Disulfiram Vzf

Package Leaflet: Information for the Patient

DISULFIRAM WZF, 100 mg, Implantation 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. 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 Disulfiram WZF and what is it used for
• 2. Important information before taking Disulfiram WZF
• 3. How to take Disulfiram WZF
• 4. Possible side effects
• 5. How to store Disulfiram WZF
• 6. Contents of the pack and other information

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

Disulfiram WZF is an aldehyde dehydrogenase inhibitor, an enzyme that converts acetaldehyde (the main metabolite of ethyl alcohol) to acetic acid. In the event of ethyl alcohol consumption after implantation of the drug, there is an increase in the concentration of acetaldehyde in the body and the occurrence of symptoms of poisoning with this compound. These symptoms include: nausea, vomiting, tachycardia (feeling of palpitations), hypotension, dizziness, sudden flushing of the face with a feeling of heat.
Disulfiram WZF is used as an auxiliary treatment for alcohol dependence.

2. Important information before taking Disulfiram WZF

When not to take Disulfiram WZF

Disulfiram-containing medicines should not be taken without the patient's conscious consent.

Warnings and precautions

Before starting treatment with Disulfiram WZF, discuss it with your doctor or pharmacist.
Particular caution should be exercised when taking Disulfiram WZF:

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

Note

During disulfiram treatment, there is an absolute ban on consuming alcoholic beverages.
Consuming alcohol during disulfiram treatment can cause life-threatening symptoms.
Symptoms of alcohol intolerance may also occur after using liquids containing alcohol (e.g. mouthwashes, sauces, vinegar, cough syrups, warming agents, aftershave lotions and other cosmetics containing alcohol).

Disulfiram WZF 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 and chlorpromazine may enhance, and diazepam may weaken the symptoms of the so-called disulfiram reaction.
• Disulfiram inhibits the oxidation reactions and excretion of rifampicin by the kidneys.
• Concomitant use of isoniazid and disulfiram may affect the function of the central nervous system and cause dizziness, coordination disorders, irritability, insomnia.
• Metronidazole and disulfiram used concomitantly may cause disorientation and psychotic states. It is not recommended to take these medicines at the same time.
• Contact with organic solvents containing alcohol, acetaldehyde, paraldehyde during disulfiram therapy may cause a disulfiram reaction.
• Disulfiram may prolong the duration of action of alfentanil.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Disulfiram should not be used during the first three months of pregnancy, unless your doctor decides otherwise.
Disulfiram should not be used in breastfeeding women, unless your doctor decides otherwise.

Driving and using machines

It is unlikely that the medicine will affect your ability to drive or use machines.

Disulfiram contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Disulfiram WZF

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist.
The implantation tablets in the original packaging are sterile.
The procedure is performed by a doctor. The medicine is implanted subcutaneously, distributing 8 to 10 tablets in a star shape. The procedure can be repeated after 8 months.

Taking a higher dose of Disulfiram WZF than recommended

Disulfiram has low toxicity. If accidental oral ingestion of a large number of implantation tablets occurs, medical personnel may perform gastric lavage (if it has been less than an hour since ingestion) and recommend monitoring the patient.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Disulfiram WZF can cause side effects, although not everybody gets them.
Sleepiness, nausea, vomiting, metallic taste or smell of garlic in the mouth, transient impotence, you may get tired easily.
In rare cases, psychotic reactions, including depressive states, paranoid states, schizophrenia, mania have been reported.
Skin allergic reactions, peripheral neuropathy, hepatocyte damage have been reported.

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
Phone: +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 Disulfiram WZF

Store in a temperature below 25°C. Store 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 after: EXP.
The expiry date refers to the last day of the month stated.
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 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 compress, closed with a sterile stopper and capped, in a cardboard box.
10 implantation tablets

Marketing authorization holder

Polpharma S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Warsaw Pharmaceutical Works Polfa S.A.
Karolkowa 22/24, 01-207 Warsaw

Date of last revision of the leaflet: