PMS-Rosiglitazone-Metformin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

pms-ROSIGLITAZONE-METFORMIN 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.

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

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

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:

pms-ROSIGLITAZONE-METFORMIN combines two glucose-lowering medicines, rosiglitazone and metformin, together in one tablet. These two medicines work together to help you achieve better blood sugar control. 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. Metformin helps to lower the amount of sugar made by the liver.

Together, these medicines keep 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. One of the two medicines that make up pms-ROSIGLITAZONE-METFORMIN, 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 have kidney disease or impairment (reduced kidney function).
• If you are allergic pms-ROSIGLITAZONE-METFORMIN or any of its components.
• If you have diabetic ketoacidosis (dangerously high levels of ketones, which signals the body doesn't have enough insulin).

• If you have had a condition called lactic acidosis. Lactic acidosis is caused by a build-up of lactic acid in the blood. Because of the possibility of lactic acidosis, you should not take pms-ROSIGLITAZONE-METFORMIN if:

  • You drink alcohol excessively (all the time or short-term “binge” drinking).
  • You are seriously dehydrated (have lost a large amount of body fluids).
  • You have a severe infection or experience serious physical trauma, including surgery or while recovering from surgery.
  • You develop a serious condition such as a heart attack, stroke or have severe heart or breathing difficulties.
  • You are 80 years of age or older and have NOT had your kidney function tested.
• If you have serious liver problems.
• If you have Type I diabetes – this needs different treatment.

• If you are pregnant or breast feeding.

pms-ROSIGLITAZONE-METFORMIN therapy will need to be stopped temporarily if you are going to have certain x-ray procedures with injectable contrast agents.

What the medicinal ingredients are:

pms-ROSIGLITAZONE-METFORMIN tablets contain two active ingredients, rosiglitazone maleate and metformin hydrochloride, in one tablet.

What the nonmedicinal ingredients are:

colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate. Additionally, each tablet is coated with the following non-medicinal ingredients:

(1 mg/ 500 mg) Hydroxypropyl Methylcellulose, Iron Oxide Yellow, Polyethylene Glycol, and Titanium Dioxide; (2 mg/ 500 mg) Hydroxypropyl Methylcellulose, Iron Oxide Red, Polyethylene Glycol and Titanium Dioxide.; (4 mg/ 500 mg) Hydroxypropyl Methylcellulose, Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol and Titanium Dioxide; (2 mg/ 1000 mg) Hydroxypropyl Methylcellulose, Iron Oxide Yellow, Polyethylene Glycol and Titanium Dioxide; (4 mg/ 1000 mg) Hydroxypropyl Methylcellulose, Iron Oxide Red, Polyethylene Glycol and Titanium Dioxide

What dosage forms it comes in:

Tablets: 1 mg/500 mg, 2 mg/500 mg, 4 mg/500 mg 2 mg/1000 mg, 4 mg/1000 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

pms-ROSIGLITAZONE-METFORMIN, which contains 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)

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

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

Before, or while taking pms-ROSIGLITAZONE-METFORMIN, talk to your doctor 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). pms-

  ROSIGLITAZONE-METFORMIN 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).

  • you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents (substances that help physicians see the tissues more clearly). pms-ROSIGLITAZONE-METFORMIN therapy will need to be stopped temporarily in such instances.

Broken bones usually in the hand, upper arm or foot, have been seen in people taking rosiglitazone, one of the active ingredients of pms-ROSIGLITAZONE-METFORMIN. Talk to your doctor about the risk of fracture.

Decreases in spine and hip bone mineral density (a measure of bone strength, based on the amount of calcium and other minerals in your bones) have been reported in men and women taking rosiglitazone.

Muscle problems, including muscle tenderness, weakness, or pain that you cannot explain, have been seen in people taking rosiglitazone, one of the active ingredients of pms-ROSIGLITAZONE-METFORMIN. Talk with your doctor if you experience these symptoms. If you experience brownish or discoloured urine with your muscle problems, stop taking pms-ROSIGLITAZONE-METFORMIN and call your doctor right away.

