Check Availability & Expiry
INTRODUCTION
PIOSAFE MF is a combination of Metformin and Pioglitazone which belongs to the group of medicines called Antidiabetic agents. PIOSAFE MF 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 PIOSAFE MF, follow a regular exercise and diet plan as advised by your doctor to achieve better results.
Before and during therapy with PIOSAFE MF, 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 PIOSAFE MF and inform your doctor if you did not notice any improvements even after using this medicine for 3-6 months.
PIOSAFE MF 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 PIOSAFE MF.
PIOSAFE MF 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 PIOSAFE MF 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 PIOSAFE MF
- Treats type II diabetes mellitus (as the second line of therapy)
HOW PIOSAFE MF 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 PIOSAFE MF 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 PIOSAFE MF without informing your doctor.
SIDE EFFECTS OF PIOSAFE MF
COMMON
- signs of upper respiratory tract infection (cough, sore throat, chest tightness or wheezing)
- anemia
- hypo-aesthesia (diminished sense of touch)
- headache
- visual disturbance
- arthralgia (joint pain)
- erectile dysfunction
- blood in the urine (hematuria)
- weight gain
- nausea, vomiting, diarrhoea, abdominal pain and loss of appetite
- taste disturbance
- numbness
UNCOMMON
- difficulty sleeping
- inflammation of the sinus (sinusitis)
- bladder cancer
- flatulence
RARE
Stop taking PIOSAFE MF and contact your doctor immediately if you experience any of the following side effects:
- serious allergic reaction (such as skin rash, itching, swelling of the face, lips, mouth, tongue or throat, difficulty in swelling or breathing)
- symptoms of lactic acidosis (such as vomiting, stomach pain, decreased heartbeat, difficulty in breathing, muscle cramps, general weakness with severe tiredness or reduced body temperature)
- signs of liver inflammation (such as tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes)
- signs of heart failure (such as unusual shortness of breath, rapid increase in body weight or localized swelling)
- signs of kidney problems (such as hematuria or bladder cancer)
- hypoglycemia (decreased blood glucose level)
- bone fracture
- blurred vision due to swelling at the back of the eye
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
PREGNANCY
PIOSAFE MF is not recommended for use in pregnant women. Consult your doctor before taking PIOSAFE MF.
BREASTFEEDING
PIOSAFE MF is not recommended for use during breastfeeding as it is not known whether it may be present in the breast milk. Consult your doctor before taking PIOSAFE MF.
DRIVING AND USING MACHINES
Do not drive or operate any machines if your ability is affected after taking PIOSAFE MF and should be alerted about the risk of low blood sugar levels before performing activities which require mental attention.
ALCOHOL
Avoid consumption of alcohol while taking PIOSAFE MF due to the increased risk of lactic acidosis.
KIDNEY
PIOSAFE MF 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 PIOSAFE MF.
LIVER
PIOSAFE MF is not recommended for use in patients with active liver disease. Consult your doctor before taking PIOSAFE MF.
ALLERGY
Do not take PIOSAFE MF if you are allergic to Metformin or Pioglitazone.
LUNGS
PIOSAFE MF is not recommended for use in patients with infection affecting the lungs or bronchial system. Consult your doctor before taking PIOSAFE MF.
HEART DISEASE
PIOSAFE MF is not recommended for use in patients with severe heart disease (such as grade III-IV heart failure, recent myocardial infarction, edema or circulatory failure. Consult your doctor before taking PIOSAFE MF.
OTHERS
PIOSAFE MF is not recommended for use if you:
- have acute alcohol intoxication (abnormal behaviour during or after alcohol consumption) or alcoholism
- have diabetic pre-coma
- have diabetic ketoacidosis (a diabetic complication causing nausea, vomiting, stomach pain and rapid weight loss)
- have severe dehydration (either due to vomiting, diarrhoea, or shock)
- have severe infection
- are scheduled for X-ray or scan using iodination contrast agents
- have an upcoming major surgery
Before taking PIOSAFE MF inform your doctor if you:
- have or had a previous history of smoking
- had previous irradiation of the pelvic region
- are receiving chemotherapy or radiotherapy
- have macular oedema (swelling of the back of the eye with worsening of the vision)
- have polycystic ovary syndrome (presence of cysts on your ovaries)
- are fasting or malnourished
Use in pediatrics:
PIOSAFE MF 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. Consult your child’s doctor for advice.
Use in geriatrics:
PIOSAFE MF 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 PIOSAFE MF.
INTERACTIONS
A. Drug-Drug interactions:
Before taking PIOSAFE MF 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 PIOSAFE MF, 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
| Drug | : | Metformin, Pioglitazone |
| Pharmacological Category | : | Biguanides, Thiazolidinediones |
| Therapeutic Indication | : | Type II diabetes mellitus |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep PIOSAFE MF out of reach of children
- Store at room temperature
FAQs ABOUT PIOSAFE MF
Can I consume alcohol while taking PIOSAFE MF?
No, avoid consumption of alcohol while taking PIOSAFE MF since it may increase the risk of lactic acidosis. Also, prior to the treatment with PIOSAFE MF, please inform your doctor if you have a history of alcoholism or acute alcohol intoxication as a precaution.
Is PIOSAFE MF safe to use in elderly patients?
Yes, PIOSAFE MF 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 PIOSAFE MF.
Can PIOSAFE MF be taken during pregnancy?
PIOSAFE MF is not recommended for use in pregnant women. If you are pregnant or planning to get pregnant, consult your doctor for advice before taking PIOSAFE MF.
Can PIOSAFE MF cause weight gain?
Yes, PIOSAFE MF 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 PIOSAFE MF, 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 PIOSAFE MF safe to use in patients with kidney problems?
PIOSAFE MF 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 PIOSAFE MF.
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
PRODUCT DETAILS
ALTERNATE BRANDS View All
The contents of this website are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Do not disregard professional medical advice or delay in seeking it because of something you have read on this website.
