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 ingredient that makes Demovo work (the active substance) is called desmopressin. Desmopressin is very similar to a substance that is produced naturally in the body (the pituitary hormone vasopressin), which temporarily reduces the amount of urine produced by the body. This medicine is intended for oral use only. This medicine is used to treat:
2.
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Central diabetes insipidus, a disease characterised by causing extreme thirst and continuous production of large volumes of dilute urine as a result of an insufficient production of the hormone vasopressin.
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Bed-wetting (involuntary nightly urination or primary nocturnal enuresis) in patients older than 5 years with normal capacity to concentrate urine.
e Demovo 360 micrograms/ml oral solution
Do not take Demovo: –
if you are allergic (hypersensitive) to desmopressin or any of the other ingredients of this medicine (listed in section 6). if you drink unusually large amounts of fluid (have habitual or psychogenic polydipsia) if you take medicines which increase urine production (diuretics) if you suffer from heart problems if you suffer predisposition to or have low levels of sodium in your blood (hyponatremia) if you suffer from reduced kidney function if you have uncontrolled blood pressure if you suffer from the 'Syndrome of Inappropriate High Secretion of Antidiuretic Hormone' (SIADH)
Warnings and precautions Talk to your doctor or pharmacist before taking this medicine When taking this medicine, avoid excessive fluid intake because it may lead to a build-up of water in the body and / or decrease in blood sodium with or without side effects (see section 4 – Possible side effects). Special care with this medicine is required to avoid build-up of water in the body and decreased blood sodium: –
if you are elderly if you have a medical condition causing fluid and / or electrolyte imbalance in the body, such as an infection, fever or stomach upset if you suffer from a serious bladder problem or impaired urine outflow if you suffer from asthma, epilepsy and migraine if you have reduced renal function and / or cardiovascular disease. In chronic renal disease, the antidiuretic effect of desmopressin would be less than usual.
Other medicines and Demovo Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially: • • • • • •
Tricyclic or SSRI antidepressants (used to treat depression) Carbamazepine (used to treat epilepsy) Chlorpromazine (used to treat psychosis or schizophrenia) Medicines for pain and / or inflammation called non-steroidal anti-inflammatory drugs (NSAIDs) e.g. indomethacin, ibuprofen, acetylsalicylic acid. Loperamide (used to treat diarrhoea), Diuretic agents.
These medicinal products increase the risk of build-up of water, which dilutes the salt in the body. •
Dimeticone (used in the treatment of pain due to intestinal gas), due to decreased absorption of desmopressin.
Demovo with food and drink At low doses, this medicine may be affected by food intake. If you notice that this medicine is less effective, then you should take it without food before increasing the dose. When using this medicine for bed-wetting keep your fluid intake to a minimum from 1 hour before you take the Demovo dose until 8 hours after a dose. 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. It is preferable to avoid using this medicine during pregnancy. Desmopressin passes into breast milk. If you are going to be treated with desmopressin, you should stop breast-feeding. Driving and using machines Demovo does not affect your ability to drive and use machines.
Demovo contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Demovo contains sodium This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodium free'. 3.
Demovo 360 micrograms/ml oral solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Usual doses Treatment of central diabetes insipidus: Adults and Children: Your doctor will prescribe the dose most suitable for you. The usual starting dose is 0.25 ml (90 micrograms) three times daily. Subsequently, the doctor will adjust the dose according to individual patient response. The usual daily dose is between 0.5 ml (180 micrograms) to 3 ml (1080 micrograms) of this medicine. The maintenance dose ranges from 0.25 to 0.5 ml (90 – 180 micrograms) of this medicine three times per day. It is important to note if symptoms of build-up of water in the body and / or decreased blood sodium appear (see section 4 – Possible side effects). If so, treatment will be stopped and the dose will be changed. Bed-wetting (involuntary nightly urination or primary nocturnal enuresis) in patients older than 5 years: Adults and Children: The usual starting dose is 0.5 ml (180 micrograms) of this medicine one hour before bedtime. The dose may be increased up to 1 ml (360 micrograms) of this medicine if the starting dose is not enough. The need for continued treatment is normally checked every three months by introducing a treatment free period of at least one week. Elderly: If the doctor decides to treat you, your blood sodium levels should be measured before and three days after starting the treatment and if the dose is increased or at any time your doctor finds it necessary. Monitoring your fluid intake is important. If symptoms of build-up of water in the body and / or decreased blood sodium occur (see section 4 – Possible side effects), discontinue treatment. Once treatment is restored, fluid intake will be rigorously controlled. Instructions for use: 1. Open the bottle (on first opening the seal is broken).
