Desmopressin Aristo

Leaflet attached to the packaging: patient information

Desmopressin Aristo, 60 micrograms, sublingual tablets

Desmopressin Aristo, 120 micrograms, sublingual tablets

Desmopressin Aristo, 240 micrograms, sublingual tablets

Desmopressin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Desmopressin Aristo and what is it used for
• 2. Important information before taking Desmopressin Aristo
• 3. How to take Desmopressin Aristo
• 4. Possible side effects
• 5. How to store Desmopressin Aristo
• 6. Contents of the packaging and other information

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

Desmopressin, the active substance of Desmopressin Aristo, works similarly to the natural hormone vasopressin and regulates the kidneys' ability to concentrate urine. Desmopressin Aristo is used to treat:

• Central diabetes insipidus (a pituitary disorder leading to strong thirst and excretion of large amounts of urine, which is usually very light and resembles water).
• Nocturnal enuresis in children aged 5 years and older with normal urine concentration ability (involuntary nocturnal urination during sleep).
• Nocturia (a condition in which a sleeping person often wakes up at night to urinate) in adult patients under 65 years of age.

2. Important information before taking Desmopressin Aristo

When not to take Desmopressin Aristo

Warnings and precautions

Treatment of nocturnal enuresis in children should be started with changes in lifestyle and a nocturnal enuresis alarm (a device that makes a sound or vibrates when it gets wet). If these measures do not help or pharmacological treatment is required, desmopressin treatment can be started.
Before starting Desmopressin Aristo, the patient should discuss it with their doctor or pharmacist:

• in the treatment of central diabetes insipidus: fluid intake should be limited and the doctor should be consulted immediately. The doctor will reduce the dose or interrupt treatment for a few hours.
• in the treatment of nocturnal enuresis or nocturia: treatment should be discontinued, fluid intake limited, and the doctor consulted immediately.

During treatment for primary nocturnal enuresis and nocturia, fluid intake should be limited to a minimum from 1 hour before taking the medicine to 8 hours after taking it.
Desmopressin Aristo should be used with caution in patients with fluid and/or electrolyte imbalance.
Children
The use of this medicine in children must be under adult supervision.
This medicine must not be given to children under 5 years of age.

Desmopressin Aristo and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
The effect of Desmopressin Aristo may be enhanced, with a greater risk of excessive fluid retention in the body, if the medicine is taken at the same time as certain medicines used to treat:

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

The effect of Desmopressin Aristo may be reduced if the medicine is taken at the same time as certain medicines used to treat:

• gas in the stomach (such as simethicone).

Desmopressin Aristo with drinking

If the patient is taking this medicine for nocturnal enuresis or nocturia, they should limit fluid intake from 1 hour before taking the tablet to 8 hours after taking the tablet.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Experience with the use of desmopressin during pregnancy is limited.
Desmopressin Aristo passes into breast milk, but it is unlikely to affect the breastfed child.

Driving and using machines

Desmopressin Aristo has no influence or negligible influence on the ability to drive and use machines.
Desmopressin Aristo contains lactose (a type of sugar).If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
Desmopressin Aristo contains sodium.The medicine contains less than 1 mmol (23 mg) of sodium per sublingual tablet, which means the medicine is considered "sodium-free".

3. How to take Desmopressin Aristo

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The dose is determined by the doctor, who will adjust it individually for the patient.
Desmopressin Aristo should always be taken at the same time.
The sublingual tablet should be placed under the tongue, where it will dissolve without the need to drink water.
Central diabetes insipidus
The recommended dose for adults and children is 1 to 2 tablets (60 micrograms) under the tongue 3 times a day.
Nocturnal enuresis
The recommended dose is 1 to 2 tablets (120 micrograms) under the tongue at night. The medicine should be taken before sleep. Fluid intake should be limited.
The attending doctor will check every three months to assess whether treatment should be continued. The doctor may recommend interrupting treatment for at least one week.
Nocturia in adult patients
The recommended dose is 1 tablet (60 micrograms) under the tongue at night.
Fluid intake should be limited.

Use in children

This medicine is used to treat central diabetes insipidus and nocturnal enuresis (see dosing for different treatment conditions above). The dosing in children is the same as in adult patients.

