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Actoplus Met XR (Generic Pioglitazone)

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WARNING

Pioglitazone and other comparable diabetes drugs may aggravate or induce heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Inform your doctor if you have or have ever had heart failure before you begin taking pioglitazone, especially if your heart failure is so severe that you must limit your activity and feel comfortable only when you are at rest or are confined to a chair or bed. Tell your doctor if you have or ever had heart disease, high cholesterol or fat levels in the blood, high blood pressure, coronary artery disease (narrowing of the blood vessels that supply blood to the heart), a heart attack, an irregular heartbeat, or sleep apnea. Also mention if you were born with a heart defect. During your therapy, your doctor may caution you against taking pioglitazone or may closely monitor you.

There are some symptoms that you might feel if you develop heart failure. If you experience any of the following symptoms, especially after taking pioglitazone for the first time or after your dose has been increased, call your doctor right once. Large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up during the night short of breath; needing to sleep with additional pillows under your head in order to breathe more easily while lying down; persistent dry cough; confusion; a fast or racing heartbeat; inability to walk or exercise as well; or increased tiredness.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start taking pioglitazone and at each time you get a new prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The hazards of taking pioglitazone should be discussed with your doctor.

Why is this medication prescribed?

Pioglitazone is used to treat type 2 diabetes along with a diet and exercise programme, and occasionally with additional drugs (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). The drug pioglitazone belongs to the thiazolidinediones class of drugs. It functions by enhancing the body’s sensitivity to insulin, a naturally occurring chemical that aids with blood sugar regulation. Pioglitazone is not used to treat diabetic ketoacidosis or type 1 diabetes, a condition in which the body does not create insulin and cannot regulate the quantity of sugar in the blood (a serious condition that may develop if high blood sugar is not treated).

People with diabetes and high blood sugar over time may experience serious or fatal complications, such as heart disease, stroke, kidney issues, nerve damage, and vision issues. It may be possible to control your diabetes and enhance your health by taking medication(s), making lifestyle changes (such as diet, exercise, and quitting smoking), and monitoring your blood sugar frequently. This treatment may also lower your risk of heart attack, stroke, kidney failure, nerve damage (resulting in numb, cold legs or feet and diminished sex capacity in both men and women), eye issues, such as changes in eyesight or blindness, or gum disease, which are all symptoms of diabetes. The optimal strategy to manage your diabetes will be discussed with you by your doctor and other healthcare professionals.

How should this medicine be used?

Pioglitazone is available as an oral tablet. Typically, it is taken once day, with or without food. Take pioglitazone every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take pioglitazone as prescribed by your doctor. Never take it in larger or less amounts or more frequently than directed by your doctor.

You might begin taking pioglitazone at a low dose and then gradually raise it, according to your doctor.

Despite not curing type 2 diabetes, pomglitazone manages the condition. Your blood sugar may start to drop in two weeks, and it may take two to three months for pioglitazone to reach complete effect. Even if you are feeling fine, keep taking pioglitazone. Without consulting your doctor, do not discontinue taking pioglitazone.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking pioglitazone,

  • If you have an allergy to pioglitazone, any other medications, or any of the ingredients in pioglitazone tablets, tell your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention any of the following: insulin or other diabetes medications; atorvastatin (Lipitor, in Caduet); gemfibrozil (Lopid); hormonal contraceptives (birth control pills, patches, rings, implants, and injections); midazolam; nifedipine (Adalat, Afeditab; Procardia); ranitidine (Zantac); ranifampin (Rifadin, Rifater; in Rifamate); (Elixophyllin, Theo-24, Theochron). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have or have ever had any of the conditions listed in the IMPORTANT WARNING section, as well as bladder cancer, diabetic eye disease, kidney disease, or liver illness, let your doctor know.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you become pregnant while taking pioglitazone. Whenever you are taking pioglitazone, stop breastfeeding.
  • You should be aware that pioglitazone may enhance your probability of getting pregnant even if you don’t have regular monthly periods or have a condition that prevents you from ovulating if you haven’t yet reached menopause (change of life; end of monthly periods) (releasing an egg from the ovaries). Consult your doctor about birth control options that are right for you.
  • Inform your doctor or dentist that you are taking pioglitazone if you will be undergoing surgery, including dental surgery.
  • Consult your doctor for advice if you become ill, suffer extraordinary stress, acquire an infection or fever, or if you sustain an injury. Your blood sugar levels and the quantity of pioglitazone you may require can be impacted by these situations.

What special dietary instructions should I follow?

Make sure to abide by all dietary and exercise advice given to you by your physician or nutritionist. It’s crucial to maintain a nutritious diet, exercise frequently, and, if required, reduce weight. Your diabetes will be easier to manage and pioglitazone will function more efficiently as a result.

Blood sugar levels may drop as a result of alcohol. Inquire with your doctor if drinking alcohol is okay for you to do while taking pioglitazone.

What should I do if I forget a dose?

Take the missed dose the moment you recollect it if you remember that day. On the other hand, skip the missed dose and carry on with your regular dosing plan if you don’t remember until the following day. Never take two doses in a single day, and never double the dose to make up for a missing one.

What side effects can this medication cause?

Your blood sugar levels may alter as a result of this drug. You should be aware of the signs of low and high blood sugar as well as what to do if you experience these signs.

There may be negative effects from pomglitazone. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Muscle ache
  • Either the arms or legs hurt
  • Throat pain
  • Gas

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following signs or those listed in the IMPORTANT WARNING section:

  • Alterations to vision
  • Loss of vision
  • Urination that is frequent, unpleasant, or challenging
  • Urine that is cloudy, discoloured, or bloody
  • Stomach or back ache

It’s important to be aware that pioglitazone may induce liver issues. If you have nausea, vomiting, loss of appetite, pain in the upper right region of the stomach, flu-like symptoms, dark urine, yellowing of the skin or eyes, unusual bleeding or bruises, or a lack of energy, stop taking pioglitazone and contact your doctor straight away.

In clinical trials, bladder cancer occurred more frequently in those who took pioglitazone for more than a year than in those who did not. The risks of using this drug should be discussed with your doctor.

In clinical tests, pioglitazone-taking women experienced fractures (broken bones) more frequently than placebo-taking women, particularly in the hands, upper arms, and feet. When compared to males who did not take the medicine, those who took pioglitazone did not have a higher incidence of fractures. If you’re a woman, discuss the potential risks of using this drug with your doctor.

Other negative effects of pioglitazone are possible. If you have any strange side effects while taking this medicine, contact your doctor right once.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excess heat, light, and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with the lab, your physician, and your eye physician. Before and during your treatment, your doctor may likely request specific laboratory tests and routine eye exams to monitor your body’s response to pioglitazone. You should routinely monitor your blood sugar levels and glycosolated haemoglobin to see how pioglitazone is working for you. Your doctor will also instruct you on how to measure your blood or urine sugar levels at home in order to monitor your response to pioglitazone. Pay close attention to these guidelines.

Wearing a diabetes identity bracelet will ensure that you receive the right care in an emergency.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Actos®
  • Oseni® (as a combination product containing Alogliptin, Pioglitazone)
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