Patient Information Leaflet

Minurin Flas 60 micrograms oral lyophilisate

Desmopressin

Read this leaflet carefully before you start taking 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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

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

2. What you need to know before you start taking Minurin Flas

3. How to take Minurin Flas

4. Possible side effects

5. Storage of Minurin Flas

6. Contents of the pack and additional information

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

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

Do not take Minurin Flas:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• if you have habitual (prolonged excessive thirst) or psychogenic (originating from emotional or psychological factors) polydipsia,
• if you have heart failureand other conditions that require treatment with diuretics (medications that increase urine elimination),
• if you have kidney insufficiency
• if you have known hyponatremia (low sodium levels in the blood),
• if you have a syndrome of inadequate antidiuretic hormone (ADH) secretion.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Minurin Flas.

- If you have primary nocturnal enuresis, be especially careful to restrict fluid intake by not drinking between 1 hour before

administration and for 8 hours afterwards.

A treatment without simultaneous reduction of water intake may produce water retention

and/or decreased sodium levels in the blood accompanied or not by alarm symptoms and signs

(headache, nausea/vomiting, weight gain, and in severe cases, seizures). See

section 4.

You must be especially careful toavoid decreased sodium levels in the blood in the following cases:

• Infections, fever, and gastroenteritis (syndrome of inappropriate ADH secretion).
• Risk of increased intracranial pressure.
• Imbalance in the content of water and mineral salts
• Treatmentwith medications that may cause diabetes insipidus by themselves, such as:
• Tricyclic antidepressants, for example amitriptyline, selective serotonin reuptake inhibitors, for example fluoxetine, chlorpromazine, and carbamazepine.
• Concomitant treatment with NSAIDs (nonsteroidal anti-inflammatory drugs)such as acetylsalicylic acid.

Use of other medications and Minurin Flas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications

Minurin Flas may interact with medications that may cause diabetes insipidus by themselves, such as:

tricyclic antidepressants, for example amitriptiline, selective serotonin reuptake inhibitors, for example fluoxetine, chlorpromazine, and carbamacepina,as well as some antidiabetic drugs of the sulfonilureas group, especially clorpropamida.

NSAIDs may induce water retention/decreased sodium levels in the blood.

You must be cautious 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 ingest liquids with Minurin Flas.

Pregnancy, breastfeeding, and fertility

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

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

Although desmopressin passes into breast milk in small amounts, in the case of

breastfeeding, it is recommended to substitute breastfeeding.

Driving and operating machinery

Minurin Flas does not affect the ability to drive or operate machinery

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Usual dose

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

The initial recommended 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 initial recommended dose is 120 micrograms of desmopressin at bedtime administered sublingually (under the tongue). If the desired effect is not achieved with that 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 medication. Your doctor will indicate the duration of your treatment with this medication.

In case of observing symptoms or signs of water retention and/or low 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 resumed, 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 ingest liquids. The oral lyophilisate should be taken preferably with food. If you are taking Minurin Flas for nocturnal enuresis, it is recommended to take the lyophilisate at bedtime with dinner, once a day.

If you estimate that the action of Minurin Flas is too strong or too weak, inform your doctor or pharmacist.

Treatment duration

Your doctor will indicate the duration of your treatment with Minurin Flas. Do not discontinue treatment prematurely, as this may not achieve the desired effect.

Treatment for nocturnal enuresis will be continued for 3 months. Your doctor will then evaluate the need to continue treatment and, if so, will reinstate it, maintaining at least a 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 Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging 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 symptomatic treatment if necessary.

If you forgot to take Minurin Flas

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Minurin Flas

Do not discontinue treatment with this medication before completing it, as this may not achieve the desired effect. You should only change or discontinue treatment if your doctor instructs you to do so.

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

Like all medications, this medication may

produce adverse effects, although not all people will experience them.

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

Rarely (may affect up to 1 in 100 patients): Mood changes, aggression, abdominal pain, nausea, vomiting, diarrhea, urinary and urethral symptoms, peripheral edema, fatigue.

Infrequent (may affect up to 1 in 1000 patients): Anxiety symptoms, nightmares, mood swings, drowsiness, hypertension, irritability.

Unknown frequency : Anaphylactic reaction, hyponatremia, dehydration, hypernatremia, abnormal behavior, emotional disorder, depression, hallucinations, insomnia, attention alteration, hyperactivity, seizures, asthenia, coma, epistaxis, allergic dermatitis, exanthema, sweating, urticaria.

Due to the decrease in sodium in the blood caused by water retention as a result of treatment combined with a reduction in liquid intake, headache, nausea, vomiting, decreased sodium, weight gain, and in severe cases, seizures may occur.

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 of Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require any special storage temperature.

Store in the original packaging to protect from light and moisture.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the

packaging and medications you no longer need at the SIGRE drop-off pointat the pharmacy. In

case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Minurin Flas

- The active principle is desmopressin acetate. Each lyophilized oral contains 67 micrograms of desmopressin acetate corresponding to 60 micrograms of desmopressin base.

- The other components are: Gelatin, mannitol and anhydrous citric acid.

Appearance of the product and contents of the packaging.

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

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

The packaging contains 10, 30 or 100 lyophilized oral.

Only some packaging sizes may be commercially marketed.

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

Last review date of this leaflet: May 2019

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/