Noqturina

Package leaflet: Information for the patient

Noqturina, 25 micrograms, oral lyophilisate
Noqturina, 50 micrograms, oral lyophilisate
Desmopressinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.

Table of contents of the leaflet:

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

1. What Noqturina is and what it is used for

Noqturina contains desmopressin, an antidiuretic agent that reduces urine production.
Noqturina is used to treat nocturia (the need to wake up frequently at night to pass urine) caused by nocturnal polyuria (excessive urine production at night) in adults.

2. Important information before using Noqturina

When not to use Noqturina

• 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 thirst and increased fluid intake) or psychogenic polydipsia (excessive thirst and increased fluid intake caused by psychological factors);
• if the patient has established or suspected heart failure (the heart is unable to pump sufficient blood);
• if the patient has any conditions requiring treatment with diuretics;
• if the patient has moderate or severe renal impairment;
• if the patient has established or previously experienced hyponatremia (low sodium levels in the blood);
• if the patient has SIADH (syndrome of inappropriate antidiuretic hormone secretion).

Warnings and precautions
Before starting treatment with Noqturina, discuss this with your doctor.
Your doctor should exercise caution in the following cases:

• if the patient has severe bladder function disorders and difficulties in passing urine;
• if the patient is 65 years of age or older, as the doctor will need to monitor the patient's blood sodium levels (see section 3. "How to use Noqturina" below);
• if the patient has low sodium levels in the blood;
• if the patient has a medical condition causing disturbances in water and/or electrolyte balance;
• if the patient has a medical condition that could worsen due to disturbances in water and/or electrolyte balance;
• if the patient develops an acute illness during treatment (such as systemic infection, fever-related illness, or gastroenteritis), in which case the doctor may consider it necessary to discontinue treatment with Noqturina;
• if the patient has cystic fibrosis, coronary heart disease, hypertension, chronic kidney disease, or pre-eclampsia.

Fluid intake should be minimized from 1 hour before taking Noqturina up to 8 hours after taking Noqturina. Treatment without simultaneously restricting fluid intake may lead to excessive water retention in the body and/or electrolyte imbalance, which may, but does not necessarily, cause symptoms such as headache, nausea, vomiting, weight gain, or, in severe cases, seizures.

Noqturina with other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking any of the following medicines:
tricyclic antidepressants, used, among others, for the treatment of depression (such as clomipramine, imipramine, desipramine);
selective serotonin reuptake inhibitors, used, among others, for the treatment of depression or anxiety disorders (such as citalopram, paroxetine, sertraline);
chlorpromazine, an antipsychotic medicine used, among others, for the treatment of schizophrenia;
diuretics (such as thiazides or other types of diuretics);
carbamazepine, used, among others, for the treatment of bipolar disorder and epilepsy;
antidiabetic medicines, used for the treatment of type II diabetes (sulfonylurea group), especially chlorpropamide;
non-steroidal anti-inflammatory drugs, used for the treatment of pain and inflammatory conditions (such as acetylsalicylic acid and ibuprofen);
oxytocin, used during childbirth;
lithium, used, for example, for the treatment of bipolar disorder;
loperamide, used for the treatment of diarrhea.

Noqturina with food and drink
Noqturina should not be taken at the same time as food, as this may reduce its therapeutic effect.

Pregnancy, breastfeeding and fertility
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.
The doctor will decide whether a pregnant or breastfeeding patient may use this medicine.

Driving and using machines
Noqturina has no effect or negligible effect on the ability to drive and operate machinery.

3. How to use Noqturina

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult your
doctor.
The recommended dose is:

• in women: 25 micrograms once daily, taken sublingually, 1 hour before bedtime, without water;
• in men: 50 micrograms once daily, taken sublingually, 1 hour before bedtime, without water.

Noqturina should be placed under the tongue, where it dissolves without the need to take water.
Instructions for using the medicine

1. Completely remove the end strip of the blister by tearing along the perforation, starting from the corner with the printed hand symbol.
2. Tear off one blister unit along the perforation.
3. Remove the foil from the separated blister unit, starting from the corner with the printed arrow and pulling the foil in the direction indicated by the arrow. Do not push the lyophilisate through the foil.
4. Gently remove the lyophilisate from the blister unit. Place the lyophilisate under the tongue and allow it to dissolve. Do not chew or swallow the lyophilisate.
5. If the lyophilisate breaks into more than two pieces during removal from the blister unit, do not use the broken pieces. Take a new lyophilisate from another blister unit.

