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

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.