Dursea

Leaflet attached to the packaging: information for the user

Dursea, 60 micrograms, sublingual tablet

Dursea, 120 micrograms, sublingual tablet

Dursea, 240 micrograms, sublingual tablet

Desmopressin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Dursea and what is it used for
• 2. Important information before taking Dursea
• 3. How to take Dursea
• 4. Possible side effects
• 5. How to store Dursea
• 6. Package contents and other information

1. What is Dursea and what is it used for

Desmopressin, the active substance in Dursea, works similarly to the natural hormone vasopressin and regulates the kidneys' ability to concentrate urine. Dursea is used to treat:

• central diabetes insipidus (a pituitary disorder leading to strong thirst and excessive urination, usually clear and watery).
• nocturnal enuresis in children over 5 years old with normal urine concentration ability (involuntary urination during sleep).
• nocturia in adults under 65 years old (a condition where a person wakes up frequently at night to urinate).

2. Important information before taking Dursea

When not to take Dursea

• if the patient is allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6)
• if the patient has polydipsia (excessive fluid intake), heart failure, and other conditions requiring treatment with diuretics
• if the patient has moderate or severely impaired renal function
• if the patient has low sodium levels in the blood
• if the patient is unable to follow fluid intake restrictions
• if the patient has been diagnosed with the syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• if the patient is over 65 years old and has nocturia (see section 1)
• if the child is under 5 years old and has nocturnal enuresis (see section 1)

Warnings and precautions

Treatment of nocturnal enuresis (involuntary urination at night) in children begins with lifestyle changes and the use of a bedwetting alarm (a device that makes a sound or vibrates when the child urinates). If these measures fail or pharmacological therapy is necessary, desmopressin treatment can be started. Before starting Dursea, the patient should discuss the following with their doctor:

• if the patient has coronary artery disease (blood vessels supplying the heart) or high blood pressure
• if the patient has thyroid or adrenal gland disease.
• if the patient develops a disease that causes fever, vomiting, or diarrhea during treatment.
• if the patient experiences headaches, loss of appetite, nausea, vomiting, weight gain, disorientation (difficulty understanding words, difficulty concentrating), or seizures (sudden and involuntary muscle contractions); these symptoms may be signs of a dangerous condition called hyponatremia (low sodium levels in the blood).
• in the treatment of central diabetes insipidus: fluid intake should be limited and the doctor consulted immediately. The doctor will reduce the dose or interrupt treatment for a few hours.
• in the treatment of nocturnal enuresis or nocturia: treatment should be discontinued, fluid intake limited, and the doctor consulted immediately.
• if there is a risk of increased intracranial pressure.

During treatment for nocturnal enuresis and nocturnal urination, fluid intake should be limited to the necessary minimum to control thirst from 1 hour before taking the medicine to 8 hours after taking it. Dursea should be used with caution in patients with impaired fluid balance. The doctor should be contacted if there is impaired fluid and/or electrolyte balance due to acute illness. Childrenshould only take this medicine under adult supervision. The medicine should not be given to children under 5 years old unless the potential benefits outweigh the risks.

Dursea and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. The effect of Dursea may be enhanced, with a greater risk of excessive fluid retention in the body, if it is taken with certain medicines used to treat:

• depression (e.g., tricyclic antidepressants, selective serotonin reuptake inhibitors)
• psychosis (e.g., chlorpromazine)
• epilepsy (e.g., carbamazepine)
• diabetes (e.g., sulfonylurea derivatives, e.g., chlorpropamide)
• diarrhea (e.g., loperamide)
• pain and inflammation (e.g., non-steroidal anti-inflammatory drugs, NSAIDs)

The effect of Dursea may be reduced if it is taken with certain medicines used to treat:

• gases in the abdominal cavity (such as dimethicone)

Dursea and drinking

During treatment for primary isolated nocturnal enuresis and nocturia, fluid intake should be limited from 1 hour before taking the medicine to 8 hours after taking it.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Experience with desmopressin during pregnancy is limited. Dursea passes into breast milk, but it is unlikely to affect breastfed infants.

Driving and using machines

Dursea has no influence or negligible influence on the ability to drive and use machines. Dursea contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. Dursea contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per sublingual tablet, which means it is considered "sodium-free".

3. How to take Dursea

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The dose is determined by the doctor, who will adjust it individually for the patient. Dursea should always be taken at the same time. The sublingual tablet should be placed under the tongue, where the medicine dissolves without the need for water. Central diabetes insipidusThe usual dose for adults and children is 1-2 sublingual tablets (60 micrograms per tablet) 3 times a day. Nocturnal enuresisThe usual dose is 1-2 tablets (120 micrograms per tablet) sublingually at night. The medicine should be taken before bedtime. Fluid intake should be limited. Every 3 months, the doctor will check if treatment should be continued. The doctor may recommend at least a one-week break in treatment. Nocturia in adultsThe usual dose is 1 tablet (60 micrograms per tablet) sublingually before bedtime. Fluid intake should be limited.

Use in children

This medicine is used to treat central diabetes insipidus and nocturnal enuresis (see dosing for different treatment conditions above). The dosing is the same for children and adults only in the case of central diabetes insipidus.