2. Insert the oral syringe into the pourer and turn the bottle upside down to fill it with the dose to be administered.
3. Take the oral syringe out of the bottle and check to see that the correct amount appears in the bottom of the syringe. 4. Hold the syringe to your mouth and release the dose into your mouth.
5. Rinse with water after each use and close the bottle. Keep the bottle in the outer carton to protect from light. If you take more Demovo than you should An overdose may lengthen the effect of desmopressin and increase the risk of water build up in the body and / or low levels of sodium in your blood. Symptoms may include headache, nausea and vomiting, weight gain and in severe cases convulsions. It is recommended to stop the treatment, restrict fluid intake and start symptomatic treatment if necessary. If you take more Demovo than prescribed, contact your doctor or pharmacist immediately. If you forget to take Demovo Do not take a double dose to make up for a forgotten dose. If you stop taking Demovo Do not stop taking Demovo before completing the treatment as it may not have the expected effect. You should only change or stop your treatment if advised by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Demovo and see a doctor or go to a hospital straight away if the following occur: –
Common (occurs in less than 1 in 10 users): symptoms of a build-up of water in the body such as unusually bad or prolonged headache, feeling or being sick, unexplained weight gain and in serious cases, fits or unconsciousness.
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Very rare (occurs in less than 1 in 10,000 users): allergic reactions such as rash, itching, fever, swelling of your lips, face, throat or tongue causing difficulties in swallowing or breathing.
Tell your doctor or pharmacist if you notice any of the following other side effects: –
Very common (occurs in more than 1 in 10 users): headache. Common (occurs in less than 1 in 10 users): abdominal pain, nausea. Very rare (occurs in less than 1 in 10,000 users): emotional disturbances in children, allergic reactions.
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. Website: 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. 5.
Demovo 360 micrograms/ml oral solution
Keep this medicine out of the sight and reach of children. Do not store above 30oC. Store in the original package. After first opening, the product should be stored below 25oC for up to 8 weeks. Do not take this medicine after the expiry date which is stated on the label and carton after EXP. 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. 6.
What Demovo contains • •
The active substance is desmopressin. Each ml of the oral solution contains 360 micrograms of desmopressin (as acetate). The other ingredients are: o Sodium methyl parahydroxybenzoate (E 219), o Sodium propyl parahydroxybenzoate (E 217), o Hydrochloric acid (for pH adjustment) and o Purified water.
What Demovo looks like and contents of the pack Demovo is a clear solution filled into an amber glass bottle and capped with a low density polyethylene (LDPE) pourer, provided with a high density polyethylene (HDPE) screw cap. The bottle contains 15 ml of solution. A graduated 1.5 ml dosing syringe is supplied in each pack. The syringe is graduated from 0 to 1.5 ml, with divisions of 0.1 ml. The graduation corresponding to the doses of 0.25 ml, 0.5 ml and 1.0 ml are specifically marked. Demovo 360 micrograms/ml is available in packs (one carton containing a bottle with 15 ml of solution and one administration device) and in multipacks comprising 3 individual packs, each containing 15 ml of solution. Not all pack sizes may be marketed. Marketing Authorisation Holder ALTURiX Limited 287 Upper Fourth Street Milton Keynes MK9 1EH Manufacturer Laboratorio Reig Jofré S.A. Gran Capità 10 08970 Sant Joan Despí – Barcelona Spain Elara Pharmaservices Europe Ltd Regus Block 1, Blanchardstown Corporate Park Ballycoolin Road, Blanchardstown
Dublin 15, D15 AKK1 Ireland This leaflet was revised in 09/2025. Other sources of information Detailed information on this medicine is available on the website of the Medicines and Healthcare Products Regulatory Agency (MHRA).
