Medication Guide App

ANTABUSE TABLETS 200 MG

Active substance: DISULFIRAM

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For proofreading of Braille
2

18 mm
Tab

85 mm

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Braille placement only
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18 mm
Tab

85 mm

20 mm

85 mm
Glue

20 mm

Base label (Selfadhesive)
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FABRIC:
EXPIR:
LOT.NO:

Braille reads:antabuse
200mg

18 mm
Tab/Glue

Leaflet outside (Prima)

PET001095-UK KR/DRUGS/KTK/25/460/2001

®

Antabuse
200 mg
(Disulfiram)
PL 30306/0036

POM

85 mm
Glue

To be taken by mouth. Keep tightly closed. Protect from light.
Store below 25°C in a dry place.
Keep out of the reach and sight of children.
Distributor:
Actavis,
Barnstaple,
EX32 8NS, UK

85 mm
Page 9

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.

L20552KEM-30

Each tablet contains: Disulfiram 200 mg

Also contains: lactose, microcrystalline cellulose, tartaric acid.
Sodium content: 0.3 mEq

MA holder:
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjordur, Iceland

85 mm
Page 8

3. How to take
ccllabel.dk

50 tablets

85 mm
Page Front page outside

5 029801 000212

18 mm
Tab

Always take Antabuse® exactly as your doctor has told you. If you are not sure, check with your
doctor or pharmacist. 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.
8

85 mm
Page 10

Doses:
· 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 ½ 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 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 9

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 the tablets
If you forget to take a dose, and you do not remember it within 12 hours, you should not take it. Do not take
two doses the next time.

4. Possible side effects

85 mm
Page 11

Like all medicines, Antabuse® can cause side effects, although not everybody gets them.
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)
10

85 mm
Page 12

· 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
· allergic skin reactions such as itching and redness.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or
pharmacist.

85 mm
Page 13

5. How to store

Keep out of the reach and sight 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/carton/bottle. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

· The other ingredients are lactose, potato starch, povidone, microcrystalline cellulose, polysorbate 20,
tartaric acid, colloidal anhydrous silica, sodium bicarbonate, maize starch and magnesium stearate.
Contents of the pack Pack sizes are 50 tablets
Marketing Authorisation Holder
Actavis Group PTC ehf. Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
Manufacturer
Kemwell AB, Bjorkgatan 30, 751 82 Uppsala, Sweden

What Antabuse® contains
· The active substance (the ingredient that makes the tablet work) is 200mg of disulfiram.

Date of revision: September 2011

6. Further information
11

12

13

Leaflet inside (Sekunda)
85 mm
Page 1

Antabuse® 200mg tablets

(disulfiram)
Read all of this leaflet carefully before you start taking
this medicine.
· 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.

85 mm
Page 2
L20552KEM-30

Index
1. What Antabuse® is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1

85 mm
Page 3

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

Do not take Antabuse® and tell your doctor if you have:

2

· an allergy (hypersensitivity) to disulfiram or any of the other ingredients (see section 6)
· severe heart disease or heart failure
· high blood pressure
· severe psychiatric or personality disorder
· had a stroke.
· recently consumed alcohol
Check with your doctor or pharmacist before taking Antabuse® if you have:
· kidney, liver or lung disease
· diabetes
· low blood pressure

vx

85 mm
Page 4

3

· brain damage
· epilepsy.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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)

85 mm
Page 5

4

85 mm
Page 6

85 mm
(Design page)

· 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 “nonalcoholic” or “alcohol-free” beers and wines, if enough is taken they may produce unpleasant reactions.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist 5

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.
Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this
medicine, as it contains a type of sugar called lactose.
6

L20552KEM-30

50 tablets
®

Antabuse
200 mg
(Disulfiram)
PL 30306/0036

POM

85 mm
Page 7 (Front page inside)
Each tablet contains: Disulfiram 200 mg

Also contains: lactose, microcrystalline cellulose, tartaric acid.
Sodium content: 0.3 mEq
To be taken by mouth. Keep tightly closed. Protect from light.
Store below 25°C in a dry place.
Keep out of the reach and sight of children.
MA holder:
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjordur, Iceland

Distributor:
Actavis,
Barnstaple,
EX32 8NS, UK

18 mm
Tab/Glue

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.

