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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
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 growing.
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
• 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 a 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. Especially:
• probenecid (to treat gout)
• rifampicin or trimethoprim (antibiotics to treat infections)
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.
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.
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.
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.
 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
joints, tiredness, feeling or being sick, headaches, pains in the abdomen and yellowing
of eyes and skin.
• 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, 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.
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 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 white normal convex tablets 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 April 2016

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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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