The safety and effectiveness of rosiglitazone-metformin have not been established in children under 18 years of age, therefore pms-ROSIGLITAZONE-METFORMIN is not recommended for use in these patients.

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

pms-ROSIGLITAZONE-METFORMIN is not approved for use with a sulfonylurea, therefore pms-ROSIGLITAZONE-METFORMIN is not recommended for use with a sulfonylurea.

INTERACTIONS WITH THIS MEDICATION

pms-ROSIGLITAZONE-METFORMIN may affect how other medicines work, and some medicines may affect how pms-ROSIGLITAZONE-METFORMIN works. Drugs that may interact with the two active ingredients in pms-

ROSIGLITAZONE-METFORMIN (rosiglitazone and metformin) include: digoxin and quinidine (used to treat heart failure and arrhythmias), gemfibrozil (used to lower cholesterol and triglyceride levels in your blood), methotrexate (used to treat psoriasis and rheumatoid arthritis), morphine (used to relieve severe pain), ranitidine (used to treat ulcers and gastroesophageal reflux disease (GERD)), rifampin (used to treat tuberculosis).

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 pms-ROSIGLITAZONE-METFORMIN depends on your previous treatment with metformin and rosiglitazone. Your doctor will decide on the dose of pms-ROSIGLITAZONE-METFORMIN that is suitable for you.

pms-ROSIGLITAZONE-METFORMIN should be taken by mouth and with meals. Your doctor may need to adjust your dose until your blood sugar is better controlled.

pms-ROSIGLITAZONE-METFORMIN can begin to work 1 or 2 weeks after you start taking it. It may take 2-3 months to see the optimal effects.

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 pms-ROSIGLITAZONE-METFORMIN each day, as instructed by your doctor. pms-ROSIGLITAZONE-METFORMIN 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:

Take one dose as soon as you remember. Then take the next dose at the usual time. Never take extra doses in one day to make up for a missed dose the day before. If you miss a whole day of pms-ROSIGLITAZONE-METFORMIN, 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 pms-ROSIGLITAZONE-METFORMIN:

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

Your doctor may conduct various blood or laboratory tests to monitor your health and liver before you start pms-ROSIGLITAZONE-METFORMIN and repeat the tests

periodically while you are on pms-ROSIGLITAZONE-METFORMIN.

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/metformin.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Very common side effects (could affect one in 10 people or more):

• Symptoms of an upset stomach such as nausea, vomiting, diarrhea, and stomach pain. If these side effects occur, they usually occur during the first few weeks of therapy. Taking your pms-ROSIGLITAZONE-METFORMIN with meals can help reduce these side effects.

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) . 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 pms-

  ROSIGLITAZONE-METFORMIN and call your doctor right away if you experience these symptoms.

• Constipation.
• 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 rosiglitazone (8 mg) in pms-ROSIGLITAZONE-METFORMIN as fluid retention is more common.
• 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. 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. pms-

  ROSIGLITAZONE-METFORMIN 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). There is a low risk of hypoglycemia with pms-ROSIGLITAZONE-METFORMIN. 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.

• A strange or metallic taste in the mouth
• Increased weight. Tell your doctor if you gain a lot of weight in a short period of time.

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 pms-ROSIGLITAZONE-METFORMIN 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):

• Lactic acidosis

  Metformin, one of the active ingredients in pms-ROSIGLITAZONE-METFORMIN, can cause a serious side effect called lactic acidosis. This is caused by a build-up of lactic acid in your blood. This build-up can cause serious damage. Lactic acidosis is a medical emergency that must be treated in a hospital.

• 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 pms-ROSIGLITAZONE-METFORMIN 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.
• ·Muscle problems. If you experience muscle tenderness, weakness, or pain that you cannot explain, talk with your doctor. If youexperience brownishor discoloured urinewith your muscle problems, stop taking pms-ROSIGLITAZONE-METFORMIN and call your doctor right away.
• Problems related to Vitamin B12 deficiency.

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 pms-ROSIGLITAZONE-METFORMIN, contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15°C and 30°C. Protect from light. Keep 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 0701E

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

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This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.

Pharmascience Inc.

Montreal Quebec

H4P 2T4

Last revised: July 12, 2013