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 your medicine is Desmopressin 120 and 240 microrgams sublingual tablets (called Desmopressin throughout this leaflet). They are oral lyophilisates, they look like tablets but are much softer and lighter. Intended for sublingual use (to be placed under the tongue where it will dissolve completely). Desmopressin is available in two strengths: 120 and 240 micrograms. It contains Desmopressin acetate, an antidiuretic (reduces urine production).. Desmopressin is used to treat:
E DESMOPRESSIN Do not take Desmopressin if you:
Desmopressin contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Desmopressin contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per sublingual tablet, that is to say essentially 'sodiumfree'.
DESMOPRESSIN It is important to use this medicine as directed by your doctor. Desmopressin is intented for sublingual use (to be placed under the tongue where it will dissolve completely). Do NOT take more than the prescribed dose in any 24 hour period. If you have the impression that the effect of Desmopressin is too strong or too weak, talk to your doctor or pharmacist. The usual doses are: Treatment of diabetes insipidus: Your doctor will prescribe the dose most suitable for you. The most common doses in adults and children are either one Desmopressin 60 micrograms or one Desmopressin 120 micrograms three times a day. Treatment of extreme thirst and the continuous production of large volumes of dilute urine following surgical removal of the pituitary gland: Your doctor will prescribe the most suitable dose for you based on the concentration of your urine. If you take more of this medicine than you should If you take more Desmopressin than you should or if, talk to your doctor or pharmacist immediately. If you forget to take this medicine Do not take a double dose to make up for a forgotten tablet. If you are a patient with diabetes insipidus, please consult your doctor or pharmacist immediately.
Like all medicines, this medicine can cause side effects although not everybody gets them. 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. STOP USING Desmopressin if you experience:
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 blister, label, carton or bottle after EXP. The expiry date refers to the last day of that month.
Blisters Store in the original blister in order to protect from moisture. This medicine does not require any special temperature storage conditions. HDPE bottles Store in the original package. Keep the bottle tightly closed in order to protect from moisture. Do not store above 30 °C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Desmopressin contains
integrated desiccant containing 30 or 100 sublingual tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Zentiva Pharma UK Limited 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Manufacturer(s) Haupt Pharma Mϋnster GmbH Schleebrüggenkamp 15, D-48159 Münster, Germany or Adalvo Ltd., Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann, SGN 3000 Malta This leaflet was last revised in July 2024
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Package leaflet: information for the user
1065042843
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 is indicated for the treatment of vasopressin-sensitive cranial diabetes insipidus or in the treatment of post-hypophysectomy polyuria/polydipsia.
Desmopressin is for sublingual use.
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 should be controlled by measurement of urine osmolality.
Desmopressin is contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents.
Before prescribing Desmopressin, the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.
Care should be taken with patients who have reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of Desmopressin would be less than normal.
Precautions to prevent fluid overload must be taken in:
- conditions characterised by fluid and/or electrolyte imbalance
- patients at risk for increased intracranial pressure.
Excipients with known effect
Desmopressin 240 micrograms sublingual tablet contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine
This medicinal product contains less than 1 mmol sodium (23 mg) per sublingual tablet, that is to say essentially 'sodium-free'.
Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia.
NSAIDs may induce water retention and/or hyponatraemia.
Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations, which may lead to an increased risk of water retention and/or hyponatraemia. Although not investigated, other drugs slowing intestinal transport 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 diminution of effect is noted, then the effect of food should be considered before increasing the dose.
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.
Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.
Reporting of suspected side effects
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.
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 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.
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