Active ingredient
- amiodarone hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL04425/0643.
Cordarone X 150mg/3ml Solution for Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cordarone® X 150mg/3ml, solution for injection
amiodarone hydrochloride
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you start having this medicine
In this leaflet:
1. What Cordarone X is and what it is used for
2. Before you have Cordarone X
3. How Cordarone X is given
4. Possible side effects
5. How to store Cordarone X
6. Further information
1. What Cordarone X is and what it is used for
Cordarone X 150mg/3ml, solution for injection (called Cordarone X in this leaflet) contains a medicine called amiodarone hydrochloride. This belongs to a group of medicines called anti-arrhythmics.
It works by controlling the uneven beating of your heart (called ‘arrhythmias’). Having the injection helps your heartbeat to return to normal.
Cordarone X is normally only given in a hospital when a quick response is needed or when tablets cannot be given. Cordarone X can be used to:
2. Before you have Cordarone X
Do not have this medicine and tell your doctor, pharmacist or nurse if:
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Cordarone X.
If you are on a heart transplant waiting list, your doctor may change your treatment. This is because taking Cordarone X before heart transplantation has shown an increased risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart stops working properly within the first 24 hours after surgery.
Take special care with Cordarone X. Check with your doctor, pharmacist or nurse before having this medicine if:
Tell your doctor immediately if you are taking a medicine containing sofosbuvir for the treatment of hepatitis C and during treatment you experience:
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Cordarone X.
Taking other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Cordarone X can affect the way some other medicines work.
Also some medicines can affect the way Cordarone X works.
In particular, do not take this medicine and tell your doctor, if you are taking:
Tell your doctor if you are taking any of the following medicines:
The following medicines can increase the chance of you getting side effects, when taken with Cordarone X:
Cordarone X may increase the effect of the following medicines:
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Cordarone X.
Taking Cordarone X with food and drink
Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking Cordarone X can increase your chance of getting side effects.
Protect your skin from sunlight
Keep out of direct sunlight while taking this medicine and for a few months after you have finished taking it.
This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:
Pregnancy and breast-feeding
Do not take this medicine if
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Important information about some of the ingredients of Cordarone X
This medicine contains:
3. How Cordarone X is given
Your doctor or nurse will normally give you Cordarone X. This is because it needs to be given as an infusion into your vein in the hospital where the doctor can monitor your progress.
Having this medicine
If you are not sure why you are receiving Cordarone X or have any questions about how much Cordarone X is being given to you, speak to your doctor, pharmacist or nurse.
How much will be given to you
Your doctor will decide how much to give you depending on your illness
Adults
Children and adolescents
Elderly
This medicinal product must not be mixed with other preparations in the same syringe. Do not inject other preparations in the same line.
If you have more Cordarone X than you should
Your doctor will carefully calculate how much Cordarone X you should get. Therefore it is unlikely your doctor, nurse or pharmacist will give you too much of this medicine. But, if you think that you have been given too much or too little Cordarone X, tell your doctor, nurse or pharmacist.
The following effects may happen: feeling dizzy, faint, sick, tired or confused. Having an abnormally slow or fast heartbeat. Too much amiodarone can damage the heart and liver.
If you forget to have Cordarone X
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you may have missed a dose, then talk to your doctor or nurse.
If you stop having Cordarone X
It is important for you to keep having Cordarone X injections until your doctor decides to stop them. If you stop having this medicine the uneven heartbeats may come back. This could be dangerous.
Tests
Your doctor will take regular tests to check how your liver is working. Cordarone X can affect how your liver works. If this happens, your doctor will decide whether you should keep having this medicine.
Your doctor may do regular thyroid tests while you are taking this medicine. This is because Cordarone X contains iodine which can cause problems to your thyroid.
Your doctor may also do other regular tests such as blood tests, chest X-rays, ECG (electrical test of your heartbeat) and eye tests both before and while you are having Cordarone X.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Cordarone X can cause side effects, although not everybody gets them. Cordarone X may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.
Stop having Cordarone X and tell a doctor, nurse or pharmacist or go to a hospital straight away if:
Very rare (affects less than 1 in 10,000 people)
Frequency not known (Cannot be estimated from the available data)
Stop having Cordarone X and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Very rare (affects less than 1 in 10,000 people)
Tell your doctor as soon as possible if you have any of the following side effects:
Common (affects less than 1 in 10 people)
Frequency not known (Cannot be estimated from the available data)
Tell your doctor, nurse or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common (affects less than 1 in 10 people)
Very rare (affects less than 1 in 10,000 people)
Frequency not known (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Cordarone X
This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it.
Do not use Cordarone X after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original container. Only clear solutions free of particles should be used.
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.
6. Further Information
What Cordarone X contains
What Cordarone X looks like and contents of the pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 05/2020
© Sanofi, 2001-2020
704794
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 035 2525