Dusalm

Package Leaflet:

Information for the User

DUSALM, 100 mg, tablets

DUSALM, 50 mg, tablets

Dapson

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

• 1. What is Dusalm and what is it used for
• 2. Important information before taking Dusalm
• 3. How to take Dusalm
• 4. Possible side effects
• 5. How to store Dusalm
• 6. Contents of the pack and other information

1. What is Dusalm and what is it used for

Dusalm belongs to a group of medicines called antibacterials. It works by stopping the production of folic acid in certain bacteria, thereby stopping their growth. Dusalm can be used for:

• treatment of all forms of leprosy,
• treatment of herpetiform dermatitis and other blistering skin diseases
• prevention of pneumonia caused by Pneumocystis jiroveci in patients with impaired immune systems, particularly in patients with AIDS

2. Important information before taking Dusalm

When not to take Dusalm

• if you are allergic to dapsone or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides, as patients allergic to sulfonamides are usually also allergic to sulphones, and therefore to dapsone.
• if you have severe liver disease.

Warnings and precautions

Before starting treatment with Dusalm, discuss with your doctor or pharmacist if:

• you have any other blood disorder. In the case of anemia, when the hemoglobin level in the blood is below 10 g/dl, dapsone should not be used.
• you have a deficiency of glucose-6-phosphate dehydrogenase, dapsone may cause more red blood cell breakdown. In such cases, dapsone should be avoided. However, if dapsone treatment is necessary, your doctor may propose treatment with half the recommended dose. During treatment:
• if a bluish discoloration (cyanosis) or breathing difficulties (due to increased production of methemoglobin) appear on the lips and nails, you should consult your doctor immediately (see also section 4: "Special instructions").
• if skin rashes occur during dapsone therapy, you should immediately inform your doctor and stop taking the medicine (see also section 4: "Possible side effects").
• if treatment is required during breastfeeding, you should stop taking dapsone (see also section 2: "Pregnancy, breastfeeding, and fertility").
• if you are going to have surgery, you should inform your doctor that you are taking Dusalm.

Laboratory test results
In diabetic patients, taking dapsone may lead to falsely low HbA1c values (blood glucose levels over a longer period) in laboratory tests, and thus simulate good control of diabetes (see also section 4: "Possible side effects").

Dusalm and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Some medicines may enhance the effect of Dusalm, and some may weaken its effect. Your doctor will decide whether you should receive Dusalm while taking other medicines and how you should be monitored.
The following medicines may enhance the effect of Dusalm and increase the risk of side effects:

• omeprazole - a medicine used to treat stomach ulcers
• probenecid - a medicine used to treat gout
• fluconazole or trimethoprim - antibiotics against bacterial infections

The following medicines may reduce the effect of Dusalm:

• rifabutin - a medicine used to treat tuberculosis
• rifampicin - used to treat infections
• ursodeoxycholic acid - used to dissolve gallstones

Medicines that increase the production of methemoglobin - an abnormal form of hemoglobin that does not carry oxygen, and its excess causes hypoxia:

• nitrates, nitrites, sulfonamides, nitroglycerin, sodium nitroprusside, nitric oxide, and local anesthetics such as prilocaine

Caution is advised if:

• you are taking zidovudine - a medicine used in patients with AIDS,
• you are taking pyrimethamine - an antimalarial medicine.

Before taking any medicines, consult your doctor or pharmacist.
Dusalm with food and drink
Dusalm can be taken before, during, or after meals. However, it is recommended to take the medicine after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Pregnancy
There are no data or limited data on the use of dapsone in pregnant women.
The use of dapsone is not recommended during pregnancy and in women of childbearing age not using contraception.
Breastfeeding
Dapsone is excreted into human milk. It cannot be excluded that it may have an effect on breastfed newborns/infants. Your doctor will decide whether you should stop breastfeeding or stop dapsone treatment. This decision will take into account the benefits of breastfeeding for the child and the benefits of therapy for the woman.
Fertility
There are no data on the effect of dapsone on fertility in humans.

Driving and using machines

Dusalm may affect your ability to react while driving or using machines. You should not drive or use machines if you do not feel well.

Dusalm contains lactose monohydrate

One 50 mg tablet contains 9.31 mg of lactose (in the form of lactose monohydrate).
One 100 mg tablet contains 18.62 mg of lactose (in the form of lactose monohydrate).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Dusalm contains sodium

Dusalm contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially 'sodium-free'.

