Patient Medication Information: uses, side effects, how to take - Amiodarone (Sivem Pharmaceuticals)
Serious warnings and precautions
AMIODARONE can cause serious and potentially life-threatening side effects, including serious issues with the:
- lungs,
- liver, and
- heart.
Because of these risks:
- only take AMIODARONE if your healthcare professional has prescribed it for you;
- you will begin your treatment in a hospital with experienced healthcare professionals; and
- your health will be closely monitor before, during, and after your treatment.
What AMIODARONE is used for:
AMIODARONE is used in adults to treat certain life-threatening abnormal heart rhythms (arrhythmias).
How AMIODARONE works:
AMIODARONE belongs to a group of medicines known as antiarrhythmic agents. It works by blocking certain channels in the heart. This helps to restore or maintain a normal heart rhythm.
The ingredients in AMIODARONE are:
Medicinal ingredient(s): amiodarone hydrochloride.
Non-medicinal ingredients: anhydrous colloidal silica, cornstarch, erythrosine, lactose, magnesium stearate, and polyvidone.
AMIODARONE comes in the following dosage form:
Tablets: 200 mg of amiodarone hydrochloride.
Do not use AMIODARONE if:
- you are allergic to amiodarone hydrochloride, iodine, or any of the other ingredients in AMIODARONE.
- you have hepatitis (inflammation of the liver).
- your thyroid is not working properly (thyroid dysfunction).
- you have problems with the tissue around the lungs (pulmonary interstitial abnormalities).
- you are experiencing cardiogenic shock (heart is not able to pump enough blood to the organs of the body).
you have any of the following heart problems:
- severe sinus-node dysfunction that causes bradycardia (heart’s natural pacemaker does not work properly, causing a low heart rate);
- second- or third-degree atrioventricular block (problem with the electrical signals in the heart, causing a delay or complete block in the heart's rhythm);
- episodes of bradycardia causing syncope (low heart rate episodes, causing fainting), unless a pacemaker is used to regulate the heart rate.
- you are undergoing radioactive iodine therapy to treat certain thyroid conditions.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AMIODARONE. Talk about any health conditions or problems you may have, including if you:
- have or have had any other heart problems.
- are planning to get a heart transplant or are waiting to get a heart transplant.
- have an implanted defibrillator or pacemaker for your heart.
- have previously received electrical defibrillations (electrical shock that helps the heart return to a normal rhythm).
- have liver problems (e.g., hepatitis).
- have bowel problems (e.g., severe diarrhea or diarrhea for long period of time).
- are planning to undergo any surgery or operation.
- are low in potassium (hypokalemia) or low in magnesium (hypomagnesemia).
- are on a diet that does not provide adequate dietary iodine.
- have or have had any thyroid problems.
- have a fair complexion (light skin).
- are planning to be spend a lot of time in the sun.
- are elderly.
are breast-feeding or plan to breast-feed. AMIODARONE can pass into the breast milk.
- are pregnant or plan to become pregnant. If you become pregnant while taking AMIODARONE, tell your healthcare professional right away to discuss the risks for you and your baby.
- are planning to get laser eye surgery.
- are planning to get an urinary or reproductive system exam.
Other warnings you should know about:
- Protecting your skin: AMIODARONE can make your skin more sensitive to sunlight (increased photosensitivity). You are at a higher risk if you have fair skin or are exposed to a lot of sunlight. To help protect your skin, it is important to use sunscreen and wear protective clothing. If you notice your skin turning a blue-grey colour, this will usually fade slowly over several years after stopping your treatment.
Testing and check-ups: Your healthcare professional will monitor and assess your health before, during, and after your treatment with AMIODARONE. This includes monitoring the following:
- your heart (e.g., heart rhythm, heartbeats, and its electrical system);
- your thyroid gland;
- your liver;
- your electrolyte levels (e.g., potassium, magnesium, etc.);
- your breathing and lungs; and
- your eye vision.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AMIODARONE:
- anticoagulants, medicines used to thin the blood or prevent blood clots (e.g., warfarin, clopidogrel, and dabigatran).
- azoles, medicines used to treat fungal infections.
- antiarrhythmics, medicines used to treat irregular heartbeat (e.g., flecainide, quinidine, disopyramide, and procainamide).
- antibiotics, medicines used to treat bacterial infections (e.g., fluoroquinolones and rifampin).
- antihistamines, medicines used to prevent and treat allergy symptoms (e.g., loratadine).
- antivirals, medicines used to treat Hepatitis C (e.g., sofosbuvir, daclatasvir, simeprevir, and ledipasvir).
- beta-blockers, medicines used to lower blood pressure (e.g., propranolol).
- calcium channel blockers, medicines used to lower blood pressure (e.g., verapamil and diltiazem).
- cimetidine, a medicine used to treat stomach ulcers.
- cyclosporine, a medicine used to help prevent organ rejection.
- dextromethorphan, a medicine used to relieve coughing.
