What is a Patient Information Leaflet and why is it useful?

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: PL 12064/0047 .


Amiodarone 30mg/ml Solution for injection/infusion in pre-filled syringe

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiodarone 30mg/ml Solution for injection/infusion in pre-filled syringe

amiodarone hydrochloride

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again
  • If you have any further questions, ask your doctor, pharmacist or nurse
  • If you get any of the side effects talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

This medicine will be referred to as Amiodarone Injection in the rest of this leaflet.

What is in this leaflet:

1. What Amiodarone Injection is and what it is used for
2. What you need to know before you are given Amiodarone Injection
3. How Amiodarone Injection is given
4. Possible side effects
5. How to store Amiodarone Injection
6. Contents of the pack and other information

1. What Amiodarone Injection is and what it is used for

Amiodarone Injection contains the active substance amiodarone hydrochloride. It 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.

Amiodarone Injection is normally only given in a hospital when a quick response is needed or when tablets cannot be given. Amiodarone Injection can be used to:

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

2. What you need to know before you are given Amiodarone Injection

You must not be given Amiodarone Injection if:

  • You are allergic to amiodarone hydrochloride, iodine or to any of the other ingredients of this medicine (listed in section 6)
  • You 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
  • You have heart failure or weakness of the heart muscle (cardiomyopathy)
  • You have or have had thyroid problems. Your doctor will test your thyroid before giving you this medicine
  • You have severe breathing problems
  • You have very low blood pressure
  • You are taking other medicines that can make your heartbeat very quickly (these are listed below under the section ‘Taking other medicines’)
  • You are pregnant, think you may be pregnant or are breastfeeding (unless treatment is considered absolutely essential by your doctor)

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

Amiodarone Injection must not be given to premature babies, neonates or a child up to 3 years old.

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before you are given Amiodarone Injection if:

  • You have mild to moderate low blood pressure
  • You have a weak heart or heart failure
  • You have any problems with your thyroid gland
  • You have liver problems
  • You are receiving high dose oxygen therapy or have any other problems with your lungs including asthma
  • You are due to have an operation involving general anaesthesia
  • You are elderly

Taking other medicines

The following drugs must not be taken with Amiodarone Injection as together they can cause a very severe fast heartbeat that can be fatal:

  • Medicines to treat irregular heart rhythms (anti-arrhythmics), such as quinidine, procainamide, disopyramide and sotalol
  • Antibiotics, such as erythromycin, moxifloxacin, co-trimoxazole and pentamidine
  • Medicines to treat mental illness (anti-psychotics), such as chlorpromazine, thioridazine, haloperidol, fluphenazine, amisulpride, sertindole and pimozide
  • Medicines to treat depression, such as lithium and tricyclic antidepressants, including doxepin, maprotiline and amitriptyline
  • Certain medicines to treat allergic reactions (antihistamines), such as terfenadine, astemizole and mizolastine
  • Medicines used to treat or prevent malaria, such as quinine, mefloquine, chloroquine and halofantrine

If any of the above applies to you, do not use this medicine and talk to your doctor or nurse.

Other medicines and Amiodarone Injection

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicine.

  • Oral anticoagulants e.g. warfarin (used to thin the blood), phenytoin (used to treat epilepsy) and digoxin (used to treat certain heart conditions). Your doctor may reduce your dose of these medicines and your blood will need to be monitored before and after treatment
  • Stimulant laxatives such as bisacodyl and senna, medicines called diuretics or water tablets, steroids and the antifungal medicine amphotericin (when given directly into the vein). These can cause low levels of potassium in the blood, which can increase the risk of getting a fast heart rate (tachycardia).
  • Rifampicin (an antibiotic) and St. John’s Wort (a herbal medicine) can cause lower levels of Amiodarone Injection in the body if they are taken at the same time
  • Medicines that can either be affected by or effect the level of amiodarone in the body if taken at the same time:
  • Ciclosporin, tacrolimus (immunosuppressants-used to help prevent rejection of transplants)
  • Flecainide, used to treat irregular heart rhythms. Your doctor should monitor your treatment closely and may adjust your dose of flecainide.
  • Simvastatin, lovastatin, atorvastatin (drugs to reduce blood cholesterol), as there is a risk of developing muscle pains and kidney failure (rhabdomyolysis) if doses of more than 20 mg of simvastatin are taken
  • Lidocaine (a local anaesthetic)
  • Sildenafil (used for erectile dysfunction)
  • Fentanyl (used for pain relief)
  • Midazolam and triazolam (a sedative)
  • Ergotamine and dihydroergotamine (for migraine)
  • Colchicine (for gout)
  • Beta-blockers, such as metoptolol and sotalol
  • Calcium channel blockers diltiazem and verapamil, used to treat high blood pressure
  • Indinavir (an anti-viral drug)
  • Cimetidine (an anti-ulcer drug)
  • Clarithromycin (an antibiotic)
  • Ketoconazole and itraconazole (antifungal drugs)
  • Tetracosactrin ( used in the treatment of inflammatory or degenerative disorders)

Amiodarone Injection with food and drink

Do not drink grapefruit juice while using this medicine because it can increase amiodarone levels in your blood.

