Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Desmopressin acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of the medicine is Desmopressin 60, 120 and 240 micrograms sublingual lyophilizate contains the active substance desmopressin (as acetate). It belongs to a group of medicines called vasopressin and analogues (ATC code: H01BA02), which are agents with antidiuretic activity. Desmopressin is used to treat:
e Desmopressin There are general restrictions, precautions and warnings which apply to all patients using Desmopressin. General restrictions: Do not take Desmopressin if you:
Desmopressin Always take Desmopressin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Desmopressin is intended for sublingual use (to be placed under the tongue where it will dissolve completely). The recommended doses are: Diabetes insipidus: Your doctor will prescribe the dose most suitable for you.
180 x 370 mm Product Name: Desmopressin 240 mcg sublingual lyophilisate Component: Pack Insert
Front Side F.P.O
Dimension: 180 x 370 mm Buyer/Country: SPUK Mfg Location: CMO – Tenshi Kaizen Private Limited 1xxxxxx: Item code shall appear Version No.: 03 Date: 06-08-2025
Pharmacode shall appear Die-Lines
Colours: 01 Black
The total daily dose normally lies in the range of 120 micrograms to 720micrograms. A suitable starting dose in adults and children is one Desmopressin 60 micrograms sublingual tablets taken sublingually (under the tongue) three times a day. The most common doses in adults and children are either one Desmopressin 60 micrograms sublingual tablet or one Desmopressin 120micrograms sublingual tablet taken sublingually (under the tongue) three times a day. Post-hypophysectomy polyuria/polydipsia: Your doctor will prescribe the most suitable dose for you based on the concentration of your urine. Primary nocturnal enuresis (bedwetting) The recommended initial dose for children (from 5 years of age) and adults (up to 65 years of age) with normal urine concentrating ability, who have primary nocturnal enuresis, is 120 micrograms at bedtime. Depending on how well the bedwetting is controlled, your doctor may increase the dose to either two Desmopressin 120 micrograms sublingual tablets or one Desmopressin 240 micrograms sublingual tablet taken sublingually (under the tongue) at bedtime. The need for continued treatment is normally checked every three months. Method of administration Desmopressin is placed under the tongue where it dissolves without the need for water. The tablet should be placed under the tongue and allowed to dissolve. Do not swallow or chew or take with water. To remove the sublingual lyophilisate from the blister:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
–
symptoms of anxiety nightmares mood swings sleepiness (somnolence) high blood pressure irritability
Other side effects:
Desmopressin Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the container or carton after EXP. The expiry date refers to the last day of that month. Store below 25°C. Store in the original package, in order to protect from moisture. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
What Desmopressin contains sublingual lyophilisate Desmopressin 60 micrograms sublingual lyophilisate Each sublingual lyophilisate contains 60 micrograms of desmopressin (as acetate). Desmopressin 120 micrograms sublingual lyophilisate Each sublingual lyophilisate contains 120 micrograms of desmopressin (as acetate). Desmopressin 240 micrograms sublingual lyophilisate Each sublingual lyophilisate contains 240 micrograms of desmopressin (as acetate). The other ingredients are pullulan (E1204), mannitol (E421), trisodium citrate dihydrate (E 331), citric acid (E 330). What Desmopressin looks like and contents of the pack Desmopressin 60 micrograms sublingual lyophilisate
You should avoid drinking large amounts of fluid while you are being treated with Desmopressin, as this could lead to a build-up of water which dilutes the salt in the body. This is a serious problem and may lead to convulsions.
white to off-white, round, lyophilized tablet, with a diameter of approximately 12 mm.
Stop treatment immediately and contact your doctor if you experience any of the following
Desmopressin 240 micrograms sublingual lyophilisate
Common side effects (may affect up to 1 in 10 people):
white to off-white, round, lyophilized tablet, with a diameter of approximately 12 mm. white to off-white, round, lyophilized tablet, with a diameter of approximately 12 mm. Blister packaging of 10 sublingual lyophilisates in packs of 30 or 90 or 100 sublingual lyophilisates. The blister comprising PVC/polyamide/aluminium/ polyamide/PVC blister with peel-off lidding of paper/PET/ aluminium foil. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Strides Pharma UK Limited Unit 4, The Metro Centre, Dwight Road, Watford, WD18 9SS United Kingdom This leaflet was last revised in 07/2025.