- digoxin and digitalis, medicines used to treat heart failure.
- fentanyl, a medicine used to treat pain.
grapefruit juice.
- lidocaine, a medicine used as a local anesthetic.
- medicines used to lower high cholesterol (e.g., cholestyramine, simvastatin and atorvastatin).
- medicines used to treat depression (e.g., trazodone and St. John’s Wort).
- methotrexate, a medicine used to treat cancer and arthritis.
- phenytoin, a medicine used to treat convulsions or seizures.
- protease inhibitors, medicines used to treat HIV infections (e.g., indinavir).
- Stimulating laxative agents, medicines used to treat constipation.
How to take AMIODARONE:
- Take AMIODARONE exactly as directed by your healthcare professional. At the start, it will be administered by experienced healthcare professionals in a hospital.
- Make sure to take AMIODARONE at the same time with regard to your meals (e.g., at the same time before, during, or after your meal).
- Avoid grapefruit and grapefruit juice while taking AMIODARONE.
Usual dose:
Your healthcare professional will determine the right dose of AMIODARONE for you. This will depend on your age, health, if you take other medication, and how you react to AMIODARONE. Your healthcare professional may also adjust your dose to ensure that the lowest effective dose is prescribed.
Do NOT increase or decrease your dose unless your healthcare professional tells you to. This can cause serious unwanted side effects.
Overdose:
If you think you, or a person you are caring for, have taken too much AMIODARONE, contact a healthcare professional, hospital emergency department, regional poison control centre, or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669), immediately, even if there are no symptoms.
Missed dose:
If you miss a dose of AMIODARONE, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do NOT take two doses to make up for the missed dose.
Possible side effects from using AMIODARONE:
These are not all the possible side effects you may have when taking AMIODARONE. If you experience any side effects not listed here, tell your healthcare professional.
The side effects of AMIODARONE may include:
- hair loss,
- low sex drive,
- difficulty sleeping,
- headache,
- ringing in the ears,
- flushing,
- erectile dysfunction,
- feeling disoriented,
- abnormal taste in the mouth,
- dry mouth,
- stomach ache,
- vertigo,
- nightmares,
- higher than normal amounts of saliva,
- hallucinations,
- difficulty concentrating.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very Common | |||
| Eye problems: blurred vision, cloudy vision, visual halos, dry eyes, eye discomfort, increased sensitivity to light, gritty sensation in the eyes, pain in or around the eye, difficulty with colour vision, blind spots, or vision loss. | X | ||
| Common | |||
| Heart problems: fainting, dizziness, light-headedness, chest pain, shortness of breath, palpitations, racing heart, rapid or irregular heart beat, fatigue, loss of consciousness, weak pulse, or low blood pressure. | X | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when going from lying or sitting to standing up). | X | ||
| Liver problems: abdominal discomfort and pain, feeling fullness, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, fatigue, nausea, or vomiting. | X | ||
| Lung problems: shortness of breath, shallow breathing, difficult breathing, cough, weakness, weight loss, fatigue, chest discomfort, wheezing, chest tightness, confusion, blue lips, or fever. | X | ||
| Nervous system problems: tremor, abnormal involuntary movements, lack of coordination, change to the normal walking pattern, dizziness, tiredness, tingling, burning sensation, muscular weakness, or loss of sensation. | X | ||
| Severe skin reactions: increased sensitivity to sunlight, blue-grey coloured skin, rash, dry skin, itchiness, blisters, new spot on the skin, redness, blistering, peeling of the skin or inside of the lips, eyes, mouth, nasal passages or genitals, fever, chills, or body aches. | X | ||
| Thyroid problems: abnormal weight change, abnormally fast or slow heart rate, palpitations, increased sweating, tremors, fatigue, diarrhea, dry skin and hair, muscle weakness, constipation, enlarged thyroid, swelling at the base of the neck, difficulty swallowing, difficulty breathing, tightness in the throat, or cough. | X | ||
| Unknown | |||
| Allergic reactions: difficulty swallowing, difficulty breathing, wheezing, drop in blood pressure, nausea, vomiting, hives, rash, or swelling of the face, lips, tongue, or throat. | X | ||
| Blood problems: easy bruising, unexplained bruising, prolonged bleeding, frequent nosebleeds, fatigue, pale skin, shortness of breath, dark urine, infections, weakness, fever, chills, weight loss, sore throat, or mouth ulcers. | X | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heart beat, nausea, vomiting, or tenderness when touching the abdomen. | X | ||
| Kidney problems: fatigue, swelling in the legs, ankles, or feet, urinating more or less frequent, confusion, nausea, vomiting, shortness of breath, high blood pressure, low appetite, or chest pain. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store AMIODARONE between 15°C and 30°C. Protect from light.
Keep out of reach and sight of children.
If you want more information about AMIODARONE:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.sivem.ca), or by calling 1-855-788-3153.
Date of Authorization: 2025-09-12