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 100 mg 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 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.
What you need to know before you take it
e 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 ancesiry are especially at risk of this. 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. 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. You should ask your doctor or pharmacist for advice before taking any other medicines. 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.
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.
How to take it
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 carinir. 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.
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. 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. 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 stop taking Dapsone You should continue to take Dapsone for as long as your doctor tells you to do so. It may be dangerous to stop taking Dapsone without your doctor telling you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Version: V002/29/08/19/PL20117/0260-261 Supersedes: V001/11/04/17/PL20117/0260-261
4. Possible side effects
Possible 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.
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.
How to store it
Dapsone
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.
Keep this medicine out of the sight and reach of children.
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
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 Morningside Healthcare Ltd. Unit C, Harcourt Way, Leicester LE19 1WP, UK Manufacturer
Morningside Pharmaceuticals Ltd. 5 Pavilion Way, Loughborough, LE11 5GW, UK This leaflet was last revised in August 2018.
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). ¢ Aserious 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.
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Frequently asked questions about Dapsone 100 mg Tablets
How do I take Dapsone 100 mg Tablets?
Dapsone 100 mg Tablets comes as tablet containing 100mg. 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 100 mg Tablets?
The active substance in Dapsone 100 mg Tablets is dapsone.
Are there equivalent medicines to Dapsone 100 mg Tablets?
Medicines with the same active substance, strength and form include: Dapsone 100mg Tablets, Dapsone 100mg 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 100 mg 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 100 mg 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): 100 mg daily for at least two years.
Paucibacillary leprosy (2 drug regimen): 100 mg daily for at least 6 months.
Malaria prophylaxis: 100 mg weekly with 12.5 mg pyrimethamine.
Dermatitis herpetiformis: initially 50 mg daily, gradually increasing to 300 mg daily if required. Once lesions have begun to subside, the dose should be reduced to a minimum as soon as possible, usually 25 mg – 50 mg 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 mg – 100 mg daily; 100 mg twice weekly, or 200 mg once weekly.
Paediatric population
Children aged 6 years to 12 years:
Multibacillary leprosy (3 drug regimen): 50 mg daily for at least two years.
Paucibacillary leprosy (2 drug regimen): 50 mg daily for at least 6 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. Tablets should be swallowed whole with a glass of water.
4.3. Contraindications
Dapsone Tablets are contraindicated in cases of:
• Hypersensitivity to the dapsone, sulfonamides, sulfones, or to 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.
Performance of regular blood counts during dapsone therapy is recommended. 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
Oral typhoid vaccine: should not be taken until at least three days after finishing a course of dapsone, because the dapsone could make this vaccine less effective.
Probenecid: concurrent administration results in a reduction of dapsone excretion, and increase in dapsone plasma concentrations.
Rifampicin / Rifabutin: has been reported to increase the plasma clearance of dapsone.
Saquinavir: should not be used in combination, as this could increase the risk of irregular heartbeat.
Trimethoprim: increased dapsone and trimethoprim concentrations have been reported following concurrent administration in AIDS patients.
4.6. Fertility, pregnancy and lactation
Pregnancy:
It is generally considered that the benefits of dapsone in the treatment of leprosy outweigh any potential risk to the pregnant patient. Some leprologists recommend 5 mg folic acid supplementation daily for leprosy patients receiving dapsone during pregnancy.
Breast-feeding:
Dapsone is excreted into breast milk, and there has been a report of haemolytic anaemia in a breast-fed infant. While there is an opinion that dapsone should not be used in lactating mothers, in general therapy for leprosy is continued in such patients.
Fertility:
There is limited information available on the effect of dapsone on fertility; it may reduce the numbers and / or motility of sperm, thereby rendering impregnation less likely.
4.7. Effects on ability to drive and use machines
Dapsone has no or negligible influence on the ability to drive and use machines.
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
Unknown:
Cannot be estimated
System Organ Class (SOC)
Frequency
Undesirable Effect
Blood Disorders:
Common
Uncommon
Rare
Haemolysis1)
Methaemoglobinaemia1)
Haemolytic anaemia
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
Rare
Very rare
Photosensitivity
Pruritis
Rash
Exfoliative dermatitis
Maculopapular rash
Toxic epidermal necrolysis
Stevens – Johnson syndrome
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 200 mg daily; doses of up to 100 mg daily do not cause significant haemolysis, but subjects deficient in glucose-6-phosphate dehydrogenase are affected by doses above about 50 mg 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. Id 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 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms:
The typical symptoms of overdose are hypoxia, methaemoglobinaemia, and haemolytic anaemia.
Treatment:
In instances of severe overdosage, gastric lavage should be used to empty the stomach. Administration of oral activated charcoal has been shown to enhance elimination of both dapsone and the monoacetyl metabolite. Methaemoglobinaemia may be treated with slow intravenous injections of methylene blue, 1 mg-2 mg/Kg body weight, which may be repeated after 1 hour if required. In patienst with glucose-6-phosphate dehydrogenase deficiency methylene blue should not be administered since it will be ineffective. Haemolysis may be 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 100 mg 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.