MINIRIN contains desmopressin. Desmopressin is similar to the naturally occurring antidiuretic hormone (ADH) and reduces urinary excretion.
MINIRIN is used for:
• Treatment of nocturnal enuresis (night-time bedwetting) in patients from the age of 5 after organic disorders of the urinary organs have been excluded:
- Within an overall therapeutical concept, e.g. in cases of failure of other non-medicinal therapies or with indication of a medicinal therapy.
- Caused by nocturnal ADH deficiency (lack of antidiuretic hormone).
• Increased, at least twice nocturnal urination due to increased night-time urine production (nocturia in connection with nocturnal polyuria) in adults.
• Trauma-induced polyuria (over production of urine) and polydipsia (increased thirst and increased fluid intake) after hypophysectomy (disconnection of the pituitary gland), after surgery in the pituitary gland area or craniocerebral injury.
• Central diabetes insipidus (disease characterized by excretion of large amounts of water due to impaired ADH secretion in the brain; ADH = antidiuretic hormone is a hormone of the pituitary gland that reduces excretion of water).

MINIRIN must not be used:
- if you are allergic to desmopressin acetate or any of the other ingredients of this medicine (listed in section 6)
- if you are suffering from habitual polydipsia (habitually increased fluid intake) or psychogenic polydipsia (mentally caused increased thirst and increased fluid intake)
- if you are suffering from polydipsia and are alcohol-dependent
- if you have a known or suspected cardiac insufficiency
- if you have any other disease requiring treatment with diuretics
- if you have low sodium levels in your blood (hyponatraemia)
- if you have moderate to severe renal insufficiency
- if you have conditions with increased ADH secretion (syndrome of inadequate ADH secretion)
- for treatment of increased night-time urination if you are 65 or older
Excessive fluid intake may lead to retention of water in tissue, in particular in infants under the age of 1 or elderly patients, depending on their general health (please see also section 4 Possible side effects).
Warnings and precautions: Talk to your doctor or pharmacist before taking MINIRIN.
Take special caution with MINIRIN
- When used for primary nocturnal enuresis and nocturia indications, you must limit the fluid intake to a minimum from 1 hour before administration until the next morning (at least 8 hours after administration).Treatment without concomitant reduction of fluid intake may lead to water retention and/or mineral metabolism disorder with or without accompanying warning signs and symptoms such as headache, nausea/vomiting,weight gain and, in severe cases cerebral oedema sometimes associated with convulsions and/or clouding of consciousness up to loss of consciousness.
- All patients, in case of children their parents and, where applicable, responsible nursing staff should be carefully instructed to adhere to the fluid restrictions.
- You should use desmopressin with caution if you have a mild renal insufficiency.
- Severe bladder dysfunction and outlet obstruction should be precluded before starting treatment with MINIRIN.
- Elderly patients and patients with low sodium levels in the blood have an increased risk of developing highly reduced sodium levels (hyponatraemia).
- If you develop a disease which could affect fluid and/or mineral metabolism, e.g. diseases with fever or diarrhoea, your doctor might stop treatment with MINIRIN.
- If you are at risk for increased intracranial pressure.
- You should adhere to fluid restrictions to prevent strongly decreased sodium levels in the blood. Additionally, your doctor should determine your sodium levels in the blood more frequently, if you take medicinal products which induce SIADH (see section Other medicines and MINIRIN) or if you take medicinal products for rheumatic diseases.
