Minirin 0.1

Patient Information Leaflet

MINIRIN 0.1, 0.1 mg, tablets
Desmopressini acetas
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. The medicine may harm someone else, 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.

Table of contents:

1. What Minirin 0.1 is and what it is used for
2. Important information before taking Minirin 0.1
3. How to take Minirin 0.1
4. Possible side effects
5. How to store Minirin 0.1
6. Contents of the pack and other information

1. What Minirin 0.1 is and what it is used for

Minirin 0.1 is available in tablet form. It contains desmopressin acetate, which acts similarly to the natural pituitary hormone vasopressin. Unlike vasopressin, Minirin 0.1 has no vasoconstrictive effect and has a prolonged antidiuretic action, meaning it reduces urine production.
Minirin 0.1 is used to treat:
central diabetes insipidus,
primary nocturnal enuresis in patients over 7 years of age (exceptionally over 5 years of age) with normal urine concentrating ability,
nocturia in adults associated with nocturnal polyuria.

2. Important information before using Minirin 0.1

When not to use Minirin 0.1
if the patient is allergic to desmopressin or any of the other ingredients of this medicine
(listed in section 6),
if the patient suffers from psychogenic or habitual polydipsia (excessive thirst),
if the patient has heart failure 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 blood),
if the patient has syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Warnings and precautions
Exercise caution:
if increased intracranial pressure may occur,
if the patient has low serum sodium levels,
if the patient is over 65 years of age,
if the patient has fluid and/or electrolyte imbalance,
if the medicine is used concomitantly with other drugs; see section "Other medicines and Minirin 0.1".
Before starting treatment, severe bladder dysfunction and infravesical obstruction should be ruled out.
Particular caution is required in patients with renal impairment and cardiovascular diseases.
In case of acute illness with fluid and electrolyte disturbances, such as systemic infection, fever-related conditions, or gastroenteritis, treatment with Minirin 0.1 should be discontinued and medical advice sought.

Children
Minirin 0.1 is indicated for the treatment of central diabetes insipidus and primary nocturnal enuresis in children above 7 years of age (exceptionally above 5 years of age) who have normal urine concentrating ability.

Minirin 0.1 and other medicines
Some medicines may affect the action of Minirin 0.1.
Inform your doctor about all medicines currently taken or recently used, as well as any medicines the patient intends to take.
In particular, inform the doctor if the patient is taking:
tricyclic antidepressants,
selective serotonin reuptake inhibitors (SSRIs),
chlorpromazine,
carbamazepine,
nonsteroidal anti-inflammatory drugs (NSAIDs),
loperamide,
antidiabetic sulfonylureas, e.g. chlorpropamide.
The above-mentioned medicines may lead to excessive water retention in the body or decreased sodium levels in blood.

Minirin 0.1 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 taking the medicine until the next morning (at least 8 hours after taking the medicine). Using Minirin 0.1 without simultaneously restricting fluid intake may lead to excessive water retention in the body or decreased sodium concentration in blood, 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 0.1 for the treatment of central diabetes insipidus.
Taking the medicine with food may reduce its strength and duration of action.

Minirin 0.1 in patients with renal and/or hepatic impairment
Consult a doctor before using the medicine.

Minirin 0.1 in elderly patients
Initiating treatment for nocturia is not recommended in patients over 65 years of age.

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

Driving and operating machinery
Minirin 0.1 has no effect or has negligible effect on the ability to drive and operate machinery.

Minirin 0.1 contains lactose
The medicine contains monohydrated lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Minirin 0.1

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor.

Use of Minirin 0.1 in the treatment of central diabetes insipidus

The doctor determines the dosage individually for each patient, but the total daily dose usually ranges from 0.2 mg to 1.2 mg (2–12 tablets).
Treatment in adults and children usually begins with a dose of 0.1 mg (1 tablet) three times daily. The subsequent doses are adjusted by the doctor according to the patient's response.
In most patients, the maintenance dose is 0.1 mg to 0.2 mg (1–2 tablets) three times daily.

