Consumer Information for: SANDOZ AMIODARONE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Treatment of certain abnormal heart rhythms (arrhythmias).

What it does

Sandoz Amiodarone has been prescribed to you by your doctor to restore or maintain a normal heart rhythm.

When it should not be used
  • Do not use Sandoz Amiodarone if you are allergic to it or to any of the components of its formulation (see full list of components below). Contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
  • Do not use Sandoz Amiodarone if you have hepatitis, thyroid problems, or pulmonary disease (certain lung problems).
What the medicinal ingredient is

Sandoz Amiodarone is available in tablets containing 200 mg amiodarone hydrochloride as the active ingredient.

What the non-medicinal ingredients are

The non-medicinal ingredients in Sandoz Amiodarone are: anhydrous colloidal silica, cornstarch, erythrosine, lactose, magnesium stearate and polyvidone.

What dosage form it comes in

Sandoz Amiodarone (amiodarone hydrochloride tablets, BP) 200 mg is available as an oral tablet

Warnings and precautions

Serious Warnings and Precautions

  • Sandoz Amiodarone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.
  • Pulmonary fibrosis (permanent scarring of the lungs) can occur and can be fatal
  • Like other antiarrhythmics, Sandoz Amiodarone can worsen or start an irregular heartbeat (arrhythmias).
  • Liver injury is common with Sandoz Amiodarone, but is usually mild, however it can be serious and even fatal in some cases.

BEFORE you use Sandoz Amiodarone talk to your doctor if:

  • you have hepatitis, thyroid problems or lung abnormalities
  • you are breast feeding, pregnant or planning on becoming pregnant,
  • you anticipate undergoing any surgery
  • you have any allergies to this drug or its ingredients or components of the container,
  • you are taking any medications (see INTERACTIONS WITH THIS MEDICATION).

Precautions when taking Sandoz Amiodarone
Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted:

  • Sandoz Amiodarone may cause a worsening of the existing arrhythmias or precipitate a new arrhythmia
  • Both hyper- and hypothyroidism (too much or too little thyroid hormone released into the blood by the thyroid gland) may occur during, or soon after treatment with Sandoz Amiodarone.
  • One of the most serious complications is pulmonary (lung) toxicity, characterized by scarring or inflammation of the lungs. Clinical symptoms include cough, progressive shortness of breath, accompanied by weight loss and weakness
  • Sandoz Amiodarone induces photosensitization in about 10% of patients. Sunscreen preparations or protective clothing may afford some protection to individual patients experiencing photosensitization. Blue-grey discoloration of exposed skin has been reported during long-term treatment. With discontinuation of therapy, the pigmentation fades slowly over a period of up to several years. The risk may be increased in patients of fair complexion or those with excessive sun exposure, and may be related to cumulative dose and duration of therapy.
  • Loss of vision or other visual disturbances such as visual halos or blurred vision.
  • Symptoms of nerve damage (peripheral neuropathy) such as pain, burning, or numbness.
  • Progressive skin rash, often with blisters or lesions, which may lead to severe skin reactions that are sometimes fatal.
Interactions with this medication

You should ensure that your doctor and pharmacist know all the medicines you are taking, prescription, non-prescription or herbal.

Drugs that may interact with Sandoz Amiodarone include:
Azoles, Cholestyramine, Beta blockers (e.g., propranolol), Calcium channel antagonists (e.g., verapamil), Cholesterollowering medications (e.g., simvastatin, atorvastatin), Cimetidine, Cyclosporine, Dabigatran, Digitalis, Digoxin, Disopyramide, Fentanyl, Flecainide, Fluoroquinolones, Lidocaine, Macrolide Antibiotics, Phenytoin, Procainamide, Protease inhibitors (e.g., indinavir), Quinidine, Warfarin.

Grapefruit Juice and the herbal preparation St. John’s Wort may also interact with Sandoz Amiodarone.