Other medicines and MINIRIN
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. If you take medicinal products which induce SIADH (syndrome of inadequate ADH secretion) like e.g. some medicinal
products for depressions (tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine), medicinal products with the active ingredient carbamazepine for epilepsy and some medicinal products for diabetes (sulfonylurea
group, particularly chlorpropamide) the effect of MINIRIN may be increased. This leads to an increased risk of water retention and lack of sodium in the blood. If you use medicinal products for rheumatic diseases (NSAID=non-steroidal
anti-inflammatory drugs like e.g. indometacin), the inhibitory effect of MINIRIN on water excretion may be intensified. Accompanying treatment with loperamide, a substance used for diarrhoea, may also increase the risk of hyperhydration
of the body. Other medicinal products which slow down the intestinal transport can have the same effect. If used concomitantly with oxytocin (a drug used to stimulate labour pains), an even stronger reduction of water excretion and a
weaker perfusion of the uterus may result. If you use clofibrate (a drug used to lower blood lipid levels), indomethacin (a drug used in rheumatic diseases) or carbamazepine (a drug used, for instance, in epilepsy) concomitantly with
MINIRIN, the inhibitory effect of MINIRIN on water excretion may be increased. Glibenclamide (a drug used to reduce blood sugar levels) may reduce the effect of MINIRIN.
MINIRIN with food and drink: If MINIRIN is taken together with food, the intensity and duration of effect may be reduced.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.If you are pregnant, caution should be exercised. Monitoring of blood pressure is recommended. MINIRIN may be administered to pregnant women after thoroughly weighing up the risks and benefits. Only small amounts of desmopressin pass to the mother’s milk. When administering therapeutic doses of desmopressin, no effects on the newborn/child are to be expected.
Driving and using machines: MINIRIN has no or negligible effect on the ability to drive and operate machinery.

Always take MINIRIN exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. In the event of signs of water retention and/or decreased sodium levels in the blood (headache, fluid accumulation in the tissue, nausea/vomiting, weight gain and, in severe cases, cramps) treatment should be interrupted until you have fully recovered. When restarting treatment, you must strictly restrict fluid supply. In addition, your doctor will closely monitor blood sodium levels.
Special populations:Treatment of elderly patients is not recommended. If, nevertheless, your doctor decides for treatment, your blood sodium levels will be monitored on several days before start of treatment. Melt tablets with a higher
concentration are available for higher and highest doses.
The recommended dose is:
Primary nocturnal enuresis (night-time bedwetting)
For the treatment of night-time bedwetting, an initial dosage of 120 micrograms (2 MINIRIN melt tablets with 60 micrograms or 1 MINIRIN melt tablet with 120 micrograms) before going to bed is recommended. In cases of insufficient therapy success, your doctor may increase the dose to 240 micrograms (2 MINIRIN melt tablets with 120 micrograms or 1 MINIRIN melt tablet with 240 micrograms). You may not increase the dose without your doctor’s approval. Fluid supply should be reduced.The determined effective dose will also be the maintenance dose. It will be determined individually by your doctor and should be used throughout the entire treatment period. Duration of administration: After a treatment period of up to 3 months there should be a treatment-free interval of at least 1 week to check whether healing has taken place or whether therapy should be continued.
Increased night-time voiding (nocturia) due to increased urine production during the night
For treatment of increased night-time urination, the recommended initial dose is 60 micrograms desmopressin (1 MINIRIN melt tablet with 60 micrograms) before going to bed. If this dose is not sufficient after one week, it may be increased up to 120 micrograms (2 MINIRIN melt tablets with 60 micrograms or 1 MINIRIN melt tablet with 120 micrograms) and subsequently to 240 micrograms (2 MINIRIN melt tablets with 120 micrograms or 1 MINIRIN melt tablet with 240 micrograms) by weekly dose escalations. You should reduce nocturnal fluid supply as far as possible (see section 2). Your doctor will discuss with you the measures required before start of treatment. Before start of treatment, you should record the times of urination and the amount of urine for at least 48 hours. In addition, your doctor will measure sodium levels in your blood before start of treatment.You should check your body weight over several days at the beginning of treatment and after each dose increase. If adequate effect is not achieved within 1 week with appropriate dosage, the medication should be discontinued.
