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DAPSONE 50 MG TABLETS

Active substance(s): DAPSONE

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PATIENT INFORMATION LEAFLET

DAPSONE 50MG 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
including medicines obtained without a prescription.
1. What Dapsone is and what it is used for
In particular, tell your doctor or pharmacist if you
Dapsone belongs to a group of medicines called
are taking any of the following medicines:
antibacterials. It works by stopping the production
• probenecid (to treat gout)
of folic acid in certain bacteria, therefore stopping
• rifampicin or trimethoprim (antibiotics to
them growing.
treat infections).
Dapsone may be used for:
If you are unsure of the types of medicines you are
• leprosy
taking, ask your doctor or pharmacist.
• skin problems
Pregnancy and breast feeding
• the prevention of malaria in combination with
If you are pregnant or planning to become pregnant,
pyrimethamine
• the prevention of pneumonia in immunodeficient your doctor may prescribe you folic acid
supplements. Dapsone can be present in breast
patients, especially in AIDS patients.
milk. There has been a report of anaemia in an
2. What you need to know before you take infant being breast fed by a mother taking Dapsone
Dapsone Tablets
tablets. If you are concerned, check with your
doctor or pharmacist.
Do not take Dapsone tablets and tell your
Ask your doctor or pharmacist for advice before
doctor if you:
taking any medicines.
• are allergic (hypersensitive) to Dapsone, any of
Driving and using machines
the other ingredients in the tablet, or to similar
medicines such as sulphonamide or sulphone (see You should be able to drive and use machinery
section 6). An allergic reaction may include a rash, whilst taking Dapsone tablets.
itching, difficulty breathing or swelling of the face,
Important information about some of the
lips, throat or tongue
ingredients of Dapsone
• suffer from severe anaemia
This product contains lactose. If you have been
• have porphyria (a genetic or inherited disorder
told by your doctor that you have an intolerance
of the red blood pigment, haemoglobin)
to some sugars, please contact your doctor before
• suffer from severe glucose-6-phosphate
taking this medicinal product.
dehydrogenase (G6PD) deficiency, (including
3. How to take Dapsone tablets
breast feeding of affected children), this can cause
episodes of anaemia after eating certain foods
Always take this medicine exactly as your doctor or
such as fava beans (favism).
pharmacist has told you.You should check with
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,

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.
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.
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 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 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
(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
XX/YYYY]. The expiry date refers to the last day of
that month.
Keep the tablets in the original packaging 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 50mg
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 50mg 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 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 September
2016

PL 34793/0004 PIL YP0004-16/01

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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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