Friday, October 7, 2016

Persantin Ampoules 10mg / 2ml





Persantin Ampoules 10 mg / 2 ml Solution for Infusion



(dipyridamole)






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



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

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

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




In this leaflet:



  • 1. What PERSANTIN Ampoules are and what they are used for

  • 2. Before you receive PERSANTIN Ampoules

  • 3. How PERSANTIN Ampoules will be given

  • 4. Possible side effects

  • 5. How to store PERSANTIN Ampoules

  • 6. Further information





What Persantin Ampoules Are And What They Are Used For



The name of your injection is PERSANTIN Ampoules 10 mg / 2 ml Solution for Infusion (called PERSANTIN Ampoules in this leaflet).



  • It contains a medicine called dipyridamole. This belongs to a group of medicines called ‘coronary vasodilators’

  • It works by opening up (dilating) the blood vessels in the heart

PERSANTIN Ampoules are used instead of exercise during scans to assess heart conditions.





Before You Receive Persantin Ampoules




You should not be given PERSANTIN Ampoules if:



  • You are allergic (hypersensitive) to dipyridamole or any of the other ingredients of PERSANTIN Ampoules (listed in Section 6 below)

  • You have heart problems such as a recent heart attack (within the last 4 weeks), angina (chest pain) at rest, irregular heart beat, heart block (this usually causes a slow heart beat), heart failure or a problem affecting the heart valves

  • You have low blood pressure or have recently fainted (within the last 4 weeks) for no apparent reason

  • You have had a stroke or something called a ‘transient ischemic attack’ (a temporary stroke that lasts less than 24 hours)

  • You have breathing problems such as asthma, shortness of breath or wheezing

  • You have myasthenia gravis (a rare muscle problem)

  • You are pregnant, likely to get pregnant or are breast-feeding

You should not receive this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having PERSANTIN Ampoules.





Take special care with PERSANTIN Ampoules



Check with your doctor or pharmacist before having this medicine if:



  • The person having the injection is a young infant whose liver is not fully grown




Taking other medicines



Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.



This includes medicines obtained without a prescription and herbal medicines. This is because PERSANTIN Ampoules can affect the way some other medicines work. Also some other medicines can affect the way PERSANTIN Ampoules work.



In particular tell your doctor or pharmacist if you are taking any of the following medicines:



  • Medicines used to treat high or low blood pressure

  • Medicines that contain something called “xanthine derivatives” such as caffeine and theophylline. This also includes drinks such as tea, coffee and cola. If you have taken any of these you need to wait at least 24 hours before having PERSANTIN Ampoules. This is because the caffeine can stop the injection working properly

  • Medicines containing dipyridamole




Having PERSANTIN Ampoules with food and drink



You need to wait at least 24 hours before receiving PERSANTIN Ampoules if you have had a drink with caffeine in it such as tea, coffee or cola. This is because the caffeine can stop the injection working properly





Pregnancy and breast-feeding



You should not be given PERSANTIN Ampoules if you are pregnant, likely to get pregnant or are breast-feeding.






How Persantin Ampoules Will Be Given



PERSANTIN Ampoules are usually given by a doctor or nurse. How much you are given depends on how much you weigh.




Receiving the injection



  • PERSANTIN Ampoules are slowly injected into a vein over 4 minutes

  • This process is often called having an infusion

  • An injection of something called ‘thallium - 201’ is then given within 3-5 minutes of the first injection




If you have more PERSANTIN Ampoules than you should



It is unlikely that you will be given too much of this medicine. However, tell the doctor or nurse if you think that you have been given too much.






Possible Side Effects



Like all medicines, PERSANTIN Ampoules can cause side effects although not everybody gets them. The following side effects may happen with this medicine:




Allergic reactions



  • Rash or itching

  • Swelling of the face or mouth or wheezing

  • In a few cases this could be sudden and severe (anaphylactoid reaction)




Heart problems



  • Heart beat problems

  • Chest pain

  • Cardiac arrest and heart attack (in a few cases fatal)




Other side effects



  • Higher or lower blood pressure than normal

  • Hot flushes or fainting

  • Feeling sick (nausea), being sick (vomiting), indigestion or diarrhoea

  • Feeling dizzy, tired (fatigue) or having a headache

  • Gut (abdominal ) or muscle (myalgia) pain

  • Pins and needles (paraesthesia)

  • A bitter taste is sometimes experienced immediately after the injection of PERSANTIN Ampoules

  • Stroke

  • Fits (seizures)



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





How To Store Persantin Ampoules



  • Keep out of the reach and sight of children

  • PERSANTIN Ampoules should be kept in the outer carton

  • Do not use the ampoules after the expiry date which is printed on the packaging

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.





Further Information




What PERSANTIN Ampoules contain



  • The active substance is dipyridamole. One 2 ml ampoule contains 10 mg dipyridamole

  • The other ingredients in the injection are tartaric acid, macrogol 600, hydrochloric acid and water for injections




What PERSANTIN Ampoules looks like and contents of the pack



PERSANTIN Ampoules are clear glass vials containing a clear, yellow liquid. They are supplied in cartons of 5 ampoules.





Marketing Authorisation Holder and Manufacturer



The Marketing Authorisation for PERSANTIN Ampoules is held by:




Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS



and the ampoules are manufactured at:




Boehringer Ingelheim Spain

TurĂ³ de can Matas

Ctra de Rubi

San Cugat del Valles

Barcelona

Spain





This leaflet was revised in September 2007.



© Boehringer Ingelheim Limited 2007



22C765GB5



20020725






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