Demovo 360 micrograms / ml Oral Solution comes as oral solution containing 360mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Demovo 360 micrograms / ml Oral Solution is desmopressin acetate.
This leaflet reproduces the patient information leaflet approved for Demovo 360 micrograms / ml Oral Solution, 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.
Demovo 360 micrograms/ml oral solution is indicated in the treatment of central diabetes insipidus and in the treatment of primary nocturnal enuresis in patients (over 5 years) with normal capacity to concentrate urine.
Posology
Treatment of central diabetes insipidus:
Adults and paediatric population
A suitable starting dose in adults and children is 90 micrograms (0.25 ml) three times daily. The dosage is individually adjusted in diabetes insipidus, but clinical experience has demonstrated that the total daily dose normally lies in the range from 180 micrograms (0.5 ml) to 1080 micrograms (3 ml) of desmopressin. Thereafter, this dosage regimen should then be adjusted in accordance with the patient's response. In most of patients, the maintenance dose is 90-180 micrograms (0.25 – 0.5 ml) three times daily.
If symptoms of fluid retention and/or hyponatremia appear (headache, nausea, vomiting, weight gain, and, in severe cases, seizures), the treatment should be discontinued and the dose of desmopressin should be readjusted.
Primary nocturnal enuresis:
Adults and Children above the age of 5
The appropriate starting dose is 180 micrograms (0.5 ml) of desmopressin at bedtime. The dose may be increased up to 360 micrograms (1 ml) if the lower dose is not effective enough.
Demovo 360 micrograms/ml oral solution is recommended for treatment periods of 3 months. In connection with long-term treatment, a treatment free period of at least one week should be introduced every three months to assess whether spontaneous healing has occurred.
Fluid intake should be controlled.
If symptoms or signs of fluid retention and/or hyponatremia appear (headache, nausea, vomiting, weight gain, and, in severe cases, seizures), the treatment should be discontinued until the patient has recovered. Once again reinstated treatment, fluid intake should be tightly controlled (see section 4.4).
If the desired clinical effect is not achieved after 4 weeks of dose titration, treatment should be discontinued.
Treatment of elderly patients (≥65 years of age) should be followed closely due to the increased risk of hyponatremia. Serum sodium should be measured at baseline, three days after onset of treatment or at any dose increase and regularly during prolonged therapy.
Method of administration
Demovo 360 micrograms/ml oral solution is for oral use.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Psychogenic or habitual polydipsia.
- Known or suspected history of cardiac insufficiency.
- Hyponatraemia or predisposition to hyponatraemia.
- Conditions requiring concomitant treatment with diuretic agents (see section 4.5).
- Moderate or severe renal failure (creatinine clearance < 50 ml/min).
- Uncontrolled blood pressure.
- Syndrome of inadequate ADH Production (SIADH) – a condition involving inappropriately high ADH production.
Special warnings:
In the case of primary nocturnal enuresis, fluid intake shall be limited from 1 hour before administration until the next morning (at least 8 hours).
Treatment without concomitant reduction in water intake may result in fluid retention and/or hyponatraemia with or without warning symptoms and signs (headache, nausea / vomiting, weight gain, and, in severe cases, seizures). See section 4.8.
It is therefore recommended that this danger be pointed out to patients, in particular elderly patients and the parents of young children. Cerebral oedema has repeatedly been reported in children and young adults treated with desmopressin for nocturnal enuresis.
During treatment with desmopressin, body weight, serum sodium and/or blood pressure may have to be monitored.
Care should be taken in patients with reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of Demovo 360 micrograms/ml oral solution would be less than usual.
