Skip to Content

DAPSONE 50 MG TABLETS

Active substance(s): DAPSONE / DAPSONE / DAPSONE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Dapsone

50mg and 100mg Tablets

Dapsone

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. See section 4.
• The name of your medicine is either Dapsone 50mg
Tablets or Dapsone 100mg Tablets. For easy reference
both will be called Dapsone in this leaflet.
What is in this leaflet
1. What Dapsone is and what it is used for
2. What you need to know before you take Dapsone
3. How to take Dapsone
4. Possible side effects
5. How to store Dapsone
6. Contents of the pack and other information
1. What Dapsone is and what it is used for
Dapsone is one of a group of medicines called antibacterials.
It works by stopping the production of folic acid in certain
bacteria. This stops the bacteria growing.
Dapsone may be used to treat:
• Leprosy.
• Skin problems.
• Prevention of malaria, only when used with another
medicine called pyrimethamine.
• Prevention of pneumonia in immunodeficient patients,
especially in AIDS patients.
Your doctor will explain what you are being treated for;
if not you should ask the doctor.
2. What you need to know before you take Dapsone
Do not take Dapsone
• If you are allergic to dapsone or any of the other
ingredients of this medicine (listed in section 6).
• If you are allergic to similar medicines such as
sulfonamide or sulfone.
• If you suffer from a lack of iron in your blood (severe
anaemia).
• If you have an inherited disorder of the red blood
pigment, haemoglobin, called porphyria.
• If you suffer from severe glucose-6-phosphate
dehydrogenase deficiency (G6PD); this can cause
episodes of anaemia after eating certain foods such
as fava beans (favism). People of African, Asian,
or Mediterranean ancestry are especially at risk of this.

Dapsone with food, drink and alcohol
You can take dapsone before, during, or after meals,
including with milk. Moderate consumption of alcohol while
taking dapsone should not have any effect.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
You may be prescribed folic acid supplements by your
doctor if you are pregnant or planning to become pregnant.
Dapsone can be present in breast milk. There have been
reports of low iron in blood (anaemia) of infants breast-fed
while the mother has been taking Dapsone. If you are
breast-feeding, or you are concerned, you should discuss
this with your doctor.
Dapsone may reduce the number and/or the movement of
sperm; this may make it more difficult to make your partner
pregnant; if you are concerned you should discuss this
with your doctor.
Driving and using machines
Dapsone should not affect your ability to drive or operate
machinery. Long term use may cause eye damage, if this
happens you should talk to your doctor; see also section 4.
3. How to take Dapsone
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed whole with some water.
Use in Adults and Children over 12 years:
Multibacillary (also called MB or lepromatous) leprosy:
100 mg daily for at least two years.
Paucibacillary (also called PB or tuberculoid) leprosy:
100 mg daily for at least 6 months.
Prevention of malaria: 100 mg weekly with 12.5 mg
pyrimethamine.
Intensely itchy, blistering rash, called dermatitis
herpetiformis: initially 50 mg daily, which may be gradually
increased to 300 mg daily, and then reduced to a usual
maintenance dose of 25 mg - 50 mg daily.
Pneumonia caused by a germ called Pneumocystis carinii:
in combination with another medicine called trimethoprim,
50 mg - 100 mg daily, or 100 mg twice a week, or 200 mg
once a week.
Use in the Elderly:
If you have a damaged liver, your doctor may give you a
lower dose than for adults.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dapsone:
• If you suffer from any other blood disorder.
• If you have heart disease.
• If you have lung disease.

Use in children aged 6 - 12 years:
Multibacillary (also called MB or lepromatous) leprosy:
50 mg daily for at least two years.
Paucibacillary (also called PB or tuberculoid) leprosy:
50 mg daily for at least 6 months.

Other medicines and Dapsone
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other medicines.
This includes medicines obtained without a prescription.
It is especially important:
• If you are taking a medicine for gout called probenecid.
• If you are taking antibiotics for infections called
rifampicin, rifabutin, or trimethoprim.
• If you are to have an oral typhoid vaccination, as it may
not be effective.

If you take more Dapsone than you should
If you, or someone else swallow a lot of tablets together,
or you think a child may have swallowed some, contact
your nearest hospital emergency department, or tell your
doctor immediately.

