Medication Guide
Pioglitazone Hydrochloride and Glimepiride Tablets
Read this Medication Guide carefully before you start taking pioglitazone hydrochloride and glimepiride tablets and each time
you get a refill. There may be new information. This information does not take the place of talking with your doctor about
your medical condition or your treatment. If you have any questions about pioglitazone hydrochloride and glimepiride tablets,
ask your doctor or pharmacist.
What is the most important information I should know about pioglitazone hydrochloride and glimepiride tablets?
Pioglitazone hydrochloride and glimepiride tablets can cause serious side effects, including new or worse heart failure.
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- Pioglitazone, one of the medicines in pioglitazone hydrochloride and glimepiride 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.
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- If you have severe heart failure, you cannot start pioglitazone hydrochloride and glimepiride tablets.
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- If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe,
pioglitazone hydrochloride and glimepiride tablets may not be right for you.
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- Call your doctor right away if you have any of the following:
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- swelling or fluid retention, especially in the ankles or legs.
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- shortness of breath or trouble breathing, especially when you lie down.
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- an unusually fast increase in weight.
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- unusual tiredness.
Pioglitazone hydrochloride and glimepiride tablets can have other serious side effects. See “What are the possible side effects
of pioglitazone hydrochloride and glimepiride tablets?”
What are pioglitazone hydrochloride and glimepiride tablets?
Pioglitazone hydrochloride and glimepiride tablets are prescription medicine used with diet and exercise to improve blood
sugar (glucose) control in adults with type 2 diabetes.
Pioglitazone hydrochloride and glimepiride tablets contain 2 prescription diabetes medicines called, pioglitazone hydrochloride
and glimepiride, a sulfonylurea.
Your doctor will decide if you should take pioglitazone hydrochloride and glimepiride tablets.
It is important to eat the right foods, lose weight if needed, and exercise regularly in order to manage your type 2 diabetes.
Diet, weight loss, and exercise are the main treatments for type 2 diabetes and they also help your diabetes medicines work
better for you.
Pioglitazone hydrochloride and glimepiride tablets have not been studied in children and are not recommended for children
under the age of 18. The risks of giving pioglitazone hydrochloride and glimepiride tablets to a child are not known. See
“What are some other possible side effects of pioglitazone hydrochloride and glimepiride tablets?”
Who should not take pioglitazone hydrochloride and glimepiride tablets?
Do not take pioglitazone hydrochloride and glimepiride tablets if you:
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- are allergic to any of the ingredients in pioglitazone hydrochloride and glimepiride tablets. See the end of this Medication
Guide for a complete list of ingredients in pioglitazone hydrochloride and glimepiride tablets.
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- have a condition called diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
People with severe heart failure should not start taking pioglitazone hydrochloride and glimepiride tablets. See “What is
the most important information I should know about pioglitazone hydrochloride and glimepiride tablets?”.
What should I tell my doctor before taking pioglitazone hydrochloride and glimepiride tablets?
Before starting pioglitazone hydrochloride and glimepiride tablets, ask your doctor about what the choices are for diabetes
medicines and what the expected benefits and possible risks are for you in particular.
Tell your doctor about all of your medical conditions, especially if you:
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- have heart failure.
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- have kidney problems.
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- have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin.
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- have a type of diabetic eye disease called macular edema (swelling of the back of the eye).
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- have liver problems. Your doctor should do blood tests to check your liver before you start taking pioglitazone hydrochloride and glimepiride
tablets and during treatment as needed.
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- are pregnant or planning to become pregnant. Pioglitazone hydrochloride and glimepiride tablets should not be used during pregnancy. It is not known if pioglitazone hydrochloride
and glimepiride tablets can harm your unborn baby. Talk to your doctor about the best way to control your blood glucose levels
while pregnant.
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- are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all. Pioglitazone hydrochloride and glimepiride tablets may increase your chance of becoming pregnant. Talk to your doctor about
birth control choices while taking pioglitazone hydrochloride and glimepiride tablets. Tell your doctor right away if you
become pregnant while taking pioglitazone hydrochloride and glimepiride tablets.
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- are breastfeeding or plan to breastfeed. It is not known if pioglitazone hydrochloride and glimepiride tablets passes into your milk and if it can harm your baby.
You should not take pioglitazone hydrochloride and glimepiride tablets if you breastfeed your baby. Talk to your doctor about
the best way to control your blood glucose levels while breastfeeding.
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- have G6PD deficiency (an inherited condition where you don’t produce enough of the enzyme (G6PD). Taking glimepiride, one of the medicines in
pioglitazone hydrochloride and glimepiride tablets, with this condition may cause your red blood cells to be destroyed too
quickly (hemolytic anemia).
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal
supplements. Pioglitazone hydrochloride and glimepiride tablets and some of your other medicines can affect each other. You
may need to have your dose of pioglitazone hydrochloride and glimepiride tablets or certain other medicines adjusted. Certain
other medicines can affect your blood sugar (glucose) control.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new
medicine. They will tell you if it is okay to take pioglitazone hydrochloride and glimepiride tablets with other medicines.
How should I take pioglitazone hydrochloride and glimepiride tablets?
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- Take pioglitazone hydrochloride and glimepiride tablets exactly as prescribed.
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- Your doctor may need to change your dose of pioglitazone hydrochloride and glimepiride tablets to control your blood glucose.
Do not change your dose unless told to do so by your doctor.
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- Pioglitazone hydrochloride and glimepiride tablets may be prescribed alone or with other diabetes medicines. This will depend
on how well your blood sugar is controlled.
