drug-medicine : amiodarone hydrochloride

PATIENT INFORMATION LEAFLET

This leaflet contains important information about your medicine; read it carefully.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Amiodarone Hydrochloride 50 mg/ml Sterile Concentrate

The active substance is amiodarone hydrochloride
The other ingredients are polysorbate 80, benzyl alcohol and Water for Injections

1. What Amiodarone Hydrochloride Sterile Concentrate is and what it is used for

Amiodarone Hydrochloride Sterile Concentrate is an antiarrhythmic medicine (used to control an irregular heart rhythm) in the form of a sterile concentrate which is used to prepare a solution for infusion (injection via a drip).

Each millilitre of Amiodarone Hydrochloride Sterile Concentrate contains 50 mg of amiodarone hydrochloride. It is presented in glass containers called ampoules. The 3 ml ampoule contains 150 mg of amiodarone hydrochloride and the 6 ml ampoule contains 300 mg of amiodarone hydrochloride. It is available in packs containing 10 x 3 ml or 10 x 6 ml ampoules.

Amiodarone hydrochloride is used to treat certain heart conditions, for example, when the heart is beating much too rapidly.

2. Before Amiodarone Hydrochloride Sterile Concentrate is used

Amiodarone Hydrochloride Sterile Concentrate should not be used:

if you have certain heart problems such as sinus bradycardia (very slow heart beat)
if you have or have previously had thyroid problems
if you have severe breathing problems
if you have severe blood circulation problems or very low blood pressure
if you have shown signs of hypersensitivity (severe allergy) to amiodarone hydrochloride or to iodine on previous occasions
if you are being treated with any other medicines which may cause a heart condition called Torsades de Pointes (heart rhythm disturbance), medicines include:
- other antiarrhythmic medicines e.g. quinidine, disopyramide, procainamide, sotalol, bretylium
- some antibiotic injections e.g. erythromycin, co-trimoxazole or pentamidine
- some medicines used to treat mental illness e.g. chlorpromazine, thioridazine, pimozide, haloperidol
- lithium and tricyclic antidepressants (e.g. doxepin, maprotiline, amitriptyline)
- some antihistamines - used to treat allergies and hayfever (e.g. terfenadine, astemizole)
- anti-malarials - used to treat or prevent malaria (e.g. quinine, mefloquine, chloroquine, halofantrine)
in children below 3 years of age
if you are pregnant
if you are breast-feeding

Special care will be taken:

if you have low blood pressure
if you are an elderly person
if you are to undergo a general anaesthetic
if you require oxygen treatment
if you are taking certain other medicines such as:
- anticoagulants - used to thin the blood (e.g. warfarin)
- digoxin (taken for heart problems)
- phenytoin (most often used to treat epilepsy)
- some medicines used to treat high blood pressure and angina (e.g. betablockers, verapamil, diltiazem)
- laxatives
- some diuretics (water tablets)
- steroids
- tetracosactrin (used in some blood tests or sometimes in the treatment of Crohn's disease)
- the antifungal amphotericin (when injected)
- the immune response suppressant cyclosporin

Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones you have bought yourself.

Do not drive or use machines:

if you feel drowsy
if you experience any other effect which may impair your ability to drive or use machines

Important information about one of the ingredients of Amiodarone Hydrochloride Sterile Concentrate

This medicine contains the preservative benzyl alcohol which should not be given to infants and children below 3 years of age.

During treatment with Amiodarone Hydrochloride Sterile Concentrate

You should limit the amount of alcohol you drink whilst being treated with this medicine

3. How Amiodarone Hydrochloride Sterile Concentrate is used

The dose of medicine given will depend upon your medical condition, your age and your bodyweight.

The standard recommended dose is 5 mg/kg bodyweight however this may vary depending upon your age and how well you respond to treatment.

This medicine will be diluted using 5% dextrose solution before it is given to you. It will be given slowly, usually via a drip into a vein in your arm or chest.

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, however tell your doctor or pharmacist if you have any concerns.

4. Possible side-effects

Like all medicines, amiodarone hydrochloride can have side-effects.

If any of the following happen, tell your doctor immediately or go to the casualty department at your nearest hospital:

breathing difficulties
chest pain
severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), you may feel you are going to faint and there may be inflammation of some of your blood vessels.

These are very serious side-effects. You may need urgent medical attention.

If you experience any of the following tell your doctor as soon as possible:

persistent cough
very slow heart beat (may lead to faintness)
loss of general health (fatigue, fever)
jaundice (yellowing of the skin)
weight loss, restlessness, increased heart rate (increased thyroid function)
weight gain, intolerance to the cold, mental dullness, reduced activity (reduced thyroid function)
blurring or difficulties with your eye sight
sensitivity to sunlight, with tingling and sometimes a burning sensation of the exposed skin. A bluish/grey colour to the skin may occasionally be seen
nightmares, vertigo, headaches, sleeplessness, pins and needles, unsteadiness, muscle weakness, tremor
nausea and vomiting
metallic taste
impotence
painful swelling of the testicles
loss of hair
hot flushes, sweating
your doctor will monitor some side effects by blood tests (e.g. liver enzymes, thyroid function, anaemia and reduced clotting factors).

If you notice any side-effect not mentioned in this leaflet, please tell your doctor or pharmacist

5. Storing Amiodarone Hydrochloride Sterile Concentrate

Keep out of the reach of children.

The ampoules should be stored below 25°C.

The ampoules should be stored in the outer carton to provide protection from light.

This medicine should not be used after the expiry date printed on the ampoule.