DAPSONE 50 MG TABLETS

Active substance: DAPSONE

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Product

Dapsone 50mg Tablets

PIL Code

A1000261/1

Date started

Artwork

PIL

Version

001

AW/V

Notes

24.08.2012

Finished folded size: 210mm(h) x 148mm (w)

001/v6 (DS) 10.07.2013

Author

MP-AUD/GH-DS

148mm

PATIENT INFORMATION LEAFLET

DAPSONE 50 MG TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In this leaflet: 1. What DAPSONE is and what it is used for
2. What you need to know before you take DAPSONE Tablets
3. How to take DAPSONE Tablets
4. Possible side effects
5. How to store DAPSONE Tablets
6. Contents of the pack and other information

1. What DAPSONE is and what it is used for
Dapsone belongs to a group of medicines called antibacterials. It works by stopping the production of folic acid in
certain bacteria, therefore stopping them growing.
Dapsone may be used for:
• leprosy
• skin problems
• the prevention of malaria in combination with
pyrimethamine
• the prevention of pneumonia in immunodeficient patients,
especially in AIDS patients.

Do not take DAPSONE tablets and tell your doctor
if you:
• are allergic (hypersensitive) to Dapsone, any of the other
ingredients in the tablet, or to similar medicines such as
sulphonamide or sulphone (see section 6). An allergic
reaction may include a rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue
• suffer from severe anaemia
• have porphyria (a genetic or inherited disorder of the
red blood pigment, haemoglobin)
• suffer from severe glucose-6-phosphate dehydrogenase
(G6PD) deficiency (including breast feeding of affected
children), this can cause episodes of anaemia
after eating certain foods such as fava beans (favism).
Take special care with Dapsone tablets and tell your
doctor if:
• suffer from other blood disorders.
• suffer from heart or lung disease.
• suffer from glucose-6-phosphate dehydrogenase
(G6PD) deficiency.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking this medicine.
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.

Pregnancy and breast feeding
If you are pregnant or planning to become pregnant, your
doctor may prescribe you folic acid supplements.
Dapsone can be present in breast milk. There has been a
report of anaemia in an infant being breast fed by a mother
taking Dapsone tablets.
If you are concerned, check with your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any
medicines.

210mm

2. What you need to know before you take
DAPSONE Tablets

In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• probenecid (to treat gout)
• rifampicin or trimethoprim (antibiotics to treat
infections).
If you are unsure of the types of medicines you are taking,
ask your doctor or pharmacist.

Driving and using machines
You should be able to drive and use machinery whilst taking
Dapsone tablets.
Important information about some of the
ingredients of DAPSONE
This product contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, please
contact your doctor before taking this medicinal product.
3. How to take DAPSONE Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you.You should check with them if you
are not sure.
Swallow the tablets with some water.
The usual doses are:
Adults and children over 12 years:
• Multibacillary leprosy: 100mg daily for at least two years.
• Paucibacillary leprosy: 100mg daily for at least six months.
• Malaria prophylaxis: 100mg weekly with
12.5mg pyrimethamine.
• Dermatitis herpetiformis: Initially 50mg daily which may be
gradually increased to 300mg daily and then reduced to a
usual maintenance dose of 25mg-50mg daily.

© Auden Mckenzie (Pharma Division) Ltd,
Mckenzie House, Bury Street,
Ruislip, Middlesex HA4 7TL.
Tel: 01895 627 420
info@audemmckenzie.com

Product

Dapsone 50mg Tablets

PIL Code

A1000261/1

Date started

Artwork

PIL

Version

001

AW/V

Notes

24.08.2012

Finished folded size: 210mm(h) x 148mm (w)

001/v6 (DS) 10.07.2013

Author

MP-AUD/GH-DS

148mm

• Pneumocystis carinii pneumonia: In combination with
trimethoprim, 50-100mg daily or 100mg twice weekly or
200mg once weekly.
Elderly
If you have a damaged liver your doctor may give you a lower
dose.
Children 6-12 years:
• Multibacillary leprosy: 50mg daily for at least two years.
• Paucibacillary leprosy: 50mg daily for at least six months.
Continue to take them for as long as your doctor tells you
to, it may be dangerous to stop without their advice.
If you take more DAPSONE 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.
If you forget to take DAPSONE:
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose take it as soon as you remember
it and then take the next dose at the right time.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. Possible side effects