7

For proofreading of Braille
2

18 mm
Tab

85 mm

a

n

t

a

Nums

2

0

0

b

u

s

m

20 mm

e

g

Braille placement only
2

a

n

t

a

Nums

2

0

u

s

m

0

b

85 mm

20 mm

85 mm
Glue

20 mm

e

g

Base label (Selfadhesive)
2

18 mm
Tab/Glue

FABRIC:
EXPIR:
LOT.NO:

Braille reads:antabuse
200mg

18 mm
Tab

Leaflet outside (Prima)
85 mm
Page Front page outside

Antabuse
200 mg
(Disulfiram)
PL 30306/0036

POM

To be taken by mouth. Keep tightly closed. Protect from light.
Store below 25°C in a dry place.
Keep out of the reach and sight of children.
MA holder:
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjordur, Iceland

Distributor:
Actavis,
Barnstaple,
EX32 8NS, UK

85 mm
Page 9

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.

L20553KEM-30

PET001094-UK

Each tablet contains: Disulfiram 200 mg
Also contains: lactose, microcrystalline cellulose, tartaric acid.
Sodium content: 0.3 mEq

3. How to take

ccllabel.dk

50 tablets KR/DRUGS/KTK/25/460/2001
®

85 mm
Page 8

85 mm
Glue

5 029801 000212

18 mm
Tab

Always take Antabuse® exactly as your doctor has told you. If you are not sure, check with your doctor or
pharmacist. 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.
Doses:
· Adults and the elderly: Initially 4 tablets (800mg) on day 1, then 3 tablets (600mg) on day 2,
8

85 mm
Page 10

85 mm
Page 11

If you forget to take the tablets
If you forget to take a dose, and you do not remember it within 12 hours, you should not take it.
Do not take two doses the next time.

then 2 tablets (400mg) on day 3 and then 1 tablet (200mg) on days 4 and 5. Then ½ 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 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.

4. Possible side effects

9

Like all medicines, Antabuse® can cause side effects, although not everybody gets them.
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)
10

85 mm
Page 12

85 mm
Page 13

· 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
· allergic skin reactions such as itching and redness.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

Keep out of the reach and sight 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/carton/bottle. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will help to protect the environment.

11

12

5. How to store

6. Further 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.
Contents of the pack Pack sizes are 50 tablets
Marketing Authorisation Holder Actavis Group PTC ehf. Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
Manufacturer Kemwell AB, Bjorkgatan 30, 751 82 Uppsala, Sweden

Date of revision: September 2011

13

Leaflet inside (Sekunda)
85 mm
Page 1

Antabuse® 200mg tablets

(disulfiram)
Read all of this leaflet carefully before you start taking this
medicine.
· 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.

85 mm
Page 2
L20553KEM-30

Index
1. What Antabuse® is and what
it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1

85 mm
Page 3

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

Do not take Antabuse® and tell your doctor if you have:

2

· an allergy (hypersensitivity) to disulfiram or any of the other ingredients (see section 6)
· severe heart disease or heart failure
· high blood pressure
· severe psychiatric or personality disorder
· had a stroke.
· recently consumed alcohol
Check with your doctor or pharmacist before taking Antabuse® if you have:
· kidney, liver or lung disease
· diabetes
· low blood pressure

85 mm
Page 4

3

85 mm
Page 5

85 mm
Page 6

· brain damage
· epilepsy.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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)
4
· 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.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for 5

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.
Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine,
as it contains a type of sugar called lactose.
6

85 mm
(Design page)
L20553KEM-30

50 tablets
®

Antabuse
200 mg
(Disulfiram)
PL 30306/0036

POM

85 mm
Page 7 (Front page inside)

Each tablet contains: Disulfiram 200 mg
Also contains: lactose, microcrystalline cellulose, tartaric acid.
Sodium content: 0.3 mEq
To be taken by mouth. Keep tightly closed. Protect from light.
Store below 25°C in a dry place.
Keep out of the reach and sight of children.
MA holder:
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjordur, Iceland

Distributor:
Actavis,
Barnstaple,
EX32 8NS, UK

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
7
problems, blood disorders.

18 mm
Tab/Glue

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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