Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Desmopressin 60, 120 and 240 micrograms sublingual tablets contain desmopressin (as acetate). Each tablet contains 60, 120 or 240 micrograms of desmopressin (as acetate). This medicine belongs to a group of medicines called vasopressin and analogues, it is an antidiuretic i.e. it reduces urine production.
This medicine is used to treat:
- diabetes insipidus (extreme thirst and the
continuous production of large volumes of dilute urine). IMPORTANT: This should not beconfused with diabetes mellitus (sugar diabetes) - post-hypophysectomy polyuria/polydipsia
(extreme thirst and the continuous production of large volumes of dilute urine following surgical removal of the pituitary gland)
The 120 and 240 microgram tablets are also used to treat:
- Primary nocturnal enuresis (bedwetting) in
children (from 5 years of age) and adults (up to 65 years of age).
DO NOT take Desmopressin sublingual tab lets if you: • are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6) • have a serious heart or kidney disease • are taking diuretics (water tablets) • drink unusually large quantities of fluids, including alcohol • under 5 or over 65 years old if taking this medicine for nocturnal enuresis (bedwetting) • are taking medication for high blood pressure or have been told that your blood pressure is abnormal • are suffering from habitual polydipsia (habitually increased fluid intake) or psychogenic polydipsia (mentally caused increased thirst and increased fluid intake) • have low sodium levels in your blood (hyponatraemia) • have conditions with increased ADH secretion (syndrome of inadequate ADH secretion)
You should avoid drinking large amounts of fluid while you are being treated with Desmopressin sublingual tablets, as this could lead to a build-up of water which di lutes the salt in the body. This may lead to headaches, nausea/vomiting, weight gain and in severe cases convulsions.
Warnings and precautions Talk to your doctor or pharmacist before taking Desmopressin sublingual tablets.
Uncommon side effects may affect up to 1 in 100 people: - aggression - emotional instability - stomach pain - nausea - vomiting - diarrhoea - urinary symptoms - swelling of the tissue in the lower limbs
your doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose to suit your condition.
Method of administration This medicine is intended for sublingual use (under the tongue). The tablet should be placed under the tongue and allowed to dissolve. Do not swallow or chew or take with water. If the tablet breaks into more than two pieces while you are taking the tablet out of the container, do not take the broken pieces. Take a new tablet. The tablet will dissolve within 30 seconds and have a sweet taste due to the presence of the sweeteners mannitol and aspartame in the tablets. The tablets are supplied with desiccant canisters, which should not be put in the mouth.
(Oedema peripheral) - tiredness (Fatigue)
Take special care with Desmopressin sub lingual tablets: • if you have an illness causing fluid and/ or electrolyte imbalance e.g. vomiting, diarrhoea, systemic infections, fever or gastroenteritis • if you have a medical condition that could be made worse by fluid and/or electrolyte disturbance. A condition where your blood sodium levels are too low or you are likely to build up too much water in your body • if you have cystic fibrosis • if you have difficulty in passing water (severe bladder dysfunction).
Rare side effects may affect up to 1 in 1,000 people: - symptoms of anxiety - nightmares - mood swings - sleepiness (somnolence) - high blood pressure - irritability
Doses Diabetes insipidus: Your doctor will prescribe the dose most suitable for you. 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.
Other side effects: - anaphylactic reactions (severe allergic
reactions) - low levels of sodium in the blood
(hyponatraemia) - abnormal behaviour - emotional disorder - depression - hallucination - trouble sleeping (Insomnia) - increased restlessness and movement
While taking Desmopressin sublingual tablets for the treatment of primary nocturnal enuresis (bedwetting) : • fluid intake must be limited to a minimum from 1 hour before taking the dose at bedtime until the following morning (and, in any case, for at least 8 hours) • stop taking this medicine when suffering from vomiting and/or diarrhoea until you are better • swallowing water while swimming should be avoided because it could lead to a build-up of water in the body.
(psychomotor hyperactivity)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects, you can help provide more information on the safety of this medicine.
Post-hypophysectomy polyuria/polydipsia: Your doctor will prescribe the most suitable dose for you based on the concentration of your urine.
Children This medicine is NOT suitable for children under 5 years of age when used to treat nocturnal enuresis (bedwetting).
