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.
DesmoMelt 240mcg oral lyophilisate
⚠ 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 2. What you need to know before you take DesmoMelt 3. How to take DesmoMelt 4. Possible side effects 5. How to store DesmoMelt 6. Contents of the pack and other information
1. What DesmoMelt is what it is used for
Talk to your doctor or pharmacist before taking DesmoMelt. Take special care with DesmoMelt:
- 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. 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 DesmoMelt:
- 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.
DesmoMelt are oral lyophiliates, they look like tables but are much softer and lighter. Intended for sublingual use (to be placed under the tongue where it will dissolve completely). They are reffered to as DesmoMelt or melt(s) in this leaflet.
DesmoMelt with food and drink: DesmoMelt is taken together with food, the intensity and duration of effect may be reduced.
DesmoMelt is available in two strengths: 120 or 240 micrograms. It contains Desmopressin acetate, an antidiuretic which reduces urine production.
All patients, in case of children their parents and, where applicable, responsible nursing staff should be carefully instructed to adhere to the fluid restrictions.
DesmoMelt is used to treat:
- Primary nocturnal enuresis (bedwetting) in children (from 5 years of age) and adults (up to 65 years of age).
Other medicines and DesmoMelt: Please inform your doctor or pharmacist:
- if you are taking or have recently taken or used any other medicines, even those not prescribed
- if you are on medication for depression. epilepsy or type II diabetes
- if you are taking a medicine for pain and/or inflammation containing non-steroidal anti-inflammatory drugs (also known as NSAIDs) e.g. indometacin
- if you are taking a medicine containing loperamide for diarrhoea
What you need to know before you take it
e DesmoMelt Do not take DesmoMelt:
- if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6)
- if you have a serious heart or kidney disease
- if you are taking diuretics (water tablets)
- if you drink unusually large quantities of fluids, including alcohol
- if you are under 5 or over 65 years old
- if you are taking medication for high blood pressure or have been told that your blood pressure is abnormal
- if you are suffering from habitual polydipsia (habitually increased fluid intake) or psychogenic polydipsia (mentally caused increased thirst and increased fluid intake)
- if you have low sodium levels in your blood (hyponatraemia)
- if you 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 DesmoMelt, 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.
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).
How to take it
DesmoMelt Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: The usual starting dose is one DesmoMelt 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 DesmoMelts 120 micrograms or one DesmoMelt 240 micrograms sublingually (under the tongue) at bedtime. The need for continued treatment is normally checked every three months.
Warnings and precautions:
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again
- If you have further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If any of the side effects gets serious, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
= No print area
75 mm from top and bottem.
= Folding line
PATIENT INSTRUCTION DesmoMelt is intended for sublingual use, to be placed under the tongue where it will dissolve completely without the need for water. 1. Completely remove the end tab of a blister strip by tearing along the perforations, starting from the corner with the hand symbol.
Drawring E-MS-3053
2. Now remove one blister from the strip by tearing along the perforations.
Size A 210x297mm
3. Remove the foil on each blister, starting at the corner with the printed arrow, by peeling off the foil in the direction of the arrow. Do not pust the melt through the foil.
Fiber direction
5. If a melt breaks into more than two pieces while you are taking it out of its blister, do not take the broken pieces. Take a melt from another blister. Do NOT take more than the prescribed dose in any 24 hour period. If you have the impression that the effect of DesmoMelt is too strong or too weak, talk to your doctor or pharmacist. If you take more DesmoMelt than you should: If you take more DesmoMelt than you should, talk to your doctor or pharmacist immediately. If you forget to take DesmoMelt: Do not use 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.
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 DesmoMelt, 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 TAKING DesmoMelt if you experience:
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 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 (Oedema peripheral)
- tiredness (Fatigue)
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, pharmacist or nurse. can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
DesmoMelt Keep DesmoMelt out of the sight and reach of children. This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture and light. 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 DesmoMelt contains
- The active substance is desmopressin added as desmopressin acetate. Each oral lyophilisate contains 120 or 240 mcirograms of desmopressin.
- The other ingredients are gelatin, mannitol (E421) and citric acid, anhydrous. What DesmoMelt looks like and contents of the pack melt is marked on one side with two or three drops, indicating a strength of 120 or 240 micrograms respectively. Each carton contains 30 melts in blister strips of 10 melts per strip. Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd. Drayton Hall, Church Road,, West Drayton, UB7 7PS, (UK). Manufacturer: Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. DesmoMelt 120 micrograms oral lyophilisate PL 03194/0094 DesmoMelt 240 micrograms oral lyophilisate PL 03194/0095 This leaflet was last revised in December 2018. DesmoMelt is a registered trademark of Ferring BV.
- 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 (vertigo) or falls
- allergic reactions including itching, skin rashes, swelling of the
Rare side effects may affect up to 1 in 1,000 people:
- symptoms of anxiety
- nightmares
- mood swings
- sleepiness (somnolence)
- high blood pressure
- irritability
4. Carefully take a melt out of its blister. Place the melt under the tongue and allow it to dissolve completely. Do not swallow or chew.
=Perforation
Frequently asked questions about DesmoMelt 240mcg oral lyophilisate
What is the active substance in DesmoMelt 240mcg oral lyophilisate?
The active substance in DesmoMelt 240mcg oral lyophilisate is desmopressin acetate.
Are there equivalent medicines to DesmoMelt 240mcg oral lyophilisate?
Medicines with the same active substance, strength and form include: DDAVP Melt 240mcg oral lyophilisate, Desmopressin Melt 240 micrograms oral lyophilisate. 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 DesmoMelt 240mcg oral lyophilisate, 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 DesmoMelt 240mcg oral lyophilisate 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
DesmoMelt is indicated for the treatment of primary nocturnal enuresis.
4.2. Posology and method of administration
Posology
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.
DesmoMelt is 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 DesmoMelt.
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
DesmoMelt 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
DesmoMelt is indication 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 melt 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 the active substance or to any of the excipients listed in section 6.1
• Known or suspected cardiac insufficiency and other conditions requiring treatment with diuretic agents. DesmoMelt 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)
• 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)
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 DesmoMelt would be less than normal.
When DesmoMelt is 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:
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).
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.
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.
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 transport might have the same effect.
A standardised 27% fat meal significantly decreased the absorption (rate and extent) of desmopressin tablets. No significant affect was observed with respect to pharmacodynamics (urine production and osmolality).
Food intake may reduce the intensity and duration of the antidiuretic effect at low oral doses of desmopressin tablet.
4.6. Fertility, pregnancy and lactation
Pregnancy:
Caution should be exercised when prescribing to pregnant women.
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.
Breastfeeding:
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
DesmoMelt 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 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 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 DesmoMelt, 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, website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms:
Overdose of DesmoMelt 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 DesmoMelt 240mcg oral lyophilisate. 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.
Medicines containing Desmopressin acetate
- DDAVP Melt 120mcg oral lyophilisate
- DDAVP Melt 240mcg oral lyophilisate
- DDAVP Melt 60mcg oral lyophilisate
- DDAVP Tablets 0.1mg
- DDAVP Tablets 0.2mg
- DDAVP/Desmopressin Injection
- Demovo 360 micrograms / ml Oral Solution
- DesmoMelt 120mcg oral lyophilisate
- Desmopressin 240 microgram sublingual tablets
- Desmopressin 120 microgram Sublingual tablet
- Desmopressin 120 microgram sublingual tablets
- Desmopressin 120 microgram Tablet
- Desmopressin 120 micrograms Sublingual Tablets
- Desmopressin 240 microgram Sublingual tablet