Galvus Met 50/850 mg Tablets 60

Product Description:

• The active substances in Vildagliptin/Metformin, vildagliptin and metformin, belong to a group of medicines called "oral antidiabetics".
• Vildagliptin/Metformin is used to treat adult patients with type 2 diabetes.
• This form of diabetes is also known as non-insulin dependent diabetes mellitus.
• Vildagliptin/Metformin is used when the diabetes cannot be controlled with diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulphonylurea).
• Type 2 diabetes develops if the body does not produce enough insulin, or if the insulin produced by the body does not work as well as it should.
• Diabetes can also develop if the body makes too much glucagon .
• Both insulin and glucagon are made in the pancreas.
• Insulin helps to reduce blood sugar levels, especially after meals.
• Glucagon induces the production of sugar in the liver, and causes blood sugar levels to rise.

How Vildagliptin/Metformin works:

• Both active substances, vildagliptin and metformin, help regulate blood sugar levels.
• The active substance vildagliptin works so that the pancreas produces more insulin and less glucagon .
• The active substance metformin works so that the body can better utilize insulin.
• This medicine has been shown to reduce blood sugar, which can help prevent complications of your diabetes.

How To Use:

• How much Vildagliptin/Metformin a person should take depends on his/her condition.
• The doctor will tell you exactly how many tablets to take of Vildagliptin/Metformin.
• 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 either 50 mg/850 mg or 50 mg/1000 mg twice daily.
• If you have reduced kidney function, the doctor may prescribe a lower dose.
• The doctor may also prescribe a lower dose if you are taking a medicine for diabetes called a sulfonylurea.
• The doctor may prescribe this medicine alone or together with certain other medicines that lower your 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 will be reduced.
• Continue to follow the dietary recommendations you have received from your doctor.
• If you follow a diabetic weight control diet, it is particularly important that you continue this while taking Vildagliptin/Metformin.

If you take too much Vildagliptin/Metformin:

• Contact a doctor or pharmacist immediately if you take too many tablets of Vildagliptin/Metformin or someone else has taken your tablets.
• Medical supervision may be necessary.
• If you have to see a doctor or hospital, you must take the package and this package insert with you.

If you have forgotten to take Vildagliptin/Metformin:

• If you forget to take a tablet, take it with your next meal unless you are going to take one anyway.
• You should not take a double dose (two tablets) to replace a forgotten tablet.

If you stop treatment with Vildagliptin/Metformin:

• Continue to take this medicine as long as your doctor prescribes it so that it can control your blood sugar.
• You must 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 the use of 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 may be allergic to any of these substances.
• If you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea , vomiting, diarrhoea , rapid weight loss, lactic acidosis (see "risk of lactic acidosis" below) or ketoacidosis.
• Ketoacidosis is a condition where substances called ketone bodies accumulate in the blood, and this can lead to diabetic pre-coma.
• Symptoms include stomach pain, rapid and deep breathing, sleepiness or the breath taking on an unusual and fruity smell.
• If you have recently had a heart attack or you have heart failure, severe problems with blood circulation 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 (have lost a lot of water from the body).
• If you are going to have a contrast x-ray (a special type of x-ray that involves an injectable dye).
• If you have liver problems.
• If you drink excessive 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 your kidneys are not working properly.
• The risk of developing lactic acidosis is also elevated with uncontrolled diabetes, severe infections , prolonged fasting or alcohol intake, dehydration, liver problems and any medical condition where part of the body has reduced oxygen supply (such as acute severe heart disease).
• Talk to your doctor for further information if any of the above applies to you.
• Interrupt treatment with Vildagliptin/Metformin for a short period if you have a condition that may be associated with dehydration (have lost a lot of body fluid), such as severe vomiting, diarrhea , fever , exposure to heat or if you drink less fluid than normal.
• Talk to your doctor for further information.
• Stop treatment with Vildagliptin/Metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis , as this condition can lead to coma.

Symptoms of lactic acidosis include:

• Stomach pain (abdominal pain).
• Muscle cramps.
• A general feeling of malaise with severe fatigue.
• Breathing difficulties.
• Reduced body temperature and pulse.

Ingredients:

• The active Ingredients are vildagliptin and metformin hydrochloride.

Its available with two different concentrations and 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).