DESMOPRESSIN SANDOZ 120 micrograms SUBLINGUAL TABLETS

2. What you need to know before taking Desmopresina Sandoz

Do not take Desmopresina Sandoz if:

• you are allergic to desmopresina or any of the other components of this medication (listed in section 6),
• you drink large amounts of unusual liquids,
• you have heart problemsor other diseasesthat require treatment with medications that increase urine secretion through the kidneys,
• you have moderately or severelyreduced kidney function,
• you know you have low sodium levelsin your blood,
• you suffer from a syndrome of inadequate secretion of antidiuretic hormone called SIADH.

Warnings and precautions

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

• regarding fluid intake, drink as little as possiblefrom 1 hour beforetaking the tablet until 8 hoursafter taking it,
• if you are an elderly patient,
• if you have a medical condition that causes fluid and/or electrolyte imbalance in the body, such as an infection, fever, or stomach upset,
• if you have severe bladder problemsor decreased urine production,
• if you have asthma, epilepsy, cystic fibrosis, or migraine,
• if you are at risk of suffering from increased intracranial pressure (a disease that your doctor will inform you about).

Other medications and Desmopresina Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• medications for treating depression called tricyclic antidepressants or ISRS,
• carbamazepine(for treating epilepsy),
• chlorpromazine(for treating psychosis or schizophrenia),
• medications for treating diabetes called sulfonylureas,
• loperamide(for treating diarrhea),
• medications for treating pain and/or inflammation, called non-steroidal anti-inflammatory drugs, such as indomethacin, ibuprofen.

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

• dimethicone(for treating stomach gas symptoms).

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 possiblefrom 1 hourbefore taking the tablet until 8 hoursafter.
• If you drink too much, fluid retention may occur, diluting salt in the body. This can happen with or without warnings or symptoms, which may include:

• severe or prolonged headache,
• nausea or vomiting,
• unexplained weight gain,
• in severe cases, seizures and loss of consciousness.

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

Pregnancy and breastfeeding

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

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

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

Driving and using machines

There is no evidence to suggest that desmopresina affects the ability to drive or use machines.

Desmopresina Sandoz contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, 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".

3. How to take Desmopresina Sandoz

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

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

The recommended dose is:

• Diabetes insipidus

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

• Enuresis (nocturnal urination)

Adults and children from 5 years old- 120 micrograms at bedtime and after emptying the bladder. Your doctor may increase the dose 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 treatment-free period of at least one week.

Use in the elderly

Desmopresina should not be initiated until it has been established that the sodium level in the blood is normal. Sodium levels in the blood should be measured before and three days after starting treatment, and if the dose is increased or at any time your doctor considers it necessary.

If you are taking this medication for nocturnal enuresis, drink as little as possiblefrom 1 hourbefore taking a tablet until 8 hoursafter.

Instructions for use

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

If you take more Desmopresina Sandoz than you should

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

An overdose may prolong the effect of desmopresina and increase the risk of fluid retention in the body and low sodium levels in the blood. The symptoms of severe fluid retention include seizures and loss of consciousness.

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

If you forget to take Desmopresina Sandoz

Do not take a double dose to make up for forgotten doses.

If you stop taking Desmopresina Sandoz

You should only change or stop treatment if your doctor advises you to do so.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop treatment and consult your doctor immediately if you experience any of the following serious side effects:

• multiple or severe symptoms of fluid 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*.
  1. 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*,
• urination problems (frequent and abnormal urination during the day),
• swelling of the tissues of the hands, arms, feet, or legs,
• fatigue.
  1. Uncommon(may affect up to 1 in 100 people):

• sleeping difficulties,
• drowsiness,
• clumsiness,
• visual disturbances,
• vertigo*,
• feeling of increased heart rate,
• low blood pressure when standing up from a lying position,
• shortness of breath,
• stomach upset (indigestion, acidity, flatulence, bloating),
• sweating,
• itching,
• skin rash,
• hives,
• muscle spasms,
• muscle pain,
• urinary disorders (such as urgent urination),
• discomfort*,
• chest pain,
• flu-like symptoms,
• weight gain*,
• increased liver enzymes,
• low potassium levels in the blood.
  1. Rare(may affect up to 1 in 1,000 people):

• confusion*,
• skin allergic reaction.

• Frequency not known(cannot be estimated from available data):

• severe allergic reaction,
• seizures,
• dehydration,
• muscle weakness,
• coma,
• high sodium levels in the blood.

Side effects observed in children up to 18 years old:

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

• headache*.

• Uncommon(may affect up to 1 in 100 people):
• emotional problems,
• aggressiveness,
• 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 changes.

• Frequency not known(cannot be estimated from available data):
• severe allergic reaction,
• low sodium levels in the blood,
• abnormal behavior,
• depression,
• hallucinations,
• insomnia (difficulty falling asleep/staying asleep),
• reduced attention,
• increased muscle movements,
• seizures*,
• nosebleeds,
• skin allergic reaction,
• rash,
• sweating,
• hives.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Desmopresina Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Desmopresina Sandoz 120 micrograms sublingual tablets

• The active ingredient is desmopresina. Each sublingual tablet contains 120 micrograms of desmopresina (as desmopresina acetate).
• The other excipients are: lactose monohydrate, cornstarch, citric acid (E330), sodium croscarmellose (E468), magnesium stearate (E470b).

Appearance of the product and package contents

Sublingual tablet.

Octagonal white or almost white tablet, rounded on the top and bottom 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.

Package sizes

30 sublingual tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Haupt Pharma Münster 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

Date of last revision of this leaflet:June 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/