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
Desmopressinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Contents of the leaflet:

1. What Minirin Melt is and what it is used for
2. What you need to know 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 pituitary hormone,
arginine vasopressin. Desmopressin has a significantly prolonged antidiuretic effect (reducing urine production) and completely lacks vasoconstrictive activity 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 (nocturnal urine volume exceeds bladder capacity).

2. Important information before using Minirin Melt

When not to use Minirin Melt

• if the patient is allergic to desmopressin acetate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been diagnosed with psychogenic or habitual polydipsia (excessive thirst);
• if the patient has circulatory insufficiency or other conditions requiring treatment with diuretics;
• if the patient has moderate or severe renal impairment with creatinine clearance below 50 ml/min;
• if the patient has hyponatremia (low sodium levels in the blood);
• if the patient has been diagnosed with syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Warnings and precautions
Before starting treatment with Pentasa, discuss this with your doctor.
Your doctor should exercise caution in the following cases:

• if this medicine is used concomitantly with other medicines; see section "Use with other medicines";
• if the patient is over 65 years of age;
• if the patient has low serum sodium levels;
• if increased intracranial pressure may occur;
• if the patient has a disturbance in fluid and/or electrolyte balance.

Before starting treatment, severe bladder dysfunction and infravesical obstruction should be ruled out.
Particular caution should be exercised in patients with renal impairment and cardiovascular diseases.
If acute illnesses with fluid and electrolyte disturbances occur, such as systemic infection, fever-related conditions, or gastroenteritis, treatment with Minirin Melt should be discontinued and medical advice sought.

Children
Minirin Melt is used for the treatment of central diabetes insipidus and primary nocturnal enuresis in children over 6 years of age who have normal urine concentrating ability.

Minirin Melt and other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines planned for future use. In particular, inform your doctor if the patient is taking:
tricyclic antidepressants;
selective serotonin reuptake inhibitors (SSRIs);
chlorpromazine;
carbamazepine;
antidiabetic sulfonylureas, e.g. chlorpropamide;
nonsteroidal anti-inflammatory drugs (NSAIDs);
loperamide.

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

Minirin Melt with food and drink
During treatment of primary nocturnal enuresis in children and nocturia in adults, fluid intake should be minimized from 1 hour before administration of the medicine up to 8 hours after administration. Using Minirin Melt without simultaneously restricting fluid intake may lead to excessive water retention in the body or decreased blood sodium levels, which may, but does not necessarily, manifest as headache, nausea, vomiting, weight gain, or in severe cases, seizures.

The above warning does not apply to patients using Minirin Melt for the treatment of central diabetes insipidus.
Taking the medicine with food may reduce its strength and duration of effect.

Minirin Melt in patients with renal and/or hepatic impairment
Consult a doctor before using this medicine.

Minirin Melt in elderly patients
Initiating treatment for nocturia in patients over 65 years of age is not recommended.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Driving and operating machinery
Minirin Melt has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to use Minirin Melt

This medicine should always be used exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

Minirin Melt should be placed under the tongue, where it dissolves without the need to take water.

Use of Minirin Melt in the treatment of central diabetes insipidus

The doctor determines the dosage individually for each patient, but the total daily dose usually ranges from 120 to 720 micrograms administered sublingually.

Treatment in children and adults is usually initiated with a sublingual dose of 60 micrograms of desmopressin three times daily. The doctor will adjust subsequent doses depending on the patient's response. In most patients, the maintenance dose is 60 to 120 micrograms of desmopressin administered sublingually three times daily.

Use of Minirin Melt in the treatment of primary monosymptomatic nocturnal enuresis in children

Treatment usually starts with a dose of 120 micrograms. The medicine is administered sublingually once daily before bedtime. If this dose is insufficient, the doctor may instruct to increase the dose to 240 micrograms.

Fluid intake should be restricted to a minimum from 1 hour before taking the medicine until 8 hours after administration.

After three months of treatment, the doctor should instruct a break from the medicine for at least one week and assess whether further treatment is necessary.