1200013341
if you experience any of the following side effects:
Desmopressin 120 micrograms sublingual lyophilisate
Rare side effects may affect up to 1 in 1,000 people:
180 x 370 mm Product Name: Desmopressin 240 mcg sublingual lyophilisate Component:503 Pack Insert
Back Side
F.P.O
Dimension: 180 x 370 mm Buyer/Country: SPUK Mfg Location: CMO – Tenshi Kaizen Private Limited 1xxxxxx: Item code shall appear Version No.: 03 Date: 06-08-2025
Pharmacode shall appear Die-Lines
Colours: 01 Black
Desmopressin 240 microgram Tablet comes as tablet containing 240mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Desmopressin 240 microgram Tablet is desmopressin acetate.
Medicines with the same active substance, strength and form include: Desmopressin 240 microgram sublingual tablets, Desmopressin 240 microgram Sublingual tablet, Desmopressin 240 micrograms Sublingual Tablets. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Desmopressin 240 microgram Tablet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
• Treatment of vasopressin-sensitive cranial diabetes insipidus
• Treatment of post-hypophysectomy polyuria/polydipsia
• Treatment of primary nocturnal enuresis.
Posology
Treatment of diabetes insipidus:
Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 micrograms to 720 micrograms. A suitable starting dose in adults and children is 60 micrograms three times daily, administered sublingually.
This dosage regimen should then be adjusted in accordance with the patient's response. For the majority of patients, the maintenance dose is 60 micrograms to 120 micrograms sublingually three times daily.
Post-hypophysectomy polyuria/polydipsia:
The dose of desmopressin sublingual tablets should be controlled by measurement of urine osmolality.
Primary nocturnal enuresis
The recommended initial dose for children (from 5 years of age) and adults (up to 65 years of age) with normal urine concentrating ability, who have primary nocturnal enuresis, is 120 micrograms at bedtime administered sublingually. If this dose is not sufficiently effective, the dose may be increased up to 240 micrograms, administered sublingually. Fluid restriction should be observed.
Desmopressin sublingual tablets are intended for treatment periods of up to 3 months. The need for continued treatment should be reassessed by means of a period of at least 1 week without Desmopressin sublingual tablets.
In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. When restarting treatment strict fluid restriction should be enforced (see section 4.4).
If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the medication should be discontinued.
Special Populations
Elderly patients (65 years of age and older)
The initiation of treatment in patients over 65 years of age is not recommended (see section 4.3 and 4.4).
Renal impairment
Desmopressin sublingual tablets are contraindicated in patients with moderate and severe renal insufficiency (see section 4.3).
Hepatic impairment
No dose adjustment is needed for patients with hepatic impairment (see section 5.2).
Paediatric population
Desmopressin sublingual tablets are indicated for treatment in this population (see section 4.2 above). Dose recommendations are the same as in adults.
Method of administration
Sublingual use, place the tablet under the tongue where it dissolves without the need for water.
Food intake may reduce the intensity and duration of the antidiuretic effect at low doses of desmopressin (see section 4.5).
Contraindications related to the treatment of primary nocturnal enuresis
Hypersensitivity to the active substance or any of the excipients listed in section 6.1
Known or suspected cardiac insufficiency and other conditions requiring treatment with diuretic agents. Desmopressin sublingual tablets should only be used in patients with normal blood pressure.
Before prescribing Desmopressin, the diagnoses of habitual or psychogenic polydipsia (resulting in a urine production exceeding 40 ml/kg/24 hours) and alcohol abuse should be excluded.
Desmopressin should not be prescribed to patients over the age of 65
Moderate and severe renal insufficiency (creatinine clearance below 50ml/min) Known hyponatremia
Syndrome of inappropriate ADH secretion (SIADH)
Contraindications related to the treatment of diabetes insipidus and posy- hypophysectomy polyuria/polydipsia
When treated for the above conditions desmopressin sublingual tablets are contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents.
Before prescribing desmopressin sublingual tablets, the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.
Special warnings:
Care should be taken with patients who have reduced renal function and/or cardiovascular disease or cystic fibrosis. In chronic renal disease, the antidiuretic effect of desmopressin sublingual lyophilisate would be less than normal.
Safety warnings specific to the treatment of primary nocturnal enuresis:
When desmopressin 120 or 240 microgram sublingual tablets are used for the treatment of enuresis, the fluid intake must be limited to a minimum from 1 hour before until the next morning (at least 8 hours) after administration. Treatment without concomitant reduction of fluid intake may lead to water retention and/or hyponatraemia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions).
