Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Dapsone belongs to a group of medicines called antibacterials. It works by stopping the production of folic acid in certain bacteria, therefore preventing them from growing.
Dapsone can be used to treat leprosy, to treat blistering skin disorders such as dermatitis herpetiformis (which is connected to gluten sensitivity) or to prevent pneumonia in immunodeficient patients (in particular patients with AIDS).
Do not take Dapsone: • if you are allergic to dapsone, sulfonamides, sulfones or any of the other ingredients of this medicine listed in section 6.
• if you suffer from severe anaemia;
• if you have porphyria (A group of rare inherited or acquired disorders where there is a problem with the production of haem (used to make haemoglobin in red blood cells) within the body);
• if you suffer from severe glucose-6-phosphate dehydrogenase deficiency (A hereditary condition in which red blood cells break down when the body is exposed to certain medicines or infection);
Warnings and Precautions Talk to your doctor or pharmacist before taking Dapsone if you:
• suffer from other blood disorders;
• suffer from heart or lung disorders.
Other medicines and Dapsone Tell your doctor or pharmacist if you are taking any of the below listed medicines or if you have recently taken any other medicines, including medicines obtained without a prescription:
• probenecid (to treat gout);
• rifampicin or trimethoprim (to treat infections);
Driving and using machines Dapsone has no known effect on the ability to drive or operate machinery.
Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no or very limited data from the use of dapsone in pregnant women.
The use of dapsone is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
Dapsone is excreted in breast milk. Effects on the breastfed newborn/infant cannot be excluded.
Always take Dapsone exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole with a glass of water.
The tablets can be divided into equal doses.
Unless otherwise prescribed by the doctor, the recommended doses are:
• Adults and children (aged over 12 years):
Multibacillary leprosy: 100mg daily for at least two years.
Paucibacillary leprosy: 100mg daily for at least six months.
Dermatitis herpetiformis: Initially 50mg daily, which may be gradually increased to 300mg daily and then reduced back down to the 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.
• Children aged 6-12 years:
Multibacillary leprosy: 50mg daily for at least two years.
Paucibacillary leprosy: 50mg daily for at least six months.
• Elderly:
If you have liver problems, your doctor may give you a lower dose.
If you take more Dapsone than you should If you accidentally take more Dapsone than you should, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
Symptoms of overdose are: (low level of oxygen in the blood (hypoxia), methaemoglobinaemia (blood disorder in which an abnormal amount of methemoglobin (a form of haemoglobin) is produced) and haemolytic anaemia (reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness).
If you forget to take Dapsone Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Dapsone Do not stop taking Dapsone without first talking to your doctor. Your medicine may not work properly if you stop taking it too soon.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Dapsone can cause side effects, particularly when you first start taking it, although not everybody gets them.
Stop taking Dapsone and seek medical advice immediately if you develop the following symptoms: • Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness.
• Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
• "Dapsone syndrome". Fever, malaise, skin rashes, jaundice, swollen lymph glands, glandular fever, eosinophilia (increase in white blood cells), anaemia (low blood count) may occur.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed in this leaflet: Common (may affect up to 1 in 10 people):
• Haemolysis (breakdown of red blood cells).
• A blood disorder in which an abnormal amount of methemoglobin (a form of haemoglobin) is produced (methaemoglobinaemia).
Uncommon (may affect up to 1 in 100 people):
• Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia).
• Faster heartbeat (tachycardia).
• Loss of appetite (anorexia).
• Feeling or being sick (nausea, vomiting).
• Inflammation of the liver (hepatitis).
• Yellowing of skin or whites of the eyes (jaundice).
• Changes in liver function tests.
• Low levels of albumin in the blood (hypoalbuminaemia).
• Headache.
• Nerve damage affecting movement processes (peripheral neuropathy, peripheral motor neuropathy).
• Difficulty in sleeping (insomnia).
• Mental illness (psychosis).
• Abnormal sensitivity of the skin to sunlight (photosensitivity).
• Severe itching (pruritis).
• Skin rash.
Rare (may affect up to 1 in 1,000 people):
• Depletion of white blood cells (agranulocytosis).
• Peeling of the skin over large areas of the body (exfoliative dermatitis).
Very rare (may affect up to 1 in 10,000 people):
• A type of allergic reaction to a medicine causing skin lesions (fixed drug eruption).
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 or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Dapsone after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
What Dapsone contains • The active substance is dapsone. Each tablet contains either 50mg or 100mg of dapsone.
• The other ingredients are maize starch, silica colloidal anhydrous, magnesium stearate and microcrystalline cellulose.
What Dapsone looks like and contents of the pack Dapsone Tablets come in aluminium and PVC/PVDC Unit Dose blister packs.
Dapsone 50mg Tablets are available in packs of 28, 50 and 100 tablets.
Dapsone 100mg Tablets are available in packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Tillomed Laboratories Limited
220 Butterfield
Great Marlings
Luton
LU2 8DL
United Kingdom
Manufacturer 1
MIAS Pharma Limited
Suite 2
Stafford House
Strand Road
Portmarnock
Co. Dublin
Ireland
Tillomed Laboratories Limited
220 Butterfield
Great Marlings
Luton
LU2 8DL
United Kingdom
This leaflet was last revised in 05/2023.
1 Only actual site will be listed on printed leaflet
Tillomed Laboratories Ltd
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220 Butterfield, Great Marlings, Luton, LU2 8DL, UK
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+44 (0)1480 402 400
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+44 (0)1480 402 400 [option 2]
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[email protected]
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Dapsone 50mg Tablets comes as tablet containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Dapsone 50mg Tablets is dapsone.
Medicines with the same active substance, strength and form include: Dapsone 50 mg Tablets, Dapsone 50mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Dapsone 50mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Dapsone is indicated for the treatment of the following infections (see section 5.1):
1) As part of a multidrug regimen in the treatment of all forms of leprosy.
