Tuesday, July 24, 2012

Desmopressin Nasal Spray (Actavis UK Ltd)






Desmopressin Nasal Spray 10micrograms/dose



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


  • Keep this leaflet. You may need to read it again.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If you have any further questions, ask your doctor or pharmacist.

  • If you have any of the side effects, or if you notice any side effects not listed, please tell your doctor or pharmacist.



In this leaflet:



  • 1. What Desmopressin is and what it is 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




What Desmopressin is and what it is used for


The ingredient that makes the spray work (the active substance) is called desmopressin. Desmopressin is an antidiuretic, which reduces the amount of urine produced by the kidneys.


Desmopressin nasal spray is used to:


  • treat and diagnose a chronic disease called diabetes insipidus which causes extreme thirst and continuous production of large volumes of dilute urine. Important: Not to be confused with diabetes mellitus (sugar diabetes)

  • treat frequent urination during the night in adults (nocturia) associated with multiple sclerosis


  • investigate kidney function.



Before you use Desmopressin nasal spray



Do not use Desmopressin nasal spray if you:


  • are allergic (hypersensitive) to desmopressin or any of the other ingredients in Desmopressin nasal spray (see section 6)


  • drink unusually large amounts of fluid (polydipsia)

  • suffer from heart problems, high blood pressure or other diseases needing treatment with diuretics (water tablets)

  • are elderly (over the age of 65 years)

  • suffer with alcohol abuse.



Check with your doctor or pharmacist before using Desmopressin nasal spray if you have:



  • kidney disease


  • cystic fibrosis

  • a medical condition causing fluid and/or electrolyte imbalance in the body


  • increased pressure in the skull (intracranial pressure).



Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:



  • tricyclic antidepressants (used to treat depression e.g. amitriptyline or imipramine)


  • carbamazepine (used to treat epilepsy)


  • chlorpromazine (used to treat psychosis or schizophrenia)


  • indomethacin (painkillers called non-steroidal anti-inflammatory drugs (NSAIDs)).



Fluid intake


  • Before you start treatment with this medicine, your doctor should give you advice about fluid intake.

  • When using this medicine for nocturia or to investigate kidney function, keep your fluid intake to a minimum from 1 hour before a dose until 8 hours after a dose.

  • Too much fluid intake may lead to a build up of water, which dilutes the salt in the body. This can occur with or without warnings or symptoms, which include unusually bad or prolonged headache, feeling or being sick, unexplained weight gain and in serious cases, fits or swelling of the brain. If you have any of these symptoms, stop the treatment and contact your doctor at once.



Pregnancy and breastfeeding


Desmopressin nasal spray can be used during breastfeeding but should only be used in pregnancy as directed by a doctor.


Ask your doctor or pharmacist for advice before taking any medicine.




Tests


Your blood pressure and weight may be monitored whilst you are using this medicine.





How to use Desmopressin nasal spray


Always use Desmopressin nasal spray exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.



Usual doses:


Where 2 sprays are required you should give 1 spray into each nostril unless directed otherwise.



  • Nocturia

    Adults under 65 years old- 1 or 2 sprays at bedtime.

    Do not repeat the dose in a 24 hour period. Do not drink for 8 hours after using the spray except to satisfy thirst.


  • Diabetes insipidus

    Treatment: Adults and children – 1 or 2 sprays once or twice a day.

    Diagnosis: Adults and children – 2 sprays.


  • To investigate kidney function

    Adults – 2 sprays into each nostril

    Children aged 1 – 15 year old – 1 spray into each nostril

    Children under 1 year old – 1 spray

When using this medicine for diabetes insipidus or kidney function investigations keep your fluid intake to a minimum (not more than 0.5 litres) from 1 hour before a dose until 8 hours after a dose.




Instructions for use:



  • 1. Blow your nose, then remove the dust cap on the spray bottle.


  • 2. To ensure the correct dose, it is important that the bottom of the plastic tube inside the bottle is covered with the fluid.

Before you use the spray for the first time, the pump must be filled. To do this, press the pump down 5 times or until you get a fine mist. The spray is then ready for use. If the nasal spray is not used daily, the pump has to be filled again before use.



  • 3. Hold the spray bottle as shown in the picture.


  • 4. Tilt your head back slightly and insert the tip of the spray into the nostril. Hold your breath without sniffing. Press the spray once. If you have to take more than one dose, alternate between the right and left nostril.


  • 5. Replace the dust cap. Store the bottle at room temperature.



If you use more Desmopressin nasal spray than you should


An overdose may lengthen the effect of desmopressin and increase the risk of water build up in the body and low blood salt, symptoms include fits. If you use more Desmopressin nasal spray than prescribed, contact your doctor, pharmacist or the nearest hospital at once.




If you forget to use Desmopressin nasal spray


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




If you stop using Desmopressin nasal spray


You should only change or stop your treatment if advised by your doctor.





Possible side effects


Like all medicines, Desmopressin nasal spray can cause side effects, although not everybody gets them.



Tell your doctor or pharmacist if you notice any of the following other side effects, or if you notice any not listed:


  • symptoms of a build up of water in the body, reducing the amount of salt in the body: unusually unexplained weight gain and in serious cases, fits or brain swelling.

  • others: headache, abdominal pain, feeling sick, blocked or runny nose, nosebleeds.




How to store Desmopressin nasal spray


Keep out of the reach and sight of children.


Store Desmopressin nasal spray below 25°C.


Do not use Desmopressin nasal spray after the expiry date, stated on the pack.


Always return any left over medicine to you pharmacist.




Further information



What Desmopressin nasal spray contains


  • the active substance (the ingredient that makes the spray work) is desmopressin acetate. Each spray contains 10micrograms (0.1mg in 1ml) of the active substance.

  • the other ingredients are potassium sorbate, sodium chloride, hydrogen chloride and purified water.



What Desmopressin nasal spray looks like and contents of the pack


Desmopressin nasal spray is a solution in an amber, glass bottle with a nasal applicator.


Pack size 6ml.




Marketing Authorisation Holder



Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfjordur

Iceland




Manufacturer



Inpac AS

Gjellebekkstubben 10

3420 Lierskogen

Norway




Distributor



Acatvis

Barnstaple

EX32 8NS

UK




This leaflet was last revised in December 2008.




Actavis Group hf.

Hafnarfjordur

Island


21101-33





No comments:

Post a Comment