Label: Patient Information

Nictur 360 micrograms/mL oral solution

(desmopressin)

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

Contents of the package and additional information

The active ingredient that makesNicturwork (the active substance) is desmopressin. Desmopressin is very similar to a substance that is produced naturally in the body (the antidiuretic hormone vasopressin), which temporarily reduces the amount of urine produced by the body.

This medicationis used to treat:

• Central diabetes insipidus, a disease that causes excessive thirst and the continuous production of large amounts of diluted urine as a result of insufficient production of the vasopressin hormone.

Nocturnal enuresis (involuntary urination at night or primary nocturnal enuresis) in patients over 5 years old with normal ability toconcentrate urine.

Do not take Nictur

• if you are allergic (hypersensitive) to desmopressin or to any of the other components of this medication (listed in section 6),
• if you drink large amounts of liquids in an unusual manner (you have habitual or psychogenic polydipsia),
• if you take medications that increase urine production (diuretics),
• if you have heart problems,
• if you have a predisposition or low sodium levels in the blood (hyponatremia),
• if you have kidney problems,
• if you have uncontrolled high blood pressure,
• if you have the "Syndrome of Inadequate Antidiuretic Hormone Secretion" (SIADH).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

During treatment with this medication, avoid drinking excessive amounts of liquids because it may cause water retention in the body and/or a decrease in sodium levels in the blood with or without adverse effects (see section 4 Possible adverse effects).

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

• if you are an elderly person,
• if you have a medical condition that causesimbalance of liquids and/or electrolytesin the body, such as an infection, fever, or stomach upset.
• if you sufferserious bladder problems or alteration of urine flow,
• if you suffer fromasthma, epilepsy, and migraine,
• if you have kidney problems and/or cardiovascular diseases. Inchronic kidney diseasesthe antidiuretic effect of desmopressin is less than usual.

Other medications and Nictur

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

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

These medications increase the risk of water retention, which dilutes the salt in the body.

• Dimethicone (used in the treatment of gas accumulation), due to the decrease in the absorption of desmopressin.

Taking Nictur with food and drinks

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

When using this medication for enuresis, reduce theliquid intake to a minimum,from1 hour beforetaking Nicturto 8 hours afterhaving taken a dose.

Pregnancy, breastfeeding, and fertility

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

It is preferable to avoid the use of thismedication during pregnancy.

Desmopressin passes into breast milk. If you are being treated with desmopressin, you should stop breastfeeding.

Driving and operating machines

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

Nictur contains methyl parahydroxybenzoate sodium and propyl parahydroxybenzoate sodium.

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

Nictur contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Usual dose

Treatment of central diabetes insipidus

Adults and children:Your doctorwill adjust the dose individually. Theinitial doserecommended is 0.25 ml (90micrograms) three times a day. Subsequently, the doctor will adjust the dose according to the response of each patient. Theusual daily doseranges from 0.5 ml (180micrograms) to 3 ml (1080micrograms) of this medication. Themaintenance doseusually ranges from 0.25 ml to 0.5ml (90–180micrograms) ofthis medicationthree times a day.

It is essential to observe if symptoms of water retention in the body and/or decreased sodium inbloodappear (see section 4 Possible adverse effects). In this case, treatment will be interrupted and the dose will be adjusted again.

Nocturnal enuresis (involuntary urination during the night or primary nocturnal enuresis) in patients over 5 years:

Adults and children:The usual initial dose is 0.5 ml (180 micrograms) ofthis medicationone hour before bedtime. If this is not sufficiently active, the dose of this medicationcan be increased up to 1 ml (360 micrograms). The need to continue treatment is usually checked every three months by intercalating a period without treatment for at least one week.

Older adults:If the doctor decides to treat you, the levels of sodium in the blood should be measured before and three days after starting treatment and if the dose is increased or at any time the doctor considers it appropriate.

It is essential to control fluid intake. If symptoms of water retention in the body and/or decreased sodium in blood (see section 4 Possible adverse effects) appear, treatment will be interrupted. Once treatment is reinstated, fluid intake will be strictly controlled.

Instructions for use:

1. Open the bottle (the seal breaks on the first opening).

2. Insert the oral syringe into theadapterand turn the bottle upside down to fill it with the dose to be administered.

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

4.Holdthe syringe in the mouth and release the dose into the mouth.

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

If you take moreNicturthan you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicological Information Service, phone915620420 indicating the medication and the amount ingested.

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

If you forgotto takeNictur

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withNictur

Do not discontinue treatment withNicturbefore completing it, as it may not have the expected effect. You should only change or discontinue treatment if your doctor instructs you to do so.

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

Like all medications, this medicationmay produce adverse effects, although not all people will experience them.

Discontinue treatment withNictur andvisit a doctor or the nearest hospital if the following occurs:

• Frequent(may affect up to 1 in 10 people): symptoms resulting from fluid retentionin the body, such as unusual or prolonged headache, feeling or being nauseous, unexplained weight gain, and in severe cases, convulsions, loss of consciousness.
• Very Rare(may affect up to 1 in 10,000 people):allergic reactionssuch as hives, itching, fever, swelling in the lips, face, throat, or tongue causing difficulty swallowing or breathing.

Inform 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 to1 in 10 people): abdominal pain, nausea.
• Very Rare(may affectup to 1 in 10,000 people): emotional disturbances in children, allergic reactions.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 86°F (30°C). Store in the original packaging.

After the first opening, the medication should be stored below 77°F (25°C) for up to 8 weeks.

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Nictur

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

Appearance of Nictur and contents of the package

Nictur is a clear solution introduced into an amber glass bottle with a low-density polyethylene (LDPE) adapter, provided with a high-density polyethylene (HDPE) cap. The bottle contains 15 ml of solution. With each package, a 1.5 ml graduated syringe is supplied. The syringe is graduated from 0 to 1.5 ml, with divisions every 0.1 ml. The graduations corresponding to the doses of 0.25 ml, 0.5 ml, and 1.0 ml are specifically marked.

Nictur is available in individual packaging (one 15 ml solution bottle and one graduated syringe) and in a multipack of 3 individual packages, each containing 15 ml of solution.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

GP-Pharm, S.A.

Polígono Industrial Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona) ESPAÑA

Responsible for manufacturing

Laboratorio Reig Jofré S.A.

Gran Capità 10

08970 Sant Joan Despí – Barcelona

España

Elara Pharmaservices Europe Limited

239 Blanchardstown Corporate Park

Ballycoolin

Dublin D15 KV21

Ireland

This medicine is authorized in the member states of the European Economic Area with 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:Desmopressin 360 micrograms/ml oral solution

Germany:Niwinas 360 Mikrogramm/ml Lösung zum Einnehmen

Last review date of this leaflet: January 2021

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/