Noqturina

Package leaflet: Information for the patient

Noqturina, 25 micrograms, oral lyophilisate
Noqturina, 50 micrograms, oral lyophilisate
Desmopressinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 only. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any 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 taking Noqturina
3. How to take 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 (frequent need to urinate during the night) 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 cardiac insufficiency (the heart is unable to pump sufficient blood);
• if the patient has any diseases requiring treatment with diuretics;
• if the patient has moderate or severe renal insufficiency;
• if the patient has established or has previously had hyponatraemia (low sodium levels in the blood);
• if the patient has SIADH (inappropriate secretion of hormones).

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 dysfunction and difficulty urinating;
• 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 may 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 and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
In particular, inform your doctor if the patient is taking any of the following medicines:

• tricyclic antidepressants, used, among others, for treating depression (such as clomipramine, imipramine, desipramine);
• selective serotonin reuptake inhibitors, used, among others, for treating depression or anxiety disorders (such as citalopram, paroxetine, sertraline);
• chlorpromazine, an antipsychotic medicine used, among others, for treating schizophrenia;
• diuretics (such as thiazides or other types of diuretics);
• carbamazepine, used, among others, for treating bipolar affective disorder and epilepsy;
• antidiabetic medicines used for treating type II diabetes (sulfonylurea group), especially chlorpropamide;
• non-steroidal anti-inflammatory drugs, used for treating pain and inflammatory conditions (such as acetylsalicylic acid and ibuprofen);
• oxytocin, used during childbirth;
• lithium, used, for example, for treating bipolar affective disorder;
• loperamide, used for treating diarrhoea.

Taking Noqturina with food and drink
Noqturina should not be taken with food, as this may reduce its therapeutic effect.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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 woman may use this medicine.

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

3. How to use Noqturina

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

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

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

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, treatment must be stopped and the doctor contacted: headache, nausea, vomiting, weight gain, or in severe cases, seizures (see section "Warnings and precautions" above). The doctor may consider resuming treatment. If treatment is resumed, strict fluid restriction is required. Additionally, the doctor will closely monitor the patient's blood sodium levels.

Use in elderly patients (aged 65 years and older)
In patients aged 65 years or older, the doctor will need to monitor the patient's blood sodium levels before starting treatment, during the first week of treatment (4–8 days after starting), and again approximately one month after starting treatment.

Use in patients with renal impairment
Noqturina must not be used in patients with moderate or severe renal impairment. Consult your doctor.

Use in patients with hepatic impairment
If the 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 immediately.

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 the doctor.

If you have any further doubts concerning the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Excessive fluid intake may lead to water retention, which in severe cases may dilute the sodium in the body. This may constitute a serious disorder and may lead to seizures.
The medicine should be discontinued and the treating physician should be contacted immediately or the emergency department visited if the patient experiences one or more of the following symptoms:

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

The following are adverse effects:
Very common: may occur in more than 1 in 10 patients:

• dryness of the mouth.

Common: may occur in up to 1 in 10 patients:

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

Uncommon: may occur in up to 1 in 100 patients:

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 authorisation holder.
Reporting of 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 storage requirements.
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 after the word EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via the sewage system 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 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.
• The 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. One blister pack divided into single doses 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 further information, please contact the representative of the Marketing Authorisation Holder.
Ferring Pharmaceuticals Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81