Minirin 0.2
Poland
Table of Contents
Package leaflet: Information for the patient
MINIRIN 0,2, 0.2 mg, tablets
Desmopressini acetas
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
- 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 pass it on to others. The medicine may harm another person, even if their symptoms are identical.
- If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.
Table of contents of the leaflet:
- What Minirin 0.2 is and what it is used for
- Important information before taking Minirin 0.2
- How to take Minirin 0.2
- Possible side effects
- How to store Minirin 0.2
- Contents of the pack and other information
1. What Minirin 0.2 is and what it is used for
Minirin 0.2 is available as tablets. It contains desmopressin acetate, which acts similarly to the natural pituitary hormone – vasopressin. Unlike vasopressin, Minirin 0.2 has no vasoconstrictive effect, and its antidiuretic action, i.e. reducing urine excretion, is prolonged.
Minirin 0.2 is used to treat:
central diabetes insipidus,
primary nocturnal enuresis in patients above 7 years of age (exceptionally above 5 years of age) with normal urine concentration ability,
nocturia in adults associated with nocturnal polyuria.
2. Important information before using Minirin 0.2
When not to use Minirin 0.2
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 circulatory failure or other diseases requiring treatment with diuretics,
if the patient has moderate or severe renal impairment with creatinine clearance below
50 ml/min,
if the patient has hyponatraemia (low sodium levels in the 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 medicines; see section "Other medicines and Minirin 0.2".
Before starting treatment, severe bladder dysfunction and any post-bladder 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 diseases, or gastroenteritis, administration of Minirin 0.2 should be discontinued and medical advice sought.
Children
Minirin 0.2 is used for the treatment of central diabetes insipidus and primary nocturnal enuresis in children over 7 years of age (exceptionally over 5 years of age) who have normal urine concentrating ability.
Minirin 0.2 and other medicines
Some medicines may affect the action of Minirin 0.2.
Inform your doctor about all medicines currently used 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,
non-steroidal anti-inflammatory drugs (NSAIDs),
loperamide,
antidiabetic sulfonylureas such as chlorpropamide.
The above-mentioned medicines may lead to excessive water retention in the body or reduced sodium concentration in the blood.
Minirin 0.2 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). Use of Minirin 0.2 without simultaneously restricting fluid intake may lead to excessive water retention in the body or decreased sodium concentration in the 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 0.2 for the treatment of central diabetes insipidus.
Taking the medicine with food may reduce its strength and duration of action.
Minirin 0.2 in patients with impaired kidney and/or liver function
Consult a doctor before using this medicine.
Minirin 0.2 in elderly patients
Initiation of 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 is planning to have a baby, she should consult her doctor before using this medicine.
Driving and operating machinery
Minirin 0.2 has no effect or has a negligible effect on the ability to drive and operate machinery.
Minirin 0.2 contains lactose
The medicine contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to use Minirin 0.2
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor.
Use of Minirin 0.2 in the treatment of central diabetes insipidus
The doctor determines the dosage individually for each patient, but the total daily dose usually ranges
between 0.2 mg and 1.2 mg (1–6 tablets).
Treatment in adults and children is usually initiated with a dose of 0.1 mg (½ tablet) three times daily.
The doctor will adjust subsequent doses according to the patient's response.
In most patients, the maintenance dose is 0.1 mg to 0.2 mg (½–1 tablet) three times daily.
Use of Minirin 0.2 in the treatment of primary nocturnal enuresis in children
The medicine should be administered once daily before bedtime.
Treatment is usually initiated with a dose of 0.2 mg (1 tablet). If this dose is insufficient, the doctor may
instruct to increase the dose to 0.4 mg (2 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 from one hour before taking the medicine until the
next morning (at least 8 hours after taking the medicine).
Use of Minirin 0.2 in the treatment of nocturia in adults
The medicine should be administered once daily before bedtime.
Treatment is usually initiated with a dose of 0.1 mg (½ 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 (1 tablet), and then to
0.4 mg (2 tablets), with weekly intervals between dose increases.
Fluid intake should be restricted to a minimum from one 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 0.2
Taking a higher than recommended dose increases the risk of excessive water retention in the body
or decreased blood sodium concentration, which may (but does 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 0.2
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 everyone will experience them.
In adults:
The following adverse reactions occur very commonly, i.e. in more than 1 out of every 10 treated
patients:
- headache
The following adverse reactions occur commonly, i.e. in 1 to 10 out of every 100 treated
patients:
- hyponatremia (low sodium concentration in blood serum)
- dizziness
- hypertension
- nausea
- abdominal pain
- diarrhoea
- constipation
- vomiting
- urinary bladder and urethra-related symptoms
- oedema
- feeling of fatigue
The following adverse reactions occur uncommonly, i.e. in 1 to 10 out of every 1,000
treated patients:
- insomnia
- somnolence
- paraesthesia (tingling, pricking, or numbness sensation)
- visual disturbances
- balance disorders
- palpitations
- orthostatic hypotension (reduction in blood pressure upon changing from lying to standing position)
- dyspnoea
- dyspepsia
- flatulence
- abdominal distension
- 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 every 10,000 treated
patients:
- confusion
- allergic dermatitis
Frequency unknown (cannot be estimated based on 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 every 100 treated
patients:
- headache
The following adverse reactions occur uncommonly, i.e. in 1 to 10 out of every 1,000
treated patients:
- emotional instability
- aggression
- abdominal pain
- nausea
- vomiting
- diarrhoea
- urinary bladder and urethra-related symptoms
- peripheral oedema
- feeling of fatigue
The following adverse reactions occur rarely, i.e. in 1 to 10 out of every 10,000 treated
patients:
- restlessness
- nightmares
- mood swings
- somnolence
- hypertension
- irritability
Frequency unknown (cannot be estimated based on available data):
- anaphylactic reactions
- hyponatremia
- abnormal behaviour
- emotional disturbances
- depression
- hallucinations
- insomnia
- attention disturbance
- psychomotor hyperactivity
- seizures
- nosebleeds
- 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]. By reporting adverse reactions, additional information on the safety of this medicine can be collected.
5. How to store Minirin 0.2
Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging.
This medicine is sensitive to moisture. Do not remove the desiccant capsule from the cap.
Do not use this medicine after the expiry date stated on the carton and label of the bottle
after 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. These measures will help protect
the environment.
6. Contents of the pack and other information
What Minirin 0,2 contains
- The active substance is desmopressin acetate.
- The other ingredients are: monohydrate lactose, potato starch, povidone, and magnesium stearate.
What Minirin 0,2 looks like and contents of the pack
Minirin 0,2 is a white, oval, convex tablet with a division line and the inscription "0,2" on one side.
The division line on the tablet is intended only to facilitate breaking for ease of swallowing and does not ensure equal dosing.
One pack of Minirin 0,2 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