Consumer Information for: ROSIGLITAZONE

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

ROSIGLITAZONE is used with diet and exercise to lower blood sugar:

  • In adults with type 2 diabetes.
  • When all other diabetes medicines have not lowered blood sugar enough or cannot be used.

ROSIGLITAZONE may be used alone or with either metformin OR a sulfonylurea to treat your diabetes. However, ROSIGLITAZONE is not recommended for use with both metformin AND a sulfonylurea together.

Talk about the benefits and side effects with your doctor. Together decide if it is right for you. The doctor will ask you to read and sign a form showing you understand the risks of ROSIGLITAZONE.

What it does

ROSIGLITAZONE helps to control high blood sugar. It can help your body respond better to insulin made in your body. ROSIGLITAZONE does not cause your body to make more insulin.

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. 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 ROSIGLITAZONE or any of its components.
  • If you have serious liver problems.
  • If you are pregnant.
What the medicinal ingredient is

ROSIGLITAZONE tablets contain the active ingredient rosiglitazone maleate.

What the non-medicinal ingredients are

hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate and titanium dioxide.

What dosage form it comes in

2 mg, 4 mg and 8 mg tablets.

Warnings and precautions

Serious Warnings and Precautions

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)

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

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

BEFORE you use 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 you 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). 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).

ROSIGLITAZONE can cause a decrease in the amount of calcium and other minerals in your bones. The strength of your bones may be decreased especially in the hips and spine.
ROSIGLITAZONE is not recommended for use in children under 18 years of age

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).

ROSIGLITAZONE is not recommended for use with insulin.

ROSIGLITAZONE is not recommended for use with both metformin and a sulfonylurea together.

Interactions with this medication

ROSIGLITAZONE may affect how other medicines work and some medicines may affect how ROSIGLITAZONE works.
Tell your doctor about all medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

In particular, tell your doctor if you are using any of the following medicines:

  • drugs used to lower cholesterol and triglyceride levels in your blood (gemfibrozil)
  • drugs used to treat tuberculosis (rifampin)
  • drugs used to treat psoriasis or rheumatoid arthritis (methotrexate).
  • drugs for heart pain (nitrate medicines). Examples are nitroglycerine or isosorbide dinitrate
Proper use of this medication

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

Take ROSIGLITAZONE:

  • by mouth.
  • with or without food.
  • each day. Either once a day (in the morning) or twice a day (in the morning and in the evening).

Diet and exercise can help your body control its blood sugar better. It is important to stay on the diet and exercise program recommended by your doctor.

Usual Dose: 4 mg per day.

Your doctor will decide on the dose of ROSIGLITAZONE that is suitable for you.

Overdose

Taking too much of any medicine can be dangerous.

If you think you have taken too much ROSIGLITAZONE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

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

If you take 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 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 ROSIGLITAZONE:
Your doctor may do additional blood sugar tests to see how well ROSIGLITAZONE is working.
Your doctor may also recommend a blood test to monitor your liver before you start ROSIGLITAZONE and repeat the test periodically while you are on 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.

Side effects and what to do about them

If any of the side effects listed becomes severe or troublesome, tell your doctor or pharmacist.

Side effects may include:

Common side effects:

  • Broken bones, usually in the hand, upper arm or foot. Talk to your doctor about the risk of fracture.
  • A small increase in total cholesterol levels.
  • Weight gain in a short period of time.

Uncommon side effects

  • Constipation
  • Increased hunger.

Very rare side effects

  • Abnormal vaginal bleeding or spotting.
  • Swelling of the parotid gland (salivary glands located over the jaw, in front of the ears).

ROSIGLITAZONE can cause abnormal liver and blood sugar test results. Your doctor will decide when to perform blood tests and will interpret the results.

Your doctor should check your eyes regularly. Some patients may experience vision changes. This can be due to swelling in the back of the eye while taking ROSIGLITAZONE.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
Common
Anemia (Low red blood cell count): Feeling very weak or tired   ✔  
Edema (Fluid retention) : swelling in( arms and legs, hands and feet. Rapid or unexpected increase in weight   ✔  
Hypoglycemia (Low blood sugar levels): Dizziness, lack of energy, drowsiness, headache, trembling sweating, or hunger   ✔  
Heart failure or fluid in the lungs : Trouble breathing or shortness of breath, getting tired easily after light physical activity, unusual tiredness, waking up short of breath at night, an unusually rapid increase in weight. Fluid may also cause swollen ankles or feet     ✔
Rare
Liver problems: Nausea, vomiting, stomach pain, lack of appetite, tiredness, dark urine, or yellowing of the skin or eyes     ✔
Blurred vision or decreased vision     ✔
Very rare
Allergic reactions: 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 (may cause difficulty in swallowing or breathing)     ✔
Muscle Disorders: Muscle tenderness or weakness, muscle pain that you cannot explain.   ✔  
Fatigue: Generalized weakness, especially if you do not feel well.   ✔  
Hematuria: Brownish or discoloured urine.     ✔

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

How to store

Store ROSIGLITAZONE at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF), out of the reach of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about ROSIGLITAZONE:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website (https://www.aapharma.ca/en/), or by calling 1-877-998-9097

This leaflet was prepared by AA Pharma Inc

Date prepared : January 7, 2019

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