Desmopressin Mylan

Italy
Brand name Desmopressin Mylan
Form powder, sublingual
Active substance / Dosage
DESMOPRESSIN ACETATE
Prescription type Prescription only
ATC code
H01BA02
Registration number 052582
Manufacturer MYLAN S.P.A.

Table of Contents

Patient Information Leaflet: Information for the User

Desmopressin Mylan 60 micrograms sublingual lyophilisate, 120 micrograms sublingual lyophilisate, 240 micrograms sublingual lyophilisate

desmopressin
Equivalent medicine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Desmopressina Mylan is and what it is used for

This medicine contains desmopressin. Desmopressin is similar to the natural antidiuretic hormone (ADH) and reduces urine production.
Desmopressin is used to treat:

  • primary nocturnal enuresis ( involuntary loss of urine during the night ) in patients aged 6 years and older with normal urine concentrating ability, when organic disorders of the urinary tract have been ruled out, as part of a comprehensive therapeutic approach, or when caused by a nocturnal deficiency of ADH (antidiuretic hormone deficiency).
  • nocturia associated with nocturnal polyuria ( frequent urination at least twice per night , due to increased urine production during the night) in adults up to 65 years of age.
  • a chronic condition called central diabetes insipidus (a disease causing intense thirst and increased production of diluted urine, in which ADH production in the brain is impaired).

2. What you need to know before taking Desmopressina Mylan

Do not take Desmopressina Mylan

  • if you are allergic to desmopressin acetate or to any of the other ingredients of this medicine (listed in section 6)
  • if you suffer from habitual polydipsia (chronic excessive fluid intake) or psychogenic polydipsia (mental urge to drink excessive fluids and increased fluid intake)
  • if the patient is unable to comply with fluid restriction and has severe cognitive impairment, dementia, or a neurological disease
  • if you suffer from polydipsia and are an alcoholic
  • if you have known or suspected heart failure
  • if you have other conditions being treated with diuretics (water tablets)
  • if you have hyponatremia (low levels of sodium in the blood)
  • if you have moderate or severe renal impairment
  • if you have diseases associated with increased secretion of ADH (syndrome of inappropriate antidiuretic hormone secretion)
  • if the patient being treated for nocturnal enuresis is under 6 years of age
  • for treating nocturia (frequent nighttime urination) if you are 65 years of age or older.

Avoid drinking large amounts of fluids during treatment with desmopressin, as excessive fluid intake may cause water accumulation in tissues (fluid retention) and disturbances in electrolyte balance, particularly in elderly patients, depending on their general condition.
This may lead to headache, nausea/vomiting, weight gain and, in more severe cases, muscle cramps, sometimes accompanied by drowsiness or even prolonged unconsciousness (see also section 4, “Possible side effects”).

Warnings and precautions
When treating primary nocturnal enuresis and nocturia (involuntary loss of urine at night and frequent nighttime urination), you must drink as little fluid as possible from 1 hour before taking the medicine until the following morning (at least 8 hours after taking the medicine).
In addition, it is recommended to empty the bladder before administration.
Without this fluid restriction, fluid retention and/or disturbances in electrolyte balance may occur, which can happen with or without warning signs and may lead to symptoms such as headache, nausea/vomiting, weight gain and, in more severe cases, cerebral edema, sometimes associated with seizures and/or altered consciousness or even loss of consciousness. If these symptoms occur, in the indications of isolated nocturnal enuresis in children and nocturia in adults, treatment must be stopped and blood electrolyte analysis should be performed to measure serum sodium levels. If treatment is resumed, fluid intake must be more strictly limited.
Patients whose serum sodium levels are at the lower end of the normal range are at higher risk of developing hyponatremia.
All patients, caregivers and, where applicable, nursing staff must ensure that fluid intake is limited.
Ensure that administration in children occurs under adult supervision.

Talk to your doctor or pharmacist before taking desmopressin:

  • If you have mild renal impairment (kidney function).
  • If you have bladder problems or reduced urine output.
  • If you are elderly and/or already have low sodium levels in the blood, as you are at higher risk of developing hyponatremia (very low sodium levels).
  • If you develop an illness that could alter fluid and/or electrolyte balance, such as fever or diarrhea, your doctor may discontinue treatment with Desmopressina Mylan.
  • If you are at risk of increased intracranial pressure (a condition your doctor will discuss with you).

To avoid extremely low sodium levels in the blood, drink as little fluid as possible. In addition, your doctor will monitor your blood sodium levels more frequently if you are taking medicines that cause SIADH, such as certain medicines for depression, epilepsy or diabetes (see section “Other medicines and Desmopressina Mylan”) or if you are taking medicines for rheumatic diseases.

Other medicines and Desmopressina Mylan
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important to inform your doctor if you are taking any of the following medicines, as they may increase the effect of desmopressin. This increases the risk of overhydration and low sodium levels in the blood. These include:

  • certain medicines for depression (tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine)
  • medicines for epilepsy (e.g. carbamazepine)
  • certain medicines for diabetes (e.g. sulfonylureas such as chlorpropamide and glibenclamide)
  • medicines used to treat diarrhea (e.g. loperamide) or other medicines that slow gastrointestinal transit
  • medicines for rheumatic diseases, to treat pain and/or inflammation (non-steroidal anti-inflammatory drugs - NSAIDs - such as indomethacin or ibuprofen)
  • a medicine that lowers blood lipid levels called clofibrate
  • a medicine that stimulates labor (e.g. oxytocin), as blood flow to the uterus may be reduced.