Please tell your doctor or pharmacist if you notice any of the
following effects or any effects not listed.
Contact your doctor at once if the following occur:
• Dapsone syndrome: a ‘Dapsone syndrome’ may occur
after 3-6 weeks of treatment. Symptoms always include
rash, fever and changes in blood cells. It is important to
seek medical help immediately as severe skin reactions,
inflammation of the liver, kidney damage and mental illness
have occurred if treatment is not stopped or reduced.
Some deaths have been reported.
• Effects on your leprosy: if you are being treated for
leprosy and your condition does not improve or you get
eye or nerve damage, talk to your doctor.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
• Effects on the blood: anaemia caused by destruction of
red blood cells, changes in the type and number of other
blood cells (you may develop ulcers in your mouth or on
your skin).
• Effects on the skin: rash which can be raised,
discoloured, tender, destructive or itchy, sensitivity to
sunlight or artificial light such as sun-bed (symptoms such
as tingling, burning or redness of the skin). Rarely skin
conditions may be associated with fever, malaise, and lung
or kidney damage.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme (Tel: Freephone 0808 100 3352 or Website:
www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this
medicine.
5. How to store DAPSONE Tablets
Keep all medicines out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and blister as [EXP MM/YYYY]. The
expiry date refers to the last day of that month.
Keep the tablets in the original package in order to protect
from light.
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.
6. Contents of the pack and other information
What DAPSONE contains:
The active substance (the ingredient that makes the tablets
work) is dapsone. Each tablet contains 50 mg of the active
ingredient.

210mm

Like all medicines, Dapsone tablets can cause side effects,
particularly when you first start taking it, although not
everybody gets them.

• Effects on the nervous system: headache, difficulty
sleeping, nerve damage which may cause tingling in your
arms or legs and some weakness.
• Effects on the gastrointestinal system: loss of
appetite, feeling or being sick, inflammation of the liver.
• Other effects: fast heart beat, mental disturbances,
changes in liver function tests, jaundice.

The tablets also contain lactose monohydrate, pregelatinised
maize starch, maize starch, sodium lauryl sulfate, stearic acid
and magnesium stearate.
What DAPSONE looks like and contents of the pack:
Dapsone 50 mg Tablets are white, circular, biconvex tablets,
debossed with ‘50’ on one side and with a score line
between ‘D’ & ‘P’ on the other side.
Dapsone tablets are available in boxes of 28 tablets.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House,
Bury Street, Ruislip, Middlesex, HA4 7TL, UK.
Manufacturer:
TioFarma B.V., Benjamin Franklinstraat 7-9,
3261 LW Oud-Beijereland, The Netherlands.
This leaflet was last revised in July 2013.

For information in large print,
on tape, on CD or in Braille,
phone +44 (0)1895 627 420.
A1000261/1

Auden Mckenzie

© Auden Mckenzie (Pharma Division) Ltd,
Mckenzie House, Bury Street,
Ruislip, Middlesex HA4 7TL.
Tel: 01895 627 420
info@audemmckenzie.com

148mm

PATIENT INFORMATION LEAFLET

DAPSONE 50 MG TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In this leaflet: 1. What DAPSONE is and what it is used for
2. What you need to know before you take DAPSONE Tablets
3. How to take DAPSONE Tablets
4. Possible side effects
5. How to store DAPSONE Tablets
6. Contents of the pack and other information

1. What DAPSONE is and what it is used for
Dapsone belongs to a group of medicines called antibacterials. It works by stopping the production of folic acid in
certain bacteria, therefore stopping them growing.
Dapsone may be used for:
• leprosy
• skin problems
• the prevention of malaria in combination with
pyrimethamine
• the prevention of pneumonia in immunodeficient patients,
especially in AIDS patients.

Do not take DAPSONE tablets and tell your doctor
if you:
• are allergic (hypersensitive) to Dapsone, any of the other
ingredients in the tablet, or to similar medicines such as
sulphonamide or sulphone (see section 6). An allergic
reaction may include a rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue
• suffer from severe anaemia
• have porphyria (a genetic or inherited disorder of the
red blood pigment, haemoglobin)
• suffer from severe glucose-6-phosphate dehydrogenase
(G6PD) deficiency (including breast feeding of affected
children), this can cause episodes of anaemia
after eating certain foods such as fava beans (favism).
Take special care with Dapsone tablets and tell your
doctor if:
• suffer from other blood disorders.
• suffer from heart or lung disease.
• suffer from glucose-6-phosphate dehydrogenase
(G6PD) deficiency.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking this medicine.
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.

