Disulfiram WZF looks like and contents of the pack
A glass vial with a sterile swab, closed with a sterile stopper and sealed with a cap, packed in a cardboard box.
10 implantation tablets

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

Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warszawa