Dom-Rosiglitazone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Dom-ROSIGLITAZONE is a medicine used in addition to diet and exercise to lower blood sugar in patients with type 2 diabetes (non-insulin dependent) when all other diabetes medicines taken orally (by mouth) have not lowered blood sugar enough or are not appropriate.

Dom-ROSIGLITAZONE may be used together with one of the following other diabetes medicines:

• Metformin, or
• a sulfonylurea.

Before starting Dom-ROSIGLITAZONE, your doctor will discuss the possible benefits and possible side effects of Dom-ROSIGLITAZONE to decide if Dom-ROSIGLITAZONE is right for you. Your doctor will ask you to read and sign a form indicating you understand the cardiovascular risks of Dom-ROSIGLITAZONE. In order for Dom-ROSIGLITAZONE to be effective, you should continue to exercise and follow the diet recommended for your diabetes while taking Dom-ROSIGLITAZONE.

People who have diabetes have problems with insulin. Insulin is produced by an organ called the pancreas (PAN-kree-us). Inside the pancreas are special cells called beta-cells that actually make insulin. Insulin is a hormone (body’s own natural chemical) that allows the body's tissues to absorb glucose (known as "sugar") from the bloodstream to provide the body energy.

People with Type 2 diabetes do not make enough insulin, or the body tissues become less sensitive to insulin. When the tissues do not respond normally to insulin, it is as if they cannot “hear” the signals insulin sends out – this is called "insulin resistance."

With diabetes, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, heart disease, loss of limbs, and blindness. The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent

or delay complications of diabetes such as heart disease, kidney disease or blindness.

What it does:

Dom-ROSIGLITAZONE helps your body use its own insulin better by making the tissues more sensitive to insulin. The tissues are better able to "hear" the signals insulin sends out. That means the tissues will absorb sugar more easily. This in turn, keeps the amount of sugar in your blood at a more normal level.

When it should not be used:

• If you have or have had heart problems or heart failure

  (the heart cannot pump enough blood to the body’s other organs), talk to your doctor. Dom-ROSIGLITAZONE can cause your body to keep extra fluid (fluid retention), which can make some heart problems worse lead to heart failure, swelling and weight gain.

• If you are allergic to Dom-ROSIGLITAZONE or any of its components.
• If you have serious liver problems.

• If you are pregnant.

What the medicinal ingredient is:

Dom-ROSIGLITAZONE tablets contain the active ingredient rosiglitazone maleate.

What the nonmedicinal ingredients are:

hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, pregelatinized starch titanium dioxide, and one or more of the following: red iron oxide and black iron oxide.

What dosage forms it comes in:

Tablets: 2 mg, 4 mg and 8 mg

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Dom-ROSIGLITAZONE may increase the risk of serious heart problems, including:

• heart failure
• angina (chest pain)
• heart attack (myocardial infarction)
• fluid retention (with or without rapid weight gain)

Dom-ROSIGLITAZONE should not be used if you have or have had heart problems.

Before you use Dom-ROSIGLITAZONE, talk to your doctor about other options to treat your diabetes.

BEFORE you use Dom-ROSIGLITAZONE talk to your doctor or pharmacist about all your medical conditions, including if:

• you have experienced edema (swelling in the wrists,

  hands, feet or ankles).

• you have been diagnosed with angina (chest pain) or have

  had a heart attack.

• you have heart-related risks, including cigarette smoking,

  high blood pressure, high cholesterol, or a family history of heart attack.

• you are taking nitrate medicines (such as nitroglycerin or

  isosorbide dinitrate).

• you have a type of diabetic eye disease called macular

  edema (swelling in the back of the eye).

• you have liver problems.
• you are breastfeeding.
• you are pregnant or planning to become pregnant.

• you are not near menopause but not ovulating (e.g., you

  are a patient with polycystic ovary syndrome). Dom-ROSIGLITAZONE could make you ovulate again, which means you could get pregnant. Talk to your doctor about effective methods of birth control (e.g., hormonal contraceptive pills).