All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid restrictions.
Precautions:
Desmopressin should be used with caution in patients with conditions characterised by fluid and/or electrolyte imbalance.
Precautions must be taken in patients at risk for increased intracranial pressure.
Precaution specific to the treatment of primary nocturnal enuresis:
Severe bladder dysfunction and outlet obstruction should be considered before starting treatment.
Elderly patients and patients with serum sodium levels in the lower range of normal may have an increased risk of hyponatraemia.
Treatment with desmopressin should be interrupted during acute intercurrent illnesses characterized by fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis).
Precautions to avoid hyponatraemia including careful attention to fluid restriction and more frequent monitoring of serum sodium must be taken in case of concomitant treatment with drugs, which are known to induce SIADH, e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine, case of concomitant treatment with NSAIDs.
Information related to excipients:
This medicine contains less than 1 mmol sodium (23 mg) per sublingual lyophilisate, that is to say essentially 'sodium-free'.
Pharmacodynamic interactions
Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine, as well as some antidiabetics of the sulfonylurea group particularly chlorpropamide, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia (see section 4.4).
NSAIDs may induce water retention and/or hyponatraemia. Pharmacokinetic interactions
Concomitant treatment with loperamide may result in a 3-fold increase in plasma desmopressin concentrations, which may lead to an increased risk of water retention and/or hyponatraemia. Although not investigated, other drugs slowing intestinal transit might have the same effect.
A standardised 27% fat meal significantly decreased the absorption (rate and extent) of a 0.4mg dose of oral desmopressin tablets. Although it did not significantly affect the pharmacodynamic effect (urine production and osmolality), there is the potential for this to occur at lower doses. If a reduction of the effect is noted, then the effect of food should be considered before increasing the dose.
Food intake may reduce the intensity and duration of the antidiuretic effect at low oral doses of desmopressin tablets.
Pregnancy:
Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia.
Lactation:
Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis. Therefore it is not considered necessary to stop breastfeeding.
Desmopressin has no or negligible influence on the ability to drive and use machines.
The most serious adverse reaction with desmopressin is hyponatraemia, which is associated with headache, nausea, vomiting, decreased serum sodium, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusion, decreased consciousness and in severe cases convulsions and coma. The cause of the potential hyponatraemia is the anticipated antidiuretic effect. The hyponatraemia is reversible and in children, it is often seen to occur in relation to changes in daily routines affecting fluid intake and/or perspiration. In both adults and children, special attention should be paid to the precautions addressed in section 4.4.
Tabulated summary of adverse reactions
The table below is based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in children and adolescents for the treatment of Primary Nocturnal Enuresis (PNE) (N = 1923).
System Organ Class
Common
(≥ 1/100 to < 1/10)
Uncommon
(≥ 1/1,000 to < 1/100)
Rare
(≥ 1/10,000 to < 1/1,000)
Psychiatric disorders
Affect lability
Aggression
Anxiety symptoms, Nightmare, Mood swings
Nervous system disorders
Headache
Somnolence
Vascular disorders
Hypertension
Gastrointestinal disorders
Abdominal pain, Nausea, Vomiting, Diarrhoea,
Renal and urinary disorders
Bladder and urethral symptoms
General disorders and administration site conditions
Oedema peripheral, Fatigue
Irritability
In the case of hyponatraemia, the treatment of hyponatraemia should be individualised (see section 4.9).
Caution should be taken when substances with increased risk of water retention are taken concurrently with desmopressin sublingual tablets, since the concurrent use may increase the risk of hyponatraemia (see section 4.4). Anaphylactic reactions, Psychomotor hyperactivity and some Psychiatric reactions such as abnormal behaviour, emotional disorder, depression, hallucination & insomnia, have not been seen in clinical trials but spontaneous reports have been received.
In children, psychiatric disorders including affect lability, aggression, anxiety, mood swings & nightmare are generally reversed upon treatment discontinuation.
Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported.
Other special populations:
Elderly patients and patients with serum sodium levels in the lower range of normal may have an increased risk of developing hyponatraemia (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms:
An overdose of desmopressin leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia.
Treatment:
Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given. Hyponatraemia is treated by discontinuing the desmopressin treatment, fluid restriction and symptomatic treatment if needed
Ask anything about Desmopressin 240 microgram Tablet. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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