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hiijdrocriloride 50 mg/ml -sterile concentrate

AMIODARONE HYDROCHLORIDE

PACKAGE LEAFLET: INFORMATION FOR THE USER

In this leaflet :

1.    What Amiodarone Hydrochloride 50 mg/ml sterile concentrate is and what it is used for

2.    Before Amiodarone Hydrochloride 50 mg/ml sterile concentrate is given

3.    How Amiodarone Hydrochloride 50 mg/ml sterile concentrate is given

4.    Possible side effects

5.    How to store Amiodarone Hydrochloride 50 mg/ml sterile concentrate

6.    Further information

1. WHAT AMIODARONE HYDROCHLORIDE 50 MG/ML STERILE CONCENTRATE IS AND WHAT IT IS USED FOR

Amiodarone Hydrochloride 50 mg/ml is an anti-arrhythmic drug used to control an irregular or rapid heart rate. Treatment should be initiated and normally monitored only under hospital or specialist supervision.

2. BEFORE AMIODARONE HYDROCHLORIDE 50 MG/ML STERILE CONCENTRATE IS GIVEN

Amiodarone Hydrochloride 50 mg/ml should not be given to you if

•    you have heart block- which may cause a very slow, very fast or irregular pulse, or dizziness

•you have or have had thyroid problems

•you have severe respiratory failure or very low blood pressure

•    it is being given as a single injection and you have low blood pressure, heart failure or cardiomyopathy (weakness of the heart muscle)

•    you have an allergy to amiodarone, iodine or any of the other ingredients

•    you are pregnant or likely to become pregnant. You should talk to your doctor regarding this.

•you are breast-feeding

•    you are taking certain other drugs including some other heart drugs (e.g.sotalol), anti-arrhythmics (such as quinidine), moxifloxacin and other antibiotics, antipsychotics, antidepressants (including lithium), antihistamines, antimalarials, anti-infectives or stimulant laxatives.

You must inform your doctor if you are taking any of these medications.

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

Amiodarone Hydrochloride 50 mg/ml should be given with care if

•    it is being given as an infusion and you have low blood pressure, severe heart failure or severe cardiomyopathy (weakness of the heart muscle)

•    you are going to have an anaesthetic or high dose oxygen therapy •you are asthmatic.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine - even those which your doctor has not prescribed for you, but which you have bought yourself from your chemist/pharmacy.

Before using Amiodarone Hydrochloride 50 mg/ml please check with your doctor if you are taking any of the following, in addition to the drugs listed in section 2.

'Before Amiodarone Hydrochloride 50 mg/ml is given', Amiodarone Hydrochloride 50 mg/ml should not be given to you if you are taking any of the following medicines:

•    digoxin

•    anticoagulants - used to thin the blood (e.g. warfarin)

•    phenytoin

•    some calcium channel inhibitors - used to treat high blood pressure and angina (e.g. verapamil, diltiazem)

•    ciclosporin - used after transplant operations

•    flecainide

•    fluoroquinolones e.g. ciprofloxacin

•    beta blockers e.g. atenolol

•    stimulant laxatives e.g. senna

•    lidocaine •tacrolimus

•    sildenafil

•    fentanyl

•    midazolam

•    ergotamine

•    simvastatin or other statins (used to lower cholesterol levels)

•    drugs which may change the levels of potassium or magnesium in your blood e.g. diuretics (water tablets), steroid tablets or the antifungal amphotericin (when given directly into a vein).

Taking Amiodarone Hydrochloride 50 mg/ml with food and drink

Grapefruit juice can increase the blood level of Amiodarone Hydrochloride 50 mg/ml and should be avoided during treatment with Amiodarone Hydrochloride 50 mg/ml.

Pregnancy and breast-feeding

Your doctor will prescribe Amiodarone Hydrochloride 50 mg/ml only if they consider the benefit of treatment outweighs the risks during your pregnancy.

You should not be given Amiodarone Hydrochloride 50 mg/ml if you are breast-feeding.

Important information about some of the ingredients of Amiodarone Hydrochloride 50 mg/ml

This product contains benzylalcohol (20 mg/ml) as a preservative. It may cause toxic reactions and allergic reactions in infants and children up to 3 years old.

3.    HOW AMIODARONE HYDROCHLORIDE 50 MG/ML IS GIVEN

Amiodarone Hydrochloride 50 mg/ml is given directly into the blood stream using a drip (or central line). It should not be given too rapidly. This medicine is given diluted in a sugar (5% dextrose) solution. The usual dose of Amiodarone Hydrochloride 50 mg/ml is 5 mg for every kg body weight given over 20 minutes to 2 hours. This may then be followed by further infusions up to 1200 mg in 24 hours. The correct dose and dilution for you will have been decided by the doctor and will depend upon your condition. Children and the elderly may be prescribed lower doses.

