What Pioglitazone hydrochloride/ Metformin hydrochloride is used for: Pioglitazone hydrochloride is a medication that belongs to a class of medications known as “thiazolidinediones”. Metformin hydrochloride is a medication that belongs to a class of medicines known as “biguanides”. This combination of active ingredients is used for the treatment of adult patients with type 2 diabetes mellitus (high blood glucose levels due to insulin resistance) who are already taking pioglitazone and metformin in separate tablets or have previously used either pioglitazone or metformin but did not have a controlled glycemic control. It is used as an adjunct therapy to diet and exercise to help improve the glycemic control. Do not take Pioglitazone hydrochloride/ Metformin hydrochloride: If you are allergic to Pioglitazone hydrochloride or Metformin hydrochloride, or any of the ingredients in this medicine. Tell your doctor about the allergy and what signs you had. if you are diagnosed with NYHA Class III or IV heart failure (advanced stages of heart failure which is a disorder that causes your heart muscle to lose its ability to pump blood properly). If you have acute or chronic metabolic acidosis (a type of acid-base disturbance), including diabetic ketoacidosis, with or without coma (complete loss of consciousness). If you have very severe kidney damage. If you have active liver disease or very elevated liver enzymes tests. If you are older than 80 years old (unless kidney function was shown to be tolerant to the medicine). If you will be undergoing an x-ray test involving injection of dyes (medicine will be temporarily discontinued). Warnings & Precautions: Talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness. This medicine may cause fluid retention which can worsen or lead to heart failure. The risk of fluid retention was shown to be higher in patients who are using insulin in combination with this medicine and suffer from congestive heart failure NYHA Class I and II (first classes of heart failure; NYHA Class I means that you have no symptoms and no limitation in ordinary physical activity like shortness of breath when climbing stairs or walking; Class II means that you experience mild symptoms like mild chest pain or shortness of breath and mild limitation during normal physical activity). Make sure to talk to your doctor before starting this medicine if you have heart problems (e.g. heart failure). Talk to your doctor if you develop signs of heart failure while taking this medicine like, swelling of the feet, ankles or abdomen, weight gain, fatigue upon exertion, difficulty breathing and irregular heart rhythms. This medicine may cause edema (swelling) that is dose-related. If this happens, make sure to tell your doctor about it. Your doctor may reduce the dose if needed. This medicine may be linked to liver problems that can be fatal. If your doctor suspects a liver injury, he/she will make sure to stop the medicine immediately and will assess you for the real cause behind your liver damage. This medicine should not be restarted if the doctor was not able to identify another possible cause for the liver damage. Your doctor may recommend liver blood tests if you have liver problems and will decide accordingly if any dose adjustments are needed. This medicine may increase the risk of fractures in female patients. This medicine may cause an increased risk of bladder cancer especially when used for a prolonged period of time. Make sure to tell your doctor if you have bladder cancer or if you previously had bladder cancer. You should not take this medicine if you have bladder cancer. This medicine may cause hypoglycemia (low blood glucose levels) when given with insulin or an insulin secretagogue. Your doctor may recommend a lower dose of the insulin or insulin secretagogue to prevent hypoglycemia. Talk to your doctor if you experience signs of hypoglycemia like shaking, tremors, palpitations, sweating and dizziness. High blood glucose levels may cause macular edema (eye edema). It is recommended that you do regular eye check-ups at your doctor’s office. This medicine was not shown to decrease the risk of macrovascular outcomes (e.g. heart, kidney, eye, brain and nerves complications). Talk to your doctor before taking this medicine if you have liver, kidney or heart problems including heart failure, type 1 diabetes (juvenile diabetes) or diabetic ketoacidosis, or if you are 80 years of age or older, regular alcohol drinker (“binge drinking” or drinking alcohol too often), pregnant or plan to get pregnant or breastfeeding. Your doctor should do some blood tests including HbA1c (used to assess your glycemic control) before you start taking pioglitazone. Talk to your doctor before taking this medicine if you are a premenopausal woman (woman of childbearing potential). This medicine may increase ovulation which may increase the chance of pregnancy. Ask your doctor for contraceptive methods (birth control) that you can use to prevent pregnancy when taking this medication. Make sure to tell your doctor immediately if you get pregnant when taking this medicine. This medicine should be temporarily