Ozomet V 0.2/500mg Tablet 10'S

INTRODUCTION

OZOMET V 0.2/500MG TABLET is a combination of Metformin and Voglibose which belongs to the group of medicines called Antidiabetic agents. OZOMET V 0.2/500MG TABLET is indicated as a second-line therapy for the management of type II diabetes mellitus when diet, exercise and therapy with 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 management with OZOMET V 0.2/500MG TABLET, follow regular exercise and diet plan as advised by your doctor to achieve better results. 

Prior and during therapy with OZOMET V 0.2/500MG TABLET, your doctor might access your kidney functions frequently to avoid the risk of side effects, especially if you are elderly with poor kidney functions. Avoid consumption of alcohol while taking OZOMET V 0.2/500MG TABLET as it could aggravate your existing disease condition and increase the risk of lactic acidosis.

OZOMET V 0.2/500MG TABLET is generally not recommended for use in pregnant or breastfeeding women and in children (aged less than 18 years) due to lack of safety and effectiveness. It should be used with caution in elderly patients (aged 65 years or above).

The most common side effects of taking OZOMET V 0.2/500MG TABLET are nausea, vomiting, diarrhea, stomach pain, headache and dizziness. Consult your doctor if any of the side effects worsen.   

USES OF OZOMET V 0.2/500MG TABLET

• To manage type II diabetes mellitus (as second-line of therapy) when diet, exercise and therapy with single agents does not result in adequate glycemic control

HOW OZOMET V 0.2/500MG 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 voglibose acts by reversibly inhibiting the activity of various carbohydrate digestive enzymes (Ex. sucrose, maltose, zomaltase, etc.) in the gut, thus leading to delayed digestion and absorption of glucose into the blood stream.

DIRECTIONS FOR USE

Take OZOMET V 0.2/500MG TABLET as advised by your physician. Swallow OZOMET V 0.2/500MG TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF OZOMET V 0.2/500MG TABLET

HOW TO MANAGE SIDE EFFECTS

Diarrhea

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

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

Headache

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

Loss Of Appetite

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

Nausea And Vomiting

Try to take OZOMET V 0.2/500MG TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.

Stomach Pain

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

WARNING & PRECAUTIONS

PREGNANCY

Contraindicated

OZOMET V 0.2/500MG TABLET is not recommended for use in pregnant women. Consult your doctor before taking OZOMET V 0.2/500MG TABLET.   

BREASTFEEDING

Contraindicated

OZOMET V 0.2/500MG TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking OZOMET V 0.2/500MG TABLET.

DRIVING AND USING MACHINES

Use with Caution

OZOMET V 0.2/500MG TABLET has no direct influence on the ability to drive and use machines, however it may cause hypoglycemia (low blood sugar levels). Patients should be warned about signs of hypoglycemia (such as weakness, dizziness, fast heartbeat, vision disorders or difficulty in concentration) before or while driving or using machines. Do not drive or use any machines if you start to feel these symptoms.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking OZOMET V 0.2/500MG TABLET since it may increase the risk of lactic acidosis, dizziness or sleepiness. Consult your doctor before taking OZOMET V 0.2/500MG TABLET.

KIDNEY

Contraindicated

OZOMET V 0.2/500MG TABLET is not recommended for use in patients with severe kidney disease. Consult your doctor before taking OZOMET V 0.2/500MG TABLET.

LIVER

Contraindicated

OZOMET V 0.2/500MG TABLET is not recommended for use in patients with liver problems. Consult your doctor before taking OZOMET V 0.2/500MG TABLET.

ALLERGY

Contraindicated

Do not take OZOMET V 0.2/500MG TABLET if you are allergic to Metformin or Voglibose.

HEART DISEASE

Contraindicated

OZOMET V 0.2/500MG TABLET is not recommended for use in patients with heart problems (such as recent heart attack or failure, cardiogenic shock (problems in blood circulation) or abnormal breathing). Consult your doctor before taking OZOMET V 0.2/500MG TABLET.

USE IN PEDIATRICS

Contraindicated

OZOMET V 0.2/500MG TABLET is generally not recommended for use in children and adolescents (under 18 years) due to lack of safety and effectiveness. Consult your doctor before taking OZOMET V 0.2/500MG TABLET.

USE IN GERIATRICS

Use with Caution

OZOMET V 0.2/500MG TABLET should be used with caution in elderly patients (aged 65 years or above). Management with OZOMET V 0.2/500MG TABLET will be usually initiated at the low effective dose depending on kidney, liver or heart function and your doctor may assess the kidney function more frequently. Consult your doctor before taking OZOMET V 0.2/500MG TABLET.

