Desmopressin Zentiva

Package leaflet: Information for the patient

Desmopressin Zentiva 60 microgram tablets (sublingual), 120 microgram tablets (sublingual), 240 microgram tablets (sublingual)

Equivalent medicinal product
Please read all of this leaflet carefully before taking this medicine, because it contains impor-
tant information for you.

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

Contents of this leaflet

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

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

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

• Central diabetes insipidus (a pituitary disorder causing excessive thirst and the production of large amounts of urine, usually pale and watery).
• Nocturnal enuresis in children aged 5 years and older with normal urine concentrating ability (involuntary urination during sleep at night).
• Nocturia in adults under 65 years of age (a condition in which a person wakes up frequently during the night to urinate).

2. What you need to know before taking Desmopressin Zentiva

Do not take Desmopressin Zentiva:

• if you are allergic to desmopressin or to any of the other ingredients of this medicine (listed in section 6)
• if you have polydipsia (abnormally high fluid intake), heart failure, or other conditions requiring treatment with diuretics
• if you have moderate or severe reduction in kidney function
• if you have low levels of sodium in the blood
• if you are unable to comply with fluid restriction
• if you have a disturbed hormone secretion (so-called SIADH)
• if you are over 65 years old 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
The management of nocturnal enuresis (involuntary nighttime urination) in children begins with lifestyle
measures and a nocturnal enuresis alarm (a device that emits a sound or vibration at the time of urine
leakage). If these measures fail or pharmacological treatment is required, desmopressin treatment may
be initiated. Inform your doctor before using Desmopressin Zentiva:

• if you suffer from coronary heart disease (blood vessels supplying the heart) or hypertension
• if you have a thyroid gland (gland in the throat) or adrenal gland (gland above the kidney) disorder
• if during treatment you develop an illness causing fever, vomiting, or diarrhea
• if during treatment you experience headache, loss of appetite, nausea, vomiting, weight gain, confusion (difficulty understanding words, difficulty concentrating), or seizures (violent, involuntary contractions of one or more limbs); these symptoms may be signs of a dangerous condition known as hyponatremia (low sodium levels in the blood)
  • for the treatment of central diabetes insipidus: reduce water intake and contact a doctor immediately. The doctor will reduce the dose or interrupt treatment for several hours.
  • for the treatment of nocturnal enuresis or nocturia: stop treatment, reduce water intake, and contact a doctor immediately.
• if you are at risk of increased intracranial pressure

When treating nocturnal enuresis or nocturia, fluid intake must be limited to the minimum necessary to
manage thirst during the period from 1 hour before to 8 hours after taking this medicine.
Desmopressin Zentiva should be used with caution in patients with disturbances in fluid balance.
Talk to your doctor if, due to an acute illness, your fluid and/or electrolyte balance is disturbed.
Children
In children, this medicine should be used under the supervision of an adult. Do not give this medicine to
children under 5 years of age.
Other medicines and Desmopressin Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
The effect of Desmopressin Zentiva may be increased, with a higher risk of abnormal fluid retention in the
body, if taken together with certain medicines used to treat:

• depression (such as tricyclic antidepressants, selective serotonin reuptake inhibitors)
• psychosis (such as chlorpromazine)
• epilepsy (such as carbamazepine)
• diabetes (so-called sulfonylureas, e.g., chlorpropamide)
• diarrhea (such as loperamide)
• pain and inflammation (so-called NSAIDs)

The effect of Desmopressin Zentiva may be reduced if taken together with certain medicines for:

• stomach gas (such as dimethicone)

Desmopressin Zentiva with food and drinks
If you are taking this medicine for nocturnal enuresis or nocturia, you must limit fluid intake from 1 hour before taking the tablet until 8 hours after taking it.
The effect of this medicine may be reduced if the tablet is taken with food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Experience with the use of desmopressin during pregnancy is limited. Desmopressin Zentiva passes into breast milk, but is unlikely to affect breastfed infants.
Driving and using machines
Desmopressin Zentiva has no effect or a negligible effect on the ability to drive vehicles and use machinery.
Desmopressin Zentiva contains lactose
Desmopressin Zentiva contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Desmopressin Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.
For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take Desmopressina Zentiva

Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The dose is determined by your doctor, who will adjust it individually for you. Desmopressina Zentiva must always be taken at the same time in relation to food intake.
The sublingual tablet must be placed under the tongue, where it dissolves without water.

Diabetes insipidus
The usual dose for adults and children is 1–2 tablets under the tongue (60 microgram tablet) three times a day.

Nocturnal enuresis
The usual dose is 1–2 tablets (120 microgram tablet) under the tongue in the evening. You must take this medicine before going to bed. Fluid intake must be limited.
Your doctor will review your treatment every three months to determine whether it should continue. Your doctor may establish a treatment-free period of at least one week.

Nocturia in adults
The usual dose is 1 tablet (60 microgram tablet) under the tongue before going to bed. Fluid intake must be limited.

Use in children
This medicine is used for the treatment of diabetes insipidus and nocturnal enuresis (see dosage above for the different conditions being treated). The dosage is the same for children and adults only for diabetes insipidus.

If you take more Desmopressina Zentiva than you should
If you take more medicine than you should, or if, for example, a child accidentally ingests the medicine, contact a doctor, hospital, or pharmacist immediately for risk assessment and advice. Taking too much Desmopressina Zentiva can prolong the effect of this medicine and increase the risk of fluid retention in the body and low sodium levels in the blood. Symptoms of severe fluid retention include seizures and loss of consciousness.

If you forget to take Desmopressina Zentiva
Do not take a double dose to make up for the forgotten tablet. If you have any further questions about the use of this product, ask your doctor or pharmacist.

If you stop taking Desmopressina Zentiva
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.
If fluid intake is not restricted according to the instructions above, abnormal amounts of fluid may
accumulate in the body, which can lead to headache, stomach ache, nausea/vomiting, weight gain,
dizziness, confusion, malaise, spinning sensation, and in severe cases, seizures and coma. These signs
may reflect mild to significant water retention. They usually occur with high doses of Desmopressin Zentiva
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
• Hypertension
• Stomach ache
• Nausea
• Diarrhoea
• Constipation
• Vomiting
• Bladder and urethral discomfort
• Swelling of hands, arms, feet or legs
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Difficulty sleeping
• Drowsiness
• Tingling sensations
• Visual disturbances
• General sensation of spinning (dizziness)
• Awareness of heartbeat
• Low blood pressure when standing up from a lying position
• Shortness of breath
• Stomach disorders (indigestion, flatulence, bloating)
• Sweating
• Itching
• Rash
• Hives
• Muscle spasms
• Muscle pain
• Chest pain
• Influenza-like symptoms
• Weight gain
• Increased liver enzymes
• Low potassium levels in the blood

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

• Confusion
• 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)

• Rapidly changing emotions
• Aggressiveness
• Nausea
• Stomach ache
• Vomiting
• Diarrhoea
• Bladder and urethral discomfort
• Swollen hands and feet
• Fatigue

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

• Anxiety
• Nightmares
• Mood swings
• Drowsiness
• 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 behaviour
• Emotional disorders
• Depression
• Hallucinations
• Difficulty sleeping
• Reduced attention
• Increased muscle movements
• Cramps
• Nosebleeds
• Rash
• Allergic skin inflammation
• Sweating
• Hives

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

5. How to store Desmopressin Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, label, box or bottle after "EXP". The expiry date refers to the last day of that month.
[For blisters]
Store in the original blister pack to protect from moisture. This medicine does not require any special storage temperature.
[For HDPE containers]
Keep in the original packaging. Keep the bottle tightly closed to protect from moisture. Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Desmopressina Zentiva contains
The active substance is desmopressin.
Desmopressina Zentiva 60 micrograms sublingual tablets
Each tablet contains 60 micrograms of desmopressin (as desmopressin acetate).
Desmopressina Zentiva 120 micrograms sublingual tablets
Each tablet contains 120 micrograms of desmopressin (as desmopressin acetate).
Desmopressina Zentiva 240 micrograms sublingual tablets
Each tablet contains 240 micrograms of desmopressin (as desmopressin acetate).

• The other ingredients are: monohydrate lactose, maize starch, citric acid (E 330), sodium croscarmellose (E 468), magnesium stearate (E 470b).

Description of the appearance of Desmopressina Zentiva and contents of the pack
Desmopressina Zentiva 60 micrograms sublingual tablets
White or almost white, round, biconvex tablet, engraved with "I" on one side and flat on the other side, 6.5 mm in diameter and 2 mm thick.
Desmopressina Zentiva 120 micrograms sublingual tablets
White or almost white, octagonal, biconvex tablet, engraved with "II" on one side and flat on the other side, 6.5 mm in length/width and 2 mm thick.
Desmopressina Zentiva 240 micrograms sublingual tablets
White or almost white, square, biconvex tablet, engraved with "III" on one side and flat on the other side, 6 mm in length/width and 2 mm thick.
Desmopressina Zentiva is supplied in a cardboard box containing OPA/Al/PVC/PE-Al blisters with an integrated desiccant layer in packs of 10, 20, 30, 50, 60, 90, or 100 sublingual tablets, or unit-dose perforated blisters of 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1, 90 x 1, and 100 x 1 sublingual tablets. Alternatively, it is supplied in HDPE bottles with PP caps and integrated desiccant containing 30 or 100 sublingual tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15,
D-48159 Münster, Germany
Adalvo Ltd.
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000 Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Iceland, Denmark, Finland, Norway, and Sweden – Desmopressin Zentiva
Italy – Desmopressina Zentiva
France – DESMOPRESSINE ZENTIVA 60 microgrammes, comprime sublingual
DESMOPRESSINE ZENTIVA 120 microgrammes, comprime sublingual
DESMOPRESSINE ZENTIVA 240 microgrammes, comprime sublingual
Portugal (60/120 mcg only) – Desmopressina Zentiva