Broken bones, usually in the hand, upper arm or foot, have been seen in people taking rosiglitazone. Talk to your doctor about the risk of fracture.

The safety and effectiveness of Dom-ROSIGLITAZONE have not been established in children under 18 years of age, therefore Dom-ROSIGLITAZONE should not recommended for use in these patients.

Dom-ROSIGLITAZONE is not recommended for type 1 diabetes or diabetic ketoacidosis (dangerously high levels of ketones, which signals the body doesn't have enough insulin).

Dom-ROSIGLITAZONE is not approved for use with insulin therapy, therefore Dom-ROSIGLITAZONE is not recommended for use with insulin.

Dom-ROSIGLITAZONE is not approved for use with metformin AND a sulfonylurea, therefore Dom-ROSIGLITAZONE is not recommended for use with metformin AND a sulfonylurea.

INTERACTIONS WITH THIS MEDICATION

Dom-ROSIGLITAZONE may affect how other medicines work and some medicines may affect how Dom-ROSIGLITAZONE works. Drugs that may interact with Dom-ROSIGLITAZONE (rosiglitazone) include: gemfibrozil (used to lower cholesterol and triglyceride levels in your blood) rifampin (used to treat tuberculosis), methotrexate (used to treat psoriasis or rheumatoid arthritis).

Keep a list of all the medicines you take and tell your doctor and pharmacist about every medication you take. This means both prescription medications (the ones your doctor writes for you) and over-the-counter medications (the ones you buy in

the drugstore, like cold or allergy medicines), or natural health products (herbal medicines).

PROPER USE OF THIS MEDICATION

Usual dose:

The usual starting dose of Dom-ROSIGLITAZONE is 4 mg per day. Your doctor will decide on the dose of Dom-ROSIGLITAZONE that is suitable for you.

Dom-ROSIGLITAZONE should be taken by mouth once a day (in the morning) or twice a day (in the morning and in the evening), depending on the dose your doctor has given you. Dom-ROSIGLITAZONE is a medicine that works over time. It may take anywhere from eight to twelve weeks to see the optimal effects.

Since food doesn't affect how your body uses Dom-ROSIGLITAZONE, you can take it with meals or without. To help you remember to take Dom-ROSIGLITAZONE, try to take it at the same time every day.

Test your blood sugar regularly as your doctor tells you.

Remember: this medicine has been prescribed only for you. Do not give it to anybody else.

Take your Dom-ROSIGLITAZONE each day, as instructed by your doctor. Dom-ROSIGLITAZONE can help control your blood sugar levels only if you take it regularly.

Overdose:

Taking too much of any medicine can be dangerous.

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

Missed Dose:

If you take Dom-ROSIGLITAZONE once a day and miss one dose, take the dose as soon as you remember anytime during the day.

If you take Dom-ROSIGLITAZONE twice a day, take the missed dose as soon as you remember. Then take the next dose at the usual time.

Never take three doses in one day to make up for a missed dose the day before.

If you miss a whole day of Dom-ROSIGLITAZONE, just take your dose as usual the next day. Don't try to make it up by taking extra tablets.

Recommended clinical and laboratory tests while taking Dom-ROSIGLITAZONE:

Your doctor may do additional blood sugar tests to see how well Dom-ROSIGLITAZONE is working.

Your doctor may also recommend a blood test to monitor your liver before you start Dom-ROSIGLITAZONE and repeat the test periodically while you are on Dom-ROSIGLITAZONE.

Your doctor should check your eyes regularly. Rarely, some patients have experienced vision changes due to swelling in the back of the eye while taking rosiglitazone maleate.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Common side effects (could affect up to one in 10 people):

• Anemia (low red blood cell count) which may make you

  feel very weak or tired.

• Chest pain (angina)

• Heart failure or pulmonary edema (fluid accumulation in

  the lungs) when Dom-ROSIGLITAZONE is taken in combination with a sulfonylurea, or metformin. Symptoms of heart failure include shortness of breath, getting tired easily after light physical activity such as walking, unusual tiredness, waking up short of breath at night, swollen ankles or feet, and an unusually rapid increase in weight. Symptoms of fluid in the lungs are breathlessness, which may be very severe and usually worsens on lying down. Stop taking Dom-ROSIGLITAZONE and call your doctor right away if you experience these symptoms.

