Minurin Flas 60 micrograms oral lyophilisate
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Minurin Flas 60 micrograms lyophilisate for oral solution
Desmopressin
Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Minurin Flas is and what it is used for
- What you need to know before taking Minurin Flas
- How to take Minurin Flas
- Possible adverse effects
- Storage of Minurin Flas
- Contents of the pack and other 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 drugs known as analogues of the antidiuretic hormone (vasopressin), which temporarily reduces the amount of urine produced by the body.
Minurin Flas is used to treat central diabetes insipidus (continuous thirst and continuous excretion of very dilute urine) and primary nocturnal enuresis (nocturnal urinary incontinence) in patients over 5 years of age who have a normal urine concentrating ability.
2. What you need to know before taking Minurin Flas
Do not take Minurin Flas:
- if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
- if you have habitual polydipsia (prolonged excessive thirst) or psychogenic polydipsia (thirst of emotional or psychological origin),
- if you suffer from heart failure or other conditions requiring treatment with diuretics (medicines that increase urine elimination),
- if you have renal insufficiency,
- if you have known hyponatremia (low sodium levels in the blood),
- if you suffer from syndrome of inappropriate antidiuretic hormone secretion (ADH).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Minurin Flas.
- If you have primary nocturnal enuresis, take special care to restrict fluid intake by not drinking between 1 hour before administration and up to 8 hours afterwards.
Treatment without simultaneous reduction of water intake may cause water retention and/or decreased blood sodium levels, with or without alarm symptoms and signs (headache, nausea/vomiting, weight gain, and in severe cases, seizures). See section 4.
Special care should be taken to avoid lowering sodium levels in the blood in the following cases:
- Systemic infections, fever, and gastroenteritis (syndrome of inappropriate ADH secretion).
- Risk of increased intracranial pressure.
- Imbalance in water and mineral salts content.
- Treatment concomitantly with medications that may themselves cause diabetes insipidus, such as: antidepressant drugs like tricyclic antidepressants (e.g. amitriptyline), selective serotonin reuptake inhibitors (e.g. fluoxetine), chlorpromazine, and carbamazepine.
- Concomitant treatment with NSAIDs (non-steroidal anti-inflammatory drugs) such as acetylsalicylic acid.
Taking other medicines with Minurin Flas
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Minurin Flas may interact with drugs that can themselves cause diabetes insipidus, such as: antidepressant medications like tricyclic antidepressants (e.g. amitriptyline), selective serotonin reuptake inhibitors (e.g. fluoxetine), chlorpromazine, and carbamazepine, as well as certain antidiabetic agents of the sulfonylurea group, particularly chlorpropamide.
Non-steroidal anti-inflammatory drugs (NSAIDs) may induce water retention and/or decreased sodium levels in the blood.
Caution is advised if you are being treated with loperamide (a medicine used to treat diarrhea), as it may increase the risk of water retention and decreased blood sodium levels.
Use of Minurin Flas with beverages
Do not drink liquids with Minurin Flas.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There are insufficient clinical data to support its use during pregnancy. Animal studies have not shown a fetal risk potential with desmopressin administration.
Desmopressin passes into breast milk, although in small amounts; therefore, if you are breastfeeding, it is recommended to substitute breastfeeding with formula feeding.
Driving and using machines
Minurin Flas does not affect the ability to drive or operate machinery.
3. How to take Minurin Flas
Follow exactly the instructions for administration of this medicine as given by your
physician. If in doubt, consult your doctor or pharmacist again.
Recommended dosage
Central diabetes insipidus: The physician will adjust the dose individually.
The recommended initial dose for children and adults is 60 micrograms (one lyophilisate) administered sublingually (under the tongue) three times daily. Subsequently, the physician will 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 daily.
Primary nocturnal enuresis: The recommended initial dose is 120 micrograms of desmopressin taken at bedtime, administered sublingually (under the tongue). If this dose does not achieve the desired effect, your doctor may increase the dose up to 240 micrograms. It is important to control fluid intake (see section 2).
Remember to take your medication. Your doctor will indicate how long your treatment with this medicine should last.
If symptoms or signs of water retention and/or decreased blood sodium occur (headache, nausea and vomiting, weight gain, and in severe cases, seizures), treatment must be discontinued until the patient has recovered. When restarting treatment, fluid intake must 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 take liquids. The oral lyophilisate should preferably be taken with food. If you are taking Minurin Flas for nocturnal enuresis, it is recommended to take the lyophilisate at bedtime with dinner, once daily.
If you feel that the effect of Minurin Flas is too strong or too weak, inform your doctor or pharmacist.
Duration of treatment
Your doctor will indicate how long your treatment with Minurin Flas should last. Do not stop treatment prematurely, as it may not achieve the intended effect.
Treatment for nocturnal enuresis will last for 3 months. After this period, your doctor will assess whether further treatment is necessary. If so, treatment will be resumed, ensuring at least one week without medication.
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 at telephone (91) 562 04 20, indicating the medicine 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, seizures. It is recommended to discontinue 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 missed doses.
If you stop treatment with Minurin Flas
Do not discontinue treatment with this medicine before completing it, as it may not have the intended effect. Only change or discontinue treatment on the advice of your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Common (may affect up to 1 in 10 people): Headache.
Uncommon (may affect up to 1 in 100 people): Mood changes, aggression, abdominal pain, nausea, vomiting, diarrhoea, bladder and urethral symptoms, peripheral oedema, fatigue.
Rare (may affect up to 1 in 1,000 people): Anxiety symptoms, nightmares, mood changes, somnolence, hypertension, irritability.
Frequency not known: Anaphylactic reaction, hyponatraemia, dehydration, hypernatraemia, abnormal behaviour, emotional disorder, depression, hallucinations, insomnia, attention disturbance, psychomotor hyperactivity, seizures, asthenia, coma, epistaxis, allergic dermatitis, exanthema, sweating, urticaria.
Due to decreased sodium levels in the blood caused by water retention as a result of treatment, together with reduced fluid intake, headache, nausea, vomiting, decreased sodium levels, weight gain, and in severe cases, seizures may occur.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Minurin Flasl
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy.
If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This 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 67 micrograms of desmopressin acetate, equivalent to 60 micrograms of desmopressin base.
- The other components are: Gelatin, mannitol, and anhydrous citric acid.
Appearance of the medicinal product and contents of the pack
The oral lyophilisate is white, round, and features the outline of a drop on one side.
It is presented in aluminum/aluminum blisters containing 10 oral lyophilisates.
The pack contains 10, 30, or 100 oral lyophilisates.
Only certain pack sizes may be commercially available.
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 the most recent review of this package leaflet: May 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/