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The product code for this leaflet is: PL 03265/0076

 

Amiodarone Injection Minijet 30mg/ml

Company Details

International Medication Systems (UK) Ltd


208 Bath RoadSloughBerkshireSL1 3WE
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AMIODARONE INJECTION MINIJET® 30mg/ml

Solution for Injection (300mg in 10ml)

6913811E/5-07

Patient Information Leaflet

Read all of this leaflet carefully

Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or nurse. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

  • 1. What Amiodarone Injection Minijet is and what it is used for
  • 2. Before you are given Amiodarone Injection Minijet
  • 3. How Amiodarone Injection Minijet is used
  • 4. Possible side effects
  • 5. Storing Amiodarone Injection Minijet
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Marketing Authorisation Holder:

International Medication Systems (UK) Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
UK
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Manufacturer:

Ashton Pharmaceuticals Ltd
Vale of Bardsley
Ashton-under-Lyne
OL7 9RR
UK
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1. What Amiodarone Injection Minijet is and what it is used for

The name of your medicine is Amiodarone Injection Minijet. It is a sterile solution for injection.

It contains 30 milligrams (mg) amiodarone hydrochloride as the active ingredient in every millilitre (ml). It also contains benzyl alcohol, polysorbate 80 and water for injections. The 10ml vial contains 300mg of amiodarone hydrochloride.

It is used in emergencies when the heartbeat is very irregular or very fast.

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2. Before you are given Amiodarone Injection Minijet

Before being given Amiodarone Injection Minijet your doctor will have decided it was absolutely vital that you had it. However, please tell your doctor if the answer to any of the following questions is YES, he or she may want to give you special advice or alter your treatment.

  • Do you have any heart condition causing a very slow heart rate (such as heart block or sinus bradycardia), any other heart condition or severe circulatory problem? Do you have very low blood pressure?
  • Do you have, or have you had any thyroid problems?
  • Do you suffer with severe breathing problems?
  • Are you pregnant, likely to become pregnant or breast feeding?
  • Are you allergic to any of the ingredients or iodine?
  • Is the patient under 3 years old? Children under 3 years should not be given this injection because it contains benzyl alcohol.
  • Are you taking any other drugs? See ‘Taking other medicines’ below.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed:

Are you taking any other medicines which may cause a disturbance to your heart beat rhythm (a condition called ‘torsades de pointes’) such as:

  • other medicines for heart rhythm e.g. quinidine, disopyramide, procainamide, sotalol, bretylium;
  • some antibiotic injections e.g. erythromycin, co-trimoxazole or pentamidine;
  • some medicines used for treatment of mental illness e.g. chlorpromazine, thioridazine, pimozide, haloperidol;
  • lithium and tricyclic antidepressants (e.g. doxepin, maprotiline, amitriptyline) ;
  • some antihistamines – used for allergies and hayfever (e.g. terfenadine, astemizole) or
  • anti-malarials - used to treat or prevent malaria (e.g. quinine, mefloquine, chloroquine, halofantrine).

In addition, please check with your doctor if you are taking or have recently taken any of the following:

  • anticoagulants used to thin the blood (e.g. warfarin);
  • digoxin or flecainide (for heart conditions);
  • phenytoin (most often taken for epilepsy);
  • beta blockers and some calcium channel blockers (e.g. diltiazem, verapamil) which are used to treat high blood pressure or angina;
  • laxatives, diuretics (water tablets), steroids, tetracosactrin (sometimes used in Crohn’s disease, arthritis, or bloodtests) or amphotericin injection (antifungal) – these medicines can cause changes in your potassium or magnesium levels;
  • ciclosporin, tacrolimus (used to suppress the immune system).
  • simvastatin or atorvastatin (used to lower cholesterol)
  • erythromycin, azithromycin, clarithromycin, spiramycin, rifampicin or telithromycin (antibiotic medicines used for infection);
  • clotirmazole, econazole, fenticonazole, sulconazole, tioconazole, ketoconazole, miconazole, fluconazole, itraconazole or voriconazole (antifungal medicines used for infection);
  • herbal medicines, e.g. St John’s Wort (used for depression)
  • any of the following medicines: lidocaine (local anaesthetics), sildenafil (used for erectile dysfunction), fentanyl (pain relief), midazolan (sedative) or ergotamine (for migraine);
  • indinavir (an antiviral medicine)
  • metroprolol (a medicine which reduces blood pressure)
  • dextromethorphan (a type of cough medicine).
  • Are you going to be given a general anaesthetic or require high oxygen treatment?

This medicine may increase the effect of alcohol on your liver, so you should limit the amount of alcohol you drink whilst being treated. When changing from intravenous to oral administration, grapefruit juice should also be avoided as it affects the levels of Amiodarone in the bloodstream.

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3. How much will I be given

The doctor will work out exactly how much you need. The following is for guidance. Initially you will have been given 5mg for every kg that you weigh. So, if you weigh 50kg you will be given 250mg. Amiodarone Injection Minijet is diluted in a sugar solution (dextrose) and given by an infusion into the bloodstream. It needs to be given slowly over at least 20 minutes. In extreme cases it may be given as a slow injection of 150-300mg over 3 minutes. Repeated infusions or injections may be given if necessary. It is likely that you will be in an intensive care unit so you will be monitored continuously.

If you think you have been given too much please tell the doctor.

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4. Possible side effects

Like all medicines, amiodarone can have side effects. You have probably been very unwell if you have been given this medicine.

When this medicine is given by infusion into a vein, it is possible that the vein may become swollen and uncomfortable, in which case your doctor may decide to give the next dose using a different vein.

If Amiodarone Injection Minijet has been given too quickly you may experience hot flushes, sweating or low blood pressure.

Amiodarone can cause some people to become sensitive to sunlight or cause skin discolouration or a rash. You should avoid exposing your skin to the sun or sun lamps after receiving this injection. You should take precautions when you are in the sun by wearing a wide brimmed hat, keeping arms and legs covered and using a total sun block cream on exposed skin.

Very occasionally Amiodarone Injection Minijet may cause one or more of the following side effects:

  • severe allergic reaction
  • anaphylactic shock
  • pulmonary toxicity (pneumonia, fibrosis, pleuritis, bronchitis, breathing difficulties, bronchospasm, non-productive cough, coughing up blood, fatigue, weight loss, fever)
  • slow or irregular heartbeat
  • cirrhosis, hepatitis, jaundice, increased liver enzymes, enlarged liver
  • excessive thyroid activity (weight loss, weakness, restlessness, increased heart rate, irregular heart beat, angina, heart failure)
  • decreased thyroid activity (weight gain, reduced activity, slow heart beat)
  • micro-deposits in the eyes, blurred or decreased vision
  • dermatitis and rashes
  • disease of the nerves or muscles
  • nightmares, vertigo, headaches, sleeplessness, tingling sensations
  • tremor, shaking
  • feeling or being sick, metallic taste
  • tiredness
  • impotence
  • pain, redness and swelling of the testicles
  • hair loss
  • hypersensitivity
  • inflammation of blood vessels
  • bruising of the skin
  • anaemia

If you experience any of these or notice any side effects not mentioned in this leaflet, please inform your doctor or nurse. Your doctor may also carry out tests such as blood tests, chest X-rays and eye examinations to monitor your condition.

This leaflet does not include all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

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5. Storing Amiodarone Injection

Keep out of the reach and sight of children.

Do not store above 25°C. Keep the vial in the outer carton, in order to protect from light.

This medicine should not be used after the expiry date stated on the carton.

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This leaflet only applies to Amiodarone Injection Minijet®

Leaflet prepared: August 2007


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