• Edema (fluid retention or swelling) which could lead to or

  worsen heart failure. If you notice swelling in your extremities (arms and legs, hands and feet), an unusually rapid increase in weight, or if you experience unusual tiredness, trouble breathing or shortness of breath, call your doctor. These symptoms, although not specific, may signal heart problems or heart failure. Pay closer attention to these symptoms if you are using the higher dose of Dom-ROSIGLITAZONE 8 mg by itself or Dom-ROSIGLITAZONE 4 mg in combination with a sulfonylurea as fluid retention is more common.

• Broken bones usually in the hand, upper arm or foot in

  people taking rosiglitazone maleate. Talk to your doctor about the risk of fracture.

• A small increase in total cholesterol levels. Total

  cholesterol is made up of "good cholesterol" (HDLc) and "bad cholesterol" (LDLc) and it is the balance of these that is more important than the total level. Dom-ROSIGLITAZONE does not affect the balance of good and bad cholesterol. If you have any concerns about your cholesterol levels, you should speak to your doctor.

• Low blood sugar (hypoglycemia) if you are taking Dom-

  ROSIGLITAZONE in combination with another diabetes medicine (e.g., metformin or a sulfonylurea). Dizziness, lack of energy, drowsiness, headache, trembling, sweating, or hunger may mean that your blood sugar is

  too low. This can happen if you skip meals, drink alcohol, use another medicine that lowers blood sugar, exercise (particularly hard or long), or if you have certain medical problems. Call your doctor if you feel that your symptoms of low blood sugar are uncomfortable. If you are using Dom-ROSIGLITAZONE by itself, the risk of low blood sugar is low.

  • Increased weight. Tell your doctor if you gain a lot of weight in a short period of time.

Uncommon side effects (could affect up to one in 100 people):

• Heart failure or pulmonary edema (fluid accumulation in the lungs) when rosiglitazone maleate is used alone. Symptoms of heart failure include shortness of breath, getting tired easily after light physical activity such as walking, unusual tiredness, waking up short of breath at night, swollen ankles or feet, and an unusually rapid increase in weight. Symptoms of fluid in the lungs are breathlessness, which may be very severe and usually worsens on lying down. Stop taking Dom-ROSIGLITAZONE and call your doctor right away if you experience these symptoms.
• Constipation.
• Increased hunger.

Rare side effects (could affect up to one in 1,000 people):

• Liver problems. If you experience nausea, vomiting, stomach pain, lack of appetite, tiredness, dark urine, or yellowing of the skin, stop taking Dom-ROSIGLITAZONE and call your doctor right away.
• Blurred vision due to swelling (or fluid) in the back of the eye.

Very rare side effects (could affect up to one in 10,000 people):

• Allergic reactions, which may include hives or rash

  (which may be itchy), or more serious symptoms which may occur suddenly, such as swelling of the face, lips, mouth, tongue or throat (which may cause difficulty in swallowing or breathing). Stop taking Dom-ROSIGLITAZONE and call your doctor right away if you experience these symptoms.

• Breakthrough bleeding (unexpected vaginal bleeding or spotting) while using oral contraceptives, or generally, if you experience any symptoms that persist or become troublesome, these should be discussed with your doctor.

You may experience swelling of the parotid gland (salivary glands located over the jaw, in front of the ears).

This is not a complete list of side effects. If you experience any unexpected effects while taking Dom-ROSIGLITAZONE, contact your doctor or pharmacist.

HOW TO STORE IT

Store Dom-ROSIGLITAZONE at room temperature (15°C to 30°C), out of the reach of children.

REPORTING SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Dominion Pharmacal at, 1-888-380-9800.

DOMINION PHARMACAL

Montreal, Quebec

H4P 2T4

Last revised: November 25, 2011