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 2. Before you take DDAVP Melt 3. How to take DDAVP Melt 4. Possible side effects
DDAVP Melt PATIENT INSTRUCTIONS It is important to use your medicine as directed by your doctor. DDAVP Melt is intended for sublingual use (to be placed under the tongue where it will dissolve completely). 1. Completely remove the end tab of a blister strip by tearing along the perforations, starting from the corner with the hand symbol.
If you experience one or more of these side effects or any other undesirable effects, please inform your doctor or pharmacist.
5. Storing DDAVP Melt Keep DDAVP Melt out of the reach and sight of children.
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.
Store in the original package in order to protect from moisture and light.
4. Carefully take a melt out of its blister. Place the melt under the tongue and allow it to dissolve completely.
Do not take this medicine after the expiry date on the packaging. The expiry date refers to the last day of that month.
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 DDAVP Melt 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 DDAVP Melt 60 micrograms or one DDAVP Melt 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 DDAVP Melt than you should, talk to your doctor or pharmacist immediately. If you forget to take this medicine: Do not use a double dose to make up for a forgotten dose. If you are a patient with diabetes insipidus, please consult your doctor or pharmacist for advice.
Like all medicines DDAVP Melt can have side effects. You should avoid drinking large amounts of fluid while you are being treated with DDAVP Melt, 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 DDAVP Melt if you experience:
If you are unsure about the storage, ask your pharmacist. It is best to return all old and unused medicines to your pharmacist for safe disposal.
6. Further information
Very rare cases of emotional disorders including aggression in children have also been reported.
2. Now remove one blister from the strip by tearing along the perforations.
Most people using DDAVP Melt find it causes them no problems. However, common side effects can include:
1162 St-Prex Switzerland Nathalie Chateau Item No : Title :
2009052593
Leaflet DDAVP MELT tab oral blis GB E-MS No : Barcode : Date : Proof version : Braille Perforation Format (mm) : Colours :
3053 1735 2014-04-08 2 vignette 210×297 mm Black
Variable data line 1 (eng) : Variable data line 2 (eng) : Variable data line 3 (eng) : Country : Name : Date : Signature : E-2009052593.01
other
DDAVP Melt 6. Further information
1. What DDAVP Melt is what it is used for DDAVP Melts 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). They are referred to as DDAVP Melt or melt(s) in this leaflet. DDAVP Melt is available in three strengths: 60, 120 or 240 micrograms. It contains Desmopressin acetate, an antidiuretic (reduces urine production). It is used:
General restrictions: Do not take DDAVP Melt if you:
2009052593
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine.
There are general restrictions, precautions and warnings which apply to all patients using DDAVP Melt.
Fiber direction
Read all of this leaflet carefully before you start using this medicine.
2. Before you take DDAVP Melt
The active substance in DDAVP Melt 120mcg oral lyophilisate is desmopressin acetate.
Medicines with the same active substance, strength and form include: DesmoMelt 120mcg oral lyophilisate, Desmopressin Melt 120 micrograms oral lyophilisate. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for DDAVP Melt 120mcg 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.
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.
DDAVP Melt is indicated for the treatment of vasopressin-sensitive cranial diabetes insipidus or in the treatment of post-hypophysectomy polyuria/polydipsia.
DDAVP Melt 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 DDAVP Melt should be controlled by measurement of urine osmolality.
DDAVP Melt is contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents.Before prescribing DDAVP Melt, 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 DDAVP Melt 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.
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.
An overdose of DDAVP Melt 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 DDAVP Melt 120mcg 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.
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