Desmopressin 0.1 Mg/Ml Nasal Spray
PATIENT INFORMATION
Desmopressin Nasal Spray
desmopressin acetate
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 you need to know:
• Desmopressin Nasal Spray is used
- to treat patients with multiple sclerosis suffering from nocturia (the need to get up at night to pass urine), when others have failed
- to diagnose and treat cranial diabetes insipidus (a condition that causes extreme thirst and the continuous production of large volumes of dilute urine)
- as a test to check if the kidneys are functioning properly (renal function test)
• You should avoid drinking large amounts of fluid while you are being treated with Desmopressin Nasal Spray, 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 headache, confusion, unexplained weight gain, ankle swelling, nausea or vomiting STOP USING DESMOPRESSIN NASAL SPRAY. 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 that might be especially important for you.
In this leaflet:
1. What Desmopressin Nasal Spray is and what is it used for
2. Before you use Desmopressin Nasal Spray
3. How to use Desmopressin Nasal Spray
4. Possible side effects
5. How to store Desmopressin Nasal Spray
6. Further information
1. What Desmopressin Nasal Spray is and what it is used for
Desmopressin Nasal Spray 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 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 Desmopressin Nasal Spray
There are general restrictions, precautions and warnings which apply to all patients using Desmopressin Nasal Spray and there are additional restrictions, precautions and warnings which apply depending on the use of Desmopressin Nasal Spray.
General restrictions (all patients)
Do not use Desmopressin Nasal Spray 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 Desmopressin Nasal Spray as this could lead to a build up of water which dilutes 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 Desmopressin Nasal Spray 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 Desmopressin Nasal Spray 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 Desmopressin Nasal Spray:
• 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 Desmopressin Nasal Spray 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 Desmopressin Nasal Spray 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 Desmopressin Nasal Spray 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 Desmopressin Nasal Spray 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 Desmopressin Nasal Spray.
Important information about some of the ingredients in Desmopressin Nasal Spray
Desmopressin Nasal Spray contains Benzalkonium Chloride which may cause bronchospasm (when your breathing airway suddenly narrows, causing coughing and difficulty in breathing).
3. How to use Desmopressin Nasal Spray
PATIENT INSTRUCTIONS
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 Desmopressin Nasal Spray
1. Remove the protective cap.
2. When first used, prime the spray by pressing several times until a consistent, fine spray is seen.
3. Ensure that the dip-tube is in the liquid when using Desmopressin Nasal Spray. 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 the 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.
Do NOT use more than the prescribed dose in any 24 hour period.
If you have the impression that the effect of Desmopressin Nasal Spray is too strong or too weak, talk to your doctor or pharmacist.
The usual doses are:
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 use more Desmopressin Nasal Spray than you should
If you have used more Desmopressin Nasal Spray than you should, talk to your doctor or pharmacist immediately.
If you forget to use Desmopressin Nasal Spray
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 Desmopressin Nasal Spray until the usual time for your next dose.
If you are a patient with diabetes insipidus, please consult your doctor or pharmacist for advice.
4. Possible side effects
Like all medicines, Desmopressin Nasal Spray can cause side effects.
You should avoid drinking large amounts of fluid while you are being treated with Desmopressin Nasal Spray, as this could lead to a build up of water which dilutes salt in the body. This is a serious problem and may lead to convulsions.
STOP USING Desmopressin Nasal Spray 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 Desmopressin Nasal Spray 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing Desmopressin Nasal Spray
Keep Desmopressin Nasal Spray out of the reach and sight of children.
Do not store above 25°C. Keep container in the outer carton.
Use by date: Do NOT use Desmopressin Nasal Spray 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.
6. Further information
Your medicine is called Desmopressin Nasal Spray. 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 Desmopressin Nasal Spray are citric acid monohydrate, disodium phosphate dihydrate, sodium chloride, benzalkonium chloride solution 50% and purified water.
Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd Drayton Hall,
Church Road,
West Drayton,
UB7 7PS, UK
Manufacturer:
Ferring GmbH Wittland 11 D-24109 Kiel Germany
Distributor:
Aspire Pharma Limited Bellamy House Winton Road Petersfield Hampshire GU323HA
Desmopressin Nasal Spray PL 03194/0090 This leaflet was last revised in August 2015
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