You should ask your doctor or pharmacist for advice before
taking any other medicines.

If you stop taking Dapsone
You should continue to take Dapsone for as long as you
doctor tells you to do so. It may be dangerous to stop
taking Dapsone without your doctor telling you to stop.

If you forget to take Dapsone
Do not take a double dose to make up for a forgotten dose.
If you forget a dose, take it as soon as you remember,
and then take the next dose at the right time.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Side effects may be
more likely when you first start taking Dapsone.
Contact your doctor immediately if the following occur:
• 
Dapsone syndrome: Rarely (may affect up to 1 in
1,000 people) a condition called “dapsone syndrome”
may occur after 3 - 6 weeks of treatment. The signs
always include rash, high temperature, and changes in
blood cells. You must seek medical advice at once since
severe skin reactions, liver inflammation, 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 the condition does not improve or if you get
eye damage or nerve damage, you should talk to your
doctor at once.
Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
Common (may affect up to 1 in 10 people):
• Haemolysis (destruction of red blood cells), which may
make you feel tired.
• Shortness of breath, feeling tired, bluish tinge to the skin
(Methaemoglobinaemia).
Uncommon (may affect up to 1 in 100 people):
• Lack of iron in the blood (anaemia), caused by
destruction of red blood cells, which may make you feel
tired.
• Fast heart-beat.
• Loss of appetite.
• Nausea.
• Vomiting.
• Inflammation of the liver characterised by tiredness,
abdominal pain, poor appetite (hepatitis).
• Yellowing of skin or whites of the eye (jaundice).
• Changes in liver function tests (your doctor will check
this).
• Low levels of albumin in the blood (Hypoalbuminaemia) your doctor will check this.
• Headache.
• Nerve damage which may result in tingling in your arms
or legs and some weakness (peripheral neuropathy,
peripheral motor neuropathy).
• Difficulty in sleeping.
• Hallucinations, delusions, excessive movements, loss of
contact with reality (Psychosis).
• Skin being more sensitive to the sun or to light
(photosensitivity).
• Itching.
• Skin rash.

5. How to store Dapsone
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date which is
stated on the blister and carton after EXP. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Dapsone contains
• The active substance is dapsone.
• The other ingredients (excipients) are microcrystalline
cellulose (E 460), pregelatinised maize starch, sodium
laurilsulfate (E 487), colloidal anhydrous silica (E 551),
stearic acid (E 570) and magnesium stearate (E 470b).
What Dapsone looks like and contents of the pack
Dapsone 50mg Tablets: White to off-white, circular,
biconvex uncoated tablets debossed with ‘50’ on one
side and plain on other side, with dimensions of 5.5 mm
diameter and 2.8 mm thick.
Dapsone 100mg Tablets: White to off-white, circular,
biconvex uncoated tablets debossed with ‘100’ on one side
and plain on other side, with dimensions of 7 mm diameter
and 3.6 mm thick.
Dapsone tablets are packed in white opaque PVCaluminium blisters.
Packs containing 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100
or 112 tablets are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd
115, Narborough Road, Leicester, LE3 0PA, UK
Manufacturer
Morningside Pharmaceuticals Ltd
5, Pavilion Way, Loughborough, LE11 5GW, UK
This leaflet was last revised in February 2017.

Rare (may affect up to 1 in 1,000 people):
• Sudden fever, chills, soreness of the throat, mouth and
gums, mouth ulcers, gum bleeding (Agranulocytosis).
• A serious skin reaction with symptoms such as rash,
blistering or peeling of the skin (Exfoliative dermatitis).
• Severe, raised, red, lumpy rash (Maculopapular rash).
• Red, painful raised rash, with skin loss (Toxic epidermal
necrolysis).
• Flu like symptoms, followed by a red or purple rash
which spreads and forms blisters, followed by skin loss
(Stevens-Johnson syndrome).
Very rare (may affect up to 1 in 10,000 people):
• Well defined, round or oval areas of reddening and
swelling of the skin, typically on the arms and legs
(Fixed drug eruptions).
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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

M0260LAMUKNAS-001

Expand view ⇕

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.

Hide