Patient Medication Information: uses, side effects, how to take - AG-Pioglitazone

ABOUT THIS MEDICATION

What AG-Pioglitazone are used for:

Your doctor has prescribed AG-Pioglitazone to treat type 2 diabetes, as an addition to diet and exercise, in order to improve your blood sugar control.

What Is Type 2 Diabetes?

Insulin is a hormone that the body makes to help use food for energy. There are two types of diabetes: in type 1 diabetes, the body stops producing insulin. In type 2 diabetes, the body does not respond to insulin as well as it should, and/or cannot make enough insulin on its own. When this happens, glucose (sugar) builds up in the blood. This can lead to serious medical problems, including kidney damage, eye damage, nerve damage, heart disease, or stroke. The main goal of diabetes treatment is to lower blood sugar to a normal level.

How Is Type 2 Diabetes Usually Controlled?

Treatment of type 2 diabetes must always include proper diet, exercise and weight control under the guidance of your physician.

What AG-Pioglitazone do:

AG-Pioglitazone are a member of a class of drugs that are insulin-sensitizing agents. AG-Pioglitazone help your body respond better to its own insulin, thereby reducing blood sugar levels in the body. Because AG-Pioglitazone do not cause your body to produce more insulin, they rarely cause hypoglycemia (low blood sugar) when used alone. Even if you are taking Pioglitazone Hydrochloride Tablets, you should still exercise and follow the recommended nutritional plan for your diabetes.

When AG-Pioglitazone should not be used:

AG-Pioglitazone should not be used by patients who:

have or have had heart problems or heart failure
have serious liver damage
are pregnant
are allergic to pioglitazone hydrochloride or any other
ingredients of Pioglitazone Hydrochloride Tablets

What the medicinal ingredient is:

Pioglitazone Hydrochloride

What the nonmedicinal ingredients are:

Lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, magnesium stearate.

What dosage forms it comes in:

AG-Pioglitazone are available as tablets of 30 mg or 45 mg.

WARNINGS AND PRECAUTIONS

Because AG-Pioglitazone work only in the presence of insulin, it should not be used if you have type 1 diabetes (when the pancreas does not produce insulin).

Serious side effects with AG-Pioglitazone include:

heart failure. Symptoms of heart failure include shortness of breath, weakness, tiredness, swelling (edema), or unusual weight gain
liver problems. Symptoms of liver problems include tiredness, lack of appetite, dark urine, yellowing of the skin or the white part of the eye

AG-Pioglitazone are not approved for use with metformin and/or a sulfonylurea, therefore AG-Pioglitazone should not be taken with metformin and/or a sulfonylurea.

AG-Pioglitazone are not approved for use with insulin therapy, therefore AG-Pioglitazone should not be taken with insulin.

Make sure to ask your doctor, pharmacist, or diabetes educator what to do if your blood sugar is low. Teach you friends, coworkers, and family members what they can do to help you if you have low blood sugar.

Consult your doctor promptly during periods of stress, such as fever, trauma, infection or surgery, since your medication requirements may change during these times.

Fractures, usually in the hand, upper arm or foot, have been seen with pioglitazone hydrochloride use in women. Talk to your doctor about the risk of fracture.

Before or while taking Pioglitazone Hydrochloride Tablets, talk

to your doctor or pharmacist if you:

have liver disease. AG-Pioglitazone are not
recommended in patients with liver disease.
are planning to become pregnant. Only insulin should
be used during pregnancy to maintain blood glucose levels as close to normal as possible.
are breastfeeding
are a woman who has not reached menopause but have
no menstrual periods. You may become pregnant unless you use an effective method of birth control. Pioglitazone Hydrochloride Tablets, like other drugs in this class, may cause women with insulin resistance to ovulate again.
have edema (water retention)

AG-Pioglitazone should not be used in children under 18 years of age.

INTERACTIONS WITH THIS MEDICATION

Women using oral birth control pills should check with their doctor about the possible need to adjust the dose or use alternative methods of contraception when taking Pioglitazone Hydrochloride Tablets. Women should also inform their doctors of any changes in their monthly cycle.

AG-Pioglitazone may also interact with some other drugs such as gemfibrozil, rifampicin, nifedipine and atorvastatin calcium. Tell your doctor if you are taking these medicines.

PROPER USE OF THIS MEDICATION

Usual dose: AG-Pioglitazone should be taken once daily without regard to meals. Do not break the tablets in half. The initial dose is 30 mg once daily. Do not exceed 45 mg once daily.

Take your AG-Pioglitazone each day, as instructed by your doctor or pharmacist. AG-Pioglitazone can help you control your blood glucose levels only if you take it regularly. AG-Pioglitazone should generally be taken at the same time each day at whatever time you find most convenient to remember.

