MINURIN 0.1 mg/mL NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Minurin 0.1 mg/ml Nasal Spray Solution

Desmopressin Acetate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Minurin nasal spray solution is and what it is used for
2. What you need to know before you use 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 other information

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

Minurin belongs to a group of medicines called antidiuretic hormone analogues (vasopressin), which temporarily reduce the amount of urine produced by the body.

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

• Central diabetes insipidus sensitive to vasopressin in infants from 3 months of age, children, adolescents, and adults.
• Symptomatic treatment of short duration of primary nocturnal enuresis in patients (over 5 years of age), caused by nocturnal deficiency of ADH (Antidiuretic Hormone).

Diagnostic test of renal concentration capacity.

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

Do not use Minurin:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have excessive prolonged thirst or thirst due to a mental disorder.
• if you suffer from inappropriate ADH (antidiuretic hormone) secretion syndrome.
• if you suffer from heart failure and other conditions that require treatment with diuretics (medicines that increase urine secretion).
• if you suffer from moderate or severe renal insufficiency
• if you have low sodium levels in the 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 careful to restrict fluid intake by not drinking between 1 hour before administration and until the next morning (at least 8 hours).

Treatment without simultaneous reduction of fluid intake may cause water retention and/or decrease sodium levels in the blood, accompanied by or without symptoms or warning signs (headache, nausea, vomiting, weight gain, and in severe cases, convulsions. (See section 4).

Special care should be taken 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 and avoid accidental overdosing.

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

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

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

Your doctor will monitor your sodium levels in the blood.

If the medicine is used for primary nocturnal enuresis, you should 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 excess fluid retention, you should monitor that your weight and blood pressure do not increase during treatment. Treatment should be interrupted in case of signs of fluid retention/hyponatremia (decrease in 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 above circumstances have occurred to you.

Using Minurin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is known that some substances such as tricyclic antidepressants, chlorpromazine (a medicine for the treatment of psychiatric problems), carbamazepine (a medicine to prevent seizures), and chlorpropamide (a medicine for the treatment of diabetes mellitus) may increase the risk of fluid retention.

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

Using Minurin with food and drinks

During treatment for primary 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use Minurin nasal spray solution if you are pregnant or planning to have a baby, as it may harm your baby. See section 2, Minurin nasal spray solution contains chlorobutanol.

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

Desmopressin, although in small amounts, passes into breast milk, so if you are breastfeeding, it is recommended to replace breastfeeding.

Minurin nasal spray solution contains chlorobutanol

Chlorobutanol may increase the risk of heart rhythm problems.

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

Driving and using machines

Minurin has no or negligible influence on the ability to drive and use machines.

3. How to use Minurin nasal spray solution

Follow exactly the administration instructions of this medicine 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 overdosing.

Instructions for use

Before using Minurin nasal spray solution for the first time, prepare the pump by pressing down 4 times or until a constant spray is obtained. If the nasal spray solution 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 spray 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 solution has not been used in the last week.

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

1. Hold the bottle with your thumb, index, and middle fingers. The head should be slightly tilted back while the applicator is inserted directly into the nostril.

Start the spray by covering the other nostril simultaneously. Inhale the product gently in each dose (figures 2 and 3).

1. When a higher dose is needed, spray alternately in each nostril.
2. Replace the protective cap after use and store in a vertical position. (figure 4)

The bottle should always be stored in a vertical position.

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

Frequency of administration

• Diabetes insipidus:

Infants from 3 months of age and older and 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, other presentations are available on the market (Minurin nasal drops in solution).

• Nocturnal enuresisin children over 5 years, adolescents, and adults:

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

The duration of treatment should be a maximum of 3 months. The need to continue treatment should be re-evaluated during a period of at least one week without Minurin.

For restrictions on fluid intake or possible signs of overdosing, see section 2.

• Diagnosis of renal concentration capacity:

Fluid intake should be limited to a 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, telephone 915 620 420, indicating the medicine and the amount used. It is recommended to carry the package leaflet and the medicine package to the healthcare professional.

If you have used Minurin more than you should or ingested it accidentally, the symptoms would be those consequent to water retention and/or decrease in sodium levels in the blood: headache, nausea, vomiting, weight gain, and in severe cases, convulsions.

Treatment should be interrupted and fluid intake restricted, 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 make up for forgotten doses.

If you stop treatment with Minurin

Your doctor will indicate the duration of your treatment with Minurin. Do not stop treatment before, as it may not have the expected effect.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Minurin can cause side effects, although not everybody gets them.

The following side effects are very common, they may affect more than 1 in 10 people:

• nasal congestion, rhinitis, increased body temperature.

The following side effects are common, they may affect up to 1 in 10 people:

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

The following side effects are rare, they may affect up to 1 in 100 people:

• hyponatremia (low sodium levels in the blood) and vomiting.

Other side effects for which the frequency is not known:

• allergic reaction, dehydration, confusional state, convulsions, coma, dizziness, somnolence, hypertension, dyspnea, diarrhea, itching, redness, muscle spasms, fatigue, peripheral edema, chest pain, chills, weight gain.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for human use medicines, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Minurin nasal spray solution

Keep out of the sight and reach of children.

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

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

Store in a vertical position.

Validity period once opened: 4 weeks.

Do not use Minurin after the expiry date stated on the package after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Minurin

The active substance is desmopressin acetate. Each milliliter of Minurin nasal spray solution contains 0.1 mg of desmopressin acetate.

Each spray delivers 0.01 mg (10 micrograms) of desmopressin acetate.

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

Appearance of the product and contents of the pack

Minurin 0.1 mg/ml nasal spray solution is a clear and particle-free intranasal solution presented in an aerosol bottle with a nasal applicator and protective cap.

Marketing authorization holder and manufacturer

Marketing authorization holder

FERRING S.A.U

C/ Arquitecto Sánchez Arcas 3, 1º

28040 Madrid

Spain

Manufacturer

Ferring GmbH

Wittland 11

24109 Kiel

Germany

Date of last revision of this leaflet:November 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

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