Patient leaflet - ANTABUSE TABLETS 200 MG, DISULFIRAM TABLETS 200 MG
1. What Disulfiram is and what it is used for
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2. Before you take Disulfiram 2
3. How to take Disulfiram
4. Possible side effects
5. How to store Disulfiram
6. Contents of the pack and other information
1. What Disulfiram is and what it is used for
Disulfiram 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 3
which breaks down acetaldehyde. This leads to an increased level of acetaldehyde in the blood causing unpleasant physical reactions.
Disulfiram is used in the treatment of people with drinking problems. If you are treated with Disulfiram and drink alcohol you will experience unpleasant physical reactions, which may stop you from drinking further alcohol.
4
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2. Before you take Disulfiram
Do not take Disulfram tablets if you:
- are allergic to disulfiram or any of the other ingredients of this medicine (listed in section 6)
- have severe heart disease or heart failure
- have high blood pressure
- have severe psychiatric or personality disorder
- have had a stroke.
- have recently consumed alcohol 5
Warnings and precautions
Talk to your doctor or pharmacist before taking Disulfiram tablets if you have:
kidney, liver or lung disease
diabetes
low blood pressure
brain damage
epilepsy.
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376 mm
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| Children and adolescents Do not give this medicine to children. Other medicines and Disulfiram Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 7 | nerves (causing pain and loss of sensation in hands and feet)
|
(hepatitis), damage to liver cells, liver failure
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 24 | 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. 25 | ||||||||||||||||||||||||||
5. How to store Disulfiram
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 Disulfiram tablets 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.
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6. Contents of the pack and other information
What Disulfiram tablets contain
- 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 Disulfiram looks like and the contents of the pack
The tablet is white and scored with a
breakline marker ‘CJO’ on the side. 29
Pack sizes are 50 tablets
Marketing Authorisation Holder
Actavis Group PTC ehf. Reykjavikurvegi 76–78, 220 Hafnarfjordur,
Iceland
30
Manufacturer AAAK1862
Recipharm Uppsala AB, Bjorkgatan 30, 751 82 Uppsala, Sweden
This leaflet was last revised in
March 2018
31
28 mm
«■
456 mm
■>
The use of Disulfiram tablets 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
Disulfiram tablets may cause drowsiness or tiredness (see ‘4. Possible side effects’). If you are affected do not drive or operate 13
machinery.
Disulfiram 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.
14
3. How to take Disulfiram
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 Disulfiram is usually started in a hospital or specialised clinic. It is 15
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. 16
Then % 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 Disulfiram 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 17
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 18
tests). Severe cases may result in coma, fits or death.
If you forget to take Disulfiram
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 Disulfiram
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
-
5. How to store Disulfiram
-
6. Contents of the pack and other information
1. What Disulfiram is and what it is used for
Disulfiram 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 3
which breaks down acetaldehyde. This leads to an increased level of acetaldehyde in the blood causing unpleasant physical reactions.
Disulfiram is used in the treatment of people with drinking problems. If you are treated with Disulfiram and drink alcohol you will experience unpleasant physical reactions, which may stop you from drinking further alcohol.
4
-
2. Before you take Disulfiram
Do not take Disulfram tablets if you:
- are allergic to disulfiram or any of the other ingredients of this medicine (listed in section 6)
- have severe heart disease or heart failure
- have high blood pressure
- have severe psychiatric or personality disorder
- have had a stroke.
- have recently consumed alcohol 5
Warnings and precautions
Talk to your doctor or pharmacist before taking Disulfiram tablets if you have:
kidney, liver or lung disease
diabetes
low blood pressure
brain damage
epilepsy.
6
S Z
14 MM BLANK FOR
GLUE AREA
<■
376 mm
28 mm
| <-----> 15 MM BLANK FOR GLUE AREA | |||||||||||||||||||||||||||||
| Children and adolescents Do not give this medicine to children. Other medicines and Disulfiram Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 7 | nerves (causing pain and loss of sensation in hands and feet)
|
(hepatitis), damage to liver cells, liver failure
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 24 | 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. 25 | 5. How to store DisulfiramKeep 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 Disulfiram tablets 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. 27 | 6. Contents of the pack and other informationWhat Disulfiram tablets contain
| cellulose, polysorbate 20, tartaric acid, colloidal anhydrous silica, sodium bicarbonate, maize starch and magnesium stearate. What Disulfiram looks like and the contents of the packThe tablet is white and scored with a breakline marker ‘CJO’ on the side. 29 | Pack sizes are 50 tablets Marketing Authorisation Holder Actavis Group PTC ehf. Reykjavikurvegi 76–78, 220 Hafnarfjordur, Iceland 30 | Manufacturer AAAK1862 Recipharm Uppsala AB, Bjorkgatan 30, 751 82 Uppsala, Sweden This leaflet was last revised in March 2018 31 | ||||||||||||||||||||
28 mm
«■
456 mm
■>
The use of Disulfiram tablets 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
Disulfiram tablets may cause drowsiness or tiredness (see ‘4. Possible side effects’). If you are affected do not drive or operate 13
machinery.
Disulfiram 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.
14
3. How to take Disulfiram
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 Disulfiram is usually started in a hospital or specialised clinic. It is 15
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. 16
Then % 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 Disulfiram 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 17
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 18
tests). Severe cases may result in coma, fits or death.
If you forget to take Disulfiram
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 Disulfiram
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 20
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
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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 22
28 mm
<■
456 mm
■>