Pregnancy and breast feeding
If you are pregnant or planning to become pregnant, your
doctor may prescribe you folic acid supplements.
Dapsone can be present in breast milk. There has been a
report of anaemia in an infant being breast fed by a mother
taking Dapsone tablets.
If you are concerned, check with your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any
medicines.
Driving and using machines
You should be able to drive and use machinery whilst taking
Dapsone tablets.
Important information about some of the
ingredients of DAPSONE
This product contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, please
contact your doctor before taking this medicinal product.
3. How to take DAPSONE Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you.You should check with them if you
are not sure.
Swallow the tablets with some water.
The usual doses are:
Adults and children over 12 years:
• Multibacillary leprosy: 100mg daily for at least two years.
• Paucibacillary leprosy: 100mg daily for at least six months.
• Malaria prophylaxis: 100mg weekly with
12.5mg pyrimethamine.
• Dermatitis herpetiformis: Initially 50mg daily which may be
gradually increased to 300mg daily and then reduced to a
usual maintenance dose of 25mg-50mg daily.

• Pneumocystis carinii pneumonia: In combination with
trimethoprim, 50-100mg daily or 100mg twice weekly or
200mg once weekly.
Elderly
If you have a damaged liver your doctor may give you a lower
dose.
Children 6-12 years:
• Multibacillary leprosy: 50mg daily for at least two years.
• Paucibacillary leprosy: 50mg daily for at least six months.
Continue to take them for as long as your doctor tells you
to, it may be dangerous to stop without their advice.
If you take more DAPSONE 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.
If you forget to take DAPSONE:
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose take it as soon as you remember
it and then take the next dose at the right time.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dapsone tablets can cause side effects,
particularly when you first start taking it, although not
everybody gets them.
Please tell your doctor or pharmacist if you notice any of the
following effects or any effects not listed.
Contact your doctor at once if the following occur:
• Dapsone syndrome: a ‘Dapsone syndrome’ may occur
after 3-6 weeks of treatment. Symptoms always include
rash, fever and changes in blood cells. It is important to
seek medical help immediately as severe skin reactions,
inflammation of the liver, kidney damage and mental illness
have occurred if treatment is not stopped or reduced.
Some deaths have been reported.
• Effects on your leprosy: if you are being treated for
leprosy and your condition does not improve or you get
eye or nerve damage, talk to your doctor.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
• Effects on the blood: anaemia caused by destruction of
red blood cells, changes in the type and number of other
blood cells (you may develop ulcers in your mouth or on
your skin).
• Effects on the skin: rash which can be raised,
discoloured, tender, destructive or itchy, sensitivity to
sunlight or artificial light such as sun-bed (symptoms such
as tingling, burning or redness of the skin). Rarely skin
conditions may be associated with fever, malaise, and lung
or kidney damage.

• Effects on the nervous system: headache, difficulty
sleeping, nerve damage which may cause tingling in your
arms or legs and some weakness.
• Effects on the gastrointestinal system: loss of
appetite, feeling or being sick, inflammation of the liver.
• Other effects: fast heart beat, mental disturbances,
changes in liver function tests, jaundice.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme (Tel: Freephone 0808 100 3352 or Website:
www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this
medicine.
5. How to store DAPSONE Tablets
Keep all medicines out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and blister as [EXP MM/YYYY]. The
expiry date refers to the last day of that month.
Keep the tablets in the original package in order to protect
from light.
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.
6. Contents of the pack and other information
What DAPSONE contains:
The active substance (the ingredient that makes the tablets
work) is dapsone. Each tablet contains 50 mg of the active
ingredient.
The tablets also contain lactose monohydrate, pregelatinised
maize starch, maize starch, sodium lauryl sulfate, stearic acid
and magnesium stearate.
What DAPSONE looks like and contents of the pack:
Dapsone 50 mg Tablets are white, circular, biconvex tablets,
debossed with ‘50’ on one side and with a score line
between ‘D’ & ‘P’ on the other side.
Dapsone tablets are available in boxes of 28 tablets.
Marketing authorisation holder and manufacturer:
Auden Mckenzie (Pharma Division) Ltd.,
Mckenzie House, Bury Street, Ruislip,
Middlesex, HA4 7TL, UK
This leaflet was last revised in April 2013.

For information in large print,
on tape, on CD or in Braille,
phone +44 (0)1895 627 420.
P0137-01/1

Auden Mckenzie

210mm

2. What you need to know before you take
DAPSONE Tablets

In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• probenecid (to treat gout)
• rifampicin or trimethoprim (antibiotics to treat
infections).
If you are unsure of the types of medicines you are taking,
ask your doctor or pharmacist.

148mm

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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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