Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Dapsone 50mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Dapsone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 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 tablets may be used for:
- leprosy
- skin problems
- the prevention of malaria in combination with pyrimethamine
- prevention of pneumonia in immunodeficient patients, especially in patients with AIDS.
What you need to know before you take it
e Dapsone tablets
• •
probenecid (to treat gout) rifampicin or trimethoprim (antibiotics to treat infections)
Ask your doctor, pharmacist or nurse for advice before taking any medicines whilst being treated with Dapsone tablets. Driving and using machines Dapsone tablets has no effect on the ability to drive or operate machinery. Pregnancy, breast-feeding and fertility If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. Your doctor may prescribe you folic acid supplements. Dapsone can be present in breast milk. There have been reports of anaemia in infants being breast fed by mothers taking Dapsone tablets. If you are concerned, check with your doctor, pharmacist or nurse. Ask your doctor, pharmacist or nurse for advice before taking any medicines whilst breastfeeding.
How to take it
Dapsone tablets Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. Swallow the tablets with some water. The tablet can be divided into equal doses. The recommended doses are: Adults and children over 12 years Multibacillary leprosy: 100mg daily for at least 2 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 the usual maintenance dose of 25mg-50mg daily. Pneumocystis carinii pneumonia: In combination with trimethoprim, 50100mg daily or 100mg twice weekly or 200mg once weekly.
Do not take Dapsone tablets:
- if you are allergic (hypersensitive) to dapsone, any of the other ingredients of this medicine, or to similar medicines such as sulfonamide or sulfone (see section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
- if you suffer from severe anaemia
- if you have porphyria (a genetic or inherited disorder of the red blood pigment, haemoglobin)
- if you suffer from severe glucose6-phosphate dehydrogenase deficiency (G6PD), this can cause episodes of anaemia after eating certain foods such as fava beans (favism).
- Elderly If you have a damaged liver, your doctor may give you a lower dose.
If any of the above applies to you, talk to your doctor, pharmacist or nurse.
If you forget to take Dapsone 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.
Other medicines and Dapsone tablets Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially:
Black Version: 08 Date & Time: 28.08.2025 & 11.50 AM Submission Code: N10554_u15f
Paucibacillary leprosy: 50mg daily for at least six months If you take more Dapsone tablets 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. Signs of an overdose include slow heart rate, bluish skin, feeling tired or weak, pale skin, headache, dizziness, confusion, fever, jaundice.
If you stop taking Dapsone tablets Do not stop taking Dapsone tablets without talking to your doctor, pharmacist or nurse. 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, please contact your doctor, pharmacist or nurse.
P15xxxxx
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Dapsone tablets if you:
- suffer from other blood disorders
- suffer from heart or lung disease.
- Children 6-12 years: Multibacillary leprosy: 50mg daily for at least two years.
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, pharmacist or nurse if you notice any of the following effects or any effects not listed in this leaflet. Contact your doctor or go to the nearest hospital immediately if you notice any of the following serious side effects:
- 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 immediately. 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 in this leaflet: 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 heartbeat
- 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 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 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.
How to store it
Dapsone tablets Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton (EXP). 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 to protect the environment.
Contents of the pack and other information
What Dapsone tablet contains
- The active substance is dapsone. Each tablet contains either 50mg or 100mg of the active ingredient.
- The other ingredients are cellulose microcrystalline (Grade – 102), maize starch, silica colloidal anhydrous and magnesium stearate. What Dapsone tablets look like and contents of the pack Dapsone 50mg tablets are white to off-white, uncoated, circular, biconvex tablets debossed "50" above and "D" below the score on one side and plain on the other side. Dapsone 100mg tablets are white to off-white, uncoated, circular, biconvex tablets debossed "100" above and "D" below the score on one side and plain on the other side. Dapsone 50mg and 100mg tablets are available in white opaque PVCAluminium foil blister pack. Blister pack sizes: 28 tablets Marketing Authorisation Holder Milpharm Limited Ares Block Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom Manufacturer APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta Or Milpharm Limited Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom Or Generis Farmacêutica, S.A., Rua João de Deus, n.o 19, Venda Nova, 2700-487 Amadora, Portugal This leaflet was last revised in 08/2025.