Central diabetes insipidus (disease characterized by excretion of large amounts of water due to impaired ADH secretion in the brain) as well as trauma-induced polyuria (overproduction of urine) and polydipsia
(increased thirst and increased fluid intake). Adults and children: the daily dose is normally between 120 micrograms (2 MINIRIN melt tablets with 60 micrograms or 1 MINIRIN melt tablet with 120 micrograms) and 720 micrograms (3 MINIRIN melt tablets with 240 micrograms). Treatment should be started with 60 micrograms 3 times daily (1 MINIRIN melt tablet with 60 micrograms each).
The maintenance dose in most of the patients is 60 – 120 micrograms 3 times daily (1 – 2 MINIRIN melt tablets with 60 micrograms each). Your doctor will individually adapt the dosage to your response to treatment.
Method of administration:MINIRIN is placed under the tongue where it dissolves. Please consult your doctor or pharmacist, if you believe that the effect of MINIRIN is too strong or too weak.
If you take more MINIRIN than you should: Special attention should be given to signs of hyperhydration of the body (water intoxication). It may also occur if there is excessive fluid intake at the same time or shortly after the administration of MINIRIN. It manifests by weight gain, headache, nausea and, in severe cases, convulsions sometimes associated with clouding of consciousness up to loss of consciousness (see also section Side effects). Please consult your doctor if you are not sure.
If you forget to take MINIRIN:In the case of primary nocturnal enuresis and nocturia you should not take the melt tablets too late. Continue taking the medicinal product as usual on the next day.
In the case of central diabetes insipidus you should repeat dosing as soon as you notice the error. Keep to the usual interval until the next dose.
If you stop taking MINIRIN: Treatment should only be interrupted or stopped on advice of your doctor. If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Treatment without simultaneous limited fluid supply can lead to retention of water in the tissue (water retention) / mineral metabolism disorder (hyponatraemia) with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain and, in severe cases, cramps sometimes associated with sleepiness up to prolonged loss of consciousness).
Adults:
Very common (may affect more than 1 of 10 treated patients): headache.
Common (may affect up to 1 of 10 treated patients): decreased blood sodium levels, drowsiness, high blood pressure, nausea, stomach pain, diarrhea, constipation, vomiting, bladder and urethral symptoms, retention of water in the tissue, tiredness.
Uncommon (may affect up to 1 of 100 treated patients): insomnia, somnolence, paraesthesia, visual impairment, dizziness, rapid heartbeats, decrease of blood pressure (orthostatic hypotension),difficulties in breathing, disorders in the upper abdomen (dyspepsia), flatulences, bloating, sweating, itching, rash, itching wheals (hives), muscle cramps, muscle pain, malaise, chest pain, influenza-like illness, weight gain, increase of liver enzymes, decreased blood potassium levels.
Rare (may affect up to 1 of 1000 treated patients): confusional state, allergic-inflammatory skin diseases.
Not known (frequency cannot be estimated from the available data): acute hypersensitivity reaction (anaphylactic reaction), decrease of body water, increased blood sodium levels, seizures, weakness, loss of consciousness (coma).
Children and adolescents:
Common (may affect up to 1 of 10 treated patients): headache.
Uncommon (may affect up to 1 of 100 treated patients): emotional fluctuations, aggressions, stomach pain, nausea, vomiting, diarrhea, bladder and urethral symptoms, swellings of arms and legs because of fluid retention, tiredness.
Rare (may affect up to 1 of 1000 treated patients): anxiety symptoms, nightmares, mood swings, somnolence, high blood pressure, irritability.
Not known (frequency cannot be estimated from the available data): acute hypersensitivity reaction (anaphylactic reaction), decreased blood sodium levels, abnormal behaviour, emotional disorder, depressions, hallucination, insomnia, disturbance in attention, psychomotoric hyperactivity, seizures, nose bleeding, rash, allergic-inflammatory skin diseases, sweating, itching wheals (hives).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Keep this medicine out of the sight and reach of children. Do not use this medicinal product after the expiry date printed on the container and the outer carton. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.