Product Description:
The active substances Vildagliptin/Metformin belong to a group of medicines called "oral antidiabetics."
Vildagliptin/Metformin is used to treat adult patients with Type 2 diabetes.
This type of diabetes is also known as non-insulin-dependent diabetes mellitus.
Vildagliptin/Metformin is used when diabetes cannot be controlled through diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulfonylureas).
Type 2 diabetes develops if the body does not produce enough insulin, or if the insulin produced by the body does not work as it should.
Diabetes can also develop if the body produces too much glucagon.
Both insulin and glucagon are made in the pancreas.
Insulin helps lower blood sugar levels, especially after meals.
Glucagon triggers sugar production in the liver, leading to high blood sugar levels.
How Vildagliptin/Metformin works:
Both active substances, Vildagliptin and Metformin, help regulate blood sugar levels.
The active substance Vildagliptin works by making the pancreas produce more insulin and less glucagon.
The active substance Metformin works so that the body can use insulin better.
This medicine has been shown to reduce blood sugar, which helps prevent complications of diabetes.
Instructions for use:
The amount of Vildagliptin/Metformin a person should take depends on their condition.
The doctor will tell you exactly how many tablets of Vildagliptin/Metformin to take.
Always use this medicine exactly as your doctor has told you. Contact a doctor or pharmacist if you are unsure.
The recommended dose is:
One film-coated tablet of 50 mg / 850 mg or 50 mg / 1000 mg twice daily.
If you have impaired kidney function, your doctor may prescribe a lower dose.
Your doctor may also prescribe a lower dose if you are taking a diabetes medicine called a sulfonylurea.
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
When and how to take Vildagliptin/Metformin:
Swallow the tablets whole with a glass of water.
Take one tablet in the morning and the other in the evening with or immediately after food.
By taking the tablet immediately after a meal, the risk of an upset stomach is reduced.
Continue to follow the dietary recommendations you received from your doctor.
If you are following a weight-control diet for diabetics, it is especially important to continue it while taking Vildagliptin/Metformin.
If you take too much Vildagliptin/Metformin:
Contact a doctor or pharmacist immediately if you take too many Vildagliptin/Metformin tablets or if someone else takes your tablets.
Medical supervision may be necessary.
If you have to see a doctor or go to a hospital, you should take the package and this enclosed leaflet with you.
If you forget to take Vildagliptin/Metformin:
If you forget to take a tablet, take it with your next meal unless you were going to take one anyway.
Do not take a double dose (two tablets) to make up for a forgotten tablet.
If you stop treatment with Vildagliptin/Metformin:
Continue taking this medicine as long as your doctor prescribes it so that it can control your blood sugar.
Do not stop treatment with Vildagliptin/Metformin unless your doctor tells you to.
If you have questions about how long you should use this medicine, contact your doctor.
Ask your doctor, pharmacist, or nurse if you have any questions about using this medicine.
Warnings and Precautions:
Do not use Vildagliptin/Metformin:
If you are allergic to Vildagliptin, Metformin, or any of the other ingredients of this medicine.
Talk to your doctor before taking Vildagliptin/Metformin if you think you are allergic to any of these substances.
If you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis.
Ketoacidosis is a condition where substances called ketone bodies build up in the blood, which can lead to a diabetic coma.
Symptoms include stomach pain, fast and deep breathing, sleepiness, or breath with an unusual fruity smell.
If you have recently had a heart attack or have heart failure, serious circulatory problems, or breathing problems, which may be signs of heart problems.
If you have severely impaired kidney function.
If you have a serious infection or are severely dehydrated (lost a lot of water from the body).
If you are going to have a contrast X-ray (a special type of X-ray involving an injectable dye).
If you have liver problems.
If you drink large amounts of alcohol (either every day or occasionally).
If you are breastfeeding.
Risk of Lactic Acidosis:
Vildagliptin/Metformin can cause a very rare but very serious side effect called lactic acidosis, especially if the kidneys are not working properly.
The risk of lactic acidosis also increases with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration, liver problems, and any medical condition where a part of the body lacks oxygen supply (such as acute heart disease).
Talk to your doctor for more information if any of the above apply to you.
Stop treatment with Vildagliptin/Metformin for a short time if you have a condition that may be associated with dehydration (loss of too much body fluid), such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal.
Talk to your doctor for more information.
Stop treatment with Vildagliptin/Metformin and contact a doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis, as this condition can lead to a coma.
Symptoms of lactic acidosis include:
Stomach pain (abdominal pain).
Muscle cramps.
A general feeling of malaise with severe fatigue.
Difficulty breathing.
Decreased body temperature and pulse.
Ingredients:
The active ingredients are Vildagliptin/Metformin.
Treatment is available in two different concentrations and two different manufacturers:
Each Vildagliptin / Metformin 50 mg / 850 mg film-coated tablet contains 50 mg Vildagliptin and 850 mg Metformin Hydrochloride (equivalent to 660 mg Metformin).
Each Vildagliptin / Metformin 50 mg / 1000 mg film-coated tablet contains 50 mg Vildagliptin and 1000 mg Metformin Hydrochloride (equivalent to 780 mg Metformin).
Product Details:
Quantity: 60 Tablets
Product Type: Tablets
Brand: Galvus
Concentration: 50/850 mg