Desmopressina Mylan with food, drinks and alcohol
Taking Desmopressina Mylan with food may reduce its effect and duration of action.
All patients, caregivers and, where applicable, nursing staff must ensure that fluid intake, including alcoholic beverages, is limited.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, your doctor will carefully evaluate the benefit-risk balance before prescribing this medicine. Your doctor will also monitor your blood pressure during treatment.
Desmopressin may be used during breastfeeding, according to your doctor’s recommendations.
This medicine passes into breast milk in small amounts. When used at recommended doses, it is unlikely that desmopressin will have effects on the breastfed newborn.

Driving and using machines
Desmopressina Mylan does not affect or has negligible effects on the ability to drive vehicles and use machinery.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Desmopressina Mylan

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you experience signs of fluid retention and/or low sodium levels in the blood (headache, fluid retention in tissues, nausea/vomiting, weight gain, and in more severe cases, cramps), stop treatment immediately and contact your doctor. When your doctor advises resuming treatment after full recovery, you must strictly limit fluid intake. Your doctor will closely monitor your blood sodium levels.

Use in the elderly
Desmopressin is not recommended in elderly patients. If your doctor decides to start treatment anyway, they will monitor your blood sodium levels at specific intervals.

Recommended dose:

  • Primary nocturnal enuresis (involuntary loss of urine during the night)
    To treat involuntary loss of urine at night, an initial dose of 120 micrograms taken before bedtime is recommended (2 sublingual lyophilisates of desmopressin 60 micrograms each, or 1 sublingual lyophilisate of desmopressin 120 micrograms). The treatment should be taken as a single evening dose.
    If the response is inadequate, your doctor may increase the dose to 240 micrograms (2 sublingual lyophilisates of desmopressin 120 micrograms each, or 1 sublingual lyophilisate of desmopressin 240 micrograms). Do not increase the dose without first consulting your doctor. Make sure to limit fluid intake.
    In children with isolated nocturnal enuresis, it is recommended that urinary frequency, fluid intake times, and the number of nights with enuresis are recorded over a 48-hour and 7-day period respectively before starting treatment.
    If the desired clinical effect is not achieved within 4 weeks after determining the minimum effective dose, treatment must be discontinued.

  • Nocturia (increased nighttime urination) due to increased urine production during the night
    To treat nocturia, an initial dose of 60 micrograms of desmopressin before bedtime is recommended (1 sublingual lyophilisate containing 60 micrograms).
    If this dose is insufficient, your doctor may increase it to 120 micrograms after one week (2 sublingual lyophilisates of desmopressin 60 micrograms each, or 1 sublingual lyophilisate of desmopressin 120 micrograms), and then weekly up to 240 micrograms (2 sublingual lyophilisates of desmopressin 120 micrograms each, or 1 sublingual lyophilisate of desmopressin 240 micrograms). Fluid intake during the night must be minimized as much as possible (see section 2 “What you need to know before taking Desmopressina Mylan”).
    In patients with nocturia, a voiding diary assessing frequency and volume of urination must be kept for at least 2 days before starting treatment to diagnose nocturnal polyuria.
    If the desired clinical effect is not achieved within 4 weeks after determining the minimum effective dose, treatment must be discontinued.
    Before starting treatment, your doctor will discuss necessary measures with you. You should allow at least 48 hours to implement these measures. Record the time of each urination and measure the amount of urine passed. Your doctor will also check your blood sodium levels before starting treatment.
    At the beginning of treatment and after each dose increase, monitor and record your body weight for several days.

  • Central diabetes insipidus (a condition characterized by increased water excretion due to impaired ADH production in the brain).
    o The daily dose is usually between 120 micrograms (2 sublingual lyophilisates of desmopressin 60 micrograms each, or 1 sublingual lyophilisate of desmopressin 120 micrograms) and 720 micrograms (3 sublingual lyophilisates of desmopressin 240 micrograms each).
    o The initial dose should be 60 micrograms (1 sublingual lyophilisate of desmopressin 60 micrograms) three times daily, but may vary depending on age and will be adjusted based on the patient’s urine output.
    o The maintenance dose for most patients is 60–120 micrograms (1–2 sublingual lyophilisates of desmopressin 60 micrograms) three times daily. Your doctor will individually adjust the dosage based on treatment response.
    The effective dose thus determined is also the maintenance dose. Your doctor will establish it individually, and you must take it for the entire duration of treatment.

Treatment monitoring
In all cases, dose adjustments should be gradual, allowing sufficient time between each dose level.
It is recommended to monitor body weight in the days following the start of treatment or any dose increase. A rapid and significant weight gain may indicate excessive fluid retention.

