Desmospray® 10 micrograms Nasal Spray

desmopressin acetate

PATIENT INFORMATION

In this leaflet:

1.    What Desmospray is and what it is used for

2.    Before you use Desmospray

3.    How to use Desmospray

4.    Possible side effects

5.    How to store Desmospray

6.    Further information

1. What Desmospray is and what it is used for

Desmospray is a solution for nasal use only. It contains Desmopressin acetate, an antidiuretic (reduces urine production). It is used:

• to treat patients with multiple sclerosis suffering from nocturia (the need to get up at night to pass urine), when other treatments have failed.

•    to diagnose and treat cranial diabetes insipidus (a condition which causes extreme thirst and the continuous production of large volumes of dilute urine). IMPORTANT: This should not be confused with diabetes mellitus (sugar diabetes)

•    as a test to check if the kidneys are functioning properly (renal function test).

2. Before you use Desmospray

There are general restrictions, precautions and warnings which apply to all patients using Desmospray and there are additional restrictions, precautions and warnings which apply depending on the use of Desmospray.

General restrictions (all patients)

Do not use Desmospray if:

•    you have a serious heart or kidney disease

•    you are taking diuretics (water tablets)

•    you are allergic to any of the ingredients listed in section 6 of this leaflet

•    you drink unusually large quantities of fluids, including alcohol.

You should avoid drinking large amounts of fluid while you are being treated with Desmospray, 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 (all patients):

Please consult your doctor before using Desmospray

if:

•    you have cystic fibrosis

•    you suffer from bladder problems e.g. incontinence (inability to hold in urine), hesitance in starting urination, frequent urination and/or urgent urination.

•    you have difficulty or problems passing urine

•    you have an illness causing fluid and/or electrolyte imbalance e.g. vomiting, diarrhoea, infections or fever

•    you have a medical condition that could be made worse by fluid and/or electrolyte disturbance. Conditions where your blood sodium levels are too low or you are likely to build up too much water in your body.

Additional restrictions, precautions and warnings:

In addition to the general restrictions, precautions and warnings:

If you are a patient with nocturia (the need to get up at night to pass urine) caused by multiple sclerosis:

Do not use Desmospray if:

•    you are over 65 years old

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

When using Desmospray:

•    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 using Desmospray when suffering from vomiting, diarrhoea, fever and/or infections until you are better

•    avoid swallowing water while swimming to prevent a build up of water in the body.

If you are using Desmospray for the diagnosis of diabetes insipidus or for the renal function test:

• limit fluid intake to no more than 500ml, from 1 hour before until 8 hours after the dose.

Patients being treated with Desmospray for any of the conditions listed in this leaflet:

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.

•    you are on medication for depression or epilepsy

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

Pregnancy:

If you are pregnant or planning a pregnancy, please inform your doctor before you use Desmospray 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).

Breast-feeding:

If you are breast-feeding ask your doctor or pharmacist for advice before using Desmospray.

Important information about some of the ingredients in Desmospray:

Desmospray contains Benzalkonium Chloride which may cause bronchospasm (when your breathing airway suddenly narrows, causing coughing and difficulty in breathing).

3. How to use Desmospray

4. Possible side effects

Like all medicines, Desmospray can cause side effects.

It is important to use your medicine as directed by your doctor. The pharmacy label on the bottle will tell you when to use your medicine and how much to use. If it does not, or you are not sure, ask your doctor or pharmacist.

How to use Desmospray:

3.    Ensure that the dip-tube is in the liquid when using Desmospray. With your head tilted slightly back, place the nozzle just inside the nostril.

4.    Hold your breath (DO NOT SNIFF) and press the spray once.

5.    Repeat this procedure using alternate nostrils until the prescribed dose is reached.

6.    Replace the protective cap after use.

7.    Do not store above 25°C. Keep container in the outer carton.

8.    If the spray is not used within 7 days of the previous dose, re-prime by pressing the spray at least once before using.

You should avoid drinking large amounts of fluid while you are being treated with Desmospray, 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 DESMOSPRAY 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 Desmospray find it causes them no problems. However, common side effects can include:

•    headache

•    stomach pain

•    blocked or runny nose, nose bleeds

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.

5. Storing Desmospray

Keep Desmospray out of the reach and sight of children.

Do NOT use more than the prescribed dose in any 24 hour period.

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

Do not store above 25°C. Keep container in the outer carton.

Use by date: Do NOT use Desmospray past the expiry date on the packaging. The expiry date refers to the last day of that month.

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.

Nocturia (the need to get up at night to pass urine) caused by multiple sclerosis:

Your doctor will prescribe a dose of one or two sprays at bedtime. If your dose is two sprays, use one spray in each nostril. The prescribed dose should NOT be used more than once in any 24 hour period. Your doctor will check your blood pressure and weight at regular intervals.

Diagnosis of diabetes insipidus (adults and children):

Your doctor will prescribe a dose of two sprays. Use one spray in each nostril.

Treatment of diabetes insipidus:

Your doctor will prescribe the dose most suitable for you. The most common dosing in adults and children is one or two sprays into the nostril, once or twice daily. Use one spray in each nostril if your dose is two sprays.

Renal function test:

To check if the kidneys are functioning properly, your doctor will prescribe the following single dose:

Adults: Two sprays into each nostril

Children: (1-15 years): One spray into each nostril

Infants: (to 1 year): One spray into one nostril

If you used more Desmospray than you should:

If you have used more of Desmospray than you should, talk to your doctor or pharmacist immediately.

6. Further information

Your medicine is called Desmospray. It is a solution for

nasal use only.

•    it is presented in a glass vial with a pump spray device. Each vial contains a volume of 6ml to allow the delivery of 60 sprays

•    each spray contains 10 micrograms of the active ingredient, Desmopressin acetate

•    other ingredients in Desmospray are citric acid monohydrate, disodium phosphate dihydrate, sodium chloride, benzalkonium cloride solution 50% and purified water.

Marketing Authorisation Holder:

Ferring PharmcceuticslL dtd., D rayton Hall,

Church Road, West Deayton, UB7 7PS, (UK).

Manufacturer:

Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.

Desmospray PL 03194/0024

This leaflet was last rvvisdd i n Ocuobre r 2015.

If you forget to use Desmospray:

Do not use a double dose to make up for a forgotten dose.

If you are a patient with nocturia caused by multiple sclerosis, do not use Desmospray until the usual time for your next dose.

If you are a patient with diabetes insipidus, please consult your doctor or pharmacist for advice.