Desmopressin Melt 240 micrograms oral lyophilisate

Patient Leaflet Updated 28-May-2024 | Aspire Pharma Ltd

Desmopressin Melt 120 micrograms oral lyophilisate Desmopressing Melt 240 micrograms oral lyophilisate

Package leaflet: Information for the user

Desmopressin Melt 120 micrograms oral lyophilisate

Desmopressin Melt 240 micrograms oral lyophilisate

Desmopressin (as acetate)

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, please 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Desmopressin Melt is and what it is used for
2. What you need to know before you take Desmopressin Melt
3. How to take Desmopressin Melt
4. Possible side effects
5. How to store Desmopressin Melt
6. Contents of the pack and other information

1. What Desmopressin Melt is and what it is used for

Desmopressin Melt are oral lyophilisates, 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). They are referred to as Desmopressin Melt or melt(s) in this leaflet.

Desmopressin Melt is available in two strengths: 120 or 240 micrograms. It contains desmopressin acetate, an antidiuretic which reduces urine production.

Desmopressin Melt is used to treat:

  • Primary nocturnal enuresis (bedwetting) in children (from 5 years of age) and adults (up to 65 years of age).

2. What you need to know before you take Desmopressin Melt
Do not take Desmopressin Melt:
  • 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 Desmopressin Melt, 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 Melt.

Take special care with Desmopressin Melt:

  • 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 Desmopressin Melt:
  • 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.

Desmopressin Melt with food and drink:

When Desmopressin Melt is taken together with food, the intensity and duration of effect may be reduced.

All patients, in the case of children their parents and, where applicable, responsible nursing staff should be carefully instructed to adhere to the fluid restrictions.

Other medicines and Desmopressin Melt:

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.

Pregnancy, breast-feeding and fertility:

If you are pregnant or breastfeeding, think you might 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).

3. How to take Desmopressin Melt

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 Desmopressin Melt 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 Melts 120 micrograms or one Desmopressin Melt 240 micrograms sublingually (under the tongue) at bedtime. The need for continued treatment is normally checked every three months.

PATIENT INSTRUCTION

Desmopressin Melt 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.
2. Now remove one blister from the strip by tearing along the perforations.
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 push the melt through the foil.
4. Carefully take the melt out of its blister. Place the melt under the tongue and allow it to dissolve completely. Do not swallow or chew.
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 Desmopressin Melt is too strong or too weak, talk to your doctor or pharmacist.

If you take more Desmopressin Melt than you should:

If you take more Desmopressin Melt than you should, talk to your doctor or pharmacist immediately.

If you forget to take Desmopressin Melt:

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.

4. 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 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 TAKING Desmopressin Melt if you experience:
  • 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 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

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)

Rare side effects may affect up to 1 in 1,000 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Desmopressin Melt

Keep this medicine 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 use this medicine after the expiry date which is stated 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.

6. Contents of the pack and other information
What Desmopressin Melt contains
  • The active substance is desmopressin added as desmopressin acetate. Each oral lyophilisate contains 120 or 240 micrograms of desmopressin.
  • The other ingredients are gelatin, mannitol (E421) and citric acid, anhydrous.

What Desmopressin Melt looks like and contents of the pack

The Desmopressin Melt oral lyophilisates are flat, round and white. Each 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)

Distributor:
Aspire Pharma Ltd
Unit 4
Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
UK

Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Desmopressin Melt 120 micrograms oral lyophilisate PL 03194/0120

Desmopressin Melt 240 micrograms oral lyophilisate PL 03194/0121

This leaflet was last revised in July 2023.

1010592-P2.4

Company Contact Details
Aspire Pharma Ltd
Address

4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK

Medical Information Direct Line

+44 (0)1730 231148

WWW

http://www.aspirepharma.co.uk

Telephone

+44 (0)1730 231148

Customer Care direct line

+44 (0)1730 231148