Fluid intake should be minimized from 1 hour before taking Noqturina until 8 hours after taking Noqturina. If any of the following symptoms occur, stop treatment and contact your doctor: headache, nausea, vomiting, weight gain, or in severe cases, seizures (see section "Warnings and precautions" above). Your doctor may consider resuming treatment. If treatment is resumed, strict fluid restriction is required. Additionally, your doctor will closely monitor the sodium concentration in your blood.
Use in elderly patients (65 years of age and older)
In patients aged 65 years or older, the doctor must monitor the blood sodium concentration before starting treatment, during the first week of treatment (4–8 days after starting treatment), and again approximately one month after starting treatment.
Use in patients with renal impairment
Noqturina should not be used in patients with moderate or severe renal impairment. Consult your doctor.
Use in patients with hepatic impairment
If a patient has impaired liver function, consult your doctor before using Noqturina.
Use in children and adolescents
This medicine is intended for use in adults only.
Use of a higher than recommended dose of Noqturina
It is important that the patient does not take more than the prescribed dose within any 24-hour period. Pay particular attention to signs of water intoxication (hyponatremia), such as weight gain, headache, nausea, and, in severe cases, seizures.
If a higher than recommended dose of Noqturina has been taken, consult your doctor.
Missed dose of Noqturina
Do not take a double dose to make up for a missed dose. Continue taking the medicine as prescribed from the next day.
Stopping Noqturina treatment
Treatment may only be interrupted or discontinued in consultation with your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Drinking excessive amounts of fluid may lead to water retention, which in severe cases can dilute the sodium in the body. This may result in a serious disorder and may lead to seizures.
Treatment should be discontinued and a doctor should be contacted immediately or emergency medical services sought if any of the following symptoms occur:

• extremely severe or prolonged headache,
• confusion,
• unexplained weight gain,
• nausea or vomiting.

The following are adverse effects:
Very common: may affect more than 1 in 10 people:

• dry mouth.

Common: may affect up to 1 in 10 people:

• nausea, malaise, muscle weakness and confusion due to reduced sodium concentration in the blood (hyponatremia),
• headache,
• dizziness,
• nausea,
• diarrhoea.

Uncommon: may affect up to 1 in 100 people:

• constipation,
• stomach discomfort,
• fatigue,
• swelling of tissues in the lower limbs (peripheral oedema).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309;
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Noqturina
Keep the medicine out of the sight and reach of children.
No special temperature requirements for storage.
Store in the original packaging to protect from moisture and light.
Use immediately after opening the blister unit containing the lyophilisate.
Do not use this medicine after the expiry date stated on the packaging following the term EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Noqturina contains

• The active substance is desmopressin in the form of desmopressin acetate. One oral lyophilisate contains 25 micrograms of desmopressin. One oral lyophilisate contains 50 micrograms of desmopressin.
• Other ingredients are: gelatin, mannitol (E 421) and anhydrous citric acid.

What Noqturina looks like and contents of the pack
Noqturina 25 micrograms:
White, round oral lyophilisate tablet with a diameter of approximately 12 mm, marked with "25" on one side.
Noqturina 50 micrograms:
White, round oral lyophilisate tablet with a diameter of approximately 12 mm, marked with "50" on one side.
Blister packs in a cardboard box. Each blister is divided into single-dose units and contains 10 oral lyophilisates.
Pack sizes:
10x1, 30x1, 90x1 or 100x1 oral lyophilisates.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Importer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Nocdurna 25/50 mikrogramm –Lyophilisat zum Einnehmen
Belgium Nocdurna 25/50 lyophilisaat voor oraal gebruik
Bulgaria Нокдурна 25/50 микрограма перорален лиофилизат
Croatia Nocdurna 25/50 mikrograma oralni liofilizat
Cyprus Nocdurna
Denmark Nocdurna
Estonia Nokdirna
Finland Nocdurna
France Nocdurna 25/50 microgrammes, lyophilisat oral
Greece Nocdurna Δισκίο λυοφιλοποιημένο, από του στόματος 25mcgΠAB (Γνωστή δραστική)
Nocdurna Δισκίο λυοφιλοποιημένο, από του στόματος 50mcgΠAB (Γνωστή δραστική)
Netherlands Nocdurna 25/50 microgram
Ireland Noqturina 25/50 microgram oral lyophilisate
Iceland Nocdurna
Liechtenstein Nocdurna 25/50 mikrogramm – Lyophilisat zum Einnehmen
Lithuania Nokdirna
Luxembourg Nocdurna 25 mcg lyophilisat oral / 50 microgram oral lyophilisate
Latvia Nokdirna 25/50 mikrogrami liofilizāts iekšķīgai lietošanai
Malta Noqturina 25/50 microgram oral lyophilisate
Germany Nocdurna
Norway Nocdurna
Poland Noqturina
Portugal Nocdurna
Czech Republic Nocdurna
Romania Nocdurna 25/50 micrograme liofilizat oral
Slovakia Nocdurna
Slovenia Nocdurna 25/50 mikrogramov peroralni liofilizat
Sweden Nocdurna
Hungary Nocdurna
United Kingdom Noqdirna 25/50 microgram oral lyophilisate

For more detailed information, please contact the representative of the Marketing Authorisation Holder.
Ferring Pharmaceuticals Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warszawa
Tel.: + 48 22 246 06 80, Fax: + 48 22 246 06 81