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DISULFIRAM TABLETS 200 MG, ANTABUSE TABLETS 200 MG - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - DISULFIRAM TABLETS 200 MG, ANTABUSE TABLETS 200 MG

1. What Antabuse® is and what it is used for

  • 2. Before you take Antabuse®

3. How to take Antabuse®

4. Possible side effects

5. How to store Antabuse®

6. Contents of the pack and other information

1. what antabuse® is and what it is used for

Disulfiram (Antabuse's active ingredient) is used as a supportive agent in the treatment of alcoholism. When you drink alcohol it is changed in the body into acetaldehyde, disulfiram blocks the enzyme which breaks down acetaldehyde. This leads to an increased level of acetaldehyde in the blood causing unpleasant physical reactions.

Antabuse® is used in the treatment of people with drinking problems. If you are treated with Antabuse® and drink alcohol you will experience unpleasant physical reactions, which may stop you from drinking further alcohol.

  • 2. Before you take Antabuse®

Do not take Antabuse® if you have:

  • an allergy to disulfiram or any of the other ingredients of this medicine (listed in section 6)
  • severe heart disease or heart failure
  • high blood pressure
  • severe psychiatric or personality disorder
  • had a stroke.
  • recently consumed alcohol

Warnings and precautions

Talk to your doctor or pharmacist before taking Antabuse® if you have:

  • kidney, liver or lung disease
  • diabetes
  • low blood pressure
  • brain damage
  • epilepsy.

Children and adolescents

Do not give this medicine to children.

Other medicines and Antabuse®

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially:

  • warfarin (reduces blood clotting)
  • phenytoin and paraldehyde (to treat epilepsy)
  • theophylline (to treat asthma)
  • chlordiazepoxide and diazepam (to treat anxiety)
  • pethidine and morphine (painkillers)
  • amphetamines (stimulants)
  • pimozide, and chlorpromazine (to treat mental illnesses)
  • isoniazid metronidazole, rifampicin (to treat infections)
  • amitriptyline (to treat depression)

Other precautions

Certain foods, liquid medicines, remedies, tonics, toiletries, perfumes and sprays may contain enough alcohol to cause an Antabuse®-alcohol reaction. Caution should also be exercised with low alcohol and “non-alcoholic” or “alcohol-free” beers and wines. If enough is taken they may produce unpleasant reactions.

Antabuse® and alcohol

If you drink alcohol during or within 2 weeks of stopping Antabuse®, or you have been exposed to alcohol from other sources (see ‘Other precautions’) an Antabuse®-alcohol reaction may occur. The reaction is unpredictable and symptoms may be severe or life threatening. Symptoms include;

flushing of the face and neck, increased body temperature, sweating, feeling or being sick, itchy skin or rash caused by an allergic reaction (pruritis, urticaria) anxiety, dizziness, headache, blurred vision, difficulty breathing, palpitations, rapid breathing.

In severe cases; rapid heart beat, low blood pressure, abnormally slow breathing, chest pain, abnormal heart rhythm, coma or fits may occur.

Rare complications may include; high blood pressure, breathing problems, blood disorders.

If you get some of the symptoms, contact your doctor.

The Antabuse®-alcohol reaction can occur within 15 minutes after drinking alcohol and may last several hours.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The use of Antabuse® during the first 3 months of pregnancy or breast-feeding is not advised and should only be used if directed by your doctor.

Driving and using machines

Antabuse® tablets may cause drowsiness or tiredness (see ‘4. Possible side effects’). If you are affected do not drive or operate machinery.

Antabuse® and lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take antabuse®

Always take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure. A check up is advised before starting treatment to check you are suitable for treatment.

Treatment with Antabuse® is usually started in a hospital or specialised clinic. It is important that you have not drunk alcohol for at least 24 hours before taking the first dose. Swallow the tablets with water.

The recommended dose is:

  • Adults and the elderly:

Initially 4 tablets (800mg) on day 1, then 3 tablets (600mg) on day 2, then 2 tablets (400mg) on day 3 and then 1 tablet (200mg) on days 4 and 5.

Then Z? to 1 tablet (100mg – 200mg) a day for as long as told by your doctor, but for no longer than six months without review.

If you take more Antabuse® than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include; feeling or being sick, stomach pain, diarrhoea, drowsiness, mental disorders, tiredness, rapid heart beat, rapid breathing, high body temperature, low blood pressure, loss of muscle control, high blood sugar, changes in the blood (as seen in blood tests). Severe cases may result in coma, fits or death.

If you forget to take Antabuse®

If you forget to take a dose, and you do not remember it within 12 hours, you should not take it. Do not take a double dose to make up for a forgotten dose.

If you stop taking Antabuse®

Speak to your doctor or nurse before stopping treatment with Disulfiram.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and immediately contact a doctor if you experience any of the following:

  • allergic skin reactions such as itching and redness

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

  • depression, paranoia, schizophrenia, mania,
  • decreased sexual desire
  • drowsiness and fatigue (especially at start of treatment)
  • damage/inflammation of peripheral nerves (causing pain and loss of sensation in hands and feet)
  • inflammation of the optic nerve
  • encephalopathy (brain disease)
  • feeling or being sick
  • bad breath
  • inflammation of the liver (hepatitis), damage to liver cells, liver failure
  • rash.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store antabuse®

Keep out of the sight and reach of children.

