VildNox™- M 50/500

10X10 Tablets

VildNox™- M 50/500 is a combination of Metformin and Vildagliptin. It is an anti-diabetic medicine used in the treatment of type 2 diabetes in adults. It works by increasing insulin release and improving your body's response to insulin (a hormone that enables your body to sugar sugar). It also decreases glucose production, thereby lowers your blood sugar levels.

VildNox™- M 50/500 may result in low blood sugar levels and you may feel hungry, irritable, confused, anxious, or shaky. It is always recommended to eat or drink a fast-acting source of sugar (fruit juice, candy, raisins, etc.) to quickly treat these symptoms. Other common side effects include headache, dizziness, nausea/vomiting, diarrhoea, etc. Consult your doctor if these symptoms stay for a long time or if they become severe.

VildNox™- M 50/500 should be taken exactly as advised by your doctor. Take it at the same time every day to maintain a constant level of this medicine in your body. Do not skip a dose or discontinue the treatment as it may cause an increase in your blood sugar levels. It is advised to follow proper exercise and diet routine along with this medicine to get the best results.

VildNox™- M 50/500 is not recommended if you are allergic to it. VildNox™- M 50/500 may interact with other medicines, so inform your doctor if you are taking any medicines and/or supplements. Inform your doctor if you have kidney or liver problems. This medicine is not recommended in children below 18 years of age. Consult your doctor if you are pregnant, planning a pregnancy or are breastfeeding.

Major & minor side effects for VildNox™- M 50/500

• Headache
• Low blood sugar levels (hypoglycaemia)
• Change in taste
• Nausea and vomiting
• Diarrhoea
• Stomach pain
• Loss of appetite
• Dizziness
• Fatigue

What is it prescribed for?

• Type II Diabetes Mellitus

Type 2 Diabetes is a condition that causes an increase in the blood sugar levels. In type 2 diabetes, the insulin produced by your body cannot be used properly by the cells to convert glucose into energy. VildNox™- M 50/500 effectively reduces blood sugar levels in Type II Diabetes.

Commonly asked questions

• How long does it take for this medicine to take effect?

The time required for VildNox™- M 50/500 to show its effect is not clinically known.

• How long do the effects of this medicine last?

The time for which VildNox™- M 50/500 remains active in your body is not clinically known.

• Is it safe to consume alcohol while taking this medicine?

Consumption of alcohol is not recommended during treatment with VildNox™- M 50/500  as it may increase the risk of lactic acidosis (increased blood lactic acid levels). It may also affect the ability of this medicine to control your blood sugar levels.

• Is this a habit forming medicine?

No habit forming tendency has been reported with Vildapride M 500/50 Tablet.

• Can this medicine be taken during pregnancy?

Due to a lack of sufficient safety and efficacy data, VildNox™- M 50/500 is not recommended for use in pregnancy. Consult your doctor if you are pregnant or planning a pregnancy.

• Can this medicine be taken while breast-feeding?

VildNox™- M 50/500 may passes into breastmilk. This medicine is not recommended while breastfeeding due to the increased risk of hypoglycaemia in your baby. Consult your doctor if you are breastfeeding.

Allergy

Avoid taking VildNox™- M 50/500 if you are allergic to it. However, seek immediate medical attention if you notice any symptoms such as skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulty, etc.

Type I Diabetes mellitus

Type 1 diabetes, also known as insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin. Symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. VildNox™- M 50/500 is not recommended if you have type 1 diabetes mellitus.

Metabolic Acidosis

Metabolic acidosis is characterized by high levels of acids in your blood. The symptoms include thirst, frequent urination, vomiting, abdominal pain, weakness, muscle cramps, etc. VildNox™- M 50/500 is not recommended if you have metabolic acidosis as this medicine may worsen your condition.

Liver impairment

Liver impairment is the loss of liver function. VildNox™- M 50/500 is not recommended if you have liver problems due to increased risk of severe side effects.

Severe kidney impairment

Kidney impairment is the loss of kidney function. VildNox™- M 50/500 is not recommended if you have severe kidney problems as it may cause complications such as lactic acidosis (acid build up in the blood).

Warnings for special population

Pregnancy

Due to a lack of sufficient safety and efficacy data, VildNox™- M 50/500 is not recommended for use in pregnancy. Consult your doctor if you are pregnant or planning a pregnancy.

