Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Desmopressin 60 micrograms sublingual tablets
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for Desmopressin sublingual tablets are oral dispersable tablets. They look like tablets but are much softer and lighter. Intended for sublingual use (to be placed under the tongue where they will dissolve completely). Desmopressin sublingual tablets are available in three strengths: 60, 120 or 240 micrograms. The tablets contain Desmopressin acetate, an antidiuretic (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 be confused 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). 1,5 mm
8,5-10,5 mm
What you need to know before you take it
e Desmopressin sublingual tablets
There are general restrictions, precautions and warnings which apply to all patients using Desmopressin sublingual tablets. General restrictions: Do not take Desmopressin sublingual tablets 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
- are under 5 or over 65 years old, if taking the 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 dilutes 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. Take special care with Desmopressin sublingual tablets:
- if you have an illness causing fluid and/or salt 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) 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 Children
- This medicine is NOT suitable for children under 5 years of age when used to treat nocturnal enuresis (bedwetting). Other medicines and Desmopressin sublingual 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 anti-inflammatory drugs (also known as NSAIDs) e.g. indometacin
- are taking a medicine containing loperamide for diarrhoea Desmopressin sublingual tablets with food When Desmopressin sublingual tablets are taken together with food, the intensity and duration of effect may be reduced. All patients, in case of children their parents and, where applicable, responsible nursing staff should be carefully instructed to adhere to the fluid instructions. 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 and oedema (swelling due to the build up of fluid).
10-12 mm Freiraum für Pharmacode-System 10-12 mm free space for pharmacode system
INSTRUCTION FOR USE Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose to suit your condition. 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 blister, do not take the broken pieces. Take a new tablet. The tablet will dissolve within 30 seconds. 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. Doses Treatment of primary nocturnal enuresis (bedwetting) The usual starting dose is one Desmopressin tablet 120 micrograms sublingually (under the tongue) at bedtime. Depending on how well the bedwetting is controlled, your doctor may increase the dose to either two Desmopressin tablets 120 micrograms or one Desmopressin tablet 240 micrograms sublingually (under the tongue) at bedtime. The need for continued treatment is normally checked every three months. Treatment of 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 720 micrograms. A suitable starting dose in adults and children is one Desmporessin 60 micrograms sublingual tablet 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 120 micrograms sublingual tablet taken sublingually (under the tongue) three times a day. Treatment of post hypophysectomy polyuria/polydipsia 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, 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 dose. If you forget to take this medicine please consult your doctor or pharmacist for advice. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
How to take it
Desmopressin sublingual tablets
1,5 mm
Desmopressin sublingual tablets contain lactose Desmopressin contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
min. 6 mm Freiraum für Flattermarken / free space for marks on side
Uncommon side effects may affect up to 1 in 100 people:
- agression
- emotional instability
- stomach pain
- nausea
- vomiting
- diarrhoea
- urinary symptoms
- swelling of the tissue in the lower limbs (Oedema peripheral)
- tiredness (fatigue) Rare side effects may affect up to 1 in 1000 people:
- symptoms of anxiety
- nightmares
- mood swings
- sleepiness (somnolence)
- high blood pressure
- irritability 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 (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.
Possible side effects
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 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. STOP USING 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 If you experience any of the above side effects, you should contact your doctor or go to the nearest casualty department immediately. Common side effects may affect up to 1 in 10 people:
- Headache
min. 6 mm Freiraum für Flattermarken / free space for marks on side
8,5-10,5 mm
How to store it
Desmopressin sublingual tablets Keep Desmopressin sublingual tablets out of the sight and reach of children. Store in the original blister in order to protect from moisture. This medicine does not require any special temperature storage conditions. Do not take this medicine after the expiry date on the packaging. The expiry date refers to the last day of that month. 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.
Contents of the pack and other information
What Desmopressin sublingual tablets contain The active substance is: desmopressin acetate. It is available in three strengths: 60, 120 or 240 micrograms of desmopressin (as acetate). The other ingredients are: lactose monohydrate, maize starch, citric acid anhydrous, croscarmellose sodium and magnesium stearate. 1,5 mm
8,5-10,5 mm
What Desmopressin sublingual tablets looks like and contents of the pack Desmopressin 60 micrograms sublingual tablet White or almost white, round, biconvex tablet debossed with "I" on one side and plain on other side, with 6.5mm diameter and 2mm thickness. Desmopressin 120 micrograms sublingual tablet White or almost white, octagonal, biconvex tablet debossed with "II" on one side and plain on other side, with 6.5mm length/width and 2mm thickness. Desmopressin 240 micrograms sublingual tablet White or almost white, square, biconvex tablet debossed with "III" on one side and plain on other side, with 6mm length/width and 2mm thickness. The tablets are presented in:
- carton box containing OPA/Al/PVC/PE-Al blisters with integrated desiccant layer in pack sizes of 10, 20, 30, 60, 90 or 100 sublingual tablets Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road, Petersfield, Hampshire GU32 3QG, United Kingdom Manufacturer Haupt Pharma Münster 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 January 2024
10-12 mm Freiraum für Pharmacode-System 10-12 mm free space for pharmacode system
min. 6 mm Freiraum für Flattermarken / free space for marks on side
8,5-10,5 mm
1,5 mm
1010625-P1.7
Artwork for: Product name: Size: PL/PA no: Type: Artwork dimensions: Reason for request: Version no: Date of revision: Colours: Font(s): A/W software:
For Submission Only
Aspire Pharma Limited Desmopressin 60/120/240 mcg sublingual tablets X10 PL35533/0200-0202 Leaflet 180mm x 600mm Initial artwork 1.7 20.5.24 As swatches Strada Pro 9pt Indesign CC 2020
Black
Frequently asked questions about Desmopressin 60 micrograms sublingual tablets
How do I take Desmopressin 60 micrograms sublingual tablets?
Desmopressin 60 micrograms sublingual tablets comes as tablet containing 60mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Desmopressin 60 micrograms sublingual tablets?
The active substance in Desmopressin 60 micrograms sublingual tablets is desmopressin acetate.
Are there equivalent medicines to Desmopressin 60 micrograms sublingual tablets?
Medicines with the same active substance, strength and form include: Desmopressin 60 microgram Tablet, Desmopressin 60 micrograms Sublingual Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Desmopressin 60 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.
Can I get Desmopressin 60 micrograms sublingual tablets without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: desmopressin acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
- Treatment of vasopressin-sensitive cranial diabetes insipidus
- Treatment of post-hypophysectomy polyuria/polydipsia.
4.2. Posology and method of administration
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 should be controlled by measurement of urine osmolality.
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 is 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 is 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).
4.3. Contraindications
Hypersensitivity to desmopressin 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).
Before prescribing desmopressin sublingual tablets, the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.
4.4. Special warnings and precautions for use
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 would be less than normal.
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.
Lactose
This medicine contains lactose (as monohydrate). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
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 desmopressin plasma 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.
4.6. Fertility, pregnancy and lactation
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.
4.7. Effects on ability to drive and use machines
Desmopressin has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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.
4.9. Overdose
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 about this leaflet
Ask anything about Desmopressin 60 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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- DDAVP/Desmopressin Injection
- Demovo 360 micrograms / ml Oral Solution
- DesmoMelt 120mcg oral lyophilisate
- DesmoMelt 240mcg oral lyophilisate
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