MINURIN FLAS 60 micrograms ORAL LYOPHILIZED

Introduction

Package Leaflet: Information for the Patient

Minurin Flas 60 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 pack:

1. What Minurin Flas is and what it is 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 further information

1. What Minurin Flas is and what it is 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 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 or without symptoms and warning signs (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, andgastroenteritis (inappropriate antidiuretic hormone secretion syndrome).
• Risk of increased intracranial pressure.
• Imbalance in water and mineral salt content
• Treatmentwith medications that may cause diabetes insipiduson their own, such as antidepressant medications like amitriptyline, selective serotonin reuptake inhibitors like fluoxetine, chlorpromazine, and carbamazepine.
• Treatmentwith non-steroidal anti-inflammatory drugs (NSAIDs) like acetylsalicylic acid.

Use of other medicines and Minurin Flas

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

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

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

Caution should be exercised if you are being treated with loperamide (a medication 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 liquids 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. Studies in animals 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 given by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual dose

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

The recommended initial dose for children and adults is 60 micrograms (one lyophilisate) three times a day, administered sublingually (under the tongue). Your doctor will then adjust the dose according to each patient's response.

For most patients, the maintenance dose is 60 to 120 micrograms (1 to 2 lyophilisates) administered 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 the need to drink liquids. The oral lyophilisate should be taken preferably with food. 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 effect 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 packaging and 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 side effects 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 in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the packaging 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 further information

Composition of Minurin Flas

• The active substance is desmopressin acetate. Each oral lyophilisate contains 67 micrograms of desmopressin acetate, equivalent to 60 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/