DesmoMelt® 240 micrograms oral lyophilisate

(desmopressin acetate)

PATIENT INFORMATION LEAFLET

This medicine is available using the above name but will be referred to as

DesmoMelt throughout this leaflet.

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

•    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 personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Important things that you need to know:

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

•    You should avoid drinking large amounts of fluid while you are being treated with DesmoMelt, 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.

•    If you experience unusually bad or prolonged head ache, confusion, unexplained weight gain, ankle swelling, nausea or vomiting STOP USING DesmoMelt.

You should tell your doctor immediately or go to the casualty department at your nearest hospital.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine.

In this leaflet:

1.    What DesmoMelt is and what it is used for

2.    Before you take DesmoMelt

3.    How to take DesmoMelt

4.    Possible side effects

5.    How to store DesmoMelt

6.    Further information

1. What DesmoMelt is what it is used for

DesmoMelt 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).

DesmoMelt is available in two strengths: 120 or 240 micrograms. It contains Desmopressin acetate, an antidiuretic (reduces urine production).

DesmoMelt 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

There are general restrictions, precautions and warnings which apply to all patients using DesmoMelt.

General restrictions:

Do not take DesmoMelt 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

•    are under 5 or over 65 years old

•    are taking medication for high blood pressure or have been told that your blood pressure is abnormal

You should avoid drinking large amounts of fluid while you are being treated with DesmoMelt, 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.

General precautions and warnings:

Please consult your doctor before taking DesmoMelt 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

•    have cystic fibrosis

While taking DesmoMelt:

•    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.

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

•    are on medication for depression or epilepsy

•    are taking a medicine for pain and/or inflammation containing nonsteroidal anti-inflammatory drugs (also known as NSAIDs) e.g. indometacin

•    are taking a medicine containing loperamide for diarrhoea

Pregnancy:

If you are pregnant or planning a pregnancy, please inform your doctor before you take DesmoMelt, 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)

3. How to take DesmoMelt PATIENT INSTRUCTION

It is important to use your medicine as directed by your doctor. DesmoMelt 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.

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 completely.

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 DesmoMelt is too strong or too weak, talk to your doctor or pharmacist.

The usual dose is:

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 DesmoMelt 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 DesmoMelt 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 forget to take this medicine, please consult your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines DesmoMelt can have side effects.

You should avoid drinking large amounts of fluid while you are being treated with DesmoMelt, 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 DesmoMelt if you experience:

•    usually 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 one or more of these side effects or any other undesirable effects, please inform your doctor or pharmacist.

Most people using DesmoMelt 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.

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

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 at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    Storing DesmoMelt

•    Keep out of the sight and reach of children.

•    Store in the original package in order to protect from moisture and light.

•    Do not take this medicine after the expiry date on the packaging. The expiry date refers to the last day of that month.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

•    If the medicines become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

6.    Further information

•    This medicine contains the active ingredient, desmopressin (as acetate).

Each unit contains 240 micrograms desmopressin (as acetate).

•    Other ingredients in this medicine are gelatin, mannitol (E 421) and anhydrous citric acid (E 330).

•    The melts are flat, round and white. Each melt is marked on one side with three drops shaped figures.

Each carton contains blisters of 30 oral lyophilisates or 100 oral lyophilisates.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by Ferring GmbH, Wittland 11, P.O. Box 2145, D-24109 Kiel, Germany. Procured from within the EU by Product Licence holder: Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 11.08.16[2] DesmoMelt is a trademark of Ferring BV.