Primary nocturnal enuresis (bedwetting) The usual starting dose is one Desmopressin 120 micrograms sublingual tablets taken sublingually (under the tongue) 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.
Other medicines and Desmopressin sub lingual tablets Please inform your doctor or pharmacist if you: • are taking or have recently taken or used any other medicines, even those not prescribed • are on medication for depression, epilepsy or type II diabetes • are taking a medicine for pain and/or inflammation containing non-steroidal antiinflammatory drugs (also known as NSAIDs) e.g. indometacin • are taking a medicine containing loperamide for diarrhoea.
Common side effects may affect up to 1 in 10 people: - headache
Always take Desmopressin sublingual tablets exactly as your doctor has told you. Check with
This leaflet was last revised in 03/2023.
Pregnancy, breast-feeding and fertility 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. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia (a condition in pregnant women that can cause serious complications). Symptoms of pre-eclampsia include high blood pressure, oedema (swelling due to the build-up of fluid).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 bottle label and the carton. The expiry date refers to the last day of that month.
If you take more Desmopressin sublingual tablets than you should If you take more Desmopressin sublingual tablets than you should, talk to your doctor or pharmacist immediately.
After opening the container, the tablets can be used for 1 month.
Do not store above 25°C. Store in the original package to protect from moisture and light. The three desiccant canisters should not be removed from the bottle and keep the cap on the bottle as the tablets are sensitive to moisture.
Desmopressin sublingual tablets with food Desmopressin sublingual tablets are taken together with food, the intensity and duration of effect may be reduced.
If you forget to take Desmopressin sublin gual tablets Do NOT take a double dose to make up for a forgotten dose. If you forget to take this medicine please consult your doctor or pharmacist for advice.
All patients, in case of children their parents and, where applicable, responsible nursing staff should be carefully instructed to adhere to the fluid restrictions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help to protect the environment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What Desmopressin sublingual tablets contain - The active ingredient is desmopressin (as
You should avoid drinking large amounts of fluid while you are being treated with Desmopressin sublingual tablets, 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.
acetate). Each tablet contains 60, 120 or 240 micrograms of desmopressin (as acetate). - The other ingredients are citric acid
monohydrate, mannitol, crospovidone, aspartame (E 951), talc and sodium stearyl fumarate.
STOP taking Desmopressin sublingual tablets if you experience any of the following side effects: • unusually bad or prolonged headache, confusion, unexplained weight gain, ankle swelling, nausea, vomiting, dizziness, feeling of general discomfort, memory impairment, feel a whirling or spinning sensation (vertigo) or falls • allergic reactions including itching, skin rashes, swelling of the face, lips or throat, difficulty in breathing, wheeziness, chest tightness or coughing
Driving and using machines Desmopressin is unlikely to affect your ability to drive or operate machinery.
What Desmopressin sublingual tablets looks like and the contents of the pack Desmopressin sublingual tablets are white to off white, circular, flat-faced tablets. Each tablet is engraved with D1, D2 or D3 on one side and plain on the other side indicating the strength of 60, 120 or 240 micrograms respectively. The tablet diameter is approximately 5.50 mm. Each pack contains 30, 40 or 100 tablets. Not all pack sizes will be marketed.
Desmopressin sublingual tablets contain: • aspartame (E 951): this medicine contains 1.2mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. • sodium: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
Marketing Authorisation Holder Molecule Pharma Limited, 231 Kenton Road, Harrow, HA3 0HD, United Kingdom.
If you experience any of the above side effects, you should contact your doctor or go to the nearest casualty department immediately.
Manufacturer Kinedexe UK Limited, Unit 15 Moorcroft, Harling ton Road, Uxbridge, UB8 3HD, United Kingdom.
Desmopressin 240 micrograms Sublingual Tablets 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 micrograms Sublingual Tablets 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 microgram Tablet. 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 micrograms Sublingual Tablets, 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.
Desmopressin sublingual tablets are indicated for the treatment of vasopressin-sensitive cranial diabetes insipidus or in the treatment of post-hypophysectomy polyuria/polydipsia.
Desmopressin sublingual tablets are also indicated for the 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.
Habitual or psychogenic polydipsia (resulting in a urine production exceeding 40 ml/kg/24 hours) and alcohol abuse.
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 tablets 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 characterised 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.
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 of 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).
stem 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 sublingual tablets 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 micrograms Sublingual Tablets. 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.