Breast-feeding

VildNox™- M 50/500 may passes into breastmilk. This medicine is not recommended while breastfeeding due to the increased risk of hypoglycaemia in your baby. Consult your doctor if you are breastfeeding.

General warnings

Skin disorders

VildNox™- M 50/500 may increase the risk of skin lesions (abnormal changes on the skin). Therefore, monitoring for skin disorders such as blistering or ulceration (open sores) is recommended while taking this medicine.

Use in children

VildNox™- M 50/500 is not recommended for use in children below 18 years of age due to a lack of safety and efficacy data.

Kidney diseases

VildNox™- M 50/500 should be used with caution if you have kidney problems as it may increase the risk of lactic acidosis (high levels of lactic acid in the blood). Your doctor may recommend dose adjustment based on your clinical condition.

Driving or operating machines

VildNox™- M 50/500 may cause low blood sugar levels and dizziness which may affect your mental alertness. Avoid driving or operating machines if you experience these symptoms after taking this medicine.

Surgery

VildNox™- M 50/500 is not recommended to be used during surgery due to the increased risk of lactic acidosis (high levels of lactic acid in the blood). If you are taking this medicine, inform your doctor before undergoing any surgery. Your doctor may suggest you to discontinue the treatment before surgery.

Hypoglycaemia

Though less common, VildNox™- M 50/500 may cause hypoglycemia. Regular monitor your blood sugar levels to check if your blood sugar levels are in control. Your doctor may advise you to carry a sugar candy to counteract the effects of low blood sugar levels when necessary.

Liver Diseases

VildNox™- M 50/500 may increase your risk of liver damage. If you have any liver problems, your doctor may suggest test to monitor your liver functions.

Missed Dose

Try not to skip a dose of VildNox™- M 50/500. Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed one. Do not double the dose to compensate for a missed one.

Overdose

Do not take excess dose than that prescribed by your doctor. Reach the nearest emergency medical department in case of an overdose with VildNox™- M 50/500 for further guidance.

All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.

Interaction with Alcohol

Description

N/A

Instructions

Consumption of alcohol is not recommended during treatment with VildNox™- M 50/500as it may increase the risk of lactic acidosis (increased blood lactic acid levels). It may also affect the ability of this medicine to control your blood sugar levels.

Interaction with Medicine

Clozapine

Estradiol

Gatifloxacin

Corticosteroids

Iodinated Contrast Media

Acetazolamide

ACE inhibitors

Cimetidine

Disease interactions

Pancreatitis

Pancreatitis is the swelling of the pancreas. VildNox™- M 50/500may increase the risk of pancreatitis and should be used with caution if you have a history of acute pancreatitis. Consult your doctor before taking this medicine.

Vitamin B12 deficiency

VildNox™- M 50/500should be used with caution if you have vitamin B12 deficiency. This medicine interferes with the absorption of Vitamin B12 in your body. Consult your doctor if you are taking these medications together.

Food interactions

Information not available.

Lab interactions

Information not available.

This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.

Take VildNox™- M 50/500 with food or as prescribed by your doctor. Avoid taking more than the prescribed dose as it may increase the risk of side effects.

Avoid the discontinuation of VildNox™- M 50/500without consulting your doctor.

Your doctor may suggest regular monitoring of your blood sugar levels to check that your diabetes is under control.

Do a regular follow-up visits with your doctor so that your doctor can evaluate your condition.

Maintain a proper diet and do regular exercise to get maximum benefits of the treatment.

Miscelleneous

To be taken with food

To be taken as instructed by doctor

May cause sleepiness

How it works

VildNox™- M 50/500 is a combination of Metformin and Vildagliptin. Metformin works by improving the body’s response to insulin (a hormone that enables your body to use sugar) and decreasing glucose (sugar) production in the liver. This helps in lowering the increased blood sugar levels. Vildagliptin works by increasing insulin release from the pancreas and also increasing the activity of hormone (Glucagon like peptide-1) which helps to control blood sugar levels.

Legal Status

Approved

Unknown

Approved

Unknown

Classification

Category

Antidiabetic combinations, Oral Biguanides, Dipeptidyl peptidase 4 inhibitors

Schedule

Schedule H

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https://www.medicines.org.uk/emc/product/11521/smpc>