DAPSONE 100 MG TABLETS - patient leaflet, side effects, dosage

Dapsone

50mg and 100mg Tablets

Dapsone

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. See section 4.
• The name of your medicine is either Dapsone 50mg Tablets or Dapsone 100mg Tablets. For easy reference both will be called Dapsone in this leaflet.

What is in this leaflet

• 1. What Dapsone is and what it is used for

• 2. What you need to know before you take Dapsone

• 3. How to take Dapsone

• 4. Possible side effects

• 5. How to store Dapsone

• 6. Contents of the pack and other information

1. what dapsone is and what it is used 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.

2. what you need to know before you take 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 ancestry 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.

MORNINGSIDE

HEALTHCARE

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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

3. how to take 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 carinii : 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 you 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.

4. possible side effects

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.

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 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.

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:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store dapsone

Keep this medicine out of the sight and reach of children.

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.

6. 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 PVC-aluminium 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 and Manufacturer

Marketing Authorisation Holder

Morningside Healthcare Ltd 115, Narborough Road, Leicester, LE3 0PA, UK

Manufacturer

Morningside Pharmaceuticals Ltd

• 5, Pavilion Way, Loughborough, LE11 5GW, UK