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Active substance(s): DAPSONE

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Dapsone 50mg and 100mg Tablets
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.

1 W
 hat Dapsone tablets are
and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Dapsone tablets are and what

they are 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
Dapsone may be used for:
• leprosy
• skin problems
• the prevention of malaria in combination with
• the prevention of pneumonia in immunodeficient
patients, especially in AIDS patients.

2 Before you take

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 sulfonamide or sulfone (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 deficiency (G6PD), this can cause
episodes of anaemia after eating certain foods such
as fava beans (favism).
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Take special care with Dapsone tablets and
tell your doctor if you:

• suffer from other blood disorders
• suffer from heart or lung disease.

Taking other medicines

Pregnancy and breastfeeding

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription. Especially:
• probenecid (to treat gout)
• rifampicin or trimethoprim (antibiotics to treat
Ask your doctor or pharmacist for advice before
taking any medicines.

If you are pregnant or planning to become
pregnant, your doctor may prescribe you folic acid
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

Ask your doctor or pharmacist for advice before
taking any medicines.

Sugar intolerance

If you have been told you have an intolerance to
some sugars, contact your doctor before taking this
medicine, as it contains lactose.

3 How to take

Always take Dapsone tablets exactly as your doctor
has told you. If you are not sure, check with your
doctor or pharmacist.

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.

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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 than you should

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:

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 the tablets

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.

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,
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.

By reporting side effects you can help provide
more information on the safety of this medicine.

5 How to store

Keep out of the reach and sight of children.Store below
25°C in a dry place.
Do not use Dapsone tablets 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.

6 Further information

What Dapsone tablets contain

• The active substance (the ingredient that
makes the tablets work) is Dapsone. Each
tablet contains either 50mg or 100mg of the
active ingredient.
• The other ingredients are lactose, magnesium
stearate, maize starch, sodium lauryl sulfate

What Dapsone tablets look like and
contents of t he pack

Dapsone tablets are a circular, white uncoated
Pack sizes are 28
Marketing Authorisation Holder and
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in August 2015

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Actavis, Barnstaple, EX32 8NS, UK

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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.