What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL 03194/0094, PL 03194/0095.

DesmoMelt 120mcg and 240 mcg oral lyophilisate

DesmoMelt* oral lyophilisate

desmopressin (as acetate)

PATIENT INFORMATION

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet, you may need to use it again
  • If you have further questions, please ask your doctor or pharmacist
  • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Your medicine is called DesmoMelt oral lyophilisate. The lyophilisates look like tablets, but are much softer and lighter. They are intended for sublingual use (to be placed under the tongue where they will dissolve completely). They are referred to as DesmoMelt or melt(s) in this leaflet.

  • This medicine contains the active ingredient, desmopressin (as acetate). It is available in two strengths: 120 or 240 micrograms of desmopressin (as acetate).
  • Other ingredients in the melts are gelatin, mannitol and citric acid.
  • The melts are flat, white and round. 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.
The Courtyard
Waterside Drive
Langley
Berkshire
SL3 6EZ
UK

Manufacturer:

Ferring GmbH
Wittland 11
D 24109 Kiel
Germany

1. What DesmoMelt is and what it is used for

This medicine is intended for sublingual use. It is available in two strengths: 120 or 240 micrograms of desmopressin (as acetate), an antidiuretic (reduces urine production).

This medicine is used to treat primary nocturnal enuresis (bedwetting) in children (from 5 years of age) and adults (up to 65 years of age).

2. Before you take DesmoMelt

Do not take this medicine:

  • if you are under 5 or over 65 years old
  • if you have a serious heart or kidney disease
  • if you are taking diuretics (water tablets)
  • if you are taking medication for high blood pressure or have been told that your blood pressure is abnormal
  • if you drink unusually large quantities of fluids, including alcohol
  • if you are allergic to any of the ingredients listed.

Please consult your doctor before taking this medicine:

  • if you have cystic fibrosis
  • if you are on medication for depression or epilepsy
  • 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
  • if you have a medical condition causing fluid and/or electrolyte imbalance
  • if you have a medical condition that could be made worse by fluid and/or electrolyte disturbance.

Before you commence treatment with this medicine, you should have received appropriate advice concerning fluid intake, from a doctor or nurse. Excessive fluid intake may lead to a build up of water in the body. While you are on treatment with this medicine:

  • fluid intake must be limited to a minimum from 1 hour before until 8 hours after a dose
  • 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.

Pregnancy:

If you are pregnant or planning a pregnancy, please inform your doctor before you take this medicine, as blood pressure monitoring is recommended due to the increased risk of pre-eclampsia. Symptoms of pre-eclampsia include high blood pressure, oedema (swelling due to the build up of fluid) and proteinuria (protein in the urine).

Breast-feeding:

If you are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.

Taking/using other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken or used any other medicines - even those not prescribed.

3. How to take DesmoMelt

It is important that you do not take more than the prescribed dose in any 24 hour period.

If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.

  • 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.
  • 4. Carefully take a melt out of its blister. Place the melt under the tongue and allow it to dissolve.
  • 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.

Bedwetting from the age 5 years:

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.

If you take more of this medicine than you should:

If you take more of this medicine than you should, talk to your doctor or pharmacist immediately.

If you forget to take this medicine:

Do not take double doses to make up for forgotten doses. Take the next dose at the usual time.

4. Possible side effects

Most people taking this medicine find it causes them no problems. However, like all medicines, this medicine can have side effects. Excessive fluid intake may lead to a build up of water which dilutes the salt in the body in severe cases. This can become a serious problem and may lead to convulsions. Early symptoms may include an unusually bad or prolonged headache, confusion, unexplained weight gain, nausea or vomiting. If you experience one or more of these symptoms, stop taking this medicine. Tell your doctor immediately or go to your nearest casualty department.

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.

If you experience one or more of these side effects or any other undesirable effects, please inform your doctor or pharmacist.

5. Storing DesmoMelt

Keep this medicine out of the reach and sight of children.

Store in the original package.

Do not take this medicine after the expiry date on the packaging.

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.

DesmoMelt 120 micrograms oral lyophilisate PL 03194/0094

DesmoMelt 240 micrograms oral lyophilisate PL 03194/0095

This leaflet was revised in May 2008.

*DesmoMelt is a trademark of Ferring BV.

2009040028

11EP5409C