Protect your skin from sunlight

Keep out of direct sunlight while using this medicine and for a few months after you have finished using 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:

  • make sure you use a high factor sun cream
  • always wear a hat and clothes which cover your arms and legs

Pregnancy and breast-feeding

  • Your doctor will prescribe amiodarone injection only in exceptional circumstances, if the benefit of treatment outweighs the risks during your pregnancy. Amiodarone can be used during pregnancy in life-threatening circumstances only.
  • You should not be given amiodarone if you are breast-feeding. If you are given amiodarone during pregnancy or breast-feeding, breast-feeding should be stopped. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Some of the side effects in section 4 together with how you feel after your treatment may make it unsafe for you to drive or operate machinery. If you feel unwell, you must speak to your doctor or nurse before driving or operating machinery.

Important information about some of the ingredients of Amiodarone Injection

Amiodarone Injection contains Benzyl Alcohol

This medicine contains 200mg of Benzyl Alcohol in each 10ml syringe. Benzyl Alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease or 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”). Benzyl alcohol has been linked with toxic and allergic reactions called gasping syndrome in infants and children up to 3 years old

This medicine contains:

  • Iodine: Amiodarone Injection contains approximately 112mg of iodine in a 10ml pre-filled syringe. Iodine is present in amiodarone hydrochloride, the medicine your infusion contains. Iodine can cause problems with your thyroid (see ‘Tests’ below)

3. How Amiodarone Injection is given

Your doctor or nurse will normally give you Amiodarone Injection. 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.

Dosage

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.

Unless otherwise prescribed by your doctor, the usual dose is 5 mg per kg of body weight. Your medicine will be injected over a period of at least 3 minutes.

When Amiodarone is given as an injection

  • you should not be given a dose greater than 5 mg per kg of body weight.
  • the dose should be given to you slowly over a period of at least 3 minutes (unless you are being given the medicine for resuscitation).
  • the doctor must wait for at least 15 minutes before giving you another injection.
  • repeated or continuous administration may cause inflammation of the vein and damage to the skin at the injection site (the surrounding skin may feel warm and tender and redness may be present) and in such situations a “central venous catheter” is recommended for use by your doctor.

When Amiodarone is given as an infusion

  • you should be given a dose of 5 mg/kg bodyweight diluted in 250 ml of 5% dextrose solution.
  • the dose should be given to you over a period of 20 minutes to 2 hours.
  • The administration may be repeated 2-3 times per day. Most of the side effects which occur during treatment occur if you are given too much Amiodarone. You should therefore be given the lowest possible dose of Amiodarone. This will keep side effects to a minimum. See also “If you have received more Amiodarone than you should”.

Adults:

The usual dose is 5 mg for every kilogram of your weight given over a period of 20 minutes to 2 hours. You may be given another dose of 10 to 20 mg for every kilogram of weight every 24 hours depending on your illness.

In an emergency, your doctor may decide to give you a dose of 150 mg to 300 mg as a slow injection over 3 minutes.

Your doctor will monitor your response to Amiodarone and the dose will be adjusted accordingly.

Children and adolescents:

  • There is only limited information on the use in children. The child’s doctor will carefully calculate the amount of Amiodarone Injection depending on the child’s body weight.

This medicine is not for use in neonates, infants and children up to 3 years old.

Elderly:

  • As with all patients it is important that the minimum effective dose is used. Your doctor will carefully calculate how much Amiodarone you should get and monitor your heart rate and thyroid function more closely.

If you are given too much Amiodarone Injection

Your doctor will carefully calculate how much Amiodarone Injection 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 have Amiodarone Injection

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 Amiodarone Injection

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.

Tests

  • Your doctor will take regular tests to check how your liver is working. Amiodarone Injection can affect how your liver works. If this happens, your doctor will decide whether you should keep having this medicine
  • Your doctor will do regular thyroid tests while you are taking this medicine. This is because Amiodarone Injection contains iodine which can cause problems with 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 Amiodarone Injection. If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Amiodarone Injection may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.

