Prospect: Information for the user

Minurin 4 micrograms/ml injectable solution

Desmopressin acetate

Read this prospect carefully before starting to use this medicine, because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, including if they are not listed in this prospect. See section 4.

The active ingredient that makes Minurin work is desmopressin. Minurin belongs to a group of medications called vasopressin and analogs. Desmopressin is a structural analog of the natural hormone arginine-vasopressin that temporarily reduces the amount of urine produced by the body, with rapid onset of action and prolonged duration.

It is used for the treatment of:

• Central Diabetes Insipidus.
• Diagnostic test for renal concentration capacity.
• Corrective and preventive treatment of bleeding accidents observed in the following cases:
• Hemophilia A and von Willebrand Disease (Type I, with factor VIII coagulant activity greater than 5%).
• Maintenance of hemostasis before a surgical intervention.

Do not use Minurin:

• If you are allergic to desmopressin or any of the other components of Minurin (listed in section 6).
• If you have excessive and prolonged thirst or due to excessive alcohol consumption.
• If you have heart problems or other conditions that require treatment with diuretics.
• If you have unstable angina, decompensated heart failure.
• If you have type IIB von Willebrand disease, hemophilia A, and type I von Willebrand disease with factor VIII coagulant activity less than 5%.
• In hemophilia B and hemophiliacs with anti-factor VIII antibodies.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

Special care should be taken to avoid water retention in the body and decreased sodium in the blood in the following cases:

• Young or elderly patients,
• Medical conditions that cause fluid and/or electrolyte imbalance
• Patients at risk of intracranial hypertension.

Special attention should be paid to the risk of water retention. Fluid intake should be restricted to a minimum and body weight should be monitored regularly. If used for diagnostic purposes, fluid intake should not exceed 0.5 l from 1 hour before administration of the product to 8 hours after administration.

If a gradual increase in body weight is observed, a decrease in serum sodium to a level

below 130 mmol/l or a decrease in plasma osmolality below 270 mOsm/kg body weight, the fluid intake should be drastically reduced and the administration of the drug should be interrupted.

The renal concentration test should only be performed in children under 2 years under close medical supervision in a hospital setting.

In the treatment of hemorrhagic accidents, due to individual responses, a test of efficacy should be performed to verify the correction of bleeding time and, in the case of hemophilia, the elevation of factor VIII.

Special measures should be taken to prevent fluid overload in patients undergoing treatment with diuretics.

Body blood pressure should be monitored regularly.

Minurin does not reduce prolonged bleeding time in thrombocytopenia.

Minurin interaction with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, especially antidepressants, antidiabetics, or antiepileptics.

Pregnancy, breastfeeding, and fertility

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

Your doctor will carefully evaluate the benefit-risk ratio in case you become pregnant.

Breastfeeding

Desmopressin, although in small amounts, passes into breast milk, so if it needs to be administered to a breastfeeding woman, it is recommended to substitute natural breastfeeding with artificial feeding.

Driving and operating machines

Minurin does not affect the ability to drive or operate machines.

Follow exactly the administration instructions for Minurin 4 micrograms/ml solution

injectable as indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

Central diabetes insipidus:

When nasal administration (nasal drops) is considered inadequate, the injectable solution is recommended. The dose is adjusted individually for each patient depending on the urine volume and serum sodium level.

The recommended dose of injectable solution is 0.25 ml to 1 ml (1-4 micrograms) one to two times a day in adults.

It should not be administered to children under 12 years old since safety and efficacy have not been established.

In patients who were initially administered the intranasal form and then the injectable form due to poor intranasal absorption or surgical intervention, the comparable antidiuretic dose of the injectable is approximately 10% of the intranasal dose.

Renal concentration capacity test:

It is recommended to follow the administration schedule described below. The product will be injected intramuscularly or subcutaneously:

0.1micrograms (0.025 ml) (weight <10

0.2micrograms (0.05 ml) (weight between 10 and 20 kg)

1microgram (0.25 ml) (weight between 20 and 30 kg)

2micrograms (0.5 ml) (weight between 30 and 50 kg)

4micrograms (1 ml) (weight > 50 kg)

In children, nasal drops are recommended to be used first.

Hemophilia A and von Willebrand disease (Type I, with factor VIII coagulant activity above 5%) - Maintenance of hemostasis before surgical intervention:

It is recommended to administer the solution slowly by intravenous infusion of 0.3 micrograms/kg of body weight in adults and children over 10 kg of weight, diluted in 50-100 ml of physiological serum, over 15-30 minutes. If a positive effect is obtained, the initial dose can be repeated 1 or 2 times at intervals of 6-12 hours. However, another repetition of the dose would produce a decrease in the effect.

The use in children requires special care to prevent the appearance of hyponatremia. It is not recommended for use in children under 3 months.

If you use more Minurin than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicological Information Service immediately at 915 620 420 indicating the medication and the amount ingested.

Overdose increases the risk of water retention and hyponatremia. Although the treatment of hyponatremia should be individualized, the following recommendations can be followed:

in asymptomatic hyponatremia, suspend treatment with desmopressin and restrict fluid intake. In symptomatic hyponatremia, infuse an isotonic or hypertonic sodium chloride solution (physiological serum). In cases of severe water retention (convulsions or loss of consciousness) induce diuresis with furosemide.

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

Like all medications, Minurin may produce adverse effects, although not everyone will experience them.

The following adverse effects are frequent(may affect up to 1 in 10 patients):

• headache,
• stomach pain
• nausea.
• At high doses, the following were observed:

• fatigue,
• transient decrease in blood pressure, with reflex bradycardia and facial flushing at the time of administration.

The following adverse effects are infrequent(may affect up to 1 in 100 patients)

• At high doses: dizziness.

Treatment without restricting water intake may lead to water retention accompanied by signs and symptoms (reduction in serum sodium, weight gain, and, in severe cases, seizures).

Reporting Adverse Effects:

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

Keep this medication out of the sight and reach of children.

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

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 packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Minurin 4 micrograms/ml injectable solution

• The active ingredient is desmopressin acetate. Each ml of Minurin 4 micrograms/ml injectable solution contains 4 micrograms
• The other components are: sodium chloride, hydrochloric acid, and injection water.

Appearance of the product and contents of the packaging

Minurin 4 micrograms/ml injectable solution is presented in ampoules containing 1 ml of sterile solution of 4 micrograms of desmopressin acetate at a concentration of 4 micrograms/ml in injection water.

The packaging contains 10 ampoules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

FERRING S.A.U

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid, Spain

Responsible for manufacturing:

FERRING GmbH

Wittland 11,

D-24109 Kiel

Germany

This prospectus was last reviewed in November 2017

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/