Antabuse ® 400 mg

ANTABUSE is used as a supportive medicine in the treatment of alcoholism. It contains the active ingredient, disulfiram. 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.

Do not take ANTABUSE:

• if you are hypersensitive to disulfiram or any of the other ingredients of ANTABUSE (listed in section 6)
• if you are hypersensitive to thiuram compounds, such as those used in rubber compounds, pesticides (any substance used to kill, repel, or control certain forms of plant or animal life that are considered to be pests) or fungicides (any toxic substance used to kill or inhibit the growth of fungi), isoniazid (an antituberculosis medicine) and metronidazole (an antibiotic)
• if you have recently consumed alcohol
• if you have severe heart disease or heart failure
• if you have high blood pressure
• if you have had a stroke
• if you are pregnant
• loss of control of reality
• if you have severe psychiatric or personality disorder
• if you have suicidal thoughts
• if you are using a medicine for nausea such as chlorpromazine
• if you have brain damage.

Warnings and precautions: Take special care with ANTABUSE: Before treatment with ANTABUSE, tell your doctor if you suffer from:

• kidney, liver or lung disease
• diabetes
• low blood pressure
• brain damage
• epilepsy
• severe personality disorders and drug addiction
• suicidal thoughts
• nausea and using a medicine such as chlorpromazine to treat it
• heart disease.

Other precautions: Certain foods, liquid medicines, remedies, tonics, toiletries, perfumes and sprays may contain enough alcohol to cause a disulfiram tablet - 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.

Children and adolescents: Do not give ANTABUSE to children. There is no relevant use in children.

Other medicines and ANTABUSE: ANTABUSE may increase or decrease the effect of other medicines, if taken at the same time. Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Please tell your doctor if you are taking or receiving any of the following medicines:

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

ANTABUSE and sodium: This medicine contains less than 1 mmol sodium (23 mg) per dispergette, that is to say essentially “sodium-free”.

ANTABUSE with 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’) a disulfiram - alcohol reaction may occur. The reaction is unpredictable, and symptoms may be severe or life threatening (see Warnings and precautions). 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 (pruritus, urticaria) anxiety, dizziness, headache, blurred vision, difficulty breathing, palpitations, rapid breathing. In severe cases; rapid heartbeat, 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 disulfiram - alcohol reaction can occur within 15 minutes after drinking alcohol and may last several hours.

Pregnancy, breastfeeding and fertility: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby please consult your doctor, pharmacist or other healthcare provider for advice before taking ANTABUSE. You should not take ANTABUSE if you are pregnant or breastfeeding your baby.

Driving and using machines: ANTABUSE may cause drowsiness or tiredness. If you are affected do not drive or operate machinery. It is not always possible to predict to what extent ANTABUSE may interfere with your daily activities. You should ensure that you do not engage in driving a vehicle or use machines until you are aware of the measure to which ANTABUSE affects you.

Do not share medicines prescribed for you with any other person. Always take ANTABUSE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is ½ to 1 dispergette daily or one dispergette every two days instead of half dispergette daily. Your doctor will tell you how to take ANTABUSE and how long your treatment with ANTABUSE will last. If you have the impression that the effect of ANTABUSE is too strong or too weak, tell your doctor or pharmacist.

Drop the whole or part dispergette into a quarter glass of water or other liquid. It will effervesce at once and, after stirring for a few seconds, will form a palatable suspension. Drink the suspension before it has had time to settle. Alternatively, ANTABUSE can be swallowed without chewing as normal tablets.

If you take more ANTABUSE than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining ANTABUSE with you so the doctor will know what you have taken. Signs of an overdose include; feeling or being sick, stomach pain, diarrhoea, drowsiness, mental disorders, tiredness, rapid heartbeat, 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 miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take ANTABUSE at the next regularly scheduled time. Do not take a double dose to make up for forgotten individual doses. If you stop taking ANTABUSE: Speak to your doctor or pharmacist before stopping treatment with ANTABUSE.

ANTABUSE can have side effects. Not all side - effects reported for ANTABUSE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ANTABUSE, please consult healthcare provider for advice. If any of the following happens, stop taking ANTABUSE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to ANTABUSE. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• allergic skin reactions such as itching and redness. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following: Side effects with unknown frequency:

• loss of contact with reality
• depression, paranoia, schizophrenia, mania
• decreased sexual desire
• sleepiness, 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)
• headache, restlessness
• feeling or being sick
• bad taste in mouth
• body odour
• inflammation of the liver (hepatitis), damage to liver cells, liver failure
• bad breath
• elevated levels of acetone in blood, causing symptoms such as headache, irritability, bad breath (ketosis breath), sugar cravings.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ANTABUSE.

Store all medicine out of reach of children. Store at or below 25 ºC, in a well closed container and protect from light. Do not use the dispergettes after the expiry date shown on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).