INTRODUCTION

VILDANEX M is a combination of Metformin and Vildagliptin which belongs to the group of medicines called Antidiabetic agents. VILDANEX M is used to treat type 2 diabetes (also known as non-insulin dependent diabetes mellitus) in adult patients, whose diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulphonylureas such as glimepiride, glipizide). Type 2 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.

Metformin decreases hepatic glucose production and intestinal absorption of glucose and improves insulin sensitivity (increases peripheral glucose uptake and utilization). Vildagliptin works by making the pancreas produce more insulin and less glucagon, thus leading to a decrease in blood glucose levels.  Along treatment with VILDANEX M, follow regular exercise and diet plan as advised by your doctor to achieve better results.

Before taking VILDANEX M inform your doctor if you have liver, kidney, or heart problems. It should be used during pregnancy only if advised by your doctor and not recommended for use in breast-feeding women. VILDANEX M is not suitable for use in children and adolescents under 18 years of age and it should be used with caution in elderly patients (65 years of age and above). Avoid consumption of alcohol during treatment with VILDANEX M as it may increase the risk of lactic acidosis. The most common side effects of taking VILDANEX M are nausea, vomiting, stomach pain, headache, low blood sugar and diarrhoea. Contact your doctor if any of the symptoms worsen.

USES OF VILDANEX M

• To treat type II diabetes mellitus (whose diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes)

HOW VILDANEX M WORKS

VILDANEX M helps to control the level of sugar in the blood, where metformin works by helping the body to make better use of insulin and vildagliptin works by making the pancreas produce more insulin and less glucagon.

DIRECTIONS FOR USE

Take VILDANEX M as directed by your physician. Take this medicine with or just after the 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 upon age and health condition. Do not stop taking VILDANEX M without informing your doctor.    

SIDE EFFECTS OF VILDANEX M

HOW TO MANAGE SIDE EFFECTS

Diarrhoea:

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

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. 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.

Nausea and vomiting:

Stick to simple meals. Avoid eating oily, fried, or spicy food. Do not perform any strenuous activities immediately after eating. Consult your doctor if the symptom did not improve.

Headache:

Rest and relax. Drink sufficient amount of fluids such as water. Apply a pain-relieving balm on the head if required. Consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking VILDANEX M inform to your doctor, if you are taking any of these medicines:

• glucocorticoids such as dexamethasone, prednisolone (treats inflammation)
• beta-2 agonists such as albuterol, terbutaline (treats respiratory disorders)
• diuretics such as chlorthalidone, hydrochlorothiazide (used to increase urine production)
• ibuprofen and celecoxib (treats pain and inflammation)
• angiotensin-converting enzyme (ACE) inhibitors (Ex. enalapril, lisinopril) and angiotensin II receptor antagonists (Ex. losartan, telmisartan) (treats high blood pressure)
• medicines affecting the nervous system and thyroid
• other medicines used to treat diabetes (Ex. glimepiride, glipizide)
• ranolazine (treats chest pain)
• dolutegravir (treats HIV infection)
• vandetanib (treats medullary thyroid cancer)
• cimetidine (treats heartburn and peptic ulcers)

Overdosage:

If you or anyone else accidentally take too much of VILDANEX M, consult your doctor immediately. Overdosage symptoms of VILDANEX M might include low blood sugar levels, lactic acidosis, muscle pain, mild and transient burning or tickling sensation in body, fever, and edema.

SYNOPSIS

MORE INFORMATION

• Keep VILDANEX M out of reach of children
• Do not store above 30°C

FAQs ABOUT VILDANEX M

What is VILDANEX M used for?

VILDANEX M is used to treat type 2 diabetes (also known as non-insulin dependent diabetes mellitus) in adult patients, whose diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulphonylureas such as glimepiride, glipizide).

Can VILDANEX M be used in elderly patients?

VILDANEX M should be used with caution in elderly patients above 65 years of age, especially in patients with impaired kidney function. Your doctor will adjust the dose depending upon kidney function and your kidney function will be monitored regularly. Consult with your doctor before taking VILDANEX M. 

Is VILDANEX M safe to use in patients with heart problems?

VILDANEX M is not recommended in patients who recently had heart attack or heart failure or any signs of heart problems such as serious problems with blood circulation or difficulty in breathing. Consult your doctor before taking VILDANEX M.

What are the most common side effects of taking VILDANEX M?

The most common side effects of taking VILDANEX M are nausea, vomiting, stomach pain, headache, dizziness, loss of appetite, metallic taste, uncontrolled trembling, low blood sugar and diarrhoea. Contact your doctor if any of the symptoms worsen.

Can I consume alcohol while taking VILDANEX M?

Consumption of alcohol is not recommended during treatment with VILDANEX M since it may increase the risk of lactic acidosis. Consult your doctor before taking VILDANEX M if you are alcoholic or with history of alcoholism.

REFERENCES

1. KD Tripathi MD. Hormones and related drugs. Essentials of Medical Pharmacology. Seventh edition. New Delhi, May 2013. Page – 274.

2. Paresh Ved and Samrat Shah. Evaluation of vildagliptin and fixed dose combination of vildagliptin and metformin on glycemic control and insulin dose over 3 months in patients with type 2 diabetes mellitus. March 2012. [Accessed on 30th June 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3354946/

3. Serge Halimi, Anja Schweizer, Biljana Minic, James Foley and Sylvie Dejage. Combination treatment in the management of type 2 diabetes: focus on vildagliptin and metformin as a single tablet. March 2008. [Accessed on 30th June 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2515409/

4. Novartis Pharma GmbH. Electronic Medicines Compendium (EMC) [Revised in August 2021] [Accessed on 30th June 2021] https://www.medicines.org.uk/emc/files/pil.6226.pdf

5. Cipla Ltd. VYSOV-M Tablets (Vildagliptin + Metformin hydrochloride). [Revised in July 2020] [Accessed on June 30, 2021] https://ciplamed.com/print-product-pdf/37162

USEFUL DIAGNOSTIC TESTS

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