Dursea

Package leaflet: Information for the user

Dursea, 60 micrograms, sublingual tablet
Dursea, 120 micrograms, sublingual tablet
Dursea, 240 micrograms, sublingual tablet
Desmopressinum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor. See section 4.

Contents of the leaflet:

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

1. What Dursea is and what it is used for

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

• Central diabetes insipidus (a disorder of the pituitary gland leading to excessive thirst and the excretion of large amounts of urine, usually clear and water-like).
• Nocturnal enuresis in children over 5 years of age who have normal urine-concentrating ability (involuntary urination during sleep).
• Nocturia in adults under 65 years of age (a condition in which a person frequently wakes up at night to urinate).

2. Important information before using Dursea

When not to use 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, or other conditions requiring treatment with diuretics
• if the patient has moderate or severe renal impairment
• if the patient has low blood sodium levels
• if the patient is unable to comply with fluid intake restrictions
• if the patient has been diagnosed with syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• if the patient is over 65 years of age and has nocturia (see section 1)
• if the child is under 5 years of age and has nocturnal enuresis (see section 1)

Warnings and precautions
Treatment of nocturnal enuresis (involuntary urination during sleep) in children should begin with lifestyle measures and use of a bedwetting alarm (a device that sounds or vibrates when the child wets the bed). If these measures fail or pharmacological treatment is required, desmopressin may be initiated.
Before starting Dursea, discuss the following with your doctor:

• if the patient has coronary heart disease (disease of blood vessels supplying the heart) or high blood pressure
• if the patient has thyroid gland disease (a gland located in the neck) or adrenal gland disease (a gland located above the kidney)
• if during treatment the patient develops an illness causing fever, vomiting, or diarrhoea
• if during treatment the patient experiences headache, loss of appetite, nausea, vomiting, weight gain, confusion (difficulty understanding words, difficulty concentrating), or seizures (sudden, involuntary contractions of one or more limbs); these symptoms may indicate a dangerous condition called hyponatraemia (low sodium levels in the blood).
  • in the treatment of central diabetes insipidus: fluid intake should be restricted and medical advice should be sought immediately. The doctor will reduce the dose or interrupt treatment for several hours.
  • in the treatment of nocturnal enuresis or nocturia: treatment should be stopped, fluid intake reduced, and medical advice sought immediately.
• if increased intracranial pressure may occur.

During treatment for nocturnal enuresis and nocturia, fluid intake should be limited to the minimum necessary to control thirst, from 1 hour before taking the medicine until 8 hours after administration.
Dursea should be used with caution in patients with disturbed fluid balance. Contact your doctor if, due to an acute illness, there is a disturbance in fluid and/or electrolyte balance.
Children
This medicine must be administered to children under the supervision of an adult.
This medicine should not be given to children under 5 years of age unless the potential benefits outweigh the risks.
Dursea with other medicines
Tell your doctor about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.
The effect of Dursea may be enhanced, with increased risk of inappropriate fluid retention in the body, when taken concomitantly with certain medicines used to treat:

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

The effect of Dursea may be reduced when taken concomitantly with certain medicines used to treat:

• bloating (such as dimethicone)

Dursea and alcohol
During treatment of primary nocturnal enuresis and nocturia, fluid intake should be restricted from 1 hour before taking the medicine until 8 hours after administration.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Experience with the use of desmopressin during pregnancy is limited.
Dursea passes into human milk, but it is unlikely to affect breastfed newborns.
Driving and operating machinery
Dursea has no effect or has a negligible effect on the ability to drive and operate machinery.
Dursea contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Dursea contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per sublingual tablet, meaning the medicine is considered "sodium-free".
3. How to use Dursea
This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult the 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 it dissolves without the need to drink water.
Central diabetes insipidus
The usual dose in adults and children is 1–2 sublingual tablets (60 micrograms per tablet) three times daily.
Nocturnal enuresis
The usual dose is 1–2 tablets (120 micrograms per tablet) taken sublingually at bedtime. The medicine should be taken before sleep. Fluid intake should be restricted.
Every three months, the doctor will assess whether treatment should continue. The doctor may recommend at least a one-week break from treatment.
Nocturia in adults
The usual dose is 1 tablet (60 micrograms per tablet) taken sublingually before bedtime.
Fluid intake should be restricted.
Use in children
This medicine is used in the treatment of diabetes insipidus and nocturnal enuresis (see dosing for different conditions above). Dosing is the same for children and adults only in the case of diabetes insipidus.
Taking more Dursea than prescribed
If more medicine has been taken than prescribed, or if a child accidentally swallows the medicine, contact a doctor, hospital, or pharmacist immediately to assess risk and obtain advice.
Taking more Dursea than prescribed may prolong the duration of action and increase the risk of excessive fluid retention in the body and reduced blood sodium levels. Symptoms of severe fluid retention include seizures and loss of consciousness.
Missed dose of Dursea
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Stopping Dursea
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If fluid intake is not restricted according to the instructions above, abnormal amounts of fluid may
accumulate in the body, which may lead to headache, abdominal pain, nausea and (or) vomiting,
weight gain, dizziness, disorientation, malaise, vertigo, and in severe cases, seizures and coma.
These symptoms may reflect mild to severe water retention. They usually occur with high doses of Dursea and
resolve after dose reduction.

