DESMOPRESSIN ARISTO 60 micrograms SUBLINGUAL TABLETS

Introduction

Package Leaflet: Information for the User

Desmopresina Aristo60 micrograms sublingual tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Desmopresina Aristo and what is it used for
2. What you need to know before you take Desmopresina Aristo
3. How to take Desmopresina Aristo
4. Possible side effects
5. Storage of Desmopresina Aristo
6. Contents of the pack and other information

1. What is Desmopresina Aristo and what is it used for

Desmopressin, the active substance of Desmopresina Aristo, acts like the natural pituitary hormone vasopressin and regulates the amount of urine produced by the body.

Desmopressin is used to treat

• Central diabetes insipidus (a pituitary disorder that causes constant thirst and the continuous elimination of very diluted urine (usually pale and similar to water).
• Nocturnal enuresis in children from 5 years of age with normal ability to concentrate urine (urinary incontinence during the night).
• Nocturia (a situation in which a person wakes up frequently during the night to urinate) in adults under 65 years of age.

2. What you need to know before you take Desmopresina Aristo

Do not take Desmopresina Aristo:

• if you are allergic to desmopressin or any of the other components of this medicine (listed in section 6);
• if you have habitual polydipsia (excessive prolonged thirst), heart failure, and other diseases that require treatment with diuretics;
• if you have moderate or severe renal impairment;
• if you have known hyponatremia (sodium deficiency in the blood),
• if you cannot respect fluid restriction;
• if you have altered hormonal secretion (so-called SIADH);
• if you are over 65 years of age and suffer from nocturia (see section 1);
• if your child is under 5 years of age and suffers from nocturnal enuresis (see section 1).

Warnings and precautions

Consult your doctor or pharmacist before starting to take desmopressin.

Treatment of enuresis (nocturnal involuntary urination) in children begins with lifestyle measures and a nocturnal enuresis alarm (a device that emits a sound or vibrates when wet). If these measures fail or pharmacological treatment is necessary, treatment with desmopressin may be initiated.

Consult your doctor before using desmopressin

• if you suffer from coronary artery disease (blood vessels that supply the heart) or arterial hypertension;
• if you have a thyroid disease (gland located in the throat) or adrenal gland disease (gland located above the kidney);
• if during treatment you suffer from a disease that causes fever, vomiting, or diarrhea;
• if during treatment you feel headache, lack of appetite, nausea, vomiting, weight gain, confusion (difficulty understanding words, attention deficit) or convulsions (violent and involuntary contractions of one or more limbs); these symptoms may be signs of a dangerous disease known as hyponatremia (low sodium levels in the blood)

• for the treatment of central diabetes insipidus: you should reduce water intake and consult your doctor immediately. Your doctor will reduce the doses or interrupt treatment for a few hours;
• for the treatment of enuresis or nocturia: you should interrupt treatment, reduce fluid intake, and consult your doctor immediately.

• if you have a risk of increased pressure inside the cranial cavity.

When using this medicine for enuresis or nocturia, reduce fluid intake to a minimum 1 hour before taking a tablet until 8 hours after taking this medicine.

Desmopressin should be used with caution in patients with fluid imbalance. Consult your doctor if, in relation to an acute illness, you have altered fluid and/or electrolyte balance.

Children

In children, the use of this medicine should be carried out under adult supervision.

Do not administer this medicine to children under 5 years of age.

Other medicines and Desmopresina Aristo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of desmopressin may be increased, with a greater risk of fluid retention, if taken at the same time as certain medicines used to treat

• depression (tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors));
• psychosis (such as chlorpromazine);
• epilepsy (such as carbamazepine);
• diabetes (sulfonylureas, such as chlorpropamide);
• diarrhea (e.g., loperamide);
• pain and inflammation (non-steroidal anti-inflammatory drugs (NSAIDs)).

The effect of desmopressin may decrease if taken at the same time as certain medicines for:

• symptoms due to gas accumulation (such as dimethicone).

Taking desmopressin with drinks

If you are taking this medicine for enuresis or nocturia, you should limit fluid intake from 1 hour before taking a tablet until 8 hours after taking it.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Experience with the use of desmopressin during pregnancy is limited.

Desmopressin passes into breast milk, but it is unlikely to affect breastfed babies.

Driving and using machines

Desmopressin has no effects that may affect the ability to drive and use machines.

Desmopresina Aristo contains lactose(a type of sugar)

Patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Desmopresina Aristo contains sodium

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

3. How to take Desmopresina Aristo

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The dose will be determined by your doctor, who will adjust the dose according to each patient's response.

Desmopressin should always be taken at the same time.

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

Central diabetes insipidus

The recommended dose for adults and children is 1 or 2 tablets under the tongue (60 micrograms tablet) 3 times a day.

Primary nocturnal enuresis

The recommended dose is 1-2 tablets (120 micrograms) under the tongue at night. You should take this medicine at bedtime. You should limit fluid intake.

