Pioglitazone and metformin (Oral)

Pioglitazone and metformin combination is used along with a proper diet and exercise to treat high blood sugar levels from type 2 diabetes. Pioglitazone helps your body use insulin more effectively. Metformin decreases the absorption of sugar from the stomach, lowers the release of stored sugar from the liver, and improves how your body uses sugar. This medicine does not help patients who have insulin-dependent or type 1 diabetes.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly and to decide if you should keep using it. Blood and urine tests may be needed to check for unwanted effects.

If you are gaining weight quickly, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, an irregular heartbeat, or excessive swelling of the hands, wrists, ankles, or feet, contact your doctor immediately. These could be symptoms of heart problems or fluid retention (too much water in the body).

Let your doctor or dentist know that you are taking this medicine. Your doctor may advise you to stop taking this medicine before you have major surgery or diagnostic tests, especially tests that use a contrast dye.

Under certain conditions, too much metformin can lead to a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and appear quickly. Lactic acidosis usually occurs when other serious health problems are present, such as a heart attack or kidney failure. Symptoms include: abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should seek immediate emergency medical help.

Contact your doctor right away if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Contact your doctor immediately if you notice blurred vision, decreased vision, or any other change in your vision while taking this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may increase the risk of bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

This medicine may increase your risk for bladder cancer if you take it for more than 12 months. Inform your doctor right away if you notice blood in your urine, have a frequent, strong, or increased urge to urinate, experience painful urination, or have pain in your back, lower abdomen, or stomach.

This medicine can cause hypoglycemia (low blood sugar). Low blood sugar can also happen if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat due to nausea or vomiting, or take certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People experience different symptoms with low blood sugar. It is important for you to learn your specific symptoms in order to treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may happen if you do not take enough of your medicine or skip a dose, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and needs to be treated immediately. It is important for you to learn your specific symptoms in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

There may be times when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse stating that you have diabetes along with a list of all your medicines.

This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

Limit your alcohol intake while using this medicine. Heavy alcohol use can increase your risk for lactic acidosis.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been adequate studies on the effects of pioglitazone and metformin combination in children. Use is not recommended in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems for older adults that would limit the usefulness of pioglitazone and metformin combination. However, older patients are more likely to have kidney problems related to age, which may require caution and dose adjustments for patients using pioglitazone and metformin combination.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there might be an interaction. In these cases, your doctor may want to adjust the dose or take other precautions. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or change some of the other medicines you take.

• Acetrizoic Acid
• Diatrizoate
• Ethiodized Oil
• Iobenzamic Acid
• Iobitridol
• Iocarmic Acid
• Iocetamic Acid
• Iodamide
• Iodipamide
• Iodixanol
• Iodohippuric Acid
• Iodopyracet
• Iodoxamic Acid
• Ioglicic Acid
• Ioglycamic Acid
• Iohexol
• Iomeprol
• Iopamidol
• Iopanoic Acid
• Iopentol
• Iophendylate
• Iopronic Acid
• Ioseric Acid
• Iosimide
• Iotasul
• Iothalamate
• Iotrolan
• Iotroxic Acid
• Ioxaglate
• Ioxitalamic Acid
• Ipodate
• Metrizamide
• Metrizoic Acid
• Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

• Abiraterone Acetate
• Acarbose
• Acetazolamide
• Alogliptin
• Aspirin
• Bexagliflozin
• Bictegravir
• Brinzolamide
• Bupropion
• Capmatinib
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cimetidine
• Ciprofloxacin
• Dasabuvir
• Delafloxacin
• Dichlorphenamide
• Dofetilide
• Dolutegravir
• Dorzolamide
• Enoxacin
• Fedratinib
• Fexinidazole
• Furosemide
• Gatifloxacin
• Gemfibrozil
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Ifosfamide
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iopromide
• Ioversol
• Isavuconazole
• Lanreotide
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lomefloxacin
• Metformin
• Methazolamide
• Metolazone
• Moxifloxacin
• Nateglinide
• Nifedipine
• Norfloxacin
• Octreotide
• Ofloxacin
• Ombitasvir
• Paritaprevir
• Pasireotide
• Phenobarbital
• Pioglitazone
• Piperaquine
• Pixantrone
• Polythiazide
• Pramlintide
• Primidone
• Ranolazine
• Repaglinide
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Tafenoquine
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Tolvaptan
• Topiramate
• Triamterene
• Trovafloxacin
• Vandetanib
• Zonisamide

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both of the medicines.