2) Treatment of dermatitis herpetiformis and other dermatoses.
3) Prophylaxis of Pneumocystis carinii pneumonia in immunodeficient subjects, especially AIDS patients.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
Adults and children over 12 years:
Multibacillary leprosy (3-drug regimen): 100mg daily for at least two years.
Paucibacillary leprosy (2-drug regimen): 100mg daily for at least six months.
Dermatitis herpetiformis: Initially 50mg daily, gradually increased to 300mg daily if required. Once lesions have begun to subside, the dose should be reduced to a minimum as soon as possible, usually 25-50mg daily, which may be continued for a number of years. Maintenance dosage can often be reduced in patients receiving a gluten-free diet.
Pneumocystis carinii pneumonia: In combination with trimethoprim, 50-100mg daily; 100mg twice weekly or 200mg once weekly.
Paediatric population
Children 6-12 years:
Multibacillary leprosy (3-drug regimen): 50mg daily for at least two years.
Paucibacillary leprosy (2-drug regimen): 50mg daily for at least six months.
Elderly population:
Dosage should be reduced in the elderly where there is an impairment of hepatic function.
Method of administration
For oral administration.
Hypersensitivity to dapsone, sulfonamides, sulfones or any of the excipients listed in section 6.1.
Severe anaemia; porphyria; severe glucose-6-phosphate dehydrogenase deficiency.
Dapsone should be used with caution in patients with cardiac or pulmonary disease.
It is recommended that regular blood counts be performed during treatment with dapsone. Patients deficient in glucose-6-phosphate dehydrogenase, or methaemoglobin reductase, or with haemoglobin M are more susceptible to the haemolytic effects of dapsone.
Dapsone should be used with caution in anaemia. Severe anaemia should be treated before starting Dapsone.
Excretion of dapsone is reduced and plasma concentrations are increased by concurrent administration of probenecid.
Rifampicin has been reported to increase the plasma clearance of dapsone.
Increased dapsone and trimethoprim concentrations have been reported following concurrent administration in AIDS patients.
Pregnancy
It is now generally considered that the benefits of dapsone in the treatment of leprosy outweigh any potential risk to the pregnant patient. Some leprologists recommend 5mg folic acid daily for leprosy patients receiving dapsone during pregnancy.
Breast-feeding
Dapsone diffuses into breast milk and there has been a report of haemolytic anaemia in a breast fed infant. While some feel that dapsone should not be used in lactating mothers, in general treatment for leprosy is continued in such patients.
None known.
Dapsone should be discontinued or reduced in dosage if severe lepra reactions affecting the eyes or nerve trunks occur.
The frequencies of undesirable effects are reported according to the following convention:
Very Common: ≥ 1 / 10 users; Common: ≥ 1 / 100; < 1 / 10 users; Uncommon: ≥ 1 / 1,000; < 1 / 100 users; Rare: > 1 / 10,000; < 1 / 1,000 users; Very Rare: < 1 / 10,000 users; Unknown: Cannot be estimated
System Organ Class (SOC)
Frequency
Undesirable Effect
Blood disorders
Common
Uncommon
Rare
Haemolysis1
Methemoglobinaemia1
Haemolytic anaemia
Agranulocytosis*
Cardiac disorders
Uncommon
Tachycardia
Gastrointestinal disorders
Uncommon
Anorexia
Nausea
Vomiting
General disorders
Rare
Dapsone syndrome2
Hepatic disorders
Uncommon
Hepatitis
Jaundice
Changes in liver function tests
Metabolic disorders
Uncommon
Hypoalbuminaemia
Nervous system disorders
Uncommon
Headache
Peripheral Neuropathy3
Peripheral motor neuropathy3
Psychiatric disorders
Uncommon
Insomnia
Psychosis
Skin disorders
Uncommon
Rare
Very rare
Rash
Photosensitivity
Pruritis
Maculopapular rash
Exfoliative dermatitis
Toxic epidermal necrolysis
Stevens-Johnson syndrome
Fixed drug eruptions
* Although agranulocytosis has been reported rarely with dapsone when used alone, reports have been more common when dapsone has been used with other agents in the prophylaxis of malaria.
1 these are the most frequently reported adverse effects of dapsone and occur in most subjects given more than 200mg daily; doses of up to 100mg daily do not cause significant haemolysis but subjects deficient in glucose-6-phosphate dehydrogenase are affected by doses above approximately 50mg daily.
2 this may occur after 3-6 weeks therapy; symptoms include rash, which is always present, fever, and eosinophilia. If dapsone is not stopped immediately, the syndrome may progress to exfoliative dermatitis, hepatitis, albuminuria and psychosis. Deaths have been recorded. Most patients require steroid therapy for several weeks, possibly due to the prolonged elimination time of the drug.
3 Peripheral neuropathy may occur as part of leprosy reaction states and it is not an indication to discontinue dapsone.
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 at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
Symptoms are hypoxia, methaemoglobinaemia and haemolytic anaemia. In severe overdosage the stomach should be emptied by gastric lavage. Administration of activated charcoal by mouth has been shown to enhance the elimination of dapsone and its monoacetyl metabolite. Methaemoglobinaemia has been treated with slow IV injections of methylene blue 1-2mg/kg bodyweight, repeated after one hour if necessary. Methylene blue should not be administered to patients with glucose-6-phosphate dehydrogenase deficiency, since it will not be effective. Haemolysis has been treated by infusion of concentrated human red blood cells to replace the damaged cells.
Supportive therapy includes oxygen to alleviate hypoxia and administration of fluids to maintain renal flow and promote the elimination of dapsone.
Ask anything about Dapsone 50mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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