Stop having Amiodarone Injection and tell a doctor or nurse, or go to a hospital straight away if you notice any of the following:

  • Severe allergic reactions causing:
    • Swelling of hands, feet, lips, mouth, tongue or throat
    • Difficulty in breathing
    • Itchy skin rash (hives)
    • Diarrhoea
    • Stomach pains
  • Excessive thyroid activity (hyperthyroidism) causing:
    • Weight loss
    • Weakness
    • Restlessness
    • Increased heart rate
    • Irregular heart rate
    • Angina
    • Heart failure
  • Rhabdomylosis (this can occur when some medicines used to reduce blood cholesterol, called statins, are taken with Amiodarone), which can cause:
    • muscle pain, tenderness, weakness or cramps
    • breakdown of muscle tissue causing kidney damage, which may lead to swelling of the hands or feet, shortness of breath, darker urine than normal and abnormal blood test results
  • Hypersensitivity pneumonitis (swelling of the lungs), alveolar/interstitial pneumonia or fibrosis, pleuritis, bronchiolitis obliterans organising pneumonia, pulmonary haemorrhage, respiratory distress syndrome (severe fluid build-up in the lungs) causing:
    • Fever
    • Chest pains
  • 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’.

Tell your doctor if you have any of the following side effects:

Common (may affect up to 1 in 10 people):

  • 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 too quickly.

Uncommon (may affect up to 1 in 100 people)

  • feeling numb or weak, tingling or burning feelings in any part of your body

Rare: (may affect up to 1 in 1,000 people)

  • Inflammation of blood vessels (vasculitis) seen as weight loss, fever and aches and pains
  • Reduced numbers of platelets in the blood causing bleeding and bruising
  • Loss of red blood cells causing tiredness
  • Moderate kidney problems with increased creatinine show in tests
  • The excipient benzyl alcohol may cause hypersensitivity reactions.

Very rare (may affect less than 1 in 10,000 people):

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

Not known (frequency cannot be estimated from the available data):

Sudden inflammation of the pancreas (pancreatitis (acute)); confusion (delirium); increase in pressure inside the skull, accompanied by headache, feeling sick and vomiting; back pain; 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)

  • Hypothyroidism (underactive thyroid) – you may feel extremely tired, weak or ‘run-down’ and experience weight gain, constipation and aching muscles. You may be unable to cope with low temperatures.

Effects on the heart and circulation

Effects on the lungs

  • Difficulty breathing
  • Non-productive cough
  • Wheezing and breathing difficulties in patients with asthma

Effects on the liver

  • Cirrhosis (a type of chronic liver disease) causing bruising and bleeding
  • Hepatitis and jaundice causing a yellow colour to the whites of your eyes and your skin
  • An enlarged liver causing jaundice

Effects on the thyroid gland

  • An overactive thyroid gland (thyrotoxicosis) causing weight loss, a rapid heart rate, shaking, sweating and an enlarged thyroid gland at the front of the neck

Effects on nerves and muscles

  • Nightmares
  • Vertigo
  • Sleeplessness
  • A lack of co-ordination

Effects on eyes:

  • Blurred vision or seeing a coloured halo in dazzling light

Effects on the skin:

  • Sensitivity to sunlight (photosensitivity) causing skin discolouration, rash, tingling, burning, redness when exposed to sun and blistering of the skin, when severe. Avoid exposing your skin to the sun or to sun-lamps after receiving this injection, cover the skin and use high factor sun cream.

Other effects:

  • Being sick
  • A metallic taste in the mouth.
  • Impotence
  • Pain, redness and swelling of the testicles
  • Hair loss
  • Tiredness

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: 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 Amiodarone Injection

Keep this medicine out of the sight and reach of children .

  • Your doctor or pharmacist is responsible for storing Amiodarone Injection. They are also responsible for disposing of any unused Amiodarone Injection correctly
  • You should not be given Amiodarone Injection after the expiry date (EXP) which is stated on the outer packaging. The expiry date refers to the last day of that month. Your doctor or nurse will check that the date has not passed before giving this medicine to you
  • This medicine will be stored below 25°C in the original container. Only clear solutions free of particles should be used
  • Reconstituted/diluted solution should be used immediately.
  • For single use only. Discard any unused product.

6. Contents of the pack and other information

What Amiodarone Injection contains

  • Each 10ml pre-filled syringe contains 300mg of the active substance, amiodarone hydrochloride
  • The other ingredients are benzyl alcohol, polysorbate 80 and water for injections

What Amiodarone Injection looks like and contents of the pack

  • Amiodarone Injection is a clear, pale yellow solution and is available as a single 10ml pre-filled syringe.

Marketing Authorisation Holder:

Aurum Pharmaceuticals Limited
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
UK

Manufacturers:

Agila Specialties Polska Sp.z.o.o.
10 Daniszewska St.
03-230 Warsaw
Poland

or

Agila Specialities Private Limited
Opp lim
Bilekahalli
Bannerghatta Road
Bangalore
IN-560076
India

Product Licence Number: PL 12064/0047

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 or contact Medical Information at the above address.

This leaflet was last revised in October 2019

MARTINDALE PHARMA
Bampton Road
Harold Hill
Romford
RM3 8UG
UK

D04266