Minurin Flas 240 micrograms oral lyophilisate
SpainTable of Contents
Package leaflet: Information for the user
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 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 side effects, talk to your doctor or pharmacist, even if they are side 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 side effects
- How to store 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 antidiuretic hormone (vasopressin) analogues, which temporarily reduce the amount of urine produced by the body.
Minurin Flas is used to treat central diabetes insipidus (constant thirst and continuous excretion of very dilute urine) and primary nocturnal enuresis (nocturnal urinary incontinence) in patients over 5 years of age who have 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 (of emotional or psychological origin),
- if you suffer from heart failure or other conditions requiring treatment with diuretics (medications 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 ADH secretion (antidiuretic hormone).
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 sodium in the blood, with or without warning symptoms and signs (headache, nausea/vomiting, weight gain, and in severe cases, seizures). See section 4.
Special care should be taken to avoid low sodium levels in the blood in the following cases:
- Systemic infections, fever, and gastroenteritis (inappropriate ADH secretion syndrome).
- Risk of increased intracranial pressure.
- Imbalance in water and electrolyte levels.
- Treatment concomitantly with medications that may cause diabetes insipidus on their own, such as: antidepressants 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 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 certain antidiabetic sulfonylureas, especially chlorpropamide.
Non-steroidal anti-inflammatory drugs (NSAIDs) may induce water retention and decreased sodium levels in the blood.
Caution is advised if you are being treated with loperamide (a medication used to treat diarrhea), as it may increase the risk of water retention and low sodium levels in the blood.
Use of Minurin Flas with drinks
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 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, replacement of natural breastfeeding is recommended.
Driving and using machines
Minurin Flas does not affect the ability to drive or operate machinery.
3. How to take MinurinFlas
Follow exactly the instructions for administration of this medicine as given by your
doctor. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Central diabetes insipidus: The dose will be individually adjusted by your doctor.
The recommended starting dose for adults and children is 60 micrograms three times daily administered sublingually (under the tongue). Subsequently, your doctor will adjust the dose according to the individual patient's response. The maintenance dose usually ranges between 60 and 120 micrograms of desmopressin three times daily.
Primary nocturnal enuresis: The recommended starting 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 medicine. Your doctor will inform you of the duration of treatment with this medicine.
If symptoms or signs of water retention and/or decreased sodium levels in the blood occur (such as headache, nausea and vomiting, weight gain, and in severe cases, seizures), treatment must be interrupted until the patient has recovered. When treatment is restarted, 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 for liquid intake. The oral lyophilisate should be taken three times daily, preferably with meals in the case of diabetes insipidus. If you are taking Minurin Flas for
nocturnal enuresis, it is recommended to take the lyophilisate once daily at bedtime with dinner.
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 inform you of the duration of treatment with Minurin Flas. Do not stop treatment prematurely, as it may not achieve the intended effect.
Treatment for nocturnal enuresis should continue for 3 months. After this period, your doctor will assess whether continued treatment is necessary. If so, treatment may be restarted, maintaining at least a one-week break.
If you take more Minurin Flas than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medicine and amount ingested. It is recommended to bring the package 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, seizures. 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 a missed dose.
If you stop taking Minurin Flas
Do not stop treatment with this medicine before completing it, as it may not achieve the intended effect. Only discontinue or change treatment if specifically instructed by 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 will experience them.
Frequent (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 blood sodium levels 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse 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.
Store in the original container to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy.
If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 270 micrograms of desmopressin acetate, equivalent to 240 micrograms of desmopressin base.
- The other components are: Gelatin, mannitol and anhydrous citric acid.
Nature of the product and contents of the pack
The oral lyophilisate is white, round, with a droplet-shaped imprint 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 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 the most recent revision of this leaflet: May 2019