Minirin 0,1

PATIENT INFORMATION LEAFLET

Leaflet enclosed with the packaging: patient information

MINIRIN 0.1, 0.1 mg, tablets
Desmopressin acetate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Minirin 0.1 and what is it 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 is Minirin 0.1 and what is it 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 does not have vasoconstrictive effects, and its antidiuretic effect, which reduces urine production, is prolonged.
Minirin 0.1 is used to treat:
central diabetes insipidus,
primary nocturnal enuresis in patients over 7 years old (exceptionally over 5 years old)
with normal urine concentration ability,
nocturia in adults associated with nocturnal polyuria.

2. Important information before taking Minirin 0.1

When not to take 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 has psychogenic or habitual polydipsia (excessive thirst),
if the patient has cardiovascular failure or other diseases requiring diuretic therapy,
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 the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Warnings and precautions

Caution should be exercised:
if there is a risk of increased intracranial pressure,
if the patient has low sodium levels in the serum,
if the patient is over 65 years old,
if the patient has water and/or electrolyte imbalance,
if the medicine is taken with other medicines; see the chapter "Other medicines and Minirin 0.1".
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 case of acute conditions with water and electrolyte disturbances, such as generalized infection, febrile diseases, gastroenteritis, the administration of Minirin 0.1 should be discontinued and a doctor consulted.

Children

Minirin 0.1 is used to treat central diabetes insipidus and primary nocturnal enuresis in children over 7 years old (exceptionally over 5 years old) with normal urine concentration ability.

Minirin 0.1 and other medicines

Certain medicines may affect the action of Minirin 0.1.
The doctor should be informed about all medicines currently or recently taken by the patient, as well as those planned to be taken.
In particular, the doctor should be informed about the use of:
tricyclic antidepressants,
selective serotonin reuptake inhibitors,
chlorpromazine,
carbamazepine,
non-steroidal anti-inflammatory drugs,
loperamide,
oral hypoglycemic agents from the sulfonylurea group, e.g. chlorpropamide.
The above-mentioned medicines may lead to excessive water retention in the body or decreased sodium levels in the blood.

Minirin 0.1 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 the next morning (at least 8 hours after taking the medicine). Taking Minirin 0.1 without simultaneous fluid restriction 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 headache, nausea, vomiting, weight gain, or, in severe cases, convulsions.
The above warning does not apply to patients taking Minirin 0.1 for central diabetes insipidus.
Taking the medicine with food may reduce the strength and duration of its action.

Minirin 0.1 in patients with renal and/or hepatic impairment

Before taking the medicine, a doctor should be consulted.

Minirin 0.1 in elderly patients

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor before taking this medicine.

Driving and using machines

Minirin 0.1 has no influence or insignificant influence on the ability to drive and use machines.

Minirin 0.1 contains lactose

The medicine contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Minirin 0.1

This medicine should always be taken according to the doctor's recommendations. In case of doubts, a doctor should be consulted.
Taking Minirin 0.1 for central diabetes insipidus
The doctor determines the dosage individually for each patient, but the total daily dose is usually between 0.2 mg and 1.2 mg (2-12 tablets).
Treatment of adults and children usually starts with a dose of 0.1 mg (1 tablet) 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 between 0.1 mg and 0.2 mg (1-2 tablets) 3 times a day.
Taking Minirin 0.1 for primary nocturnal enuresis in children
The medicine is taken once a day before bedtime.
Treatment usually starts with a dose of 0.2 mg (2 tablets). If this dose is insufficient, the doctor may prescribe an increase in the dose to 0.4 mg (4 tablets).
After three months of treatment, the doctor should prescribe a break in taking the medicine for at least one week and assess whether further treatment is necessary.
Fluid intake should be limited to a minimum from 1 hour before taking the medicine to the next morning (at least 8 hours after taking the medicine).
Taking Minirin 0.1 for nocturia in adults
The medicine is taken once a day 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 treatment, the doctor may prescribe an increase in the dose to 0.2 mg (2 tablets), and then to 0.4 mg (4 tablets), with weekly intervals between dose increases.
Fluid intake should be limited to a minimum from 1 hour before taking the medicine to the next morning (at least 8 hours after taking the medicine).

Taking a higher dose of Minirin 0.1 than recommended

Taking a higher dose of the medicine 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 headache, nausea, vomiting, weight gain, or, in severe cases, convulsions.
In case of taking a higher dose of the medicine than recommended, a doctor should be consulted immediately.

Missing a dose of Minirin 0.1

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Minirin 0.1 can cause side effects, although not everybody gets them.
In adults:
The following side effectsoccur very commonly, i.e. in more than 1 in 10 treated patients:

• headache

The following side effectsoccur commonly, i.e. in 1 to 10 in 100 treated patients:

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

The following side effectsoccur uncommonly, i.e. in 1 to 10 in 1,000 treated patients:

• insomnia
• drowsiness
• paresthesia (tingling, prickling, or numbness)
• blurred vision
• balance disorders
• palpitations
• orthostatic hypotension (decrease in 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)

The following side effectsoccur rarely, i.e. in 1 to 10 in 10,000 treated patients:

• confusion
• allergic skin rash

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:
The following side effectsoccur commonly, i.e. in 1 to 10 in 100 treated patients:

• headache

The following side effectsoccur uncommonly, i.e. in 1 to 10 in 1,000 treated patients:

• emotional instability
• aggression
• abdominal pain
• nausea
• vomiting
• diarrhea
• urinary tract and urethra symptoms
• peripheral edema
• fatigue

The following side effectsoccur rarely, i.e. in 1 to 10 in 10,000 treated patients:

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

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

• anaphylactic reactions
• hyponatremia
• abnormal behavior
• emotional disorders
• depression
• hallucinations
• insomnia
• attention disorders
• psychomotor hyperactivity
• seizures
• nasal bleeding
• allergic skin rash
• rash
• sweating
• hives

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products {current address ,phone and fax number of the Department} e-mail: [email protected]. Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Minirin 0.1

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging.
The medicine is sensitive to moisture. Do not remove the desiccant from the cap.
Do not use this medicine after the expiry date stated on the carton and label after the EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Minirin 0.1 contains

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

What Minirin 0.1 looks like and contents of the pack

Minirin 0.1 is a white, oval, and convex tablet with a dividing line and the inscription "0.1" on one side.
The dividing line on the tablet is only to facilitate breaking and does not divide the tablet into equal doses.
One pack of Minirin 0.1 contains 30 tablets.
Marketing authorization holder and manufacturer:
Marketing authorization holder:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
Manufacturer:
Ferring GmbH
Wittland 11, P.O. Box 2145
24109 Kiel
Germany
To obtain more detailed information, the representative of the marketing authorization holder should be contacted.
Ferring Pharmaceuticals Poland Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
Phone: +48 22 246 06 80
Fax: +48 22 246 06 81

Date of last revision of the leaflet: