Dusalm

Leaflet accompanying the packaging:

Information for the user

DUSALM, 100 mg, tablets

DUSALM, 50 mg, tablets

Dapson

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dusalm and what is it used for
• 2. Important information before using Dusalm
• 3. How to use 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 antibacterial agents. It works by stopping the production of folic acid by certain bacteria, thereby stopping their growth. Dusalm can be used in:

• treatment of all forms of leprosy,
• treatment of herpetic skin inflammation and other blistering dermatoses
• prevention of pneumonia caused by Pneumocystis jiroveci in patients with impaired immunity, particularly in patients with AIDS

2. Important information before using Dusalm

When not to use Dusalm

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

Warnings and precautions

Before starting treatment with Dusalm, the doctor or pharmacist should be consulted if:

• the patient has 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.
• the patient has 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, the doctor may propose treatment with half the recommended dose. During treatment:
• if a bluish discoloration (cyanosis) or difficulty breathing (due to increased production of methemoglobin) appears on the lips and nails, the doctor should be consulted immediately (see also section 4: "Special instructions").
• if skin rashes occur during dapsone therapy, the doctor should be informed immediately and the medicine should be discontinued (see also section 4: "Possible side effects").
• if treatment is required during breastfeeding, dapsone should be discontinued (see also section 2: "Pregnancy, breastfeeding, and fertility").
• if the patient is to undergo surgery, the doctor should be informed about the use of 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

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use. Some medicines may enhance the effect of Dusalm, and some may weaken its effect. The doctor will decide whether the patient should receive Dusalm while taking other medicines and how they 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

Cautious use is advised if:

• the patient is taking zidovudine - a medicine used in patients with AIDS,
• the patient is taking pyrimethamine - an antimalarial medicine.

Before using any medicines, the doctor or pharmacist should be consulted. 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before using this medicine. Pregnancy: There are no data or very 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. The effect on breastfed newborns/infants cannot be excluded. Therefore, the doctor should decide whether to discontinue breastfeeding or discontinue dapsone treatment. This decision should take into account both 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 the ability to react while driving or operating machines. The patient should not drive or operate machines if they 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 the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Dusalm contains sodium

Dusalm contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Dusalm

This medicine should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. If the doctor does not recommend otherwise, the recommended doses are: The average dose is 50-100 mg of dapsone per day. The 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, 50-100 mg of dapsone is usually given per day. 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 medicines effective against leprosy. Depending on the severity of the case and the bacteriologically determined success of the therapy, the use of dapsone can be discontinued after 6-12 months in most cases. Herpetic skin inflammation and other blistering dermatoses: Initially, 100 mg per day for the first week, then the doctor may gradually increase the dose to 200 mg per day until improvement is achieved, and then reduce it to the lowest possible maintenance dose. In extreme cases, it may be necessary to use 300 mg of dapsone per day for a short period. In the case of herpetic skin inflammation 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 the therapy and allow the dose to be reduced. If the patient believes that the effect of dapsone is too strong or too weak, they should consult their doctor or pharmacist. Method of administration: Oral. Tablets should be swallowed with a sufficient amount of water, preferably after a meal. Tablets can be divided into equal doses.

Using a higher dose of Dusalm than recommended

If the patient has taken a higher dose of this medicine than recommended, they should immediately inform their doctor. The packaging of the medicine should be taken along, even if it is empty.

Missing a dose of Dusalm

In case of a missed dose, it should be taken as soon as possible, and the next dose should be taken at the right time. A double dose should not be used to make up for a missed dose.

Stopping the use of Dusalm

Dusalm should be continued for as long as the doctor recommends. Stopping the use of Dusalm without the doctor's recommendation may be dangerous. In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

The doctor or the emergency department of the nearest hospital should be contacted immediately if the patient experiences 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. The doctor should be consulted immediately, as severe skin reactions, liver inflammation, kidney damage, and mental illness may occur if treatment is not discontinued or reduced. Several deaths have been reported.
• Shortness of breath, feeling of fatigue, bluish discoloration of the skin (methemoglobinemia).

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

• Reactions to dapsone may also occur in the form of severe skin rashes (erythema multiforme or exfoliative dermatitis). If skin rashes occur during dapsone therapy, the doctor should be informed immediately and the medicine should be discontinued.

The doctor should be informed immediately if any of the following side effects or any other unlisted symptoms are noticed:

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):

• Lack of iron in the blood (hemolytic anemia), caused by red blood cell breakdown, which may cause fatigue.
• Rapid heartbeat.
• Sleep disorders.
• 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) - the 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 sores, mouth ulcers, gum bleeding (agranulocytosis).

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

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

Special instructions If the hemoglobin content (blood pigment) drops below 10 g/dl, the doctor will order frequent (if necessary, daily) checks. If the hemoglobin level is below 9 g/dl, the doctor may consider discontinuing dapsone. 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 manifested by cyanosis. A methemoglobin level of 30% or more causes shortness of breath when acute methemoglobinemia develops. Lethal concentrations in the blood are 75% of total blood pigment. In case of severe and persistent production of methemoglobin, it may be necessary to discontinue therapy. In 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, early detection is possible. Grayish discoloration of the lips and nails should be reported to the doctor immediately. Side effects affecting the number of red blood cells are often more pronounced in children and elderly patients.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +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, more information can be collected on the safety of the medicine.

5. How to store Dusalm

The medicine should be stored in a place invisible and inaccessible to children. This medicine should not be used 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 precautions for storage temperature. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. 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 box 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 tel. 22 732 77 00

Manufacturer

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

Date of last revision of the leaflet: