Minirin Melt

Package Leaflet: Information for the Patient

MINIRIN Melt, 60 micrograms, oral lyophilisate

MINIRIN Melt, 120 micrograms, oral lyophilisate

MINIRIN Melt, 240 micrograms, oral lyophilisate

Desmopressin

Read the package leaflet carefully before taking the medicine, as 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor. See section 4.

Table of Contents of the Package Leaflet:

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

1. What Minirin Melt is and what it is used for

Minirin Melt contains desmopressin, which acts similarly to the natural antidiuretic hormone of the pituitary gland, arginine vasopressin. Desmopressin has a prolonged antidiuretic effect (reducing urine production) and a complete lack of vasoconstrictive effect at therapeutic doses. Minirin Melt is used to treat:

• central diabetes insipidus;
• primary nocturnal enuresis in children over 6 years of age with normal urine concentrating ability;
• nocturia in adults associated with nocturnal polyuria (the volume of urine produced at night exceeds the bladder capacity).

2. Important information before taking Minirin Melt

When not to take Minirin Melt

• if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with psychogenic or habitual polydipsia (excessive thirst);
• if you have heart failure or other conditions requiring the use of diuretics;
• if you have moderate or severe renal impairment with a creatinine clearance below 50 ml/min;
• if you have hyponatremia (low sodium levels in the blood);
• if you have been diagnosed with the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Warnings and precautions

Before starting treatment with Minirin Melt, discuss it with your doctor. Your doctor will exercise caution in the following cases:

• if the medicine is taken with other medicines; see the chapter "Concomitant use of other medicines";
• if you are over 65 years of age;
• if you have low sodium levels in the blood;
• if there is a risk of increased intracranial pressure;
• if you have water and/or electrolyte imbalance.

Before starting treatment, severe urinary bladder dysfunction and obstruction should be ruled out. Particular caution should be exercised in patients with renal impairment and cardiovascular disease. In the event of acute diseases with water and electrolyte disorders, such as generalized infection, febrile diseases, gastroenteritis, the administration of Minirin Melt should be discontinued and consultation with a doctor is necessary.

Children

Minirin Melt is used to treat central diabetes insipidus and primary nocturnal enuresis in children over 6 years of age with normal urine concentrating ability.

Minirin Melt and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor about taking:

• tricyclic antidepressants;
• selective serotonin reuptake inhibitors;
• chlorpromazine;
• carbamazepine;
• oral hypoglycemic agents of the sulfonylurea group, e.g. chlorpropamide;
• non-steroidal anti-inflammatory drugs;
• loperamide.

The above-mentioned medicines may lead to excessive water retention in the body or decreased sodium levels in the blood.

Minirin Melt with food and drink

During treatment of primary nocturnal enuresis in children and nocturia in adults, fluid intake should be limited to a minimum from 1 hour before taking the medicine to 8 hours after taking it. Taking Minirin Melt without restricting fluid intake may lead to excessive water retention in the body or decreased sodium levels in the blood, which may, but does not have to, manifest as headaches, nausea, vomiting, weight gain, or in severe cases, convulsions. The above warning does not apply to patients taking Minirin Melt for the treatment of central diabetes insipidus. Taking the medicine with food may reduce the strength and duration of the medicine's effect.

Minirin Melt in patients with renal and/or hepatic impairment

Before taking the medicine, consult your doctor.

Minirin Melt in elderly patients

It is not recommended to start treatment for nocturia in patients over 65 years of age.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Driving and using machines

Minirin Melt has no influence or negligible influence on the ability to drive and use machines.

3. How to take Minirin Melt

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor. Minirin Melt should be placed under the tongue, where the medicine dissolves without the need for water. Administration of Minirin Melt in the treatment of central diabetes insipidus The doctor determines the dosage individually for each patient, but the total daily dose is usually within the range of 120 to 720 micrograms sublingually. Treatment of children and adults usually starts with 60 micrograms of desmopressin sublingually 3 times a day. The next doses are determined by the doctor depending on the patient's response. In most patients, the maintenance dose is 60 to 120 micrograms of desmopressin sublingually 3 times a day. Administration of Minirin Melt in the treatment of primary nocturnal enuresis in children Usually, treatment starts with a dose of 120 micrograms. The medicine is given sublingually once a day before bedtime. If this dose is insufficient, the doctor may order an increase in the dose to 240 micrograms. Fluid intake should be limited to a minimum from 1 hour before taking the medicine to 8 hours after taking it. After three months of treatment, the doctor should order the discontinuation of the medicine for at least one week and assess whether further treatment is necessary. Administration of Minirin Melt in the treatment of nocturia in adults Usually, treatment starts with a dose of 60 micrograms. The medicine is given sublingually once a day before bedtime. If this dose is not sufficiently effective after one week of use, the doctor may order an increase in the dose to 120 micrograms and then to 240 micrograms, with weekly intervals when increasing the dose. Fluid intake should be limited to a minimum from 1 hour before taking the medicine to 8 hours after taking it.