Taking a higher dose of Dursea than recommended

In case of taking a higher dose of the medicine than recommended or accidental ingestion by a child, the patient should immediately contact their doctor, hospital, or pharmacist to assess the risk and obtain advice. Taking a higher dose of Dursea than recommended may prolong the duration of action and increase the risk of excessive fluid retention in the body and decrease sodium levels in the blood. Symptoms of severe fluid retention include seizures and loss of consciousness.

Missing a dose of Dursea

The patient should not take a double dose to make up for a missed dose. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

Stopping Dursea treatment

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dursea can cause side effects, although not everybody gets them. If fluid intake is not limited as instructed, excessive amounts of fluid may accumulate in the body, leading to headaches, abdominal pain, nausea, and/or vomiting, weight gain, dizziness, disorientation, malaise, dizziness, and in severe cases, seizures and coma. These symptoms may reflect more or less severe water retention. They usually occur at high doses of Dursea and disappear after dose reduction. AdultsVery common(may affect more than 1 in 10 people):

• headache.

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

• low sodium levels in the blood
• dizziness
• high blood pressure
• abdominal pain
• nausea
• diarrhea
• constipation
• vomiting
• symptoms related to the bladder and urethra
• swelling of the hands, arms, feet, or legs
• fatigue.

Uncommon(may affect up to 1 in 100 people)

• sleep disorders
• drowsiness
• tingling
• visual disturbances
• general dizziness
• palpitations
• decreased blood pressure when changing position from lying to standing
• shortness of breath
• indigestion
• gas
• bloating
• sweating
• itching
• rash
• hives
• muscle cramps
• muscle pain
• chest pain
• flu-like symptoms
• weight gain
• increased liver enzyme levels
• low potassium levels in the blood.

Rare(may affect up to 1 in 1000 people)

• disorientation
• allergic skin rash.

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

• anaphylactic reactions (severe allergic reaction)
• dehydration
• high sodium levels in the blood
• seizures
• weakness
• coma.

ChildrenCommon(may affect up to 1 in 10 people)

• headache.

Uncommon(may affect up to 1 in 100 people)

• emotional instability
• aggression
• nausea
• abdominal pain
• vomiting
• diarrhea
• discomfort related to the bladder and urethra
• swelling of the hands and feet
• fatigue.

Rare(may affect up to 1 in 1000 people)

• restlessness
• nightmares
• mood swings
• drowsiness
• high blood pressure
• irritability.

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

• anaphylactic reactions (severe allergic reaction)
• low sodium levels in the blood
• abnormal behavior
• emotional disorders
• depression
• hallucinations
• sleep disorders
• decreased attention
• increased muscle movements
• muscle spasms
• nosebleeds
• rash
• allergic skin rash
• sweating
• hives.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Aleje 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 gathered on the safety of the medicine.

5. How to store Dursea

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after the words "EXP". The expiry date refers to the last day of the month. BlistersStore in the original blister to protect from moisture. There are no special precautions for storage temperature. HDPE containerStore in the original packaging. Store the container tightly closed to protect from moisture. Store at a temperature below 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Dursea contains

• The active substance is desmopressin Dursea, 60 micrograms, sublingual tabletsEach tablet contains 60 micrograms of desmopressin (as desmopressin acetate).

Dursea, 120 micrograms, sublingual tabletsEach tablet contains 120 micrograms of desmopressin (as desmopressin acetate). Dursea, 240 micrograms, sublingual tabletsEach tablet contains 240 micrograms of desmopressin (as desmopressin acetate).

• Other ingredients are: lactose monohydrate, cornstarch, citric acid (E 330), croscarmellose sodium (E 468), magnesium stearate (E 470b)

What Dursea looks like and contents of the pack

Dursea, 60 micrograms, sublingual tablet: white or almost white, round, biconvex tablet with a diameter of 6.5 mm and a thickness of 2 mm with the inscription "I" on one side and smooth on the other. Dursea, 120 micrograms, sublingual tablet: white or almost white, round, biconvex tablet with a diameter of 6.5 mm and a thickness of 2 mm with the inscription "II" on one side and smooth on the other. Dursea, 240 micrograms, sublingual tablet: white or almost white, round, biconvex tablet with a diameter of 6 mm and a thickness of 2 mm with the inscription "III" on one side and smooth on the other. Dursea is packaged in a cardboard box containing blisters OPA/Al/PVC/PE-Al with an integrated moisture-absorbing layer in packs of 10, 20, 30, 50, 60, 90, and 100 sublingual tablets or single-dose blisters containing 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1, 90 x 1, 100 x 1 tablets, or in HDPE containers with PP caps with an integrated moisture-absorbing agent, containing 30 or 100 sublingual tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic. Manufacturer: Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, D-48159 Münster, Germany. Adalvo Ltd., Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann, SGN 3000, Malta.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Iceland: Desmopresin Zentiva Poland, Czech Republic: Dursea To obtain more detailed information, the patient should contact the representative of the marketing authorization holder: Zentiva Polska Sp. z o. o., ul. Bonifraterska 17, 00-203 Warsaw, tel: +48 22 375 92 00. Date of last revision of the leaflet:September 2024