Teva-Rosiglitazone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-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.

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

• metformin; or
• a sulfonylurea.

Before starting TEVA-ROSIGLITAZONE, your doctor will discuss the possible benefits and possible side effects of rosiglitazone to decide if rosiglitazone is right for you. Your doctor will ask you to read and sign a form indicating you understand the cardiovascular risks of TEVA-ROSIGLITAZONE.

In order for TEVA-ROSIGLITAZONE to be effective, you should continue to exercise and follow the diet recommended for your diabetes while taking TEVA-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:

TEVA-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. TEVA-ROSIGLITAZONE can cause your body to keep extra fluid (fluid retention), which can make some heart problems worse and lead to heart failure, swelling and weight gain.
• If you are allergic to TEVA-ROSIGLITAZONE or any of its components.
• If you have serious liver problems.

• If you are pregnant

What the medicinal ingredient is:

TEVA-ROSIGLITAZONE contain the active ingredient rosiglitazone maleate.

What the important nonmedicinal ingredients are: Hydroxyl propyl methyl cellulose, iron oxide red, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, titanium dioxide and triacetin.

In addition each strength contains the following ingredients:: 2 mg: FD & C Blue #2/ Indigo Carmne Aluminum Lake, 4 mg: iron oxide yellow and 8 mg: iron oxide yellow and iron oxide black.

What dosage forms it comes in:

2 mg, 4 mg and 8 mg tablets

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Rosiglitazone maleate 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)

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

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

BEFORE you use TEVA-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 paint) 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). TEVA-ROSIGLITAZONE could make you ovulate again, which means you could get pregnant. Talk to your doctor about birth control (e.g. hormonal contraceptive pills).

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

The safety and effectiveness of TEVA-ROSIGLITAZONE have not been established in children under 18 years of age, therefore rosiglitazone maleate should not be used in these patients.

TEVA-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).

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

TEVA-ROSIGLITAZONE is not approved for use with metformin AND a sulfonlurea, therefore TEVA-

ROSIGLITAZONE is not recommended for use with metformin AND sulfonylurea.

INTERACTIONS WITH THIS MEDICATION

TEVA-ROSIGLITAZONE may affect how other medicines work and some medicines may affect how TEVA-ROSIGLITAZONE works. Drugs that may interact with rosiglitazone maleate include: gemfibrozil (used to lower cholesterol and triglyceride levels in your blood) rifampin (used to treat tuberculosis), methrotrexate (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 TEVA-ROSIGLITAZONE is 4mg per day. Your doctor will decide on the dose of TEVA-ROSIGLITAZONE that is suitable for you.

TEVA-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. TEVA-ROSIGLITAZONE is a medicine that works over time. It may take anywhere from eight to twelve weeks to see the optimal effect.

Since food doesn't affect how your body uses TEVA-ROSIGLITAZONE, you can take it with meals or without. To help you remember to take TEVA-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 TEVA-ROSIGLITAZONE each day, as instructed by your doctor. TEVA-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:

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 TEVA-ROSIGLITAZONE.

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 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 TEVA-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 TEVA-ROSIGLITAZONE (8 mg) by itself or if you are using TEVA-ROSIGLITAZONE together with another diabetes medicine (e.g., a sulfonylurea) as fluid retention is more common.

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

  taking rosiglitazone. 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. TEVA-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 TEVA-

  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 TEVA-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 TEVA-ROSIGLITAZONE is used alone. Symptoms of heart failure include shortness of breath, getting tired easily after light physical activity such as walking, waking up short of breath at night and 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 TEVA-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 TEVA-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 TEVA-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. For any unexpected effects while taking TEVA-ROSIGLITAZONE, contact your doctor or pharmacist.

HOW TO STORE IT

Store TEVA-ROSIGLITAZONE at room temperature (15ºC to 30ºC) out of the reach of children.

REPORTING SUSPECTED 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 3 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 0701D

Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at:

NOTE: Should you require information related to the management of the side effects, please 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 found by contacting the sponsor, Teva Canada Limited, at:

1-800-268-4127 ext. 5005 (English)

1-877-777-9117 (French)

druginfo@tevacanada.com