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 are: PL17780/0586, PL17780/0587.
Cordarone X 100mg & 200mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cordarone ® X 100mg and 200mg Tablets
Amiodarone hydrochloride
Read all of this leaflet carefully before you start taking this medicine
In this leaflet:
1. What Cordarone X Tablets are and what they are used for
2. Before you take Cordarone X Tablets
3. How to take Cordarone X Tablets
4. Possible side effects
5. How to store Cordarone X Tablets
6. Further information
1. What Cordarone X Tablets are and what they are used for
Cordarone X 100mg or 200mg Tablets (called Cordarone X Tablets in this leaflet) contain 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’). Taking the tablets helps your heartbeat to return to normal.
Cordarone X Tablets can be used to:
2. Before you take Cordarone X Tablets
Do not take this medicine and tell your doctor if:
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Cordarone X Tablets.
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 Tablets.
Check with your doctor or pharmacist before taking your medicine if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Cordarone X Tablets.
Tell your doctor immediately if you are taking a medicine containing sofosbuvir fo the treatment of hepatitis C and during treatment you experience:
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes medicines you buy without prescription, including herbal medicines. This is because Cordarone X Tablets can affect the way some other medicines work. Also, some medicines can affect the way Cordarone X Tablets work.
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 Tablets:
Cordarone X Tablets 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 or pharmacist before taking Cordarone X Tablets.
Taking Cordarone X Tablets with food and drink
Do not drink grapefruit juice while taking this medicine.
This is because drinking grapefruit juice while taking Cordarone X Tablets can increase your chance of getting side effects.
Limit the amount of alcohol you drink whilst taking this medicine. This is because drinking alcohol while taking this medicine will increase the chance of you having problems with your liver. Talk to your doctor or pharmacist about the amount of alcohol you can drink.
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
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may have blurred eyesight after taking this medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Cordarone X Tablets
This medicine contains:
3. How to take Cordarone X Tablets
Always take Cordarone X Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
How much to take
Adults
Children and adolescents
Elderly
If you take more Cordarone X Tablets than you should
If you take more Cordarone X Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy, faint or tired, confusion, slow heartbeat, damage to the liver or being sick.
If you forget to take Cordarone X Tablets
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Cordarone X Tablets
Keep taking Cordarone X Tablets until your doctor tells you to stop. Do not stop taking Cordarone X Tablets just because you feel better. If you stop taking 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 Tablets can affect how your liver works. If this happens, your doctor will decide whether you should keep taking these tablets.
Your doctor may do regular thyroid tests while you are taking this medicine. This is because Cordarone X Tablets contain 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 taking Cordarone X Tablets.
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 Tablets can cause side effects, although not everybody gets them. Cordarone X Tablets may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.
Stop taking Cordarone X Tablets and see a doctor or go to a hospital straight away if:
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in 100 people)
Very rare (affects less than 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Stop taking Cordarone X Tablets and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Uncommon (affects less than 1 in 100 people)
Very rare (affects less than 1 in 10,000 people)
Not Known (frequency cannot be determined from the available data)
Some cases of bleeding in the lungs have been reported in patients taking Cordarone X Tablets. You should tell your doctor straight away if you cough up any blood.
Tell your doctor as soon as possible if you have any of the following side effects:
Very common (affects more than 1 in 10 people)
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in 100 people)
Very rare (affects less than 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Very common (affects more than 1 in 10 people)
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in 100 people)
Very rare (affects less than 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 Tablets
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Cordarone X Tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Keep the blister strip in the outer carton in order to protect from light. Do not store above 25°C.
Do not use Cordarone X Tablets if you notice your tablets are crumbling, broken or discoloured.
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 Tablets contain
What Cordarone X Tablets look like and contents of the pack
100mg Tablets: The tablets are round and white in colour. One side has a break-line and the other side is imprinted with ‘100’.
200mg Tablets: The tablets are round and white in colour. One side has a break-line and the other side is imprinted with ‘200’.
The tablets are available in blister-packs of 28 and 30 tablets.
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 January 2022
‘Zentiva’ is a registered trademark © 2022 Zentiva.
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