Proper use of this medication

Usual Adult Dose

  • It is very important that you take Sandoz Amiodarone exactly as your doctor has instructed.
  • Never increase or decrease the amount of Sandoz Amiodarone you are taking unless your doctor tells you to.
  • Loading Dose: normally 800 to 1600 mg/day for 1 to 3 weeks (occasionally longer). Maintenance Dose: normally 600 to 800 mg/day for one month and then 200 to 400 mg/day (occasionally 600 mg/day). Sandoz Amiodarone may be taken as a single daily dose, or in patients with severe gastrointestinal intolerance, as a twice a day dose

Overdose

What to do in case of overdose

In case of drug overdose, contact a health care practitioner, the nearest hospital emergency department or the regional Poison Centre immediately, even if there are no symptoms.

Missed Dose

If you happen to miss a dose, do not try to make up for it by doubling up on the dose next time. Just take your next regularly scheduled dose and try not to miss any more.

Side effects and what to do about them

You may experience side effects with the use of Sandoz Amiodarone.

North American experience with chronic oral Sandoz Amiodarone therapy suggest that amiodarone-associated adverse drug reactions are very common, having occurred in approximately 75% of patients taking 400 mg or more per day. The most serious adverse effects associated with the use of Sandoz Amiodarone involve your lungs, irregularities of your heart beat and hepatitis. Symptoms that suggest side effects relating to lung inflammation or scarring include: progressive shortness of breath, cough, weakness and weight loss. Symptoms that may suggest an irregularity of heart beat include: fainting, dizziness, light-headedness, weakness and chest pain.

Your doctor should monitor your blood for liver function. The following symptoms may be signs of liver problems: prolonged nausea and vomiting, abdominal pain or discolouration of the skin.

Other symptoms causing discontinuations less often have included disturbances of vision, reactions of the skin to sunlight, blue skin discoloration, life-threatening or even fatal skin reactions, eczema, hyperthyroidism and hypothyroidism.

Hypotension (low blood pressure), while seen, is uncommon (less than 1%) during Sandoz Amiodarone tablets therapy.

Chronic (i.e., long-term) administration of Sandoz Amiodarone tablets in rare instances may lead to the development of nerve damage (peripheral neuropathy) that may resolve when Sandoz Amiodarone is discontinued, but this resolution has been slow and incomplete (see “Precautions when taking Sandoz Amiodarone”).

Should you experience any of these while taking Sandoz Amiodarone, consult your doctor immediately.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
Tremor/abnormal involuntary movements, lack of coordination, abnormal gait, dizziness   ✔
Blue skin discolouration   ✔
Severe skin reactions (e.g. progressive skin rash with blisters) or allergic reaction (e.g. swelling of the lips, face, tongue and throat, trouble breathing)   ✔
Low blood pressure (fainting episodes, severe dizziness)   ✔
Shortness of breath, chest pain, irregular heart beat, racing heart ✔  
Bleeding abnormalities (excessive bruising, easy bleeding (e.g., when brushing teeth) ✔  
Visual disturbances (halos or blurred vision), visual impairment ✔  
Vomiting, abdominal pain, diarrhea ✔  
Solar dermatitis/ photosensitivity (skin becomes sensitive to light) ✔  
Paresthesias (sensation of tingling, burning, crawling of the skin) and Peripheral motor and sensory neuropathies (e.g., muscular weakness) ✔  
Cognitive disturbances (e.g., confusion, inability to concentrate) ✔  
Liver problems (e.g., yellowing skin or eyes, abdominal pain or vomiting) ✔  
Alopecia (loss of hair) ✔  

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Amiodarone, contact your doctor or pharmacist.

How to store
  • Store between 15° and 30°C.
  • Protect from light.
  • Keep out of reach of children
Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document, plus the full Product Monograph prepared for health professionals, can be obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062
or
by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8

or by e-mail at : medinfo@sandoz.com

This leaflet was prepared by Sandoz Canada Inc.

Last revised: June 1, 2016

REMINDER: This medicine has been prescribed only for you. Do not give it to anybody else. If you have any further questions, please ask your doctor or pharmacist.

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