Dusalm

Package leaflet:

Information for the user
DUSALM, 100 mg, tablets
DUSALM, 50 mg, tablets
Dapsone
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Dusalm is and what it is 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 Dusalm is and what it is used for

Dusalm belongs to a group of medicines called antibacterial agents. It works by inhibiting the production of folic acid in certain bacteria, thereby stopping their growth.
Dusalm may be used in:

• combination treatment of all forms of acne,
• treatment of dermatitis herpetiformis and other blistering dermatoses,
• prevention of Pneumocystis jiroveci pneumonia in immunocompromised patients, particularly those 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 sulfones, and therefore also to dapsone.
• if the patient suffers from severe liver disease.

Warnings and precautions
Before starting treatment with Dusalm, consult a doctor or pharmacist if:

• the patient has any other blood disorders. Dapsone should not be used in cases of anaemia when haemoglobin levels are below 10 g/dl.
• the patient has glucose-6-phosphate dehydrogenase deficiency, as dapsone may cause a greater degree of red blood cell breakdown. In such cases, dapsone should be avoided. However, if treatment with dapsone is necessary, the doctor may consider treatment with half the recommended dose. During treatment:
• if a bluish discolouration (cyanosis) appears on the lips or nails, or if breathing difficulties occur (due to increased methemoglobin production), the patient should consult a doctor immediately (see also section 4: "Special instructions").
• if skin rashes occur during dapsone therapy, the patient should immediately inform the doctor and discontinue use of the medicine (see also section 4: "Possible side effects").
• if treatment is required during breastfeeding, the use of dapsone should be discontinued (see also section 2: "Pregnancy, breastfeeding and effects on fertility").
• if the patient is due to undergo a surgical procedure, they should inform the doctor about taking Dusalm.

Laboratory test results
In diabetic patients, taking dapsone may lead to falsely low HbA1c values
(indicating long-term blood glucose levels) in laboratory tests, thereby
mimicking good metabolic control of diabetes (see also section 4: "Possible
side effects").

Dusalm and other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may enhance the effect of Dusalm, while others may reduce its effectiveness. The doctor will decide whether the patient should receive Dusalm while taking other medicines and how monitoring should be performed.
The following medicines may enhance the effect of Dusalm and increase the risk of adverse effects:

• omeprazole – a medicine used to treat stomach ulcers
• probenecid – a medicine used for gout
• fluconazole or trimethoprim – antibiotics used to treat 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 methemoglobin formation – an abnormal form of hemoglobin that does not carry oxygen, and whose excess causes hypoxia:

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

Caution is advised if:

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

Consult a doctor or pharmacist before taking any medicines.

Dusalm with food and drink
Dusalm may be taken before, during, or after meals. However, it is recommended to take the medicine after a meal.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 potential who are not using contraception.

Breastfeeding
Dapsone is excreted in human milk. An effect on breastfed newborns/infants cannot be excluded. Therefore, the doctor should decide whether breastfeeding should be discontinued or whether dapsone treatment should be stopped. This decision should take into account both the benefits of breastfeeding for the child and the benefits of therapy for the mother.

Fertility
There are no data on the effect of dapsone on fertility in humans.

Driving and operating machinery
Dusalm may affect the ability to react while driving or operating machinery. Patients should not drive or operate machinery if they do not feel well.

Dusalm contains lactose monohydrate
One 50 mg tablet contains 9.31 mg of lactose (as lactose monohydrate).
One 100 mg tablet contains 18.62 mg of lactose (as lactose monohydrate).
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

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

3. How to use Dusalm

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Unless otherwise prescribed by the doctor, the recommended doses are:
The usual dose is 50–100 mg of dapsone per day. The doctor will adjust the dosage and duration of treatment
according to the individual patient and the disease as follows:

Leprosy
For the treatment of leprosy, the usual dose is 50–100 mg of dapsone per day.
Adults and adolescents aged 15 years and older are given 100 mg of dapsone per day.
Children and adolescents aged 10 to 14 years are given 50 mg of dapsone per day.
For children under 10 years of age, the dapsone dose must be adjusted according to body weight.
Treatment of leprosy with dapsone alone may last for years or even for life. The duration of treatment can be
significantly shortened by combining dapsone with other drugs effective against leprosy. Depending on
the severity of the case and bacteriological response to therapy, dapsone treatment may be discontinued after
6–12 months in most cases.

