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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, and lung or kidney damage.

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 50 mg 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 50 mg 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 authorisation holder:

Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK.

Manufacturer:

TioFarma B.V., Benjamin Franklinstraat 7-9,

3261 LW Oud-Beijereland, The Netherlands.

This leaflet was last revised in July 2013.

For information in large print, on tape, on CD or in Braille, phone +44 (0)1895 627 420.

AI00026I/I

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Auden Mckenzie

PATIENT INFORMATION LEAFLET

_DAPSONE 50 MG 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: I. 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

I. What DAPSONE is and what it is 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 pyrimethamine

•    the prevention of pneumonia in immunodeficient patients, especially in AIDS patients.

2. What you need to know before you take DAPSONE Tablets

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 sulphonamide or sulphone (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 (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:

•    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, including medicines obtained without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    probenecid (to treat gout)

•    rifampicin or trimethoprim (antibiotics to treat infections).

If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.

Pregnancy and breast feeding

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.

Important information about some of the ingredients of DAPSONE

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.

3. How to take DAPSONE Tablets

Always take this medicine exactly as your doctor or pharmacist has told you.You should check with them if you are not sure.

Swallow the tablets with some water.

The usual doses are:

Adults and children over 12 years:

•    Multi bacillary leprosy: 100 mg daily for at least two years.

•    Paucibacillary leprosy: 100mg daily for at least six months.

•    Malaria prophylaxis: I OOmg 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:

•    Multi bacillary 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.

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,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 heart beat, mental disturbances, changes in liver function tests, jaundice.

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 (Tel: Freephone 0808 100 3352 or 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 MM/YYYY]. The expiry date refers to the last day of that month.

Keep the tablets in the original package 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 50 mg 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 50 mg 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 authorisation holder and manufacturer:

Auden Mckenzie (Pharma Division) Ltd.,

Mckenzie House, Bury Street, Ruislip,

Middlesex, HA4 7TL, UK

This leaflet was last revised in April 2013.

For information in large print, on tape, on CD or in Braille, phone +44 (0) 1895 627 420.

POI37-01/1

210mm