Package Leaflet: Information for the User

Minurin 0.1 mg/ml nasal spray solution

Desmopressin acetate

Read this leaflet carefully before you start using this medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4

1. What Minurin nasal spray solution is and what it is used for

2. What you need to know before you start using Minurin nasal spray solution

3. How to use Minurin nasal spray solution

4. Possible side effects

5. Storage of Minurin nasal spray solution

6. Contents of the pack and additional information

Minurin belongs to the group of hormone antidiuretic analog medications

(vasopressin), which temporarily reduces the amount of urine produced by the body.

It is indicated, whenever oral administration is not possible, for the treatment of:

• Central diabetes insipidus sensitive to vasopressin in infants aged 3 months and older, children, adolescents, and adults.
• Symptomatic short-term treatment of primary nocturnal enuresis in patients

(over 5 years old), caused by nocturnal ADH (Antidiuretic Hormone) deficiency.

Diagnostic test for renal concentration capacity.

Do not use Minurin:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have excessive or prolonged thirst due to a metabolic disorder.
• if you have a syndrome of inadequate secretion of ADH (antidiuretic hormone).
• if you have heart failure and other conditions that require treatment with diuretics (medications that increase urine production).
• if you have moderate or severe kidney failure.
• if you have low sodium levels in your blood (hyponatremia).

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Minurin.

Minurin nasal spray solution should only be used in patients where oral formulations are not possible.

If you have primary nocturnal enuresis, be especially careful to restrict your fluid intake by not drinking between 1 hour before and 8 hours after administration.

A treatment without simultaneous reduction of fluid intake may cause water retention and/or decreased sodium levels in the blood, accompanied or not by symptoms or signs of alarm, (headache, nausea, vomiting, weight gain, and severe convulsions. (See section 4).

Be especially careful to avoid decreased sodium levels in the blood in the following cases:

• in children, the dose should be administered under the strict supervision of an adult to ensure correct dosing.

to ensure correct dosing.

• diseases characterized by alterations in the proportion of water and electrolytes (calcium, magnesium...) in the blood.

(calcium, magnesium...) in the blood.

• children, elderly patients, and patients with sodium levels in the blood with values at the lower limit of normality.
• patients at risk of intracranial hypertension.
• generalized infections, fever, and gastroenteritis (syndrome of inappropriate secretion of ADH)

Consult your doctor if you are in any of the patient groups mentioned above.

Your doctor will monitor your sodium levels in the blood.

If the medication is used for primary nocturnal enuresis, avoid drinking water while swimming and interrupt Minurin during any episode of vomiting and/or diarrhea until your fluid balance returns to normal. Considering the possibility of excessive water retention, you should monitor that you do not gain weight and your blood pressure during treatment. Treatment should be interrupted in the case of signs of water retention/ hyponatremia (decreased sodium levels in the blood).

Patients with fluid accumulation (edema), scars, or other abnormalities in the nasal mucosa may notice irregular absorption. Consult your doctor in this situation.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of Minurin with other medications:

Inform your doctor or pharmacist if you are using, have used, or may need to use any other medication.

It is known that some substances, such as tricyclic antidepressants, clopromacina (psychiatric medication), carbamacepina (medication to prevent seizures), and clorpropamina (medication for diabetes mellitus), may increase the risk of water retention.

Non-steroidal anti-inflammatory drugs may induce water retention/decreased sodium levels in the blood.

Use of Minurin with food and beverages:

During treatment for nocturnal enuresis, fluid intake should be limited to a minimum and only to satisfy thirst from 1 hour before to 8 hours after administration.

When used for diagnostic purposes, fluid intake should be limited to a minimum and only to satisfy thirst.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Minurin nasal spray solution if you are pregnant or planning to become pregnant, as it may be harmful to your baby. Consult section 2, Minurin nasal spray solution contains clorobutanol.

If you are pregnant, your doctor will assess the risk against the benefit of treatment.

Desmopressin, although in small amounts, passes into breast milk, so in the case of breastfeeding, it is recommended to substitute natural breastfeeding.

Minurin nasal spray solution contains clorobutanol:

Clorobutanol may increase the risk of cardiac rhythm problems.

You should not use Minurin nasal spray solution if you are pregnant or planning to become pregnant. This is because clorobutanol may affect your ability to become pregnant and may be harmful to your baby.

Driving and operating machinery:

The influence of Minurin on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use in children: in children, the dose should be administered under the strict supervision of an adult to ensure correct dosing and avoid accidental overdose

and to ensure correct dosing and avoid accidental overdose.

Instructions for use

Before using Minurin nasal spray for the first time, prepare the pump by pressing it down 4 times or until a constant nebulization is obtained. If the nasal spray has not been used in a week, it will be necessary to prepare the pump again by pressing it down once or until a constant nebulization is obtained.

Before application, the patient should blow their nose.

