Prospecto:Information for the User

Desmopresina Sandoz 120 micrograms Sublingual Tablets EFG

Read this entire prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospect. See section 4.

1.What isDesmopresina Sandoz and for whatpurpose it is used

2.What you need to knowbeforestarting touseDesmopresina Sandoz

3.How to take Desmopresina Sandoz

4.Possible adverse effects

5Storage of Desmopresina Sandoz

6.Contents of the package and additional information

Desmopresina Sandoz contains the active ingredient desmopresina that reduces the amount of urine produced by the kidneys.

Desmopresina is used to treat:

• a chronic disease known asdiabetes insipidus, which causes extreme thirst and a constant production of large amounts of diluted urine.Important: it should not be confused with diabetes mellitus.
• enuresis(bedwetting) in patients over 5 years old with normal ability to concentrate urine.

Do not take Desmopresina Sandoz if:

• you are allergic to desmopresin or to any of the other components of this medication (listed in section 6),
• you drinklarge, unusual amounts of liquids,,
• you haveheart problemsor other diseasesthat require treatment with medications that increase urine secretion through the kidneys,
• you have amoderately or severely reduced renal function,,
• you know you havelow sodium levels in your blood,,
• you suffer from a condition calledSIADH (Syndrome of Inadequate Antidiuretic Hormone Secretion),.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Desmopresina Sandoz:,

• regarding fluid intake,drink as little as possiblefrom1 hour beforetaking the tabletuntil 8 hoursafter taking it,
• if you are anolder patient,,
• if you have a medical condition that causesfluid and/or electrolyte imbalance in the body, such as an infection, fever, or stomach upset,
• if you havesevere bladder problemsordecreased urine production,,
• if you haveasthma, epilepsy, cystic fibrosisormigraine,
• if you are at risk of suffering from increased intracranial pressure (a condition that your doctor will inform you about).

Other Medications and Desmopresina Sandoz

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

The effect of desmopresin may be increased and the risk of abnormal fluid retention in the body may be increased if you are already taking other medications:

• tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors),
• carbamazepine (for treating epilepsy),
• chlorpromazine (for treating psychosis or schizophrenia),
• sulfonilureas (for treating diabetes),
• loperamide (for treating diarrhea),
• anti-inflammatory medications, such as indometacin, ibuprofen (for pain and/or inflammation),

The effect of desmopresin may be reduced if you are already taking certain medications:

• dimethicone (for treating gas in the stomach).

Taking Desmopresina Sandoz with Food and Drinks

• Before starting to take this medication, your doctor should give you advice on fluid intake, including alcoholic beverages.
• If you are taking this medication for enuresis, drink as little as possible from1 hour beforetaking the tablet until8 hoursafter taking it.
• If you drink too much, fluid retention may occur, diluting salt in the body. This can happen with or without warning signs or symptoms, which may include:

-intense or prolonged headache,

-nausea or vomiting,

-unexplained weight gain,

-in severe cases, seizures and loss of consciousness.

If you experience any of these symptoms,interrupt treatment and consult your doctor immediately.

Pregnancy and Breastfeeding

Desmopresin can be used during pregnancy and breastfeeding, but only if prescribed by a doctor. There is only limited experience with the use of desmopresin in pregnant women with diabetes insipidus.

Desmopresin can be used during breastfeeding. Desmopresin passes into breast milk, but it is unlikely to affect babies during breastfeeding.

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

Driving and Operating Machinery

There is no evidence to suggest that desmopresin affects the ability to drive or operate machinery.

Desmopresina Sandoz contains lactose and sodiumsodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per sublingual tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed.In case of doubt, consult your doctor or pharmacist again.

The dosage is established by your doctor and will be adjusted individually for you.

The recommended dosage is:

• Diabetes insipidus

Adults and children- 60 micrograms three times a day. Your doctor may increase the dosage, depending on how well your symptoms are controlled.

• Nocturnal enuresis (involuntary urination at night)

Adults and children aged 5 and above- 120 micrograms at bedtime and after emptying the bladder. Your doctor may increase the dosage to 240 micrograms at bedtime, depending on how well the enuresis is controlled. Check every 3 months the need to continue treatment by establishing a period of at least one week without treatment.

Use in the elderly

Desmopressin should not be initiated until it has been established that the blood sodium level is normal.Blood sodium levels should be measured before and three days after starting treatment and if the dosage is increased or at any time your doctor considers it appropriate.

If you are taking this medication for nocturnal enuresis, drink as little as possiblefrom 1 hourbefore taking a tablet until8 hoursafter.

Instructions for use

The tablet should be placed under the tongue where it dissolves without water.

If you take more Desmopressin Sandoz than you should

If you take more desmopressin than you should, contact your doctor, pharmacist, or the nearest hospital immediately.

A overdose may prolong the effect of desmopressin acetate and increase the risk of fluid retention in the body and low sodium levels in the blood. Severe fluid retention symptoms include seizures and loss of consciousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desmopressin Sandoz

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

If you interrupt treatment with Desmopressin Sandoz

You should only change or interrupt treatment if your doctor advises you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop treatment and seek medical attention immediately if you experience any of the following severe side effects:

• Multiple or severe symptoms offluid retention. The following side effects are marked with an asterisk (*),
• allergic reactionssuch as skin rash, itching, fever, swelling of the mouth, tongue, or respiratory tract causing difficulty swallowing or breathing.

Side effects observed in adults:

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

-headache*.

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

-low sodium levels in the blood,

-dizziness,

-high blood pressure,

-nausea*,

-stomach pain*,

-diarrhea,

-constipation,

-vomiting*,

-difficulty urinating (frequent and abnormal urination during the day),

-swelling of the tissues of the hands, arms, feet, or legs,

-fatigue.

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

-difficulty sleeping,

-drowsiness,

-clumsiness,

-visual disturbances,

-dizziness*,

-feeling of increased heart rate,

-low blood pressure when standing up from a lying position,

-shortness of breath,

-stomach discomfort (indigestion, acidity, flatulence, swelling),

-sweating,

-itching,

-skin rashes,

-urticaria,

-muscle spasms,

-muscle pain,

-urinary disorders (such as frequent urination),

-unpleasantness*,

-chest pain,

-flu-like symptoms,

-weight gain*,

-increased liver enzymes,

-low potassium levels in the blood.

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

-confusion*,

-skin allergic reaction.

• Unknown frequency(cannot be estimated from available data):

-severe allergic reaction,

-convulsions,

-dehydration,

-muscle weakness,

-coma,

-high sodium levels in the blood.

Side effects observed in children up to 18 years:

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

-headache*.

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

-emotional problems,

-aggression,

-stomach pain*,

-nausea*,

-vomiting*,

-diarrhea,

-swelling of the tissues of the hands, arms, feet, or legs,

-fatigue.

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

-anxiety,

-drowsiness,

-high blood pressure,

-irritability,

-nightmares,

-mood disturbances.

• Unknown frequency(cannot be estimated from available data):
• severe allergic reaction,
• low sodium levels in the blood,
• abnormal behavior,
• depression,
• hallucinations,
• insomnia (difficulty falling asleep/maintaining sleep),
• reduced attention,
• increased muscle movements,
• convulsions*,
• nosebleed,
• skin allergic reaction,
• hives,
• sweating,
• urticaria.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original blister pack to protect it from moisture. This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Desmopresina Sandoz 120 micrograms sublingual tablets

• The active ingredient is desmopressin.Eachsublingual tabletcontains120 micrograms of desmopressin (as desmopressin acetate).
• The other excipients are: lactose monohydrate, cornstarch, citric acid (E330), sodium croscarmellose (E468), magnesium stearate (E470b).

Appearance of the product and content of the container

Sublingual tablet.

White or almost white octagonal tablet, rounded on the upper and lower faces, with the inscription "II" in relief on one face and smooth on the other, 6.5 mm in length and 2 mm in thickness.

Aluminum/aluminum blisters with integrated desiccant layer.

Container sizes

30 sublingual tablets

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Haupt PharmaM?nster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

or

Adalvo Ltd.

Malta Life Sciences Park

Building 1, Level 4

Sir Temi Zammit Buildings

San Gwann, SGN 3000

Malta

Revision date of this leaflet:June 2023

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