Use of Minirin Melt in the treatment of nocturia in adults

Treatment usually starts with a dose of 60 micrograms. The medicine is administered sublingually once daily before bedtime. If this dose is not sufficiently effective after one week of use, the doctor may recommend increasing the dose to 120 micrograms and then to 240 micrograms, with weekly intervals between dose increases.

Fluid intake should be restricted to a minimum from 1 hour before taking the medicine until 8 hours after administration.

Use of a higher than recommended dose of Minirin Melt

Using a higher than recommended dose of Minirin Melt increases the risk of excessive water retention in the body or decreased sodium concentration in the blood, which may (but not necessarily) manifest as headache, nausea, vomiting, weight gain, or in severe cases, seizures.

If a higher than recommended dose has been used, seek immediate medical advice.

Missed dose of Minirin Melt

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

In adults:
The following very common adverse reactions affect more than 1 in 10 treated patients:

• headache.

The following common adverse reactions affect 1 to 10 in 100 treated patients:

• hyponatremia (low sodium concentration in blood serum);
• dizziness;
• hypertension;
• nausea;
• abdominal pain;
• diarrhoea;
• constipation;
• vomiting;
• urinary bladder and urethral symptoms;
• oedema;
• feeling of fatigue.

The following uncommon adverse reactions affect 1 to 10 in 1,000 treated patients:

• insomnia;
• somnolence;
• paraesthesia (tingling, pricking, or numbness);
• impaired vision;
• balance disorders;
• palpitations;
• orthostatic hypotension (decrease in blood pressure upon changing from lying to standing position);
• dyspnoea;
• dyspepsia;
• flatulence;
• bloating;
• sweating;
• pruritus (itching);
• rash;
• urticaria;
• muscle cramps;
• muscle pain;
• malaise;
• chest pain;
• influenza-like symptoms;
• increased body weight;
• increased liver enzyme levels;
• hypokalaemia (low potassium concentration in blood serum).

The following rare adverse reactions affect 1 to 10 in 10,000 treated patients:

• confusion;
• allergic dermatitis.

Frequency unknown (cannot be estimated from available data):

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

In children and adolescents:
The following common adverse reactions affect 1 to 10 in 100 treated patients:

• headache.

The following uncommon adverse reactions affect 1 to 10 in 1,000 treated patients:

• emotional lability;
• aggression;
• abdominal pain;
• nausea;
• vomiting;
• diarrhoea;
• urinary bladder and urethral symptoms;
• peripheral oedema;
• feeling of fatigue.

The following rare adverse reactions affect 1 to 10 in 10,000 treated patients:

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

Frequency unknown (cannot be estimated from available data):

• anaphylactic reactions;
• hyponatremia;
• abnormal behaviour;
• emotional disorders;
• depression;
• hallucinations;
• insomnia;
• attention disturbance;
• psychomotor hyperactivity;
• seizures;
• epistaxis;
• allergic dermatitis;
• rash;
• sweating;
• urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor. Adverse reactions 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: Aleje Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Minirin Melt
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from moisture and light.
Do not use this medicine after the expiry date stated on the packaging following the word "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Minirin Melt contains

• The active substance is desmopressin in an 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 single droplet-shaped mark on one side.
Minirin Melt 120 micrograms is a white tablet with a double droplet-shaped mark on one side.
Minirin Melt 240 micrograms is a white tablet with a triple droplet-shaped mark on one side.
Each Minirin Melt pack contains 30 or 100 orodispersible lyophilisates.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ferring-Léčiva, a.s.
K Rybníku 475
252-42 Jesenice u Prahy
Czech Republic

Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For further information, please contact the representative of the Marketing Authorisation Holder.
Ferring Pharmaceuticals Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Poland
Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81

Instructions for removing lyophilisates from the blister
The lyophilisates are fragile. Do not push them through the blister foil, as they may break.
The lyophilisates should be removed from the blister after first removing the aluminium foil, as shown in the figures below:

1. Completely peel off the end strip of the blister, starting from the corner with the printed hand symbol.

2. Tear off the blister unit along the perforation.

3. Lift the foil starting from the corner with the printed arrow and gently remove the lyophilisate.

4. Repeat steps 2 and 3 to access the next lyophilisate.