3. How to take Dusalm

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
If your doctor has not prescribed otherwise, the recommended doses are:
The average dose is 50 - 100 mg of dapsone per day. Your doctor will adjust the dosage and treatment time to the individual case and the patient's disease as follows:
Leprosy
In the treatment of leprosy, usually 50 - 100 mg of dapsone per day is given.
Adults and adolescents over 15 years of age are given 100 mg of dapsone per day.
Children and adolescents between 10 and 14 years of age are given 50 mg of dapsone per day.
In children under 10 years of age, the dose of dapsone must be adjusted according to body weight.
Treatment of leprosy with dapsone alone may last for years or even a lifetime. The treatment time can be significantly shortened by combining dapsone with other leprosy-effective medicines. Depending on the severity of the case and the bacteriologically established success of therapy, the use of dapsone can be stopped after 6-12 months in most cases.
Herpetiform dermatitis and other blistering skin diseases:
Initially 100 mg per day for the first week, then your doctor may gradually increase the dose to 200 mg per day until improvement is achieved, and then reduce to the lowest possible maintenance dose.
In severe cases, it may be necessary to use 300 mg of dapsone per day for a short period of time.
In the case of herpetiform dermatitis and other skin diseases, long-term treatment lasting many years is usually required.
If the clinical picture is accompanied by gastrointestinal symptoms, a gluten-free diet may contribute to the success of therapy and allow the dose to be reduced.
If you think that the effect of dapsone is too strong or too weak, consult your doctor or pharmacist.
Method of administration:
Oral administration. Swallow the tablets with a sufficient amount of water, preferably after a meal.
The tablets can be divided into equal doses.

Overdose of Dusalm

If you have taken more than the prescribed dose of this medicine, contact your doctor immediately. Take the medicine package with you, even if it is empty.

Missed dose of Dusalm

If you miss a dose, take it as soon as possible, and take the next dose at the right time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Dusalm

Continue taking Dusalm for as long as your doctor recommends. Stopping treatment with Dusalm without your doctor's advice may be dangerous.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dusalm can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience any of the following symptoms:

Rare (may affect up to 1 in 1000 people):

• Dapsone hypersensitivity syndrome: a condition called "dapsone hypersensitivity syndrome" may occur after 3-6 weeks of treatment. Symptoms always include rash, high fever, and changes in blood cells. You should immediately consult your doctor, as severe skin reactions, liver inflammation, kidney damage, and mental illness may occur if treatment is not stopped or reduced. Several deaths have been reported.
• Shortness of breath, feeling tired, bluish discoloration of the skin (methemoglobinemia).

Frequency not known (frequency cannot be estimated from the available data)

• Dapsone hypersensitivity reactions may also occur in the form of severe skin rashes (erythema multiforme or exfoliative dermatitis). If skin rashes occur during dapsone therapy, you should immediately inform your doctor and stop taking the medicine.

Inform your doctor if you experience any of the following side effects or any other symptoms not listed in this leaflet:

Common (may affect up to 1 in 10 people):

• Hemolysis (red blood cell breakdown), which may cause fatigue.
• Headache.
• Nausea.
• Upset stomach

Uncommon (may affect up to 1 in 100 people):

• Iron deficiency in the blood (hemolytic anemia), caused by red blood cell breakdown, which may cause fatigue.
• Rapid heartbeat.
• Sleep problems.
• Hallucinations, delusions, excessive movements, loss of contact with reality (psychosis).
• Lack of appetite (anorexia).
• Vomiting.

Rare (may affect up to 1 in 1000 people):

• Low albumin level in the blood (hypoalbuminemia) - your doctor will monitor this.
• Nerve damage, which may cause tingling in the hands or feet and some weakness (peripheral neuropathy, peripheral motor neuropathy).

Very rare (may affect up to 1 in 10,000 people):

• Sudden fever, chills, sore throat, mouth and gum ulcers, bleeding gums (agranulocytosis).

Frequency not known (frequency cannot be estimated from the available data)
Reports of

• dapsone-induced thrombocytosis (increase in the number of blood cells that cause blood clotting),
• eosinophilic pneumonia (inflammatory reaction of lung tissue to chemical stimuli),
• acute pancreatitis,
• increased liver enzyme activity,
• photosensitivity (increased skin sensitivity to light),
• falsely low hemoglobin A1c values in blood tests.

Special instructions
If the hemoglobin content (blood pigment) drops below 10 g/dl, your doctor will order frequent (if necessary, daily) checks. If the hemoglobin level is below 9 g/dl, your doctor may consider stopping dapsone treatment.
Blood usually contains a small amount of methemoglobin (1% of total blood pigment or 0.15 g/dl). Methemoglobin levels in the blood of 10% or more are indicated by cyanosis. A methemoglobin level of 30% or more causes shortness of breath when acute methemoglobinemia develops. Lethal levels in the blood are 75% of total blood pigment.
In the case of severe and persistent production of methemoglobin, it may be necessary to stop therapy. In the case of long-term treatment with dapsone, it may be necessary to accept moderately elevated methemoglobin levels in the blood.
Since cyanosis appears in the safe range of 10% methemoglobin, it is possible to detect it early.
Gray discoloration of the lips and nails should be reported to your doctor immediately.
Side effects affecting the number of red blood cells are often more pronounced in children and elderly patients.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dusalm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the month.
There are no special storage precautions.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dusalm contains

• The active substance is dapsone. One tablet contains 100 mg or 50 mg of dapsone.
• The other ingredients are: lactose monohydrate, maize starch, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate.

What Dusalm looks like and contents of the pack

Dusalm, 100 mg, tablets are white or almost white, round, flat tablets with a diameter of 8.00 mm, with a dividing line on one side.
Dusalm, 50 mg, tablets are white or almost white, oval, biconvex tablets with a length of 6.50 mm, with a dividing line on one side.
The tablet can be divided into equal doses.
The tablets are available in PCV/Aluminum blisters in a carton containing 30, 60, 90, 120, 180 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
phone: 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: