PIOGLITAZONE HCL AND METFORMIN HCL- pioglitazone hcl and metformin hcl tablet
Torrent Pharmaceuticals Limited
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PIOGLITAZONE AND METFORMIN HYDROCHLORIDE (PYE o GLI ta zone and met FOR min HYE-droe-KLOR-ide) TABLETS, USP
Read this Medication Guide carefully before you start taking pioglitazone and metformin hydrochloride 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 and metformin hydrochloride tablets, ask your doctor or pharmacist.
What is the most important information I should know aboutpioglitazone and metformin hydrochloride tablets?
Pioglitazone and metformin hydrochloride tablets can cause serious side effects, including:
o Do not take pioglitazone and metformin hydrochloride tablets if you have severe heart failure
o If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, pioglitazone and metformin hydrochloride tablets may not be right for you
Call your doctor right away if you have any of the following:
o swelling or fluid retention, especially in the ankles or legs
o shortness of breath or trouble breathing, especially when you lie down
o an unusually fast increase in weight
o unusual tiredness
Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:
o you feel cold in your hands or feet
o you feel dizzy or lightheaded
o you have a slow or irregular heartbeat
o you feel very weak or tired
o you have unusual (not normal) muscle pain
o you have trouble breathing
o you feel sleepy or drowsy
o you have stomach pains, nausea, or vomiting
Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with pioglitazone and metformin hydrochloride tablets if you:
The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your pioglitazone and metformin hydrochloride tablets for a while if you have any of these things.
Pioglitazone and metformin hydrochloride tablets can have other serious side effects. See "What are the possible side effects of pioglitazone and metformin hydrochloride tablets?"
What arepioglitazone and metformin hydrochloride tablets?
Pioglitazone and metformin hydrochloride tablets contains two prescription diabetes medicines called pioglitazone and metformin hydrochloride. Pioglitazone and metformin hydrochloride tablets can be used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
Pioglitazone and metformin hydrochloride tablets are not for people with type 1 diabetes.
Pioglitazone and metformin hydrochloride tablets are not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
It is not known if pioglitazone and metformin hydrochloride tablets are safe and effective in children under the age of 18. Pioglitazone and metformin hydrochloride tablets are not recommended for use in children.
Who should not takepioglitazone and metformin hydrochloride tablets?
See "What is the most important information I should know about pioglitazone and metformin hydrochloride tablets?"
Do not take pioglitazone and metformin hydrochloride tablets if you:
Tell your doctor before taking pioglitazone and metformin hydrochloride tablets if you have any of these conditions.
What should I tell my doctor before takingpioglitazone and metformin hydrochloride tablets?
Before you take pioglitazone and metformin hydrochloride tablets, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements.
Pioglitazone and metformin hydrochloride tablets and some of your other medicines can affect ech other. You may need to have your dose of pioglitazone and metformin hydrochloride tablets or certain other medicines changed.
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 and metformin hydrochloride tablets with other medicines.
How should I takepioglitazone and metformin hydrochloride tablets?
What are the possible side effects ofpioglitazone and metformin hydrochloride tablets?
Pioglitazone and metformin hydrochloride tablets may cause serious side effects, including:
o stomach pain
o unusual or unexplained tiredness
o loss of appetite
o dark urine
o yellowing of your skin or the whites of your eyes
o blood or a red color in your urine
o an increased need to urinate
o pain while you urinate
The most common side effects of pioglitazone and metformin hydrochloride tablets include:
o cold-like symptoms (upper respiratory tract infection)
o swelling (edema)
o diarrhea
o headache
o increased weight
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 and metformin hydrochloride 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 storepioglitazone and metformin hydrochloride tablets?
Keep the pioglitazone and metformin hydrochloride tablets bottle tightly closed and keep tablets dry
Keep pioglitazone and metformin hydrochloride tablets and all medicines out of the reach of children.
General information about the safe and effective use of pioglitazone and metformin hydrochloride tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pioglitazone and metformin hydrochloride tablets for a condition for which it was not prescribed. Do not give pioglitazone and metformin hydrochloride 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 and metformin hydrochloride tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about pioglitazone and metformin hydrochloride tablets that is written for healthcare professionals.
For more information call 1-800-912-9561.
What are the ingredients inpioglitazone and metformin hydrochloride tablets?
Active Ingredients: pioglitazone hydrochloride, USP and metformin hydrochloride, USP
Inactive Ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide
Trademarks are the property of their respective owners.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Licensed - United States Patents Nos. 5,965,584, 6,166,042, 6,166,043, and 6,172,090.
TORRENT PHARMACEUTICALS LTD., Indrad-382 721,
Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC.
150 Allen Road, Suite 102
Basking Ridge, NJ 07920
8067420 Revised January 2018