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.
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:
• diabetes insipidus (a condition that causes 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).
Do not take Desmopressin if you: • have a serious heart or kidney disease
• are taking diuretics (water tablets)
• are allergic to any of the ingredients listed in section 6 of this leaflet
• drink unusually large quantities of fluids, including alcohol
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.
Warnings and precautions Please consult your doctor before taking Desmopressin if you:
• have an illness causing fluid and/or salt imbalance e.g. vomiting, diarrhoea, systemic infections, fever or gastroenteritis
• 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.
Other medicines and Desmopressin 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 or epilepsy
• are taking a medicine for pain and/or imflammation containing non-steroidal anti-inflammatory drugs (also known as NSAIDs) e.g. indometacin
• are taking a medicine containing loperamide for diarrhoea
Pregnancy and breast-feeding If you are pregnant or planning a pregnancy, please inform your doctor before you take Desmopressin, as 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) and proteinuria (protein in the urine).
If you are breast-feeding ask your doctor or pharmacist for advice before taking Desmopressin.
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 'sodium-free'.
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: • unusually bad or prolonged headache, confusion, unexplained weight gain, ankle swelling, nausea or vomiting
• itching, skin rashes, swelling of the face, lips or throat, difficulty in breathing, wheeziness, chest tightness or coughing (signs of allergic reactions).
If you experience any of the above side effects, you should contact your doctor or go to the nearest casualty department immediately.
Most people using Desmopressin find it causes them no problems. However, common side effects can include:
• headache
• stomach pain
Very rare cases of emotional disorders including aggression in children have also been reported.
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.
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 • The active substance is desmopressin.
Desmopressin 120 micrograms sublingual tablets
Each tablet contains 120 micrograms desmopressin (as acetate)
Desmopressin 240 micrograms sublingual tablets
Each tablet contains 240 micrograms desmopressin (as acetate)
• The other ingredients are: lactose monohydrate, maize starch, citric acid croscarmellose sodium magnesium stearate
What Desmopressin looks like and contents of the pack Desmopressin 120 micrograms sublingual tablets
White or almost white, octagonal, biconvex tablet debossed with 'II' on one side and plain on other side, with 6.5 mm diameter and 2 mm thickness.
Desmopressin 240 micrograms sublingual tablets
White or almost white, square, biconvex tablet debossed with 'III' on one side and plain on other side, with 6 mm length/ width and 2 mm thickness.
Desmopressin is supplied in a carton box containing OPA/Al/PVC/PE-Al blisters with integrated desiccant layer with 10 tablets each, in pack sizes of 10, 30, 60, 90 and 100 sublingual tablets or in HDPE bottles with PP caps with 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
1065042843
Zentiva
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Desmopressin 120 micrograms sublingual tablets comes as tablet containing 120mcg. 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 120 micrograms sublingual tablets is desmopressin acetate.
Medicines with the same active substance, strength and form include: Desmopressin 120 microgram Sublingual tablet, Desmopressin 120 microgram Tablet, Desmopressin 120 microgram sublingual tablets. 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 120 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. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
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. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
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 120 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'. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
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. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
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. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
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 120 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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