Co Sotalol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

CO SOTALOL is a brand name for the drug Sotalol Hydrochloride. It belongs to the group of drugs known as beta-blockers.

What the medication is used for:

CO SOTALOL is used to treat irregular and troublesome heartbeats that can be dangerous for you and in some circumstances can even cause death.

What it does:

^PrCO SOTALOL can help your heart to beat in a more normal way.

When it should not be used:

When you experience the following:

• symptoms of heart failure (such as swelling of the ankles or legs with shortness of breath on exercise);
• shortness of breath in lung disease (such as asthma, chronic bronchitis or emphysema);
• severe slowing of heart beat without an implanted artificial pacemaker;
• serious kidney problems.
• chest pain

What the medicinal ingredient is:

Sotalol hydrochloride.

What the important nonmedicinal ingredients are: Colloidal silicon dioxide, D&C Yellow #10 Aluminium Lake, FD&C Blue #1 Aluminium Lake, FD&C blue #2 Aluminium Lake, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

What dosage forms it comes in:

Tablets 80 mg and 160 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

^PrCO SOTALOL is not appropriate for everyone with irregular heartbeats. If you have atrial fibrillation (a specific type of irregular heartbeat), you and your doctor should carefully discuss the benefits and risks of ^PrCO SOTALOL and whether your symptoms are troublesome enough for you to start taking ^PrCO SOTALOL. In some patients treated with ^PrCO SOTALOL for atrial fibrillation, sotalol may cause a different type of abnormal heartbeat that can be dangerous, and in rare instances can even cause death.

Check with your doctor if you want to drink alcohol, while you are taking CO SOTALOL. Chronic use of alcohol may lead to low levels of magnesium which is cause of very serious adverse event.

Talk to your doctor or pharmacist before using salt substitutes containing potassium. If your doctor prescribes a low salt or low sodium diet, follow the directions carefully.

BEFORE you use ^PrCO SOTALOL talk to your doctor or pharmacist if:

$ You perform hazardous activities such as driving, operating machinery, or any other hazardous activities. Sotalol hydrochloride may cause drowsiness, dizziness, and blood pressure changes. If you experience drowsiness or dizziness, avoid these activities. Remember alcohol can add to the drowsiness caused by CO SOTALOL. $ You have heart, lung, kidney and liver diseases or experience symptoms that may be associated with altered electrolyte balance, such as excessive or prolonged diarrhea, sweating, or vomiting, or loss of appetite or thirst;

$ You have a history of anaphylactic reactions; $ You are pregnant, plan to become pregnant or a nursing mother; if you become pregnant while taking CO SOTALOL, contact your doctor or pharmacist.

$ you are taking prescription and non-prescription drugs, herbal remedies, complementary medicines, or an operation or a dental surgery is anticipated; $ you had an allergic reaction with one of ^PrCO

SOTALOL ingredients.

$ You are suffering from asthma or breathing difficulties.

$ You are suffering from severe diarrhoea.

IMPORTANT: PLEASE READ

INTERACTIONS WITH THIS MEDICATION

CO SOTALOL interacts with other drugs including those used for diabetes and heart diseases.

$ Do not take medicinal products (prescription and non-

prescription drugs) or natural/herbal remedies without consulting your doctor or pharmacist as they may aggravate your condition. Always carry a list of medicines you are taking, and make sure that any new or different health care provider be informed about this list in order to get a safe medicine not interacting with any other one included in that list.

PROPER USE OF THIS MEDICATION

CO SOTALOL should be taken exactly as directed by your doctor or pharmacist. Try to take the medicine at the same times each day to avoid missing any doses.

Never take more than the prescribed dose. Do not stop taking CO SOTALOL without consultation with your doctor or pharmacist. They may want to reduce your dose gradually.

CO SOTALOL is prescribed for certain medical conditions. Never give to others even if their conditions appears to be the same as yours.

Usual dose:

The initial dosing of ^PrCO SOTALOL should be done in the hospital as your heartbeat closely watched by health care professionals for the first few days. At home, it is important that you take the exact dose your doctor has prescribed for you at regular time with or without food.

Overdose:

If at any time, you experience symptoms of a sotalol overdose such as slow heartbeat or a different type of abnormal heart beat, wheezing, shortness of breath, fainting, dizziness, weakness, call immediately your doctor or go to the nearest hospital emergency room.

Missed Dose:

Do not miss a dose as it could be dangerous. However, if a dose is missed, you should not double the next dose. Instead, you should wait until the next scheduled dose, and resuming the prescribed regimen at that time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The common documented side effects are slowing the heart beat, shortness of breath and fatigue. It is important that you keep your doctor informed of all side effects, especially if you experience any for more than few days. However, keep taking ^PrCO SOTALOL until your doctor tells you to stop.

This is not a complete list of side effects. For any unexpected effects while taking ^PrCO SOTALOL, contact your doctor or pharmacist immediately.

HOW TO STORE IT

^PrCO SOTALOL tablets should be stored at room temperature (15 to 30°C) away from moisture and heat. Tablets should be kept in tightly closed container. Keep CO SOTALOL out of reach of children. Do not keep or use CO SOTALOL after the expiry date indicated on the container.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345

toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals are available by contacting the sponsor, Cobalt Pharmaceuticals Inc., at: 1-866-254-6111

Last revised: June 20, 2006