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DAPSONE 100MG TABLETS

Active substance(s): DAPSONE

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PATIENT INFORMATION LEAFLET

DAPSONE 100MG TABLETS
Please read this leaflet carefully before you start to take your tablets. Keep this leaflet. You
may need to read it again. It gives you a brief outline of the more important things you
should know. If you want to know more about this medicine or are not sure about anything
ask your doctor or pharmacist.
In this Leaflet: • What Dapsone tablets are and what they are used for
• Before you take
• How to take
• Possible side effects
• How to store
• Further information
Especially:
1. What Dapsone tablets are and what
• probenecid (to treat gout)
they are used for
• rifampicin or trimethoprim (antibiotics to
Dapsone belongs to a group of medicines called
treat infections)
antibacterials. It works by stopping the production
• Medicines that can break down blood cells
of folic acid in certain bacteria, therefore stopping
(haemolytics)
them growing.
• Medicines that slow bone marrow growth
• Aminobenzoates (used to treat skin disorders)
Dapsone may be used for:
• leprosy
• skin problems
• the prevention of malaria in combination with a
drug called pyrimethamine
• the prevention of pneumonia in immunodeficient
patients (where the patient’s immune system does
not work properly), 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 (see section 6),
or to similar medicines such as sulphonamide or
sulphone. An allergic reaction may include a rash,
itching, difficulty breathing or swelling of the face,
lips, throat or tongue
• If you are intolerant to the water tablets
furosemide or thiazide diuretics, medicines to
treat diabetes in the class of sulphonylureas or
medicines to treat glaucoma or epilepsy in the
class of carbonic anhydrase inhibitors.
• suffer from severe anaemia (low levels of red
blood cells in the body)
• have Porphyria (a genetic or inherited disorder
of the red blood pigment, haemoglobin)
• suffer from severe condition called
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 you:
• suffer from other blood disorders.
• suffer from heart or lung disease.
• suffer from glucose-6-phosphate dehydrogenase
(G6PD) deficiency.
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.

Ask your doctor or pharmacist for advice before
taking any medicines.
Pregnancy and breastfeeding
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.
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.
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
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.
Stop taking Dapsone and contact your
doctor immediately 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.
▶ Skin condition called Stevens Johnson
Syndrome: symptoms may include fever, sore
throat, tiredness, ulcers in the mouth, rashes on
the body and conjunctivitis (inflammation of the
eye).
▶ Skin condition called toxic epidermal
necrolysis: fever, sore throat, tiredness, rash,
itching, peeling of the skin and conjunctivitis
(inflammation of the eye).
▶ Hepatitis (inflammation of the liver):
symptoms may include aching muscles and joint,
tiredness, feeling or being sick, headaches, pains
in the abdomen and yellowing of eyes and skin.
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,
dizziness, 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 heartbeat, mental
disturbances, changes in liver function tests,
jaundice.
• 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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card
Scheme (Website: www.mhra.gov.uk/yellowcard).
5.

How to store

Keep out of the sight and reach of children.
Store in the original package in order to protect
from heat, light and moisture.
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
100mg of the active ingredient.
The other ingredients are povidone, magnesium
stearate, maize starch, sodium lauryl sulphate.
What Dapsone tablets look like and contents
of the pack
Dapsone tablets are a white normal convex tablet
with a breakline scored on one side.
This medicine is available in the following pack sizes
(Not all pack sizes are marketed):
Opaque plastic containers: 9, 10, 14, 15, 20, 21, 28,
30, 50, 56, 84, 100, 250, 500 and 1000 tablets
Blister packs: 9, 10, 14, 15, 20, 21, 28, 30, 56 and 84
tablets
Marketing Authorization Holder
YJB Port Limited, Unit 32 Stadium Business Centre,
North End Road, Wembley, Middlesex, HA9 0AT
Manufacturer
Tiofarma B.V. Benjamin Franklinstraat 5-9,
3261 LW Oud-Beijerland, The Netherlands
This leaflet was last revised in October 2016
PL 34793/0005 PIL YP0005-16/01

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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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