Duration of treatment
After a maximum treatment period of 3 months, your doctor will plan a treatment-free period of at least 1 week to assess whether recovery has occurred or whether continued treatment is necessary.
In some cases, treatment with desmopressin may be reconsidered; in such cases, the same rules for starting and stopping treatment apply as at initial administration.
The duration of treatment at the minimum effective dose, determined after dose adjustment, is limited to 3 months and may be renewed once.

Method of administration
Desmopressin is placed under the tongue, where it dissolves.
To remove the sublingual lyophilisate from the blister:

  • Lift the edge of the foil;
  • Completely peel off the foil;
  • Turn the blister over to allow the sublingual lyophilisate to fall out;
  • Remove the sublingual lyophilisate from the blister.

Do not push the sublingual lyophilisate through the foil.

If you take more Desmopressina Mylan than you should
If you have taken more desmopressin than you should, contact your doctor, pharmacist, or nearest hospital immediately.
Pay particular attention to signs of overhydration (water intoxication). This can occur even if you are taking desmopressin and have consumed excessive fluids.
Symptoms include weight gain, headache, nausea, and in more severe cases, seizures, sometimes associated with reduced consciousness or even loss of consciousness (see also “Possible side effects”).

If you forget to take Desmopressina Mylan
In cases of primary nocturnal enuresis and nocturia, do not delay taking desmopressin. Continue taking the medicine as usual the next day.
In cases of central diabetes insipidus, take the missed dose as soon as you remember. Maintain the usual time interval until the next scheduled dose.
Do not take a double dose to make up for the missed dose.

If you stop taking Desmopressina Mylan
You should only stop or suspend treatment after consulting your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and consult your doctor immediately if you experience any of the following
serious side effects:

  • Fluid accumulation in the tissues (fluid retention)/disturbance of mineral balance (hyponatraemia), with or without warning signs and concomitant symptoms (headache, nausea/vomiting, weight gain and, in more severe cases, cramps, sometimes with drowsiness or even prolonged unconsciousness). This may occur following treatment without concomitant restriction of fluid intake.

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

  • headache

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

  • low levels of sodium in the blood
  • dizziness
  • high blood pressure
  • nausea
  • abdominal pain
  • diarrhoea
  • constipation
  • vomiting
  • bladder and urethral disorders
  • fluid retention in tissues
  • fatigue

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

  • insomnia
  • drowsiness
  • numbness
  • reduced vision (visual impairment)
  • dizziness
  • rapid heartbeat
  • reduction in blood pressure (orthostatic hypotension)
  • difficulty breathing
  • discomfort in the upper abdomen (dyspepsia)
  • bloated stomach (flatulence)
  • feeling of fullness
  • sweating
  • itchy skin
  • rash
  • itchy hives (urticaria)
  • muscle cramps
  • muscle pain
  • general weakness (malaise)
  • chest pain
  • influenza-like symptoms
  • weight gain
  • increased liver values
  • reduced levels of potassium in the blood

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

  • confusion
  • allergic-inflammatory skin disorders

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

  • acute hypersensitivity reaction (anaphylactic reaction)
  • decrease in body water
  • increase in sodium levels in the blood
  • seizures
  • weakness
  • unconsciousness (coma)

Side effects in children and adolescents:
Common (may affect up to 1 in 10 people):

  • headache

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

  • mood swings
  • aggression
  • stomach pain
  • nausea
  • vomiting
  • diarrhoea
  • bladder and urethral problems
  • swelling of arms and legs due to fluid retention
  • fatigue

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

  • anxiety symptoms
  • nightmares
  • mood swings
  • drowsiness
  • high blood pressure
  • irritability

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

  • acute hypersensitivity reaction (anaphylactic reaction)
  • reduction in sodium levels in the blood
  • abnormal behaviour
  • emotional disturbances
  • depression
  • hallucinations
  • insomnia
  • attention disorder
  • increased physical activity
  • seizures
  • nosebleeds
  • rash
  • allergic-inflammatory skin reactions
  • sweating
  • itchy hives (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Desmopressin Mylan

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the container or carton after "Exp.". The expiry date refers to the last day of that month.
  • Store below 25°C in the original packaging to protect the medicine from moisture.
  • Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Desmopressin Mylan contains

  • The active substance is 60 micrograms, 120 micrograms, and 240 micrograms of desmopressin as desmopressin acetate.
  • The other excipients are citric acid (E330), trisodium citrate dihydrate (E331), mannitol (E421), and pullulan (E1204).

Description of the appearance of Desmopressin Mylan and contents of the pack
Sublingual lyophilisate, round, white to off-white in colour.
30, 90 or 100 sublingual lyophilisates in blisters (10 sublingual lyophilisates per blister strip)
30, 90 or 100 sublingual lyophilisates in perforated single-dose divisible blister (1 sublingual lyophilisate per blister strip)
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Mylan Germany GmbH
Benzstrasse 1
Bad Homburg
Germany
SANTA SA
Str. Panselelor nr. 25, nr. 27,
and nr. 29, Brasov,
Jud. Brasov – 500419,
Romania
Misom Labs Ltd
Malta Life Sciences Park, LS2.01.06 Industrial Estate, San Gwann SGN 3000,
Malta