P15xxxxx
Frequently asked questions about Dapsone 50mg Tablets
How do I take Dapsone 50mg Tablets?
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.
What is the active substance in Dapsone 50mg Tablets?
The active substance in Dapsone 50mg Tablets is dapsone.
Are there equivalent medicines to Dapsone 50mg Tablets?
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.
Where does this information come from?
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.
Can I get Dapsone 50mg Tablets without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dapsone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Dapsone Tablets are indicated for:
• As part of a multi-drug regimen in the treatment of all forms of leprosy.
• Treatment of dermatitis herpetiformis and other dermatoses.
• Prophylaxis of malaria in combination with pyrimethamine.
• Prophylaxis of Pneumocystis carinii pneumonia in immunodeficient subjects, especially AIDS patients.
4.2. Posology and method of administration
Posology
Adults and children over 12 years of age:
Multibacillary leprosy (3-drug regimen): 100mg daily for at least two years.
Paucibacillary leprosy (2-drug regimen): 100mg daily for at least six months.
Malaria prophylaxis: 100mg weekly with 12.5mg pyrimethamine.
Dermatitis herpetiformis: Initially 50mg daily, gradually increasing 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 aged 6 years to 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.
Children aged less than 6 years:
The safety and efficacy of Dapsone in children aged less than six years has not been established. No data are available.
Elderly population
Dosage should be reduced in the elderly where there is an impairment of hepatic function.
Method of Administration
For oral administration.
4.3. Contraindications
Dapsone Tablets are contraindicated in cases of:
• Hypersensitivity to dapsone, sulfonamides, sulfones, or any of the excipients listed in section 6.1.
• Severe anaemia.
• Porphyria.
• Severe glucose-6-phosphate dehydrogenase deficiency.
4.4. Special warnings and precautions for use
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 prior to initiation of dapsone therapy.
4.5. Interaction with other medicinal products and other forms of interaction
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.
4.6. Fertility, pregnancy and lactation
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 supplementation 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 therapy for leprosy is continued in such patients.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
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
Rare
≥1/10,000; <1/1,000 users
Common
≥1/100; <1/10 users
Very rare
<1/10,000 users
Uncommon
≥1/1,000; <1/100 users
not known
Cannot be estimated
System Organ Class (SOC)
Frequency
Undesirable Effect
Blood Disorders
Common
Haemolysis1
Methemoglobinaemia1
Uncommon
Haemolytic anaemia
Rare
Agranulocytosis2
Cardiac Disorders
Uncommon
Tachycardia
Gastrointestinal Disorders
Uncommon
Anorexia
Nausea
Vomiting
General Disorders
Rare
Dapsone syndrome3
Hepatic disorders
Uncommon
Hepatitis
Jaundice
Changes in liver function tests
Metabolic Disorders
Uncommon
Hypoalbuminaemia
Nervous system Disorders
Uncommon
Headache
Neuropathy Peripheral4
Peripheral motor neuropathy4
Psychiatric Disorders
Uncommon
Insomnia
Psychoses
Skin Disorders
Uncommon
Rash
Photosensitivity
Pruritis
Rare
Maculopapular rash
Exfoliative dermatitis
Toxic epidermal necrolysis
Stevens-Johnson syndrome
Very rare
Fixed drug eruptions
1 these are the most frequently reported adverse effects of dapsone and are dose related; occurring in most subjects administered 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 50mg daily.
2 this is rare when dapsone is used alone, reports are more common when dapsone has been used with other medicines for malarial prophylaxis.
3 this may occur following 3-6 weeks of therapy, symptoms include rash (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. The majority of patients require steroid therapy for several weeks, this is possibly due to the prolonged elimination time of dapsone.
4 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; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
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 should include oxygen to alleviate hypoxia, and administration of fluids to maintain renal flow and promote the elimination of dapsone.
💬 Ask about this leaflet
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.