IV injection may be given at an initial dose at 5 mg for every kg body weight. This dose should be given over a minimum of 3 minutes and should not be repeated less than 15 minutes after initial dose.

This dose regimen may be considered only in exceptional circumstances and emergencies.

If you think that you may have been given too much Amiodarone Hydrochloride, please inform the doctor or nurse.

Children and adolescents

There are only limited data on the efficacy and safety in children. Your doctor will decide on an appropriate dose.

4.    POSSIBLE SIDE EFFECTS_

Like all medicines, Amiodarone Hydrochloride 50 mg/ml can have side-effects.

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Heart and blood vessels

•    a slow pulse

•    a decrease in blood pressure Skin

•    local injection site reactions including swelling, pain, redness, infection and pigmentation changes

Other side-effects, which are very rare (reported in less than 1 in 100,000 people), are:

Heart and blood vessels

•    chest pain or palpitations, or abnormal heart rhythm

•    hot flushes

Digestive system

•    nausea

Bones

•    bone marrow granuloma (abnormal growth of cells in bone marrow) Liver

•    liver disorders including jaundice (yellowing of the eyes or skin)

Body as a whole (immune system)

•    generalised allergic reactions such as swelling of the face, lips and/or tongue, shortness of breath, headaches

Respiratory system

•    breathing difficulties (with or without fever), inability to breathe Skin

•    skin rash

•    sweating

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

5. HOW TO STORE AMIODARONE HYDROCHLORIDE 50 MG/ML

Keep out of the reach and sight of children.

Do not store above 30°C.

For single use only. Please discard any unused solution.

Do not use Amiodarone Hydrochloride 50 mg/ml after the expiry date which is stated on the ampoules and outer carton after EXP The expiry date refers to the last day of that month.

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.

6. FURTHER INFORMATION_

What Amiodarone Hydrochloride 50 mg/ml contains

The active substance is Amiodarone Hydrochloride. Each 3 ml ampoule contains 150 mg Amiodarone hydrochloride.

The other ingredients are Benzyl alcohol, Polysorbate 80 and Water for Injections.

What Amiodarone Hydrochloride 50 mg/ml looks like and contents of the pack

Amiodarone Hydrochloride 50 mg/ml is a clear solution.

It is supplied in boxes of 5 or 10 ampoules.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is: STRAGEN UK Ltd

CASTLE COURT 41 LONDON ROAD REIGATE SURREY RH2 9RJ

The Manufacturer is: FISIOPHARMA S.r.l.

NUCLEO INDUSTRIALE 84020 - PALOMONTE (SA) ITALY

This leaflet was last approved in 06/2011.

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY

Iodine content: One ampoule contains 56 mg iodine For single use only.

Discard any unused solution.

The dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.

Amiodarone should be administered in 5% dextrose solution only. Amiodarone must not be mixed with other medicinal products in the same syringe.

Solutions containing less than 300 mg amiodarone (2 ampoules) in 500 ml of dextrose are not stable and must not be used. Do not mix any other compounds with amiodarone infusion solution.

The standard recommended dose is 5 mg/kg bodyweight given by intravenous infusion over a period of 20 minutes to 2 hours. This should be administered as a dilute solution in 250 ml 5% dextrose. This may be followed by repeat infusion up to 1200 mg (approximately 15 mg/kg bodyweight) in up to 500 ml 5% dextrose per 24 hours, the rate of infusion being adjusted on the basis of clinical response.

In an extreme clinical emergency the drug may, at the discretion of the clinician, be given as a slow injection of 150-300 mg in 10-20 ml 5% dextrose over a minimum of 3 minutes. This should not be repeated for at least 15 minutes. Patients treated in this way with Amiodarone Hydrochloride must be closely monitored, e.g. in an intensive care unit.

Changeover from Intravenous to Oral Therapy

As soon as an adequate response has been obtained, oral therapy should be initiated concomitantly at the usual loading dose (200 mg three times a day). Amiodarone Hydrochloride should then be phased out gradually.

Paediatric population

The safety and efficacy of amiodarone in children has not been established.

Currently available data are described in sections 5.1 and 5.2 of the Summary of Product Characteristics

Due to the presence of benzyl alcohol, amiodarone intravenous administration is contraindicated 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. Whilst there is no evidence that dosage requirements are different for this group of patients they may be more susceptible to bradycardia and conduction defects if too high a dose is employed. Particular attention should be paid to monitoring thyroid function.

Cardiopulmonary resuscitation

The recommended dose for ventricular fibrillations/pulseless ventricular tachycardia resistant to defibrillation is 300 mg (or 5 mg/kg body-weight) diluted in 20 ml 5% dextrose and rapidly injected. An additional 150 mg (or 2.5 mg/kg body-weight) IV dose may be considered if ventricular fibrillation persists.