Download Patient Information Leaflet: Amiodarone Injection Minijet, 30 mg /ml

Patient Information Leaflet:
Amiodarone Injection Minijet, 30 mg /ml Solution for Injection,
Amiodarone hydrochloride
Read all of this leaflet carefully before you are given this medicine.
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Keep this leaflet. You may need to read it again
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If you have any further questions, ask your doctor or nurse
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This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours
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In this leaflet, Amiodarone Injection Minijet 30 mg/ml Solution for Injection will be called
Amiodarone Injection.
In this leaflet:
1.
What Amiodarone Injection is for
2.
Before you are given Amiodarone Injection
3.
How Amiodarone Injection will be given to you
4.
Possible side effects
5.
How to store Amiodarone Injection
6.
Further information.
What Amiodarone Injection is for
1.
Amiodarone Injection belongs to a group of medicines called antiarrhythmics. These work by
controlling a very irregular or fast heart rate (tachyarrhythmias). Amiodarone Injection is used in
emergency situations to treat:
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Different types of fast, irregular heartbeat when other medicines do not work or cannot be used
Fast, irregular heartbeat seen in a condition called Wolff-Parkinson-White Syndrome.
These severe arrythmias can be life- threatening and if left untreated, can lead to death.
Amiodarone Injection is used in emergency situations and will be given to you by a doctor or specialist
in the intensive care department of a hospital. As soon as your heartbeat improves your doctor will phase
out Amiodarone Injection and switch you to tablets.
2.
Before you are given Amiodarone Injection
You must not be given Amiodarone Injection if:
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You are allergic to the active ingredient amiodarone hydrochloride
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You are allergic to Iodine or any of the other ingredients of Amiodarone Injection (listed in
section 6)
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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
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You have heart failure or weakness of the heart muscle (cardiomyopathy)
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You have or have had thyroid problems
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You have severe breathing problems
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You have very low blood pressure
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You are taking other medicines that can make your heartbeat very quickly (these are listed in
below under the section 'Taking other medicines'
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You are pregnant, think you may be pregnant or are breastfeeding (unless treatment is considered
absolutely essential by your doctor)
If any of the above applies to you, do not use this medicine and talk to your doctor or nurse.
Amiodarone Injection must not be given to premature babies or neonates.
Check with your doctor before you are given Amiodarone Injection if:
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You have mild to moderate low blood pressure
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You have been drinking a lot of alcohol
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You are receiving high dose oxygen therapy
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You are due to have an operation involving general anaesthesia
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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:
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Medicines to treat irregular heart rhythms (anti-arrhythmics), such as quinidine, procainamide,
disopyramide and sotalol
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Antibiotic injections, such as erythromycin, co-trimoxazole and pentamidine
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Medicines to treat mental illness (anti-psychotics), such as chlorpromazine, thioridazine,
haloperidol and pimozide
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Medicines to treat depression, such as lithium and tricyclic antidepressants, including doxepin,
maprotiline and amitriptyline
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Certain medicines to treat allergic reactions (antihistamines), such as terfenadine, astemizole
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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 you should tell your doctor about:
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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
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Stimulant laxatives such as bisacodyl and senna, medicines called diuretics or water tablets,
steroids and the antifungal medicine amphotericin. These can cause low levels of potassium in the
blood, which can increase the risk of getting a fast heart rate (tachycardia).
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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
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Medicines that can either be affected by or effect the level of amiodarone in the body if taken at
the same time:
o Cyclosporin, tacrolimus (immunosuppressants)
o Flecainide, used to treat irregular heart rhythms
o Simvastatin and 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
o Lidocaine (a local anaesthetic)
o Sildenafil (used for erectile dysfunction)
o Fentanyl (used for pain relief)
o Midazolam (a sedative)
o Ergotamine (for migraine)
o Beta-blockers, such as metoptolol, sotalol and bretylium
o Calcium channel blockers diltiazem and verapamil, used to treat high blood pressure
o Indinavir (an anti-viral drug)
o Cimetidine (an anti-ulcer drug)
o Clarithromycin (an antibiotic)
o Ketoconazole and itraconazole
o (antifungal drugs)
o Dextromethorphan (cough medicine).
Tell your doctor if you are taking any other medicine, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor or nurse.
Amiodarone Injection will not be given to you if you are pregnant unless treatment is considered
absolutely essential by your doctor.
Do not breastfeed whilst you are being treated with Amiodarone Injection.
Warnings about some of the ingredients in Amiodarone Injection
Amiodarone Injection contains the ingredient benzyl alcohol (preservative). Benzyl alcohol can cause
toxic and allergic reactions in infants and children up to 3 years old.
3.
How Amiodarone Injection will be given to you
Important:
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Amiodarone Injection will be given to you by a doctor or specialist in hospital
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Your doctor will choose the dose that is right for you
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Your doctor will check how your thyroid is working before giving you Amiodarone
Injection.
Remember: This medicine can cause skin problems when exposed to sunlight. Avoid exposing your skin
to the sun or to sun-lamps after receiving this injection, cover your skin and use high factor sun cream.
Amiodarone Injection is diluted in a sugar (5% dextrose) solution and given by a slow intravenous
infusion (drip or catheter - types of tubes into a vein) into the bloodstream.
