Amiodarone 30 mg

• AMIODARONE 30 mg/ml Pre-filled syringe ACCORD contains the active substance amiodarone hydrochloride and it belongs to a group of medicines called anti-dysrhythmics.

• It works by controlling the uneven beating of your heart (called dysrhythmias).

• Having the injection helps your heartbeat to return to normal and is normally only given in a hospital under medical supervision when a quick response is needed or when tablets cannot be given.

Your doctor has prescribed AMIODARONE 30 mg/ml Pre-filled syringe ACCORD to treat the following:

• uneven heartbeats where other medicines either have not worked or cannot be used.
• an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast.
• other types of fast or uneven heartbeats known as ‘atrial flutter’ or ‘atrial fibrillation.

AMIODARONE 30 mg/ml Pre-filled syringe ACCORD should not be given to you if you:

• are allergic to amiodarone hydrochloride, iodine or to any of the other ingredients of AMIODARONE 30 mg/ml Pre-filled syringe ACCORD listed in section 6
• have heart problems such as heart block, which can cause a slow heart rate (such as sino-atrial heart block, sinus bradycardia, high grade AV block, bifascicular or trifascicular block or sinus node disease) and you do not have a pacemaker
• have heart failure or weakness of the heart muscle (cardiomyopathy)
• have or have had thyroid problems. Your doctor will test your thyroid before giving you this medicine
• have severe breathing problems
• have very low blood pressure
• are taking other medicines that can make your heartbeat very quickly (these are listed below under the section ‘Taking other medicines’)
• are pregnant or are breastfeeding

Do not use this medicine if any of the above applies to you and talk to your doctor or nurse.

AMIODARONE 30 mg/ml Pre-filled syringe ACCORD must not be given to premature babies, neonates or a child up to 3 years old.

If you are uncertain whether you can use this medicine or not, ask your doctor or pharmacist.

Warnings and precautions

Tell your doctor or health care provider before being given AMIODARONE 30 mg/ml Pre-filled syringe ACCORD. Take special care with AMIODARONE 30 mg/ml Pre-filled syringe ACCORD if you:

• have mild to moderate low blood pressure
• have a weak heart or heart failure
• have any problem with your thyroid gland. Your doctor will test your thyroid before giving you this medicine
• have liver problems
• are receiving high dose oxygen therapy or have any other problems with your lungs including asthma
• are due to have an operation involving general anaesthesia
• are elderly
• currently take a medicine containing sofosbuvir for the treatment of hepatitis C as it may result in a life-threatening slowing of your heart beat.

Tell your doctor if during treatment you experience:

• slow or irregular heartbeat or heart rhythm problems
• shortness of breath or worsening of existing shortness of breath
• chest pain
• light-headedness
• palpitations
• near-fainting or fainting

Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may require additional heart monitoring. If any of these apply to you, your doctor may want to change your treatment or give you special advice.

You will not be expected to give yourself AMIODARONE 30 mg/ml Pre-filled syringe ACCORD. It will be given to you by a person who is qualified to do so. This is because it needs to be given as an injection or infusion into your vein in the hospital where the doctor can monitor your progress.

The daily dose of Amiodarone depends on the severity of your illness. The dose and the treatment times will be determined by your doctor, who will adjust these especially for you.

If you receive more AMIODARONE 30 mg/ml Pre-filled syringe ACCORD than you should Your doctor will carefully calculate how much AMIODARONE 30 mg/ml Pre-filled syringe ACCORD you should get, therefore it is unlikely your doctor or nurse will give you too much of it. If, however, you have received higher doses than those recommended you will be carefully monitored by your doctor and will receive supportive therapy if necessary.

If you are given too much Amiodarone Injection the following effects may happen: feeling dizzy, faint, sick, tired, confused, constipation or sweating. You may have an abnormally slow or fast heartbeat. Too much amiodarone can damage the heart and liver.

