Nictur 360 micrograms/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Nictur 360 micrograms/ml oral solution

(desmopressin)

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Nictur is and what it is used for
2. What you need to know before taking Nictur
3. How to take Nictur
4. Possible adverse effects
5. Storage of Nictur

Pack contents and additional information

1. What Nictur is and what it is used for

The active ingredient that makes Nictur work (the active substance) is desmopressin. Desmopressin is very similar to a substance naturally produced in the body (the pituitary hormone vasopressin), which temporarily reduces the amount of urine produced by the body. This medicine is intended for oral use only.

This medicine is used to treat:

• Central diabetes insipidus, a condition causing excessive thirst and the continuous production of large amounts of dilute urine due to insufficient production of the hormone vasopressin.

Nocturnal enuresis (involuntary urination during sleep or primary nocturnal enuresis) in patients over 5 years of age who have a normal ability to concentrate urine.

2. What you need to know before taking Nictur

Do not take Nictur

• if you are allergic (hypersensitive) to desmopressin or to any of the other ingredients of this medicine (listed in section 6),
• if you unusually drink large amounts of fluids (you have habitual or psychogenic polydipsia),
• if you are taking medications that increase urine production (diuretics),
• if you have heart problems,
• if you have a predisposition to, or low levels of sodium in the blood (hyponatremia),
• if you have kidney problems,
• if you have uncontrolled blood pressure,
• if you have the "Syndrome of Inappropriate Antidiuretic Hormone Secretion" (SIADH).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

During treatment with this medicine, avoid drinking excessive amounts of fluids, as this may cause water retention in the body and/or a decrease in blood sodium, with or without adverse effects (see section 4 Possible side effects).

Special care should be taken to avoid water retention and low blood sodium in the following cases:

• if you are elderly,
• if you have a medical condition causing fluid and/or electrolyte imbalance in the body, such as an infection, fever, or stomach upset,
• if you suffer from severe bladder problems or impaired urine flow,
• if you suffer from asthma, epilepsy, or migraine,
• if you have kidney and/or cardiovascular diseases. In chronic kidney diseases, the antidiuretic effect of desmopressin is lower than usual.

Other medicines and Nictur

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially:

• tricyclic antidepressants or SSRIs (used to treat depression),
• carbamazepine (used to treat epilepsy),
• chlorpromazine (used to treat psychosis or schizophrenia),
• pain and/or anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs), for example indomethacin, ibuprofen, acetylsalicylic acid,
• loperamide (used to treat diarrhea),
• diuretic agents.

These medicines increase the risk of fluid retention, which dilutes the salt in the body.

• Dimethicone (used to treat gas accumulation), due to decreased absorption of desmopressin.

Taking Nictur with food and drinks

At low doses, this medicine may be affected by food intake. If you notice that this medicine is less effective, you should take it without food before increasing the dose.

When using this medicine for enuresis, reduce fluid intake to a minimum, from 1 hour before taking Nictur until 8 hours after taking a dose.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid using this medicine during pregnancy.

Desmopressin passes into breast milk. If you are to be treated with desmopressin, you must stop breastfeeding.

Driving and using machines

Nictur does not affect the ability to drive or operate machinery.

Nictur contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.

This medicine may cause allergic reactions (possibly delayed) because it contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.

Nictur contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per ml; hence, it is essentially "sodium-free".

3. How to take Nictur

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose

Treatment of central diabetes insipidus

Adults and children: Your doctor will adjust the dose individually. The recommended initial dose is 0.25 ml (90 micrograms) three times a day. Afterwards, your doctor will adjust the dose according to each patient's response. The usual daily dose ranges between 0.5 ml (180 micrograms) and 3 ml (1080 micrograms) of this medicine. The maintenance dose usually ranges between 0.25 ml and 0.5 ml (90–180 micrograms) of this medicine three times a day.

It is important to monitor for symptoms of water retention in the body and/or low blood sodium levels (see section 4 Possible side effects). In such cases, treatment will be interrupted and the dose adjusted accordingly.

Enuresis (involuntary urination at night or primary nocturnal enuresis) in patients over 5 years of age:

Adults and children: the usual initial dose is 0.5 ml (180 micrograms) of this medicine taken one hour before bedtime. If this dose is not sufficiently effective, the dose may be increased up to 1 ml (360 micrograms). The need to continue treatment is usually reassessed every three months by interrupting treatment for at least one week.