Adults
Very common (may affect more than 1 in 10 people):

• headache

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

• low sodium levels in blood
• dizziness
• hypertension
• abdominal pain
• nausea
• diarrhoea
• constipation
• vomiting
• symptoms related to urinary bladder and urethra
• swelling of hands, arms, feet or legs
• feeling of fatigue

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

• sleep disorders
• somnolence
• tingling
• blurred vision
• sensation of spinning (dizziness)
• palpitations
• drop in blood pressure upon changing position from lying to standing
• shortness of breath
• indigestion
• flatulence
• bloating
• sweating
• itching
• rash
• urticaria
• muscle cramps
• muscle pain
• chest pain
• influenza-like symptoms
• weight gain
• increased liver enzyme levels
• low potassium levels in blood

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

• disorientation
• allergic dermatitis

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

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

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

• headache

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

• emotional lability
• aggression
• nausea
• abdominal pain
• vomiting
• diarrhoea
• discomfort related to urinary bladder and urethra
• swelling of hands and feet
• feeling of fatigue

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

• anxiety
• nightmares
• mood swings
• somnolence
• high blood pressure
• irritability

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

• anaphylactic reactions (severe allergic reaction)
• low sodium levels in blood
• abnormal behaviour
• emotional disturbances
• depression
• hallucinations
• sleep problems
• reduced attention
• increased muscle movements
• cramps
• nosebleeds
• rash
• allergic dermatitis
• sweating
• urticaria

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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. Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Dursea
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.

Blister packs
Store in the original blister to protect from moisture. No special temperature requirements for storage of the medicinal product.

HDPE container
Store in the original container. Keep container tightly closed to protect from moisture. Store below 30°C.

Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dursea contains

• The active substance in Dursea is desmopressin.

Dursea, 60 micrograms, sublingual tablets:
Each tablet contains 60 micrograms of desmopressin (as desmopressin acetate).

Dursea, 120 micrograms, sublingual tablets:
Each tablet contains 120 micrograms of desmopressin (as desmopressin acetate).

Dursea, 240 micrograms, sublingual tablets:
Each tablet contains 240 micrograms of desmopressin (as desmopressin acetate).

• The other ingredients are: lactose monohydrate, maize starch, citric acid (E 330), sodium croscarmellose (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 thickness of 2 mm, embossed with the mark "I" on one side and plain on the other side.
Dursea, 120 micrograms, sublingual tablet: white or almost white, round, biconvex tablet with a diameter of 6.5 mm and thickness of 2 mm, embossed with the mark "II" on one side and plain on the other side.
Dursea, 240 micrograms, sublingual tablet: white or almost white, round, biconvex tablet with a diameter of 6 mm and thickness of 2 mm, embossed with the mark "III" on one side and plain on the other side.

Dursea is packed in cardboard boxes containing OPA/Al/PVC/PE-Al blisters with an integrated moisture-absorbing layer, in pack sizes of 10, 20, 30, 50, 60, 90, and 100 sublingual tablets, or unit-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 screw caps and an integrated desiccant, containing 30 or 100 sublingual tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Iceland: Desmopresin Zentiva
Poland, Czech Republic: Dursea

For further information, please contact the Marketing Authorisation Holder's representative:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel: +48 22 375 92 00
{logo of the Marketing Authorisation Holder}