Adults, the elderly and children over 3 years
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The recommended dose is 5 mg for every kg of bodyweight. This is given by intravenous infusion
over a period of 20 minutes to 2 hours
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This may be followed by further infusions up to 1200 mg (approximately 15mg/kg bodyweight)
over 24 hours
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In extreme cases of emergency Amiodarone Injection may be given as a slow injection at an initial
dose of 5 mg for every kilogram of body weight. This is given over a minimum of 3 minutes. It
should not be repeated for at least 15 minutes after the initial dose
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If you are elderly you may be given a lower dose.
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There are only limited data on the efficacy and safety in children and adolescents. Your doctor
will decide on an appropriate dose.
This medicine is not for use in premature babies or neonates.
Medical check-ups
While you are given this medicine, your doctor will continuously check your blood pressure, heartbeat
and heart rate.
They may also carry out blood tests to check how your thyroid and liver are working, chest X-rays and
eye examinations.
These tests are to make sure that your medicine is working properly and that the dose you are given is
right for you.
If you are given more Amiodarone Injection than you should
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too
little or too much.
Too much Amiodarone Injection can cause your heart to beat very slowly. Tell your doctor or nurse if
you have any concerns.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4.
Possible side effects
Like all medicines Amiodarone Injection can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
Severe allergic reactions causing:
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Swelling of hands, feet, lips, mouth, tongue or throat
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Difficulties in breathing
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Itchy skin rash (hives)
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Diarrhoea
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Stomach pains.
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Excessive thyroid activity (hyperthyroidism) causing:
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Weight loss
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Weakness
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Restlessness
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Increased heart rate
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Irregular heart beat
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Angina
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Heart failure.
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Rhabdomyolysis (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
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Other side effects you may get:
Common (may affect up to 1 in 10 people):
Itchy, red rash (eczema)
Very rare (affects less than 1 in 10,000 people):
Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could
be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion’ (SIADH)
Not known (frequency cannot be estimated from the available data):
Sudden inflammation of the pancreas (pancreatitis (acute)); confusion (delirium); life-threatening skin
reactions characterised by rash, blisters, peeling skin and pain (toxic epidermal necrolysis (TEN),
Stevens-Johnson syndrome (SJS), bullous dermatitis, Drug reaction with eosinophilia and systematic
symptoms (DRESS)).
Effects on the heart and circulation
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Slow or irregular heartbeat
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Abnormal heart rhythm leading to heart attack
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Heart block that can lead to slow heart rate
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Low blood pressure which can make you feel dizzy or faint
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Reduced heartbeat, which may lead to shock
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Inflammation of blood vessels (vasculitis) seen as weight loss, fever and aches and pains
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Reduced numbers of platelets in the blood causing bleeding and bruising
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Loss of red blood cells causing tiredness.
Effects on the lungs
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Hypersensitivity pneumonitis, alveolar/interstitial pneumonia or fibrosis, pleuritis, bronchiolitis
obliterans organising pneumonia, pulmonary haemorrhage, respiratory distress syndrome (severe
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fluid build-up in the lungs) causing:
Fever
Chest pains
Difficulty breathing.
Wheezing and breathing difficulties in patients with asthma.
Effects on the liver
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Cirrhosis causing bruising and bleeding
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Hepatitis and jaundice causing a yellow colour to the whites of your eyes and your skin
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Increased liver enzymes which can show up in tests
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An enlarged liver causing jaundice.
Effects on the thyroid gland
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Decreased thyroid activity and hypothyroidism causing weight gain, tiredness, aches and pains
and a slow heart beat
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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
Nerve disease (neuropathy) causing burning, numbness and pins and needles
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Muscle disease (myopathy) causing tiredness, weakness and muscle pain
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Nightmares
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Vertigo
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Headache
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Sleeplessness
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Tiredness
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Tingling
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Shaking
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A lack of co-ordination.
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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.
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Other effects:
Pain and irritation at the site of the injection
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Hot flushes, sweating and feeling sick if Amiodarone Injection is given too quickly
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Increased pressure in the skull (raised intracranial hypertension)
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Being sick
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A metallic taste in the mouth
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Impotence
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Pain, redness and swelling of the testicles
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Hair loss
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Moderate kidney problems with increased creatinine show in tests.
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Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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. By reporting side effects you can help provide more information on the
safety of this medicine.
5.
How to store Amiodarone Injection
Keep out of the reach and sight of children.
Do not use Amiodarone Injection after the expiry date on the carton and syringe label. The expiry date
refers to the last day of that month. Do not store above 25°C. Keep the syringe in the outer carton to
protect from light. Your doctor or nurse will make sure your medicine is correctly stored and disposed
of.
6.
Further information
What Amiodarone Injection contains
The active substance is amiodarone hydrochloride. There are 30 mg of amiodarone hydrochloride in
each 1 ml of solution.
The other ingredients are benzyl alcohol, polysorbate 80 and water for injections.
What Amiodarone Injection looks like
Amiodarone Injection is a sterile solution for injection in a clear glass syringe. The syringe contains 10
ml of solution. There is one syringe in each carton.
Marketing Authorisation Holder
International Medication Systems (UK) Ltd
21 St Thomas Street, Bristol,
BS1 6JS, UK
Manufacturer
UCB Pharma Ltd.
208 Bath Road, Slough, Berkshire,
SL1 3WE, UK.
This leaflet was last updated August 2016.
If this leaflet is difficult to see or read or you would like it in a different format, please contact International
Medication Systems (UK) Ltd., 21 St Thomas Street, Bristol, BS1 6JS, UK