Dermatitis herpetiformis and other blistering dermatoses:
Initially, 100 mg per day for the first week; thereafter, the doctor may gradually increase the
dose up to 200 mg per day until improvement is achieved, then reduce it to the lowest possible
maintenance dose.
In severe cases, short-term use of 300 mg of dapsone per day may be necessary.
For dermatitis herpetiformis and other skin diseases, long-term treatment lasting many years is
usually required in most cases.
If gastrointestinal symptoms accompany the clinical picture, a gluten-free diet may contribute to
therapeutic success and allow for dose reduction.

If the patient feels that the effect of dapsone is too strong or too weak, medical advice should be
sought from the doctor or pharmacist.

Method of administration:
Oral use. Swallow the tablets with sufficient liquid, preferably after a meal.
The tablets may be divided into equal doses.

Use of a higher than recommended dose of Dusalm
If the patient has taken more than the recommended dose of this medicine, the doctor must be informed immediately.
Bring the medicine packaging with you, even if it is empty.

Missed dose of Dusalm
If a dose is missed, it should be taken as soon as possible, and the next dose should be taken at the
correct time. Do not take a double dose to make up for a missed dose.

Stopping the use of Dusalm
Dusalm should be continued for as long as directed by the physician. Stopping treatment with Dusalm
without medical advice may be dangerous.

If there are any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Patients must immediately contact a doctor or go to the nearest hospital emergency department
if any of the following symptoms occur:
Rare (may affect up to 1 in 1,000 people):

• Dapsone hypersensitivity syndrome: a condition known as "dapsone hypersensitivity syndrome" may occur 3-6 weeks after starting treatment. Symptoms always include rash, high fever, and blood cell changes. Immediate medical advice must be sought, as severe skin reactions, hepatitis, kidney damage, and psychiatric illness may occur if treatment is not discontinued or reduced. Several fatalities have been reported.
• Shortness of breath, feeling of fatigue, bluish discoloration of the skin (methemoglobinemia).

Frequency unknown (frequency cannot be estimated from available data):

• Hypersensitivity 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, they must be immediately reported to a doctor and the drug should be discontinued.

Immediately inform your doctor if you notice any of the following adverse reactions
or any other symptoms not listed below:
Common (may affect up to 1 in 10 people):

• Hemolysis (breakdown of red blood cells), which may cause a feeling of fatigue.
• Headache.
• Nausea.
• Stomach upset.

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

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

Rare (may affect up to 1 in 1,000 people):

• Low albumin levels 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 pain, mouth ulcers, bleeding gums (agranulocytosis).

Frequency unknown (frequency cannot be estimated from available data):
Cases have been reported of:

• Dapsone-induced thrombocytosis (increase in blood cells responsible for 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 values of glycated hemoglobin (HbA1c) in blood tests.

Special instructions
If hemoglobin (blood pigment) levels fall below 10 g/dL, your doctor will recommend frequent monitoring (if necessary, daily). If hemoglobin levels fall below 9 g/dL, your doctor may consider discontinuing dapsone treatment.
Blood normally contains a small fraction of methemoglobin (1% of total blood pigment or 0.15 g/dL). Methemoglobin blood concentrations of 10% or more cause cyanosis. Methemoglobin concentrations of 30% or more cause shortness of breath when acute methemoglobinemia develops. Lethal blood concentrations are 75% of total blood pigment.
In cases of severe and persistent methemoglobin production, discontinuation of therapy may be necessary. In long-term dapsone treatment, it may be necessary to accept a moderately elevated level of methemoglobin in the blood.
Since cyanosis appears within the safe range of 10% methemoglobin, early detection is possible.
Greyish discoloration of lips and nails must be immediately reported to a doctor.
Adverse effects affecting red blood cell count are often more pronounced in children and elderly patients.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further information on the safety of the 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 cardboard packaging following EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements. Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, pregelatinized corn 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 score line on one side.
Dusalm 50 mg tablets are white or almost white, oblong, biconvex tablets with a length of 6.50 mm,
with a score line on one side.
The tablet can be divided into equal doses.
The tablets are available in PVC/Aluminium blisters, packed in a cardboard box containing 30, 60, 90,
120, or 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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