Precautions for use:
Precautions to prevent hyponatremia shall be taken in:
- Conditions characterised by fluid and/or electrolyte imbalance, such as systemic infections, fever, gastroenteritis, and SIADH (syndrome of inappropriate secretion of ADH),
- Concomitant treatment with drugs known to induce SIADH, such as tricyclic antidepressants, selective inhibitors of serotonin reuptake, clorpromaxina and carbamazepine,
- Concomitant treatment with non steroidal anti-inflammatory drugs (NSAIDs).
- Desmopressin should be used with caution and the dose should be adjusted on the basis of the plasma osmolality in patients with cystic fibrosis
- Serious bladder dysfunction and outlet obstruction should be considered before onset of treatment.
- In patients with urge incontinence, organic causes of increased frequency of micturition or nocturia (e.g. benign prostatic hyperplasia (BPH), urinary tract infection, bladder stones/tumours, bladder sphincter disorders), polydipsia and inadequately controlled diabetes mellitus, the specific cause of the problems should primarily be treated resp. excluded.
- Older people and patients with low serum sodium may have an increased risk of hyponatraemia.
Warnings of excipients:
This product contains sodium methyl (E-219) and sodium propyl (E-217) parahydroxybenzoate. It may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per ml, 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 fluid retention and/or hyponatraemia (see sections 4.3 and 4.4).
NSAIDs may induce fluid retention and/or hyponatraemia (see section 4.4).
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.
Concomitant treatment with diuretic agents is contraindicated (see section 4.3)It is unlikely that desmopressin interacts with other drugs which affect liver metabolism, because no significative hepatic metabolism has been observed in in vitro studies in human microsomes. However, no formal studies have been conducted in vivo.
Concomitant treatment with dimeticone may reduce the absorption of desmopressin.
A standardised 27% greasy meal decreased the absorption of desmopressin (rate and extent). It has not been observed any significant effect on the pharmacodynamics (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:
There is a limited amount of data from the use of desmopressin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Reproductive studies performed in rats and rabbits at doses 100 higher than that recommended in humans did not reveal harmful evidence of desmopressin on foetuses.
Data on a limited number of exposed pregnancies in women treated with desmopressin during pregnancy indicate rare cases of malformations in children. Nonetheless, a review of available data did not suggest an increase of malformations in children exposed to desmopressin during pregnancy. To date, no other relevant epidemiological data are available.
Caution should be exercised when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia (Section 4.3 and 4.4).
The physician should weigh the possible therapeutic advantages against the possible risk in each case.
Breastfeeding:
Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin which may be transferred to the infant are considerably lower than the amounts required to influence diuresis.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Demovo 360 micrograms/ml oral solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
No fertility data available.
Demovo 360 micrograms/ml oral solution has no or negligible influence on the ability to drive and use machines.
Treatment without concomitant restriction of fluid intake may result in fluid restriction /hyponatraemia with or without concurrent warning signs or symptoms. The symptoms concerned include headache, nausea/vomiting, reduced serum sodium, weight gain and, in serious cases, convulsions, coma (see section 4.4)
The frequency of adverse events listed below is defined using the following convention:
very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
The most common include headache and gastrointestinal disorders.
Immune system disorders:
Not known: Allergic reactions.
Metabolism and nutrition disorders:
Very rare: Hyponatremia.
Psychiatric disorders:
Very rare: Emotional disturbances.
Nervous system disorders:
Common: headache.
Gastrointestinal disorders:
Common: stomach pain and nausea.
Skin and subcutaneous tissue disorders:
Very rare: Allergic skin reactions.
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 Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
An overdose of Demovo 360 micrograms/ml oral solution leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia.
Treatment:
Although treatment of hyponatraemia should be adjusted to each patient, the following general recommendations can be followed: hyponatraemia is treated by discontinuing the treatment with desmopressin, fluid restriction and symptomatic treatment, if needed.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Demovo 360 micrograms / ml Oral Solution. 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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