Your doctor will check every three months if you should continue treatment. Your doctor may establish a treatment-free period of at least one week.

Nocturia in adults

The recommended dose is 1 tablet (60 micrograms tablet) under the tongue at bedtime.

You should limit fluid intake.

Use in children

This medicine is used for the treatment of diabetes insipidus and nocturnal enuresis (see above for dosing for different treatments). The dose is the same for children and adults only for diabetes insipidus.

If you take more Desmopresina Aristo than you should

If you take more medicine than you should or if, for example, a child has taken it accidentally, contact a doctor, hospital, or pharmacist immediately for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Desmopresina Aristo

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

If you stop taking Desmopresina Aristo

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you do not limit fluid intake according to the above instructions, abnormal amounts of fluid may accumulate in the body, which may cause headaches, stomach pain, nausea/vomiting, weight gain, dizziness, confusion, discomfort, feeling of vertigo, and, in severe cases, convulsions and coma. These symptoms may give rise to more or less significant fluid retention. They usually appear with high doses of desmopressin and disappear when the dose is reduced.

Adults

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

• Headache.

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

• Low sodium levels in the blood.
• Dizziness.
• Arterial hypertension.
• Stomach pain.
• Nausea.
• Diarrhea.
• Constipation.
• Vomiting.
• Discomfort in the bladder and urethra.
• Swelling of hands, arms, feet, or legs.
• Fatigue.

Uncommon(may affect up to 1 in 100 people)

• Insomnia.
• Somnolence.
• Numbness.
• Visual disturbances.
• Feeling of vertigo.
• Palpitations.
• Low blood pressure when standing up.
• Shortness of breath.
• Stomach discomfort (indigestion, flatulence, bloating).
• Sweating.
• Itching.
• Rash.
• Urticaria.
• Muscle spasms.
• Muscle pain.
• Chest pain.
• Flu-like symptoms.
• Weight gain.
• Increased liver enzymes.
• Low potassium levels in the blood.

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

• Confusion.
• Rash.

Frequency not known(frequency cannot be estimated from the available data)

• Anaphylactic reaction (severe allergic reaction).
• Dehydration.
• High sodium levels in the blood.
• Convulsions.
• Weakness.
• Coma.

Children

Common(may affect up to 1 in 10 people)

• Headache.

Uncommon(may affect up to 1 in 100 people)

• Rapid mood changes.
• Aggression.
• Nausea.
• Stomach pain.
• Vomiting.
• Diarrhea.
• Discomfort in the bladder and urethra.
• Swelling of hands and feet.
• Fatigue.

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

• Anxiety.
• Nightmares.
• Mood changes.
• Somnolence.
• Arterial hypertension.
• Irritability.

Frequency not known(frequency cannot be estimated from the available data)

• Anaphylactic reaction (severe allergic reaction).
• Low sodium levels in the blood.
• Abnormal behavior.
• Mood changes.
• Depression.
• Hallucinations.
• Insomnia.
• Attention deficit.
• Psychomotor hyperactivity.
• Cramps.
• Nosebleeds.
• Rash.
• Exanthema.
• Sweating.
• Urticaria.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Desmopresina Aristo

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Desmopresina Aristo

• The active substance is desmopressin. Each tablet contains 60 micrograms of desmopressin (as desmopressin acetate).

• The other ingredients (excipients) are:

lactose monohydrate, corn starch, citric acid (E 330), sodium croscarmellose (E 468), magnesium stearate (E 470b).

Appearance and packaging

White or almost white, round, biconvex tablets, marked with the inscription "I" on one face and smooth on the other, with a diameter of 6.5 mm and a thickness of 2 mm.

Desmopressin tablets are presented in cardboard boxes containing:

• OPA/Al/PVC/PE-Al blisters with integrated desiccant in packs of 30, 90, and 100 sublingual tablets or,
• perforated unit-dose blisters with 30 x 1, 90 x 1, or 100 x 1 sublingual tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin,

Germany

Manufacturer

Adalvo Ltd.

Malta Life Sciences Park,

Building 1, Level 4, Sir Temi Zammit Buildings,

San Gwann, SGN 3000 Malta

Haupt Pharma Münster GmbH

Schleebruggenkamp 15,

Uppenberg

Münster

North Rhine-Westphalia

D-48159, Germany

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin,

Germany

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Iceland Desmopressin Aristo

Austria Desmopressine Aristo

Czech Republic Desmopressin Aristo

Germany Desmopressin Aristo

Denmark Desmopressin Aristo

Italy Desmopressina Aristo

Norway Desmopressin Aristo

Portugal Desmopressina Aristo

Sweden Desmopressin Aristo

Spain Desmopresina Aristo 60 micrograms sublingual tablets EFG

Poland Desmopressin Aristo

Date of last revision of this leaflet: October 2024

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