INTRODUCTION

PIOGLAZ M TABLET is a combination of Metformin and Pioglitazone which belongs to the group of medicines called Antidiabetic agents. PIOGLAZ M TABLET is indicated as a second-line therapy for the treatment of type II diabetes mellitus in adult patients when diet, exercise and therapy with other single agents does not result in adequate glycemic control.

Type II diabetes is a chronic medical condition in which the body does not make enough insulin, or the produced insulin does not work well. Symptoms include excessive urination, excessive thirst, hunger, fatigue and blurred vision.

Along treatment with PIOGLAZ M TABLET, follow a regular exercise and diet plan as advised by your doctor to achieve better results.

Before and during therapy with PIOGLAZ M TABLET, your doctor might recommend you take several blood tests to check your liver functions and would monitor your body weight to rule out unwanted side effects.

Stop taking PIOGLAZ M TABLET and inform your doctor if you did not notice any improvements even after using this medicine for 3-6 months.

PIOGLAZ M TABLET is strictly not recommended for use in pregnant or breastfeeding women and in patients with active bladder cancer or hematuria (blood in urine). Consult your doctor before taking PIOGLAZ M TABLET.

PIOGLAZ M TABLET is not recommended for use in children and adolescents (aged under 18 years) due to lack of safety data and increased risk of serious side effects. It should be used with extreme caution in elderly patients due to risk of bladder cancer, heart failure or bone fracture.

The most common side effects of taking PIOGLAZ M TABLET are upper respiratory tract infections, headache, weight gain, changes in taste, nausea, vomiting, diarrhea or stomach pain. Consult your doctor if any of the side effects worsen.

USES OF PIOGLAZ M TABLET

• Treats type II diabetes mellitus (as the second line of therapy)

HOW PIOGLAZ M TABLET WORKS

[GBNKYWORD] helps to control blood sugar levels, where metformin works by reducing the amount of glucose released into the blood by the liver and pioglitazone acts by improving insulin sensitivity, thus leading to enhanced utilization of glucose in the peripheral organs and better glycemic control.

DIRECTIONS FOR USE

Always take PIOGLAZ M TABLET as directed by your physician. Take this medicine with or without food, swallow the medicine as a whole and do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age and disease condition. Do not stop taking PIOGLAZ M TABLET without informing your doctor.

SIDE EFFECTS OF PIOGLAZ M TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve. 

Diarrhoea:

Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhoea. Consult your doctor if the symptom did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water. Apply a pain-relieving balm on your forehead if required. Do not consume too of much alcohol. Consult your doctor if the symptom did not improve.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and more frequent meals. Keep a heating pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.

Loss of appetite:

Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Try to eat a nutritious snack that is high in calories and protein such as dried fruit and nuts. Consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking PIOGLAZ M TABLET inform your doctor, if you are taking any of these medicines:

• other medicines used to treat diabetes (Ex. insulin, glipizide, glyburide, glimepiride)
• cyclophosphamide (a medicine used to treat certain types of cancer)
• non-steroidal anti-inflammatory drugs and COX-2-inhibitors (used to treat pain) Ex. celecoxib, etoricoxib or ibuprofen
• gemfibrozil (a medicine used to lower blood cholesterol levels)
• rifampicin (a medicine used to treat tuberculosis)
• corticosteroids (used to treat inflammation) Ex. dexamethasone, prednisolone
• sympathomimetic agents (used to treat circulatory disorders) Ex. ephedrine, adrenaline, noradrenaline, isoprenaline, phenylephrine and phenylpropanolamine
• diuretics (medicines used to increase urine output) Ex. furosemide, chlorothiazide, hydrochlorothiazide
• angiotensin converting enzyme (ACE) inhibitors such as captopril, perindopril and angiotensin II receptor antagonists such as azilsartan, losartan (used to treat low blood pressure)
• beta-2 agonists such as salbutamol or terbutaline (used to treat asthma)
• cimetidine (used to treat stomach ulcers)
• dolutegravir (used to treat HIV infection)
• ranolazine (used to treat chest pain)
• trimethoprim (used to treat bacterial infections)
• isavuconazole (used to treat fungal infections)
• crizotinib (used to treat non-small cell lung cancer)
• olaparib (used to treat ovarian cancer)

Overdosage:

If you or anyone else accidentally take too much of PIOGLAZ M TABLET, contact your doctor immediately or go to a nearest hospital straight away as it could lead to severe hypoglycemia or lactic acidosis. Symptoms of lactic acidosis might include nausea, vomiting, stomach pain with muscle cramps, decreased heartbeat, general weakness with severe tiredness, difficulty in breathing or reduced body temperature.