• Acebutolol
• Atenolol
• Atorvastatin
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Clopidogrel
• Colesevelam
• Esmolol
• Fenugreek
• Glucomannan
• Guar Gum
• Isocarboxazid
• Ketoconazole
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nilotinib
• Oxprenolol
• Ozanimod
• Patiromer
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Safinamide
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tranylcypromine
• Verapamil

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected for their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland problem (underactive) or
• History of alcohol abuse or
• Cardiovascular collapse (shock) or
• Acute or unstable congestive heart failure or
• Severe dehydration or
• Acute heart attack or
• Kidney problems or
• Liver disease or
• Pituitary gland problem (underactive) or
• Poorly nourished condition or
• Sepsis (severe infection) or
• Weakened physical condition—Use with caution. May cause side effects to become worse.

• Anemia (low red blood cells) or
• Diabetic macular edema (swelling of the back of the eye) or
• Edema (fluid retention or swelling) or
• Heart disease or
• Liver disease or
• Vitamin B12 deficiency—Use with caution. May worsen these conditions.

• Active bladder cancer or
• Diabetic ketoacidosis (high ketones and acid in the blood) or
• Severe heart failure or
• Severe kidney disease or
• Active liver disease or
• Metabolic acidosis (acid in the blood) or
• Type I diabetes—Should not be used in patients with these conditions.

• Fever or
• Infection or
• Surgery or
• Trauma—Use with caution. These conditions may cause problems with blood sugar control.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor right away if you notice any of the following side effects:

More common

• Bladder pain
• Bloody or cloudy urine
• Difficult, burning, or painful urination
• Frequent urge to urinate
• Lower back or side pain
• Swelling of the face, fingers, feet, or lower legs
• Weight gain

Less common

• Pain or swelling in the arms or legs without any injury
• Pale skin
• Trouble breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Rare

• Anxiety
• Blurred vision
• Chills
• Cold sweats
• Confusion
• Cool, pale skin
• Decreased appetite
• Depression
• Diarrhea
• Dizziness
• Fast heartbeat
• Fast, shallow breathing
• General feeling of discomfort
• Headache
• Increased hunger
• Loss of consciousness
• Muscle pain or cramping
• Nausea
• Nightmares
• Seizures
• Shakiness
• Sleepiness
• Slurred speech
• Stomach discomfort

Some side effects may happen that usually do not require medical attention. These side effects may go away as your body gets used to the medicine. Your health care professional may also provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Body aches or pain
• Cough
• Ear congestion
• Fever
• Loss of voice
• Runny or stuffy nose
• Sneezing
• Sore throat

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Actoplus Met
• Actoplus Met XR

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

Carefully follow the special diet your doctor gave you. This is the most important part of controlling your diabetes and will help the medicine work properly. Exercise regularly and test for sugar in your blood or urine as directed.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine should be taken with meals to help reduce the unwanted stomach effects that may occur during the first few weeks.

Swallow the medicine whole. Do not crush, break, or chew it.

Part of the extended-release tablet may pass into your stool (bowel movement). This is normal and nothing to worry about.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For type 2 diabetes: For oral dosage form (extended-release tablets): Adults—At first, 1 tablet one or two times a day with food. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 45 milligrams (mg) of pioglitazone and 2000 mg of metformin per day. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—At first, 1 tablet one or two times a day with food. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 45 milligrams (mg) of pioglitazone and 2550 mg of metformin per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.