Overdose of Minirin Melt

Taking a higher dose than recommended increases the risk of excessive water retention in the body or decreased sodium levels in the blood, which may, but does not have to, manifest as headaches, nausea, vomiting, weight gain, or in severe cases, convulsions. If a higher dose than recommended is taken, consult your doctor immediately.

Missed dose of Minirin Melt

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Minirin Melt can cause side effects, although not everybody gets them. In adults:

• Very common side effects(affect more than 1 in 10 people):
• headache.

Common side effects(affect 1 to 10 people in 100):

• hyponatremia (low sodium levels in the blood);
• dizziness;
• hypertension;
• nausea;
• abdominal pain;
• diarrhea;
• constipation;
• vomiting;
• symptoms related to the urinary bladder and urethra;
• edema;
• fatigue.

Uncommon side effects(affect 1 to 10 people in 1,000):

• insomnia;
• drowsiness;
• paresthesia (tingling, pricking, or numbness);
• visual disturbances;
• balance disorders;
• palpitations;
• orthostatic hypotension (decreased blood pressure when changing position from lying to standing);
• shortness of breath;
• indigestion;
• flatulence;
• bloating;
• sweating;
• itching;
• rash;
• hives;
• muscle cramps;
• muscle pain;
• malaise;
• chest pain;
• flu-like symptoms;
• weight gain;
• increased liver enzyme levels;
• hypokalemia (low potassium levels in the blood).

Rare side effects(affect 1 to 10 people in 10,000):

• confusion;
• allergic skin reactions.

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

• anaphylactic reactions;
• dehydration;
• hypernatremia (high sodium levels in the blood);
• seizures;
• weakness;
• coma.

In children and adolescents:

• Common side effects(affect 1 to 10 people in 100):
• headache.

Uncommon side effects(affect 1 to 10 people in 1,000):

• emotional instability;
• aggression;
• abdominal pain;
• nausea;
• vomiting;
• diarrhea;
• symptoms related to the urinary bladder and urethra;
• peripheral edema;
• fatigue.

Rare side effects(affect 1 to 10 people in 10,000):

• restlessness;
• nightmares;
• mood swings;
• drowsiness;
• hypertension;
• irritability.

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

• anaphylactic reactions;
• hyponatremia;
• abnormal behavior;
• emotional disturbances;
• depression;
• hallucinations;
• insomnia;
• attention disorders;
• psychomotor hyperactivity;
• seizures;
• epistaxis;
• allergic skin reactions;
• rash;
• sweating;
• hives.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Minirin Melt

Keep the medicine out of the sight and reach of children. Store in the original package to protect from moisture and light. Do not use this medicine after the expiry date stated on the packaging after the words EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Minirin Melt contains

• The active substance is desmopressin in the amount of 60, 120, or 240 micrograms.
• The other ingredients are: gelatin, mannitol, anhydrous citric acid.

What Minirin Melt looks like and contents of the pack

Minirin Melt 60 micrograms is a white tablet with a marking in the shape of a drop on one side. Minirin Melt 120 micrograms is a white tablet with a marking in the shape of two drops on one side. Minirin Melt 240 micrograms is a white tablet with a marking in the shape of three drops on one side. One pack of Minirin Melt contains 30 or 100 oral lyophilisates.

Marketing authorization holder and manufacturer

Marketing authorization holder: Ferring-Léčiva, a.s., K Rybníku 475, 252-42 Jesenice u Prahy, Czech Republic. Manufacturer: Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. Date of last revision of the leaflet:10/2020. For more detailed information, please contact the representative of the marketing authorization holder. Ferring Pharmaceuticals Poland Sp. z o.o., ul. Szamocka 8, 01-748 Warsaw, Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81

Instructions for removing the lyophilisate from the blister

Lyophilisates are fragile. Do not push them through the blister foil, as this may cause them to crumble. Lyophilisates should be removed from the blister by first removing the aluminum foil, as shown in the diagrams below:

• 1.Tear off the end strip of the blister, starting from the corner with the printed symbol of a hand.

• 2.Tear off the unit of the blister along the perforation.

• 3.Pull back the foil, starting from the corner with the printed arrow, and gently remove the lyophilisate.

• 4.By repeating steps 2 and 3, you can access the next lyophilisate.