Elderly patients: if your doctor decides to treat you, blood sodium levels should be measured before starting treatment, three days after starting treatment, and whenever the dose is increased or at any time your doctor considers appropriate.

It is important to monitor fluid intake. If symptoms of water retention in the body and/or low blood sodium levels occur (see section 4 Possible side effects), treatment should be interrupted. When treatment is restarted, fluid intake must be strictly controlled.

Instructions for use:

1. Open the bottle (on first opening, the seal will break).

2. Insert the oral syringe into the adapter and turn the bottle upside down to fill the syringe with the required dose.

3. Remove the oral syringe from the bottle and check that the correct amount is inside the syringe.

4. Hold the syringe in your mouth and release the dose into your mouth.

5. Rinse with water after each use and close the bottle. Store the bottle in its original packaging to protect it from light.

If you take more Nictur than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service immediately at telephone number 915 620 420, indicating the medicine and the amount ingested.

An overdose may prolong the effect of desmopressin and increase the risk of fluid retention in the body and/or low blood sodium levels. Symptoms may include headache, nausea, vomiting, weight gain, and in severe cases, seizures. It is recommended to interrupt treatment, restrict fluid intake, and provide symptomatic treatment if necessary.

If you forget to take Nictur

Do not take a double dose to make up for a missed dose.

If you stop taking Nictur

Do not stop treatment with Nictur before completing the prescribed course, as it may not have the intended effect. You should only change or stop treatment if instructed to do so by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Stop treatment with Nictur and go to see a doctor or the nearest hospital if any of the following occur:

• Frequent (may affect up to 1 in 10 people): symptoms due to fluid retention in the body, such as unusual or prolonged headache, feeling sick or being sick, unexplained weight gain, and in severe cases, seizures, unconsciousness.
• Very rare (may affect up to 1 in 10,000 people): allergic reactions such as rash, itching, fever, swelling of the lips, face, throat or tongue causing difficulty in swallowing or breathing.

Tell your doctor or pharmacist if you notice any of the following adverse effects:

• Very frequent (may affect more than 1 in 10 people): headache
• Frequent (may affect up to 1 in 10 people): abdominal pain, nausea.
• Very rare (may affect up to 1 in 10,000 people): emotional disorders in children, allergic reactions.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nictur

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original packaging.

After first opening, the medicine should be stored below 25°C for up to 8 weeks.

Do not use this medicine after the expiry date stated on the label and on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nictur

• The active substance is desmopressin. Each ml of oral solution contains 360 micrograms of desmopressin (as desmopressin acetate).
• The other components are:
  • Sodium methyl hydroxybenzoate (E-219)
  • Sodium propyl hydroxybenzoate (E-217)
  • Hydrochloric acid (for pH adjustment)
  • Purified water.

Appearance of Nictur and contents of the pack

Nictur is a clear solution contained in an amber glass bottle with a low-density polyethylene (LDPE) adapter, fitted with a high-density polyethylene (HDPE) cap. The bottle contains 15 ml of solution. Each pack includes a 1.5 ml graduated syringe. The syringe is graduated from 0 to 1.5 ml, with markings every 0.1 ml. Graduations corresponding to doses of 0.25 ml, 0.5 ml and 1.0 ml are specifically indicated.

Nictur is available in individual packs (one 15 ml bottle of solution and one graduated syringe) and in multipacks containing three individual packs, each with 15 ml of solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

GP-Pharm, S.A.

Polígono Industrial Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona) SPAIN

Manufacturer

Laboratorio Reig Jofré S.A.

Gran Capità 10

08970 Sant Joan Despí – Barcelona

Spain

Elara Pharmaservices Europe Ltd

Regus Block 1, Blanchardstown Corporate Park

Ballycoolin Road, Blanchardstown

Dublin 15, D15 AKK1

Ireland

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

Spain: Nictur 360 micrograms/ml Oral solution

Portugal: Nictur 0.36 mg/ml Oral solution

Greece: Nictur 360 μικρογραμμ?ρια/ml π?σιμο δι?λυμα

United Kingdom: Demovo 360 micrograms/ml oral solution

Germany: Niwinas 360 Mikrogramm/ml Lösung zum Einnehmen

Cyprus: Nictur 360 μικρογραμμ?ρια/ml π?σιμο δι?λυμα

Date of the most recent revision of this leaflet: September 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/