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
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Cordarone X is and what it is used for
2. What you need to know before you use Cordarone X
3. How to use Cordarone X
4. Possible side effects
5. How to store Cordarone X
6. Contents of the pack and other 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’). Using 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. What you need to know before you use Cordarone X
Do not use this medicine and tell your doctor, pharmacist or nurse if:
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before using 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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using 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 using Cordarone X.
Other medicines and Cordarone X
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 use 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 using 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 use this medicine if:
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Cordarone X contains
Iodine: This medicine contains approximately 56 mg of iodine in a 3 ml ampoule. Iodine is present in amiodarone hydrochloride, the medicine your infusion contains. Iodine can cause problems to your thyroid (see ‘Tests’ below).
Benzyl Alcohol: This medicine contains 60mg benzyl alcohol in each 3ml ampoule which is equivalent to 20mg/ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. This medicine should not be used in newborn babies (up to 4 weeks old), unless recommended by your doctor.
This medicine should not be used for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
3. How to use Cordarone X
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.
Using 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
Use in 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 use 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 use 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 using Cordarone X
It is important for you to keep using Cordarone X injections until your doctor decides to stop them. If you stop using 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 using 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 using Cordarone X and tell a doctor, nurse or pharmacist or go to a hospital straight away if:
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Stop using 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 (may affect up to 1 in 10,000 people)
Tell your doctor as soon as possible if you have any of the following side effects:
Common (may affect up to 1 in 10 people)
Not known (frequency 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 (may affect up to 1 in 10 people)
Very rare (may affect up to 1 in 10,000 people)
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Cordarone X contains
What Cordarone X looks like and contents of the pack
Cordarone X is a pale, yellow solution and is available as 3ml glass ampoules in cartons of 6 or 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
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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 12/2021.
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