SYNOPSIS

MORE INFORMATION

• Keep PIOGLAZ M TABLET out of reach of children
• Store at room temperature

FAQs ABOUT PIOGLAZ M TABLET

Can I consume alcohol while taking PIOGLAZ M TABLET?

No, avoid consumption of alcohol while taking PIOGLAZ M TABLET since it may increase the risk of lactic acidosis. Also, prior to the treatment with PIOGLAZ M TABLET, please inform your doctor if you have a history of alcoholism or acute alcohol intoxication as a precaution.

Is PIOGLAZ M TABLET safe to use in elderly patients?

Yes, PIOGLAZ M TABLET should be used with extreme caution in elderly patients (aged 65 years or above) due to the risk of bladder cancer, heart failure and bone fracture. Proper dose adjustments and careful monitoring are required in such patients. Consult your doctor before taking PIOGLAZ M TABLET.

Can PIOGLAZ M TABLET be taken during pregnancy?

PIOGLAZ M TABLET is not recommended for use in pregnant women. If you are pregnant or planning to get pregnant, consult your doctor for advice before taking PIOGLAZ M TABLET.

Can PIOGLAZ M TABLET cause weight gain?

Yes, PIOGLAZ M TABLET may cause weight gain in some individuals, although not everybody gets them. To manage your weight, avoid eating fatty foods and stick on to the regular diabetic diet as advised by your physician. Try to exercise more regularly, for example, by going for a daily walk or run. While taking PIOGLAZ M TABLET, if you experience any other symptoms like an abnormal heartbeat, shortness of breath or edema along with a sudden rapid weight gain, contact your doctor immediately as it could be a sign of heart failure.

Is PIOGLAZ M TABLET safe to use in patients with kidney problems?

PIOGLAZ M TABLET is strictly not recommended for use in patients with kidney diseases (such as kidney failure, kidney dysfunction, hematuria (blood in urine), bladder cancer or a history of bladder cancer). Consult your doctor before taking PIOGLAZ M TABLET.

REFERENCES

1. KD. Tripathi. Insulin, Oral Hypoglycemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 275-277.

2. Gerald G. Briggs and Roger K. Freeman. P and M. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 3514-3515 & 2451-2456.

3. Takeda. Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in July 2011] [Accessed on 16th October 2021] https://clinicaltrials.gov/ct2/show/study/NCT00727857

4. Antonio Ceriello, Don Johns, Mario Widel, David J Eckland, Kathryn J Gilmore, Meng H Tan. Comparison of effect of pioglitazone with metformin or sulfonylurea (monotherapy and combination therapy) on postload glycemia and composite insulin sensitivity index during an oral glucose tolerance test in patients with type 2 diabetes. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. February 2005. [Accessed on 16th October 2021] https://pubmed.ncbi.nlm.nih.gov/15677777/

5. Kohei Kaku. Efficacy and safety of therapy with metformin plus pioglitazone in the treatment of patients with type 2 diabetes: a double-blind, placebo-controlled, clinical trial. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. May 2009. [Accessed on 16th October 2021] https://pubmed.ncbi.nlm.nih.gov/19309251/

6. Torrent Pharmaceuticals Ltd. Piopod MF Pioglitazone and Metformin Hydrochloride (Extended Release) Tablets. [Revised in January 2016] [Accessed on 16th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/1851.pdf

7. Gerard Laboratories. Electronic Medicines Compendium (EMC). [Revised in August 2016] [Accessed on 16th October 2021] https://www.medicines.org.uk/emc/files/pil.8836.pdf

8. Rx Farma Limited. Electronic Medicines Compendium (EMC). [Revised in September 2019] [Accessed on 16th October 2021] https://www.medicines.org.uk/emc/files/pil.11950.pdf

USEFUL DIAGNOSTIC TESTS

• Glucose - Fasting Blood
• Glucose - Postprandial Blood
• Glycosylated Hemoglobin