Desmopressin aristo

Package leaflet: Information for the patient

Desmopressin Aristo, 60 micrograms, sublingual tablets
Desmopressin Aristo, 120 micrograms, sublingual tablets
Desmopressin Aristo, 240 micrograms, sublingual tablets
Desmopressinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Desmopressin Aristo is and what it is 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 pack and other information

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

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

• Central diabetes insipidus (a disorder of the pituitary gland leading to excessive thirst and the excretion of large amounts of urine, which is typically very pale and watery).
• Nocturnal enuresis in children aged 5 years and older with normal urine concentration ability (involuntary nighttime urination during sleep).
• Nocturia (a condition in which a sleeping person frequently wakes up at night to pass urine) in adult patients under 65 years of age.

2. Important information before taking Desmopressin Aristo

When not to take Desmopressin Aristo

• if the patient is allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has polydipsia (excessive fluid intake); suffers from heart failure or other conditions requiring treatment with diuretics;
• if the patient has moderate or severe kidney function impairment;
• if the patient has low blood sodium levels;
• if the patient has hormonal disorders (so-called SIADH, syndrome of inappropriate antidiuretic hormone secretion);
• if the patient is over 65 years of age and is being treated for nocturia (see section 1);
• if the patient is a child under 5 years of age diagnosed with nocturnal enuresis (bedwetting) (see section 1).

Warnings and precautions
Treatment of nocturnal enuresis (involuntary nighttime urination) in children should begin with
lifestyle modifications and the use of a bedwetting alarm (a device that sounds or vibrates when
wetness is detected). If these measures are ineffective or pharmacological treatment is required,
treatment with desmopressin may be initiated.
Before starting Desmopressin Aristo, discuss the following with your doctor or
pharmacist:

• if the patient has coronary artery disease (disease of blood vessels supplying the heart) or high blood pressure;
• if the patient has thyroid gland (gland in the throat) or adrenal gland (gland above the kidney) disorders;
• if the patient develops a medical condition with fever, vomiting, or diarrhoea during treatment;
• if the patient experiences headache, loss of appetite, nausea, vomiting, weight gain, confusion (difficulty understanding words, difficulty concentrating), or seizures (sudden and involuntary contractions of one or more limbs) during treatment; these symptoms may indicate a dangerous condition called hyponatraemia (low blood sodium levels)
  • in the treatment of central diabetes insipidus: fluid intake should be restricted and medical advice should be sought immediately. The doctor will reduce the dose or temporarily discontinue treatment for several hours.
  • in the treatment of nocturnal enuresis or nocturia: treatment should be discontinued, fluid intake reduced, and medical advice sought immediately.
• if the patient is at risk of increased intracranial pressure.

During treatment for primary monosymptomatic nocturnal enuresis and nocturia, fluid intake
should be minimized from 1 hour before taking the medicine until 8 hours after taking it.
Desmopressin Aristo should be used with caution in patients with fluid and/or electrolyte imbalance.
Children
This medicine must be administered to children under the supervision of an adult.
This medicine should not be given to children under 5 years of age.
Desmopressin Aristo and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
The effect of Desmopressin Aristo may be enhanced, increasing the risk of excessive fluid retention in the body, if taken concomitantly with certain medicines used to treat:

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

The effect of Desmopressin Aristo may be reduced if taken concomitantly with certain medicines used to treat:

• stomach gas (such as simethicone).

Desmopressin Aristo and drinking
If the patient is taking this medicine for nocturnal enuresis or nighttime urination, fluid intake should be restricted from 1 hour before taking the tablet until 8 hours after taking the tablet.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using 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 infant.
Driving and operating machinery
Desmopressin Aristo has no effect or a negligible effect on the ability to drive and operate machinery.
Desmopressin Aristo contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
Desmopressin Aristo contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, meaning the medicine is considered "sodium-free".