Use of Minirin 0.1 in the treatment of primary monosymptomatic nocturnal enuresis in children

The medicine is administered once daily before bedtime.
Treatment usually starts with a dose of 0.2 mg (2 tablets). If this dose is insufficient, the doctor may instruct to increase the dose up to 0.4 mg (4 tablets).
After three months of treatment, the doctor should instruct a treatment break for at least one week to assess whether further treatment is necessary.
Fluid intake should be restricted to a minimum starting from 1 hour before taking the medicine until the next morning (at least 8 hours after taking the medicine).

Use of Minirin 0.1 in the treatment of nocturia in adults

The medicine is administered once daily before bedtime.
Treatment usually starts with a dose of 0.1 mg (1 tablet). If this dose is not sufficiently effective after one week of use, the doctor may instruct to increase the dose to 0.2 mg (2 tablets), and subsequently to 0.4 mg (4 tablets), with weekly intervals between dose increases.
Fluid intake should be restricted to a minimum starting from 1 hour before taking the medicine until the next morning (at least 8 hours after taking the medicine).

Use of a higher than recommended dose of Minirin 0.1

Taking a higher than recommended dose 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 taken, seek immediate medical advice.

Missed dose of Minirin 0.1

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 they do not occur in everyone.

In adults:

The following adverse reactions occur very commonly, i.e. in more than 1 in 10 treated patients:

• headache

The following adverse reactions occur commonly, i.e. in 1 to 10 out of 100 treated patients:

• hyponatremia (low sodium concentration in blood serum)
• dizziness
• hypertension
• nausea
• abdominal pain
• diarrhea
• constipation
• vomiting
• urinary bladder and urethra symptoms
• edema
• feeling of fatigue

The following adverse reactions occur uncommonly, i.e. in 1 to 10 out of 1,000 treated patients:

• insomnia
• somnolence
• paresthesia (tingling, prickling, or numbness sensation)
• impaired vision
• balance disorders
• palpitations
• orthostatic hypotension (decrease in blood pressure upon changing from lying to standing position)
• dyspnea
• indigestion
• flatulence
• bloating
• sweating
• skin itching
• rash
• urticaria
• muscle cramps
• muscle pain
• malaise
• chest pain
• influenza-like symptoms
• increased body weight
• increased liver enzyme levels
• hypokalemia (low potassium concentration in blood serum)

The following adverse reactions occur rarely, i.e. in 1 to 10 out of 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 adverse reactions occur commonly, i.e. in 1 to 10 out of 100 treated patients:

• headache

The following adverse reactions occur uncommonly, i.e. in 1 to 10 out of 1,000 treated patients:

• emotional lability
• aggression
• abdominal pain
• nausea
• vomiting
• diarrhea
• urinary bladder and urethra symptoms
• peripheral edema
• feeling of fatigue

The following adverse reactions occur rarely, i.e. in 1 to 10 out of 10,000 treated patients:

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

Frequency unknown (cannot be estimated from available data):

• anaphylactic reactions
• hyponatremia
• abnormal behavior
• 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 adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products {current address, telephone and fax number of the above Department} e-mail: [email protected]. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Minirin 0.1

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Store in the original packaging.
The medicine is sensitive to moisture. Do not remove the desiccant capsule from the bottle cap.
Do not use this medicine after the expiry date stated on the carton and on the label of the bottle
following the abbreviation EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What Minirin 0.1 contains

• The active substance is desmopressin acetate.
• The other ingredients are: monohydrate lactose, potato starch, povidone, and magnesium stearate.

What Minirin 0.1 looks like and contents of the pack
Minirin 0.1 is a white, oval, biconvex tablet with a division line and the imprint "0.1" on one side.
The division line on the tablet is intended only to facilitate breaking for ease of swallowing and does not indicate division into equal doses.
One pack of Minirin 0.1 contains 30 tablets.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturer:
Ferring GmbH
Wittland 11, P.O. Box 2145
24109 Kiel
Germany

For further information, please contact the representative of the Marketing Authorisation Holder:
Ferring Pharmaceuticals Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 246 06 80
Fax: +48 22 246 06 81