MINURIN FLAS 240 micrograms ORAL LYOPHILIZED

Introduction

Package Leaflet: Information for the Patient

Minurin Flas 240 micrograms Oral Lyophilisate

Desmopressin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 package leaflet:

1. What is Minurin Flas and what is it used for
2. What you need to know before you take Minurin Flas
3. How to take Minurin Flas
4. Possible side effects
5. Storage of Minurin Flas
6. Contents of the pack and other information

1. What is Minurin Flas and what is it used for

Minurin Flas contains desmopressin, a structural analogue of the natural pituitary hormone arginine vasopressin. Desmopressin belongs to the group of antidiuretic hormone (vasopressin) analogues, which temporarily reduces the amount of urine produced by the body.

Minurin Flas is used to treat central diabetes insipidus (continuous thirst and production of very diluted urine) and primary nocturnal enuresis (bedwetting at night) in patients over 5 years of age with normal urine concentration capacity.

2. What you need to know before you take Minurin Flas

Do not take Minurin Flas:

• 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 habitual or psychogenic polydipsia (excessive thirst).
• if you have heart failure or other conditions that require treatment with diuretics (medicines that increase urine production).
• if you have renal failure.
• if you have known hyponatremia (low sodium levels in the blood).
• if you have syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Warnings and precautions

Consult your doctor or pharmacist before taking Minurin Flas.

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

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

Special care should be taken to avoid decreased sodium levelsin the blood in the following cases:

• Generalized infections, fever, and gastroenteritis(inappropriate antidiuretic hormone secretion).
• Risk of increased intracranial pressure.
• Imbalance in water and mineral content.
• Treatmentwith medications that may cause diabetes insipidus, such as tricyclic antidepressants (e.g., amitriptyline), selective serotonin reuptake inhibitors (e.g., fluoxetine), chlorpromazine, and carbamazepine.
• Concomitant treatmentwith non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid.

Use of other medicines and Minurin Flas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Minurin Flas may interact with medicines that may cause diabetes insipidus, such as tricyclic antidepressants (e.g., amitriptyline), selective serotonin reuptake inhibitors (e.g., fluoxetine), chlorpromazine, and carbamazepine, as well as some antidiabetic medicines of the sulfonylurea group, especially chlorpropamide.

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

Caution should be exercised if you are being treated with loperamide (a medicine used to treat diarrhea) as it may increase the risk of water retention and decreased sodium levels in the blood.

Use of Minurin Flas with beverages

Do not drink fluids with Minurin Flas.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There are no sufficient clinical data to support its use during pregnancy. Animal studies have not shown any fetal risk with the administration of desmopressin.

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

Driving and using machines

Minurin Flas does not affect the ability to drive or use machines.

3. How to take Minurin Flas

Follow exactly the administration instructions of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist.

Usual dose:

Central diabetes insipidus: Your doctor will adjust the dose individually.

The recommended initial dose for children and adults is 60 micrograms, three times a day, administered sublingually (under the tongue). Subsequently, your doctor will adjust the dose according to each patient's response. The maintenance dose usually ranges between 60 and 120 micrograms of desmopressin, three times a day.

Primary nocturnal enuresis: The recommended initial dose is 120 micrograms of desmopressin at bedtime, administered sublingually (under the tongue). If the desired effect is not achieved with this dose, your doctor may increase the dose up to 240 micrograms.

It is essential to control fluid intake (see section 2).

Remember to take your medicine. Your doctor will indicate the duration of your treatment with this medicine.

In case of observing symptoms or signs of water retention and/or decreased sodium levels in the blood (headache, nausea, and vomiting, weight gain, and in severe cases, convulsions), treatment should be interrupted until the patient has recovered. When treatment is restarted, fluid intake will be strictly controlled.

Instructions for use and handling

Place the lyophilisate under the tongue. The lyophilisate dissolves almost instantly in the mouth without fluid intake. The oral lyophilisate should be taken three times a day, preferably with meals in the case of central diabetes insipidus. If you are taking Minurin Flas for primary nocturnal enuresis, it is recommended to take the lyophilisate at bedtime with dinner, once a day.

If you think the action of Minurin Flas is too strong or too weak, tell your doctor or pharmacist.

Duration of treatment

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

Treatment for primary nocturnal enuresis will last for 3 months. Then, your doctor will assess the need to continue treatment, and if so, it will be reinstated, maintaining at least one week of rest.

If you take more Minurin Flas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the package and the leaflet to the healthcare professional.

An overdose may prolong the effect of desmopressin and increase the risk of fluid retention in the body and/or low sodium levels in the blood. Symptoms may include headache, nausea, and vomiting, weight gain, and in severe cases, convulsions. It is recommended to interrupt treatment, restrict fluid intake, and provide symptomatic treatment if necessary.

If you forget to take Minurin Flas

Do not take a double dose to make up for forgotten doses.

If you stop taking Minurin Flas

Do not stop treatment with this medicine before completing it, as it may not have the expected effect. Only change or stop treatment if your doctor tells you to.

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

4. Possible side effects

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

Frequent, (may affect up to 1 in 10 patients):Headache.

Uncommon, (may affect up to 1 in 100 patients):Mood changes, aggression, abdominal pain, nausea, vomiting, diarrhea, symptoms in the bladder and urethra, peripheral edema, fatigue.

Rare, (may affect up to 1 in 1,000 patients):Anxiety symptoms, nightmares, mood changes, somnolence, hypertension, irritability.

Frequency not known: Anaphylactic reaction, hyponatremia, dehydration, hypernatremia, abnormal behavior, emotional disorder, depression, hallucinations, insomnia, attention disorder, psychomotor hyperactivity, convulsions, asthenia, coma, epistaxis, allergic dermatitis, exanthema, sweating, urticaria.

Due to decreased sodium levels in the blood due to water retention as a consequence of treatment, along with reduced fluid intake, headache, nausea, vomiting, decreased sodium levels, weight gain, and in severe cases, convulsions may occur.

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: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Minurin Flas

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

This medicine does not require any special storage temperature.

Keep the medicine in the original package to protect it from light and moisture.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month shown.

Medicines should 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

Composition of Minurin Flas

• The active substance is desmopressin acetate. Each oral lyophilisate contains 270 micrograms of desmopressin acetate, equivalent to 240 micrograms of desmopressin base.
• The other ingredients are: Gelatin, Mannitol, and anhydrous citric acid.

Appearance of the product and pack contents

The oral lyophilisate is white, round, with the silhouette of a drop on one of the faces.

It is presented in aluminum/aluminum blisters of 10 oral lyophilisates.

The pack contains 10, 30, or 100 oral lyophilisates.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FERRING S.A.U

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

• Spain

Manufacturer

FERRING GmbH

Wittland 11,

D-24109 Kiel

GERMANY

Date of last revision of this leaflet: May 2019

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/