Your doctor has prescribed AG-Pioglitazone specifically for you. Do not give your medicine to anyone else, even if they have a similar condition

Overdose: In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.

Missed Dose: If you miss a dose of Pioglitazone Hydrochloride Tablets, do not take a double dose to make up for the missed dose. Take your dose at the regular time on the following day.

Monitoring:

Fasting blood glucose: Test your blood sugar levels with your personal glucose meter as often as your doctor recommends.
Glycosylated hemoglobin (HbA1c): This blood test is done periodically to determine the average control of your blood sugar levels.
Liver Enzymes: Your doctor may recommend a blood test to monitor your liver function before you start AG-Pioglitazone and may repeat this test occasionally while you take pioglitazone hydrochloride tablets.
Eye: should be checked regularly. Rarely, some patients have experienced vision changes due to swelling in the back of the eye while taking Pioglitazone Hydrochloride Tablets.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The following side effects have been commonly reported with AG-Pioglitazone (could affect up to 1 in 10 patients):

Edema (fluid retention or swelling) which could lead to heart failure. If you notice swelling in extremities (arms and legs, hands and feet), unusually rapid increase in weight, tiredness, trouble breathing or shortness of breath, call your doctor. These symptoms, although not specific, may signal heart problems or heart failure.
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 AG-Pioglitazone by itself, there is less risk of having low blood sugar.
Increased weight. Tell your doctor if you gain a lot of weight in a short period of time.

The following side effects have been reported rarely with AG-Pioglitazone (could affect up to 1 in 1000 patients):

Liver problems. If you experience nausea, vomiting, stomach pain, lack of appetite, tiredness, dark urine, or yellowing of the skin, stop taking AG-Pioglitazone and call your doctor right away.
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.
Blurred vision due to swelling (or fluid) in the back of the eye.
Fractures, usually in the hand, upper arm or foot, have

been seen with AG-Pioglitazone use in women. Talk to your doctor about the risk of fracture.

The following side effects have been reported very rarely with AG-Pioglitazone (could affect up to 1 in 10,000 patients):

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, waking up short of breath at night and swollen ankles or feet. Symptoms of fluid in the lungs are breathlessness, which may be very severe and usually worsens on lying down. Stop taking AG-Pioglitazone and call your doctor right away if you experience these symptoms.
Anemia (low red blood cell count) which may make
you feel very weak or tired.
Swelling of the face, lips, mouth, tongue or throat
(which may cause difficulty in swallowing or breathing); hives or rash (which may be itchy). Stop taking AG-Pioglitazone and call your doctor right away if you experience these symptoms.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPENAND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor		Stop taking Pioglitazone Hydrochloride Tablets and call your doctor immediately
Symptom / effect		Only if severe	In all cases
Common	Fluid retention or swelling in extremities (arms and legs, hands and feet)		Yes
Common (when taken with other antidiabetic medicines)	Low blood sugar (hypoglycemia): Dizziness, lack of energy, drowsiness, headache, trembling sweating, hunger	Yes
Rare	Liver problems: nausea, vomiting, stomach pain, lack of appetite, tiredness, dark urine, or yellowing of the skin			Yes
Rare	Blurred vision or decreased vision [which may be due to swelling (or fluid) in the back of the eye].			Yes
Rare	Fractures, usually in the hand, upper arm or foot, in women.		Yes
Very rare	Heart failure or fluid in the lungs (pulmonary edema): trouble breathing or shortness of breath, getting tired easily after light physical activity, unusual tiredness, waking up short of breath at night, swollen ankles or feet, unusually rapid increase in weight			Yes
Very rare	Allergic reactions: swelling of the face, lips, mouth, tongue or throat (may cause difficulty in swallowing or breathing), hives or rash			Yes

This is not a complete list of side effects. For any unexpected effects while taking Pioglitazone Hydrochloride Tablets, contact your doctor or pharmacist.

HOW TO STORE PIOGLITAZONE HYDROCHLORIDE

TABLETS

Store AG-Pioglitazone in their bottle with the cap tightly closed at room temperature (15°-30°C). Protect from moisture and humidity.

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: CanadaVigilance Program
  Health Canada
  Postal Locator 0701C
  Ottawa ON K1A 0K9

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

NOTE: Should you require information related to the management of the side effects, 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 obtained by contacting the sponsor at: 1-866-399-9091

or at the following address:

Angita Pharma Inc.

1380 – 203 Newton Street Boucherville QC J4B 5H2

Canada

AG-Pioglitazone: Uses, Side Effects and Dosage