1. Remove the protective cap from the applicator (figure 1).

2. Check that the end of the tube inside the bottle is submerged in the liquid.

3. Prepare the pump if the nasal spray has not been used in the last week.

4. Once prepared, the pump will release a dose of 0.01 mg (10 micrograms) each time it is pressed.

5. Hold the bottle with your thumb, index finger, and middle finger. The head should be slightly tilted back while inserting the applicator directly into the nostril.

Start the nebulization by covering, simultaneously, the other nostril. Inhale gently the product in each dosing (figure 2 and 3).

6. When a higher dose is needed, spray alternately in each nostril.

7. Place the protective cap after use and store in an upright position. (figure 4)

The bottle should always be stored in an upright position.

If you have any doubt about the correct administration of the dose, do not re-administer the nasal spray until the next scheduled dose.

Frequency of administration

• Diabetes insipidus:

Newborns over 3 months of age and olderand children (from 2 years to less than 12 years of age) 5-10 micrograms per day (maximum 20 micrograms). Divided into 1-2 doses.

Adolescents (from 12 years of age)and adults: 10-20 micrograms per day (maximum 40 micrograms/day). Divided into 1-2 doses.

For doses of 5 micrograms or less, there are other presentations available on the market (Minurin nasal drops in solution).

• Nocturnal enuresis in children over 5 years, adolescents, and adults::

The dose should be adjusted individually. The dosage should be established progressively starting with a spray at bedtime. If no response is obtained, the daily dose may be increased to the maximum recommended dose of 2 sprays with a minimum duration of one week.

The duration of treatment should not exceed 3 months. The need to continue treatment should be re-evaluated during a period of at least one week without Minurin.

See section 2 for restrictions on fluid intake or possible signs of overdose.

• Diagnosis of renal concentration capacity:

Fluid intake should be limited to the minimum and only to satisfy thirst.

Duration of treatment:

Your doctor will indicate the duration of your treatment with Minurin.

If you use more Minurin than you should

If you have used more Minurin than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 620 420 indicating the medication and the amount used. It is recommended to bring the prospectus and the packaging of the medication to the healthcare professional.

If you have used Minurin more than you shouldor ingest it accidentally,thesymptoms would be the consequences of water retention and/or decreased sodium in the blood: headache, nausea, vomiting, weight gain, and in severe cases, convulsions.

It is recommended to interrupt treatment and restrict fluid intake and symptomatic treatment if necessary.

If you forget to use Minurin

If you miss a dose, apply the next dose at the usual time. Do not use a double dose to

compensate for the missed doses.

If you interrupt treatment with Minurin

Your doctor will indicate the duration of your treatment with Minurin. Do not suspend treatment

before, as it may not have the expected effect.

If you have any other doubts about the use of this medication, ask your doctor or

pharmacist.

Like all medications, Minurin can produce adverse effects, although not all people will experience them.

Not all people will experience them.

The following adverse effects, very frequent, may affect more than 1 in 10 people:

• nasal congestion, rhinitis, increased body temperature.

The following adverse effects, frequent, may affect up to 1 in 10 people:

• headache, stomach pain, nausea, gastroenteritis, insomnia, mood instability, nightmares, nervousness, aggression, nosebleeds, respiratory infections.

The following adverse effects, rare, may affect up to 1 in 100 people:

• hyponatremia (sodium deficiency in the blood) and vomiting.

Other adverse effects for which the frequency is unknown:

• allergic reaction, dehydration, confused state, seizures, coma, dizziness, somnolence, hypertension, dyspnea, diarrhea, pruritus, erythema, muscle spasms, fatigue, peripheral edema, chest pain, chills, weight gain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Keep out of sight and reach of children.

Store in refrigerator (between 2°C and 8°C).

Once opened, do not store at a temperature above 25°C.

Store in upright position.

Shelf life once opened: 4 weeks.

Do not use Minurin after the expiration date that appears on the packaging after

“CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and

medicines you no longer need at the SIGRE collection point of the pharmacy. In case of doubt

ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Minurin

The active principle is desmopressin acetate. Each milliliter of Minurin solution

for nasal pulverization contains 0.1 mg of desmopressin acetate.

Each pulverization releases 0.01 mg (10 micrograms) of desmopressin acetate

The other components are: chlorobutanol hemihydrate, sodium chloride, hydrochloric acid and purified water.

Appearance of the product and contents of the packaging

Minurin 0.1 mg/ml solution for nasal pulverization is a transparent and

particle-free intranasal solution that is presented in an aerosol bottle with a nasal applicator and a protection capsule.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FERRING S.A.U

C/ Arquitecto Sánchez Arcas 3, 1st

28040 Madrid

Spain

Responsible for manufacturing

Ferring GmbH

Wittland 11

24109 Kiel

Germany

Last review date of this leaflet: November 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/