Store below 25°C in the tightly closed container, protect from light in a dry place.

Do not use Antabuse® after the expiry date stated on the label. The expiry date refers to the last day of that month.

Do not throw throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Antabuse® contains

  • The active substance (the ingredient that makes the tablet work) is 200mg of disulfiram.
  • The other ingredients are lactose, potato starch, povidone, microcrystalline cellulose, polysorbate 20, tartaric acid, colloidal anhydrous silica, sodium bicarbonate, maize starch and magnesium stearate.

What Antabuse® looks like and contents of the pack

The tablet is white and scored with a breakline marker ‘CJO’ on the side.

Pack sizes are 50 tablets

Marketing Authorisation Holder

Actavis Group PTC ehf. Reykjavikurvegi 76–78, 220 Hafnarfjordur,

Iceland

Manufacturer

Recipharm Uppsala AB, Bjorkgatan 30, 751 82 Uppsala, Sweden

This leaflet was last revised in April 2018

Label

PL 30 306/0036

POM

50 tablets

Each tablet contains: Disulfiram 200 mg

Also contains: lactose, microcrystalline cellulose, tartaric acid.

Sodium content: 0.3mEq

To be taken by mouth. Keep tightly closed. Protect from light.

Keep out of the sight and reach of children.

MA holder:

Actavis Group PTC ehf. Reykjavikurvegi 76–78 220 Hafnar­fjordur, Iceland

Distributor:

Actavis,

Barnstaple, EX32 8NS, UK

Actavis logo

Barcode

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

N NERVOUS SYSTEM DRUGS

N07 OTHER NERVOUS SYSTEM DRUGS in ATC

N07B DRUGS USED IN ADDICTIVE DISORDERS

N07BB Drugs used in alcohol dependence

N07BB01 disulfiram

Frequently Asked Questions

What is disulfiram and how does it work?

Disulfiram is a medication used to support the treatment of alcohol dependence. It works by blocking the breakdown of alcohol, leading to unpleasant reactions when alcohol is consumed.

What should I do if I miss a dose of disulfiram?

If you miss a dose of disulfiram, take it as soon as you remember. If it’s close to your next dose, skip the missed dose and continue with your regular schedule. Do not double up.

Can I drink alcohol while taking disulfiram?

No, you should avoid alcohol completely while taking disulfiram. Consuming alcohol can cause serious side effects known as the disulfiram-alcohol reaction.

What are the common side effects of disulfiram?

Common side effects may include drowsiness, fatigue, skin rash, headache, and metallic taste in the mouth. If side effects persist or worsen, consult your doctor.

How long do I need to take disulfiram?

The duration of treatment varies depending on individual needs and recovery progress. Your doctor will guide you on how long to continue taking disulfiram.

Can disulfiram be taken with other medications?

Some medications can interact with disulfiram. Always inform your doctor about all other medications and supplements you are taking before starting disulfiram.

Is disulfiram safe for patients with liver problems?

Patients with liver issues should use disulfiram with caution as it can affect liver function. Discuss your liver health with your doctor before starting treatment.

What lifestyle changes should I make while taking disulfiram?

In addition to avoiding alcohol, consider adopting a healthier diet, regular exercise, and participating in counseling or support groups for alcohol dependence.

Can pregnant or breastfeeding women take disulfiram?

Disulfiram is not recommended for use during pregnancy or breastfeeding. Consult your healthcare provider for advice if you are pregnant or nursing.

Are there any foods I should avoid while on disulfiram?

Avoid foods containing alcohol, such as certain sauces or extracts, as well as fermented products that may trigger a reaction similar to that caused by drinking alcohol.

What happens if I consume alcohol while on disulfiram?

Consuming alcohol while taking disulfiram can lead to severe reactions including flushing, nausea, vomiting, palpitations, and low blood pressure. Seek medical help immediately if this occurs.

How should I store my disulfiram tablets?

Store your tablets in a cool, dry place away from light and moisture. Keep them out of reach of children and do not use them after their expiration date.

Can I stop taking disulfiram suddenly?

It’s important not to stop taking disulfiram abruptly without consulting your doctor. They will advise you on how to discontinue safely if necessary.

What are the signs of a serious allergic reaction to disulfiram?

Signs of an allergic reaction may include rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing. Seek medical help immediately if these occur.

Does disulfiram affect mental health?

Some patients may experience mood changes while on disulfiram. If you notice new or worsening symptoms like depression or anxiety, contact your healthcare provider promptly.

Can I take herbal supplements while on disulfiram?

Always check with your healthcare provider before taking herbal supplements alongside disulfiram, as some may interfere with its effectiveness or increase side effects.

Is it safe to operate machinery while taking disulfiram?

Disulfiram can cause drowsiness in some patients. It’s best to assess how you feel before operating machinery or driving until you're aware of how it affects you.

Will my insurance cover treatment with disulfiram tablets?

Insurance coverage varies by policy and provider. Contact your insurance company directly to find out if they cover medication like disulfiram and any associated therapy costs.

Where can I get more information about support groups for alcoholism recovery?

You can ask your healthcare provider for local resources or look online for directories of support groups such as Alcoholics Anonymous (AA) or similar organizations in your area.