Patient Leaflet Updated 10-Oct-2018 | SANOFI
PACKAGE LEAFLET: INFORMATION FOR THE USER
Adenoscan® 30 mg/10 ml solution for infusion
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Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet:
1.What Adenoscan is and what it is used for
2.What you need to know before you are given Adenoscan
3.How Adenoscan is given
4.Possible side effects
5.How to store Adenoscan
6.Contents of the pack and other information
1. What Adenoscan is and what it is used for
Adenoscan contains a medicine called adenosine. This belongs to a group of medicines called ‘coronary vasodilatators’.
This medicine is for diagnostic use only.
Adenoscan is used before a test called “myocardial perfusion imaging” to look at your heart. During this test you are given a medicine called a “radiopharmaceutical”.
Adenoscan works by opening up your heart’s blood vessels and allowing blood to flow more freely. This allows the “radiopharmaceutical” medicine to get into your heart. The doctor can see your heart and assess your heart condition. This procedure is used if you are not capable of exercise or if an exercise stress test is not possible.
2. What you need to know before you are given Adenoscan
Do not have this medicine and tell your doctor if:
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Adenoscan.
Warnings and precautions
Check with your doctor or nurse before you have Adenoscan if:
Talk to your doctor immediately if:
If you are not sure if any of the above apply to you, talk to your doctor or nurse before being given Adenoscan
Children and adolescents
Adenoscan use in children and adolescents has not been sufficiently studied
Other medicines and Adenoscan
Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Adenoscan can affect the way some other medicines work. Also some medicines can affect the way Adenoscan works.
In particular, check with your doctor or nurse if you are taking any of the following:
Adenoscan with food and drink
Food and drinks containing xanthines such as tea, coffee, chocolate and cola should be avoided for at least 12 hours before you are given Adenoscan.
Pregnancy and breast-feeding
Talk to your doctor or nurse before having this medicine if:
Ask you doctor or nurse for advice before taking any medicine if you are pregnant or breast-feeding.
Adenoscan contains sodium (34.5mg per infusion vial (10ml)). You may receive up to 0.99mg of sodium per kilogram of body weight. This should be taken into consideration by patients on a controlled sodium diet.
3. How Adenoscan is given
How Adenoscan is given
How much Adenoscan is given
If you are not sure why you are being given Adenoscan or have any questions about how much Adenoscan is being given to you, speak to your doctor or nurse.
Adults (including the elderly)
If you have more Adenoscan than you should
As this medicine is given to you by a doctor or nurse it is unlikely that you will be given too much. Your doctor will carefully work out how much Adenoscan you should be given.
If you have more of this medicine than you should, the following effects may happen:
Your doctor will be monitoring your heart throughout the procedure.
As the length of time adenosine stays in the blood is very short, any side effects of too much Adenoscan would quickly stop when the infusion is stopped.
Sometimes you may need an injection of a medicine called aminophylline or theophylline to help with any side effects
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Adenoscan can cause side effects, although not everybody gets them. While you are being given Adenoscan you may have some of the following side effects:
If any of the following side eects get worse, tell your doctor or nurse immediately and they will decide if you should continue the infusion or not:
The side effects normally settle within seconds or minutes after the infusion is finished but you should tell your doctor or nurse if any of them happen.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Very rare (may affect up to 1 in 10 000 people)
Other side effects (frequency cannot be estimated from the available data)
If any of the above side effects get worse, tell your doctor or nurse immediately and they will decide if you should continue the infusion or not. The side effects normally settle within seconds or minutes after the infusion is finished but you should tell your doctor or nurse if any of them happen.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Adenoscan
This medicine will be kept by your doctor or nurse or pharmacist in a safe place where children cannot see or reach it.
Adenoscan should not be used after the expiry date which is stated on the carton and on the label. The expiry date refers to the last day of that month.
Do not refrigerate.
The medicine is for single use only and should be used straight away after opening. Any portion of the vial not used at once should be disposed of.
Adenoscan should not be used if your doctor or nurse notice any particles in the solution or any discolouration before they give you the medicine. If the appearance of the medicine has changed, the vial must be thrown away.
Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.
6. Contents of the pack and other information
What Adenoscan contains
What Adenoscan looks like and contents of the pack
Adenoscan is a clear, sterile, colourless solution for infusion.
Each pack contains 6 single use vials of 30mg/10ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This leaflet was last approved in August 2018
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