If you forget to take AMIODARONE 30 mg/ml Pre-filled syringe ACCORD 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 taking AMIODARONE 30 mg/ml Pre-filled syringe ACCORD It is important for you to keep having Amiodarone Injections until your doctor decides to stop them. If you stop having this medicine, the uneven heartbeats may come back and this could be dangerous.

AMIODARONE 30 mg/ml Pre-filled syringe ACCORD can have side effects. Not all side effects for AMIODARONE 30 mg/ml Pre-filled syringe ACCORD are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving AMIODARONE 30 mg/ml Pre-filled syringe ACCORD, please consult your doctor, pharmacist or other healthcare professional for advice.

Amiodarone Injection may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.

If any of the following happens, stop receiving AMIODARONE 30 mg/ml Pre-filled syringe ACCORD and inform your doctor:

• anaphylactic shock (a life-threatening allergic reaction). Signs may include a sudden rash, itching or lumpy rash (hives) and swelling of the face, lips, tongue or other parts of the body. You may also have shortness of breath, wheezing or trouble breathing.
• life-threatening skin reactions characterised by rash, blisters, hives, peeling skin and pain (toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systematic symptoms (DRESS).
• excessive thyroid activity (hyperthyroidism, sometimes fatal) causing:
  • Weight loss
  • Weakness
  • Restlessness
  • Increased heart rate
  • Irregular heart rate
  • Angina
  • Heart failure
  • Shaking, Sweating
  • High temperatures
• loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called ‘optic neuropathy or neuritis’.
• serious respiratory problems such as difficulty in breathing, wheezing or coughing, build-up of fluid in the lungs, sometimes fatal.

These are all very serious side effects. If you have them, you may have had a serious reaction to AMIODARONE 30 mg/ml Pre-filled syringe ACCORD. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Frequent side effects
• blurred eyesight or seeing a coloured halo in dazzling light
• itchy, red rash (eczema)
• trembling when you move your arms or legs.
• at the site where you are given the injection or infusion you may experience: pain, skin redness or a change in skin colour, localised soft-tissue damage, fluid leakage, swelling caused by fluid within the skin, inflammation or inflamed blood vessels, abnormally hard tissue or infection
• slow or irregular heartbeat
• low blood pressure and rapid heart rate which can make you feel dizzy or faint.

These side effects occur straight after injection. The effects are usually moderate and temporary. They can be serious if you are given too much AMIODARONE 30 mg/ml Pre-filled syringe ACCORD too quickly.

Less frequent side effects

• feeling numb or weak, tingling or burning feelings in any part of your body
• the excipient benzyl alcohol may cause hypersensitivity reactions.
• feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, sweating, feeling irritable. This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion’ (SIADH)
• newly occurring heart rhythm disorder or worsening of existing heart rhythm disorders leading to heart attack
• heart block that can lead to slow heart rate
• reduced heartbeat, which may lead to shock
• increased liver enzymes which can show up in tests
• hot flushes, sweating and feeling sick if amiodarone injection is given too quickly
• headache
• feeling sick (nausea)
• lung damage
• acute liver function disorders, with increased serum levels and/or jaundice, including hepatic failure, sometimes fatal.
• increase in pressure inside the skull, accompanied by headache, vomiting.
• anaemia
• low levels of platelets
• nightmares
• feeling of spinning
• sleeplessness

Frequency unknown

• sudden inflammation of the pancreas (pancreatitis (acute))
• confusion (delirium)
• back pain.
• hypothyroidism (underactive thyroid) – you may feel extremely tired, weak or ‘rundown’ and experience weight gain, constipation and aching muscles. You may be unable to cope with low temperatures.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get 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 to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of AMIODARONE 30 mg/ml Pre-filled syringe ACCORD.

• Store at or below 25 °C.

• After opening the product should be used immediately.

• For single use only. Discard any unused product.

• Store all medicines out of reach of children.

• Store in original package until use.

• Do not use after the expiry date stated on the label.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).