stopped if you are due to undergo radiologic tests that involve administration of iodinated contrast materials into the vein at the time or prior to receiving the test and for 48 hours after the test and restarted only after your kidney function has returned to normal (re-evaluation of kidney function is needed). Administration of iodinated contrast dye while taking this medicine may cause kidney damage. It is crucial that you lose body weight when necessary, follow a healthy diet and exercise routine on a regular basis in order to control your type 2 diabetes. These lifestyle factors are the main factors that will help control your diabetes and will help your diabetes medicines work better in controlling your blood glucose levels. This medication can cause a rare but serious medical condition known as lactic acidosis (accumulation of an acid in your blood) which can be fatal. This medical condition is an emergency and should be immediately treated in the hospital. Stop taking this medicine and contact your doctor right away if you experience any of the following symptoms of lactic acidosis, feeling cold (especially in the feet and arms), tiredness or weakness, slow or irregular heartbeat, unusual muscle pain, lightheadedness or dizziness, difficulty breathing, stomach ache accompanied with vomiting, diarrhea and nausea. You are at higher risk for getting lactic acidosis if you are 80 years of age or older and have not had your kidney function assessed, or if you have congestive heart failure (your heart does not pump blood properly), liver or kidney problems, heart attack, stroke, severe infection, surgery, or if you will undergo certain x-ray tests that involve injectable dye, or if you are a regular alcohol drinker (you drink alcohol very often or binge drinking), or if you experience dehydration (loss of a large amount of body fluids). Dehydration is most likely to happen when you are ill with vomiting, fever or diarrhea or if you are excessively sweating due to physical activity and you are not drinking enough fluids. Possible Side Effects: Possible side effects include signs of an allergic reaction, like rash and itching, signs of heart failure (swelling of the feet, ankles or abdomen, weight gain, fatigue upon exertion, difficulty breathing and irregular heart rhythms), signs of liver problems (stomach pain, nausea or vomiting, unusual or unexplained tiredness, dark urine, yellowing of your skin or the whites of your eyes and loss of appetite), edema, weight gain, fractures, bladder cancer, low blood sugar levels, macular edema (accumulation of fluids in the eye) and lactic acidosis (feeling cold especially in the feet and arms, tiredness or weakness, slow or irregular heartbeat, unusual muscle pain, lightheadedness or dizziness, difficulty breathing, stomach ache accompanied with vomiting, diarrhea and nausea). Other possible side effects include upper respiratory tract infection, infection of the sinuses, headache, muscle pain, sore throat, laboratory abnormalities, ovulation and increased risk of pregnancy, diarrhea, nausea, upset stomach and anemia. Other medicines and Pioglitazone hydrochloride/ Metformin hydrochloride: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications including prescription medicines, over the counter medicines (do not require a prescription), herbals, vitamins and supplements. If you are taking gemfibrozil (used to treat high triglycerides level). If you are taking rifampin (antibiotic). How to take Pioglitazone hydrochloride/ Metformin hydrochloride: Effectiveness and safety of this medicine have not been established in children yet. Make sure to take your medication as prescribed by your doctor. Your doctor will tell you how much to take of this medication and may change doses depending on your response to the medication and other medicines that you are taking. Take tablet with food to avoid abdominal discomfort. Swallow tablet whole with a full glass of water. If you are under stress (e.g. infection, accident, diarrhea, vomiting, fever, drinking a lower amount of fluids than normal or due to a surgery or x-ray imaging with dye injection), make sure to talk to your doctor immediately. Your doctor may change the dose of your diabetes medicines if needed. Your doctor should evaluate your blood tests before starting this medicine and from time to time during therapy. These blood tests may include tests to assess your kidneys, liver, and blood cells. Make sure to follow a healthy diet and exercise program as recommended by your healthcare provider and get your blood sugar levels (hemoglobin A1C) checked on a regular basis while taking pioglitazone hydrochloride/ metformin hydrochloride. Avoid binge or too much drinking of alcohol when taking this medicine to prevent lactic acidosis. How to store Pioglitazone hydrochloride/ Metformin hydrochloride: Store medication at room temperature Keep out of the reach of children and pets Do not use beyond the expiry date mentioned on the box Keep medication in its original pack to protect it from moisture and light Do not use damaged pills Do not dispose medication in the wastewater or household waste