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- Take pioglitazone hydrochloride and glimepiride tablets one time each day with the first meal.
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- If you miss a dose of pioglitazone hydrochloride and glimepiride tablets, take your next dose as prescribed unless your doctor
tells you differently. Do not take two doses at one time the next day.
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- If you take too much pioglitazone hydrochloride and glimepiride tablets, call your doctor or poison control center right away.
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- If your body is under stress, for example: due to fever, infection, trauma (such as a car accident), or surgery, the dose
of your diabetes medicines may need to be changed. Call your doctor right away.
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- Stay on your diet and exercise programs and test your blood sugar regularly while taking pioglitazone hydrochloride and glimepiride
tablets.
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- Your doctor should do blood tests before starting pioglitazone hydrochloride and glimepiride tablets and from time to time
to check your liver, kidneys, and blood cells.
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- Your doctor should also do regular blood tests (for example, hemoglobin A1C) to check how well your blood sugar is controlled
with pioglitazone hydrochloride and glimepiride tablets.
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- Your doctor should check your eyes regularly. Some people have had vision changes due to swelling in the back of the eye,
called macular edema, while taking pioglitazone hydrochloride and glimepiride tablets.
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- It may take 2 to 3 months to see the full effect on your blood sugar level.
What are other possible side effects of pioglitazone hydrochloride and glimepiride tablets? Pioglitazone hydrochloride and
glimepiride tablets can cause other serious side effects including:
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- The chance of death from serious heart or blood vessel problems may be higher when using a sulfonylurea, an ingredient in pioglitazone hydrochloride and glimepiride tablets. The risk may be higher when
compared to using diet alone or diet and insulin to control blood sugar levels.
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- Low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness, or hunger may indicate that your blood sugar is too low. This can happen if you skip
meals, if you use another medicine that lowers blood sugar, or if you have certain medical problems. Call your doctor if low
blood sugar levels are a problem for you.
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- Weight gain. Pioglitazone, one of the medicines in pioglitazone hydrochloride and glimepiride tablets, can cause weight gain that may
be due to fluid retention or extra body fat. Weight gain due to fluid retention can be a serious problem for people with certain
heart problems. See “What is the most important information I should know about pioglitazone hydrochloride and glimepiride
tablets?”.
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- Liver problems. It is important for your liver to be working normally when you take pioglitazone hydrochloride and glimepiride tablets. Your
doctor should do blood tests to check your liver before you start taking pioglitazone hydrochloride and glimepiride tablets
and during treatment as needed. Call your doctor right away if you have unexplained symptoms such as:
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- o nausea or vomiting.
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- o stomach pain.
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- o unusual or unexplained tiredness.
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- o loss of appetite.
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- o dark urine.
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- o yellowing of your skin or the whites of your eyes.
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- Macular edema. (diabetic eye disease with swelling in the back of the eye). Tell your doctor right away if you have any changes in your
vision. Your doctor should check your eyes regularly.
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- Fractures (broken bones), usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy. It is
not known if pioglitazone hydrochloride and glimepiride tablets can affect the bones of children.
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- Bladder cancer. There may be an increased chance of having bladder cancer when you take pioglitazone hydrochloride and glimepiride tablets.
You should not take pioglitazone hydrochloride and glimepiride 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:
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- blood or a red color in your urine
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- an increased need to urinate
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- pain while you urinate
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- Low red blood cell count (anemia).
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- Ovulation. (release of an egg from an ovary in a woman) leading to pregnancy. Ovulation may happen when premenopausal women who do
not have regular monthly periods take pioglitazone hydrochloride and glimepiride tablets. This can increase the chance of
pregnancy. See “What should I tell my doctor before taking pioglitazone hydrochloride and glimepiride tablets?”.
Other common side effects of pioglitazone hydrochloride and glimepiride tablets are:
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- cold-like symptoms (upper respiratory infection),
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- headache,
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- urinary tract infection,
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- diarrhea,
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- nausea,
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- arm or leg pain.
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 hydrochloride and glimepiride tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store pioglitazone hydrochloride and glimepiride tablets?
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- Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep pioglitazone hydrochloride and glimepiride
tablets in the original container to protect from light.
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- Keep the pioglitazone hydrochloride and glimepiride tablets bottle tightly closed and protect from getting wet (away from
moisture and humidity).
Keep pioglitazone hydrochloride and glimepiride tablets and all medicines out of the reach of children.
General information about pioglitazone hydrochloride and glimepiride tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pioglitazone hydrochloride
and glimepiride tablets for a condition for which it is not prescribed. Do not give pioglitazone hydrochloride and glimepiride
tablets to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about pioglitazone hydrochloride and glimepiride tablets.
If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about pioglitazone
hydrochloride and glimepiride tablets that is written for healthcare professionals. For more information, call Sandoz Inc.
at 1-800-525-8747.
What are the ingredients in pioglitazone hydrochloride and glimepiride tablets?
Active Ingredients: pioglitazone hydrochloride and glimepiride
Inactive Ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, hydroxypropyl cellulose, polysorbate 80, and microcrystalline
cellulose.
Always check to make sure that the medicine you are taking is the correct one. Pioglitazone hydrochloride and glimepiride
tablets look like this:
30 mg/2 mg tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.
30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
LIPITOR® is the registered trademark of Pfizer.
Manufactured in Slovenia by Lek Pharmaceuticals d.d.
for Sandoz Inc., Princeton, NJ 08540
Rev. July 2012