INTERACTIONS

A. Drug-Drug interactions:

Before taking OZOMET V 0.2/500MG TABLET inform to your doctor, if you are taking any of these medicines:

• diuretics (medicines used to increase urine output) Ex. furosemide, chlorothiazide, hydrochlorothiazide
• other medicines used to treat diabetes (Ex. insulin, glipizide, glyburide, glimepiride)
• medicines used to control blood cholesterol levels such as fibric acid derivatives (Ex. fenofibrate, gemfibrozil)
• antipsychotics (used to treat mental illness) Ex. chlorpromazine, fluphenazine, mesoridazine, perphenazine, or prochlorperazine 
• monoamine oxidase inhibitors (used to treat depression) Ex. fluoxetine, sertraline
• sympathomimetic agents (used to treat circulatory disorders) Ex. ephedrine, adrenaline, noradrenaline, isoprenaline, phenylephrine and phenylpropanolamine
• medicines used to treat certain cancer (Ex. vandetanib, crizotinib, olaparib)
• cimetidine (used to treat ulcers)
• ranolazine (used to treat chest pain)
• medicines used to treat infections (isavuconazole, dolutegravir, trimethoprim)
• medicines used to treat heart problems such as alpha-blockers (alfuzosin, prazosin), beta-blockers (Ex. propranolol, atenolol), calcium channel blockers (Ex. nifedipine, verapamil)
• medicines used to treat epilepsy (Ex. phenytoin, valproic acid)
• medicines used to treat pain and inflammation (such as ibuprofen and celecoxib)
• medicines used to treat high blood pressure (Ex. captopril, enalapril, losartan, valsartan)
• bronchodilators (used to treat asthma) Ex. salbutamol, terbutaline, salmeterol, formoterol, ipratropium
• carbonic anhydrase inhibitors (used to treat glaucoma) Ex. topiramate, zonisamide, acetazolamide or dichlorphenamide
• thyroid hormones (used to treat abnormal thyroid function) Ex. thyroxine, triiodothyronine
• hormonal replacement therapy (used to correct menstrual disorders) Ex. estradiol, ethinyl estradiol
• oral contraceptives (abortion pill) Ex. mifepristone
• nicotinic acid (used to treat or prevent niacin deficiency)
• corticosteroids (used to treat inflammation) Ex. dexamethasone, prednisolone
• isoniazid (used to treat tuberculosis)
• medicines containing alcohol (such as cough syrup)
• iodinated contrast agents (used during an X-ray or scan)

Overdosage:

If you or anyone else accidentally take too much of OZOMET V 0.2/500MG TABLET, consult your doctor immediately or go to a nearest hospital straight away as it could lead to a life-threatening condition called lactic acidosis and stomach discomfort or diarrhea may occur. 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 OZOMET V 0.2/500MG TABLET out of reach of children
• Store at room temperature     

FAQs ABOUT OZOMET V 0.2/500MG TABLET

Q: Can I consume alcohol while taking OZOMET V 0.2/500MG TABLET?

A: No, avoid consumption of alcohol while taking OZOMET V 0.2/500MG TABLET since it may increase the risk of lactic acidosis, dizziness or sleepiness. Consult your doctor before taking OZOMET V 0.2/500MG TABLET if you are alcoholic or having history of alcohol consumption.

Q: Can OZOMET V 0.2/500MG TABLET be used in pregnant women?

A: No, OZOMET V 0.2/500MG TABLET is not recommended for use in pregnant women. Consult your doctor for advice before taking OZOMET V 0.2/500MG TABLET if you are pregnant or planning to get pregnant. 

Q: Is OZOMET V 0.2/500MG TABLET safe to use in elderly patients?

A: Yes, OZOMET V 0.2/500MG TABLET should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking this medicine. Your doctor might check your kidney function frequently to avoid kidney damage and for dose adjustment.

Q: What is OZOMET V 0.2/500MG TABLET used for?

A: OZOMET V 0.2/500MG TABLET is indicated as a second-line therapy for the management of type II diabetes mellitus when diet, exercise and therapy with single agents does not result in adequate glycemic control.

Q: What to do if I forget to take a dose of OZOMET V 0.2/500MG TABLET?

A: You should take OZOMET V 0.2/500MG TABLET immediately when you remember. If it is time for your next dose of OZOMET V 0.2/500MG TABLET skip the dose and follow your regular dose schedule. Do not double the dose of this medicine to match up your missed dose.  

REFERENCES

1. KD. Tripathi. Insulin, Oral Hypoglycemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 275-276 & 277.

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

3. Takeda. Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients with Impaired Glucose Tolerance". NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in December 2018]. [Accessed on 9th October 2021] https://clinicaltrials.gov/ct2/show/NCT01993927

4. Tae Jung Oh, Jae Myung Yu, Kyung Wan Min, Hyun Shik Son, Moon Kyu Lee, Kun Ho Yoon, Young Duk Song, Joong Yeol Park, In Kyung Jeong, Bong Soo Cha, Yong Seong Kim, Sei Hyun Baik, In Joo Kim, Doo Man Kim, Sung Rae Kim, Kwan Woo Lee, Jeong Hyung Park, In Kyu Lee, Tae Sun Park, Sung Hee Choi and Sung Woo Park. Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial. NCBI; PMC US National Library of Medicine, National Institute of Health. June 2019. [Accessed on 9th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6581551/

5. Torrent Pharmaceuticals Ltd. Voglitor MF. Torrentian.com. [Revised in July 2020]. [Accessed on 9th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/1720.pdf

6. Torrent Pharmaceuticals Ltd. Voglitor MF Forte. Torrentian.com. [Revised in July 2020]. [Accessed on 9th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2851.pdf

USEFUL DIAGNOSTIC TESTS

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

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 18 Oct 2023 | 05:01 PM(IST)