Dapsone 100mg Tablets
PATIENT INFORMATION LEAFLET
DAPSONE I00MGTABLETS
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
• 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.
Especially:
• probenecid (to treat gout)
• rifampicin or trimethoprim (antibiotics to treat infections)
• Medicines that can break down blood cells (haemolytics)
• Medicines that slow bone marrow growth
• Aminobenzoates (used to treat skin disorders)
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.
■. 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 I00mg 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-I6/0I