Description

Product Overview

What pioglitazone is and what it is used for

Pioglitazone tablets are a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Pioglitazone tablets are a diabetes medicine called pioglitazone that may be taken alone or with other diabetes medicines.

It is not known if pioglitazone tablets are safe and effective in children under the age of 18.
Pioglitazone tablets are not recommended for use in children.
Pioglitazone tablets are not for people with type 1 diabetes.
Pioglitazone tablets are not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

What you need to know before you take pioglitazone

What is the most important information I should know about pioglitazone tablets

Pioglitazone tablets can cause serious side effects, including new or worse heart failure.
Pioglitazone tablets can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough

Do not take pioglitazone tablets if you have severe heart failure
If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, pioglitazone tablets may not be right for you

Call your doctor right away if you have any of the following:
• swelling or fluid retention, especially in the ankles or legs
• shortness of breath or trouble breathing, especially when you lie down
• an unusually fast increase in weight
• unusual tiredness

Pioglitazone tablets can have other serious side effects. See “Possible side effects?”

Do not take pioglitazone tablet if you:
•have severe heart failure
•are allergic to any of the ingredients in pioglitazone tablets. See the end of this Medication Guide for a complete list of ingredients in pioglitazone tablets

Talk to your doctor before taking pioglitazone tablets if you have either of these conditions.

What should I tell my doctor before taking pioglitazone tablets?
Before you take pioglitazone tablets, tell your doctors if you:
•have heart failure
•have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis
•have a type of diabetic eye disease that causes swelling in the back of the eye (macular edema)
•have liver problems
•have or have had cancer of the bladder
•are pregnant or plan to become pregnant. It is not known if pioglitazone tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant about the best way to control your blood glucose levels while pregnant
•are a premenopausal woman (before the “change of life”) who does not have periods regularly or at all? Pioglitazone tablets may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking pioglitazone tablets. Tell your doctor right away if you become pregnant while taking pioglitazone tablets.
•are breastfeeding or plan to breastfeed? It is not known if pioglitazone passes into your milk and if it can harm your baby. You should not take pioglitazone tablets if you breastfeed your baby. Talk to your doctor about the best way to control your blood glucose levels while breastfeeding

Tell your doctor about all the medicines you take including prescription and over the counter medicines, vitamins, and herbal supplements.
Pioglitazone tablets and some of your other medicines can affect each other. You may need to have your dose of pioglitazone tablets or certain other medicines changed.

Know the medicines you take. Keep a list of our medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is safe to take pioglitazone tablets with other medicines.

How to take pioglitazone

•Take pioglitazone tablets exactly as your doctor tells you to take them
•Your doctor may change your dose of pioglitazone tablets.
• Do not change your pioglitazone tablets dose unless your doctor tells you to
•Pioglitazone tablets may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled
•Take pioglitazone tablets one time each day, with or without food

If you miss a dose of pioglitazone tablets
•take your next dose as prescribed unless your doctor tells you differently. Do not take two doses at one time the next day

If you take too much pioglitazone
•call your doctor or go to the nearest hospital emergency room right away

If your body is under stress such as from a fever, infection, accident, or surgery the dose of your diabetes medicines may need to be changed. Call your doctor right away

Stay on your diet and exercise programs and test your blood sugar regularly while taking pioglitazone tablets

Your doctor should do certain blood tests before you start and while you take pioglitazone tablets

Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with pioglitazone tablets

Your doctor should check your eyes regularly while you take pioglitazone tablets

Possible side effects

Pioglitazone tablets may cause serious side effects including:

• See “What is the most important information I should know about pioglitazone tablets?”
• Low blood sugar (hypoglycaemia). This can happen if you skip meals, if you also use another medicine that lowers blood sugar, or if you have certain medical problems.
Light-headedness, dizziness, shakiness, or hunger may happen if your blood sugar is too low. Call your doctor if low blood sugar levels are a problem for you

• liver problems. Call your doctor right away if you have:
•nausea or vomiting
• stomach pain
• unusual or unexplained tiredness
• loss of appetite
• dark urine
• yellowing of your skin or the whites of your eyes

• bladder cancer. There may be an increased chance of having bladder cancer when you take pioglitazone tablets. You should not take pioglitazone tablets if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:
• blood or a red color in your urine
• an increased need to urinate
• pain while you urinate

• broken bones (fractures). Usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy.

• Diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision.
Your doctor should check your eyes regularly

• release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take pioglitazone tablets. This can increase your chance of getting pregnant

The most common side effects of pioglitazone tablets include:
•cold-like symptoms (upper respiratory tract infection)
•headache
•sinus infection
•muscle pain
•sore throat

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects of pioglitazone tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

How to store pioglitazone tablets

•Store pioglitazone tablets at 20º to 25°C (68° to 77°F). Keep pioglitazone tablets in the original container and protect from light
•Keep the pioglitazone tablets bottle tightly closed and keep tablets dry
•Keep pioglitazone tablets and all medicines out of the reach of children.