3. How to take Desmopressin Aristo

This medicine should always be taken as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The dose will be determined by the doctor, who will adjust it individually for each patient.
Desmopressin Aristo tablets should always be taken at the same time each day.
The sublingual tablet should be placed under the tongue, where it will dissolve without the need to
drink water.

Diabetes insipidus
The recommended dose for adults and children is 1 to 2 sublingual tablets (60 microgram tablet) 3 times
daily.

Nocturnal enuresis
The recommended dose is 1 to 2 tablets (120 microgram tablet) taken sublingually at bedtime. This medicine should
be taken before going to sleep. Fluid intake should be restricted.
Your doctor will monitor you every three months to assess whether treatment should continue. Your doctor may
recommend interrupting treatment for at least one week.

Nocturnal enuresis in adult patients
The recommended dose is 1 tablet (60 microgram tablet) taken sublingually at bedtime.
Fluid intake should be restricted.

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

If you take more Desmopressin Aristo than you should
If you have taken more medicine than prescribed, or if, for example, a child has accidentally swallowed the tablet,
contact your doctor, hospital, or pharmacist immediately for risk assessment 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 reduced sodium concentration in the blood. Symptoms of severe fluid retention
include seizures and loss of consciousness.

If you forget to take Desmopressin Aristo
Do not take a double dose to make up for a missed tablet.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

Stopping Desmopressin Aristo
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If fluid intake is not restricted according to the recommendations above, abnormal amounts of fluid may accumulate in the body, which may lead to: headache, abdominal pain, nausea or vomiting, weight gain, dizziness, confusion, malaise, sensation of spinning; in severe cases, seizures and coma may occur.
These symptoms may reflect mild to significant water retention. They usually occur with high doses of Desmopressin Aristo and resolve upon dose reduction.

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

• Headache

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

• Low blood sodium levels
• Dizziness
• High blood pressure
• Abdominal pain
• Nausea
• Diarrhoea
• Constipation
• Vomiting
• Discomfort in the bladder and urethra
• Swelling of hands, arms, feet or legs
• Fatigue

Uncommon (may affect less than 1 in 100 people):

• Difficulty falling asleep
• Drowsiness
• Tingling
• Visual disturbances
• Vertigo (sensation of spinning)
• Palpitations
• Low blood pressure upon standing from lying down (orthostatic hypotension)
• Shortness of breath
• Stomach problems (indigestion, gas, bloating)
• Sweating
• Itching
• Rash
• Urticaria
• Muscle cramps
• Muscle pain
• Chest pain
• Influenza-like symptoms
• Weight gain
• Increased liver enzyme activity
• Low blood potassium levels

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

• Confusion
• Allergic dermatitis

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

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

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

• Headache

Uncommon (may affect less than 1 in 100 people):

• Emotional instability
• Aggression
• Nausea
• Abdominal pain
• Vomiting
• Diarrhoea
• 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
• Drowsiness
• High blood pressure
• Irritability

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

• Anaphylactic reaction (severe allergic reaction)
• Low blood sodium levels
• Unusual behaviour
• Emotional disturbances
• Depression
• Hallucinations
• Sleep disturbances
• Attention disorders
• Increased muscle movements
• Cramps
• Nosebleeds
• Rash
• Allergic dermatitis
• Sweating
• Urticaria

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Desmopressin Aristo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, label, carton,
or bottle after EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture. There are no special
storage temperature requirements for this medicine.
Medicines must 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. Package contents and other information

What Desmopressin Aristo contains

• The active substance is desmopressin.

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

• Other ingredients are: monohydrate lactose, maize starch, citric acid, sodium croscarmellose, magnesium stearate.

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

Marketing Authorisation Holder and Manufacturer

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

Manufacturers:
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 medicinal product is authorised in the European Economic Area countries 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 microgramos comprimidos sublinguales EFG
Iceland Desmopressin Aristo
Germany Desmopressin Aristo
Norway Desmopressin Aristo
Poland Desmopressin Aristo
Portugal Desmopressina Aristo
Sweden Desmopressin Aristo
Italy Desmopressina Aristo