Taking a higher dose of Desmopressin Aristo than recommended

If the patient has taken more medicine than they should or if, for example, a child has accidentally swallowed the medicine, they should immediately contact a doctor, hospital, or pharmacist for assessment of the risk and advice.
Taking too many Desmopressin Aristo tablets may prolong the effect of the medicine and increase the risk of fluid retention in the body and decreased sodium levels in the blood. Symptoms of severe fluid retention include seizures and loss of consciousness.

Missing a dose of Desmopressin Aristo

The patient should not take a double dose to make up for a missed tablet.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

Stopping Desmopressin Aristo treatment

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Desmopressin Aristo can cause side effects, although not everybody gets them.
If fluid intake is not limited as recommended, incorrect amounts of fluid may accumulate in the body, leading to: headaches, abdominal pain, nausea or vomiting, weight gain, dizziness, disorientation, malaise, feeling of spinning, and in severe cases, seizures and coma.
These symptoms may reflect more or less significant water retention. They usually occur with high doses of Desmopressin Aristo and disappear after 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
• High blood pressure
• Abdominal pain
• Nausea
• Diarrhea
• Constipation
• Vomiting
• Discomfort in the bladder and urethra
• Swelling of the hands, arms, feet, or legs
• Fatigue.

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

• Difficulty sleeping
• Drowsiness
• Numbness
• Visual disturbances
• Dizziness of labyrinthine origin (feeling of spinning)
• Palpitations
• Low blood pressure when standing up from a lying to a standing position
• Shortness of breath
• Gastrointestinal problems (indigestion, gas, bloating)
• Sweating
• Itching
• Rash
• Hives
• Muscle cramps
• Muscle pain
• Chest pain
• Flu-like symptoms
• Weight gain
• Increased liver enzyme activity
• Low potassium levels in the blood.

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

• Disorientation
• Allergic skin inflammation.

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

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

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

• Headache.

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

• Emotional instability
• Aggression
• Nausea
• Abdominal pain
• Vomiting
• Diarrhea
• Discomfort in the bladder and urethra
• Swelling of the hands and feet
• Fatigue.

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

• Anxiety
• Nightmares
• Mood changes
• Drowsiness
• High blood pressure
• 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
• Emotional disorders
• Depression
• Hallucinations
• Sleep disorders
• Attention disorder
• Increased muscle activity
• Cramps
• Nosebleeds
• Rash
• Allergic skin inflammation
• Sweating
• Hives.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Desmopressin Aristo

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, label, carton, or bottle after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture. There are no special precautions for storage temperature.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Desmopressin Aristo contains

• The active substance is desmopressin.

Desmopressin Aristo, 60 micrograms, sublingual tablets
Each tablet contains 60 micrograms of desmopressin (as desmopressin acetate).
Desmopressin Aristo, 120 micrograms, sublingual tablets
Each tablet contains 120 micrograms of desmopressin (as desmopressin acetate).
Desmopressin Aristo, 240 micrograms, sublingual tablets
Each tablet contains 240 micrograms of desmopressin (as desmopressin acetate).

• The other ingredients are: lactose monohydrate, cornstarch, citric acid, sodium croscarmellose, magnesium stearate.

What Desmopressin Aristo looks like and contents of the pack

Desmopressin Aristo, 60 micrograms, sublingual tablet
White or almost white, round, biconvex tablet with "I" embossed on one side and smooth on the other, 6.5 mm in diameter and 2 mm thick.
Desmopressin Aristo, 120 micrograms, sublingual tablet
White or almost white, octagonal, biconvex tablet with "II" embossed on one side and smooth on the other, 6.5 mm in length/width and 2 mm thick.
Desmopressin Aristo, 240 micrograms, sublingual tablet
White or almost white, square, biconvex tablet with "III" embossed on one side and smooth on the other, 6 mm in length/width and 2 mm thick.
Desmopressin Aristo is supplied in a cardboard box with blisters OPA/Aluminum/PVC/PE/Aluminum with a desiccant, containing 30 sublingual tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
tel: +48 22 855 40 93

Manufacturer:

Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15,
D-48159 Münster
Germany
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000
Malta

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Desmopressine Aristo
Czech Republic
Desmopressin Aristo
Denmark Desmopressin Aristo
Spain
Desmopresina Aristo 60/120/240 micrograms comprimidos sublinguales EFG
Iceland Desmopressin Aristo
Germany Desmopressin Aristo
Norway Desmopressin Aristo
Poland Desmopressin Aristo
Portugal
Desmopressina Aristo
Sweden
Desmopressin Aristo
Italy
Desmopressina Aristo

Date of last revision of the leaflet: October 2024