Each film coated tablet of Vilmet® 850/ 50 contains:

• Metformin HCL   850 mg
• vildagliptin   50 mg 

Each film-coated tablet of Vilmet® 1000/ 50 contains:

• Metformin HCL    500 mg 
• vildagliptin  50mg 

• Vilmet®: is used as oral antidiabetic medicine
• it is recommended as an adjunct to diet and physical exercise for the treatment of non-insulin dependent diabetes mellitus (Type 2).
• Vilmet®: is used when the monotherapy with vildagliptin or metformin dose not result in adequate glycemic control.
• Vilmet®: is used in the replacement of the free combination therapy of  vildagliptin and metformin.

Vilmet® tablets are contrainticated in:-

• if you are allergic (hypersensitive) to vildagliptin, metformin or any of the other ingredients of this medicine .
• if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis  or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
• if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems.
• if you have severely reduced kidney function.
• if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body).
• if you are going to have a contrast x-ray (a specific type of x-ray involving an injectable dye).
• if you have liver problems.
• if you drink alcohol excessively.
• if you are breast-feeding .

¤ Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Vilmet®.

¤ It is especially important to mention to your doctor if you take the following:

• Glucocorticoids generally used to treat inflammation
• Beta-2 agonists generally used to treat respiratory disorders
• Other medicines used to treat diabetes
• Medicines which increase urine production (diuretics)
• Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• Certain medicines affecting the thyroid.
• Certain medicines affecting the nervous system.
• Certain medicines used to treat angina (e.g. ranolazine).
• Certain medicines used to treat HIV infection (e.g. dolutegravir).
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g. vandetanib).
• Certain medicines used to treat heartburn and peptic ulcers (e.g cimetidine).

¤ If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Vilmet® before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Vilmet®.

• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risk of taking Vilmet® during pregnancy.
• Do not use Vilmet® if you are pregnant or breast-feeding

Like all medicines, this medicine can cause side effects, although not everybody gets them.

¤ You should stop taking Vilmet® and see your doctor immediately if you experience
  the following side effects:

• Lactic acidosis (very rare: may affect up to1 user in 10,000): Vilmet® may cause a very rare, but very serious side effect called lactic acidosis.
• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives.
• Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine.
• Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.

¤ Some patients have experienced the following side effects while taking Vilmet®:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, pain in and around the stomach (abdominal pain), loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, trembling that cannot be controlled, metallic taste, low blood glucose.
• Uncommon (may affect up to 1 in 100 people): joint pain, tiredness, constipation, swollen hands, ankle or feet (oedema).
• Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever; signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing; redness of the skin, itching; decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or memory disturbances).

¤ Some patients have experienced the following side effects while taking Vilmet® and a sulphonylurea:

• Common: dizziness, tremor, weakness, low blood glucose, excessive sweating.

¤ Some patients have had the following side effects while taking Vilmet® and insulin:

• Common: headache, chills, nausea (feeling sick), low blood glucose, heartburn.
• Uncommon: diarrhoea, flatulence.

• Always take this medicine exactly as your doctor has told you, Check with your doctor if you are not sure.
• The amount of Vilmet® that people have to take varies depending on their condition.
• The recommended dose is one film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg taken twice a day.
• If you have reduced kidney function, your doctor may prescribe a lower dose.
• Also if you are taking an anti-diabetic medicine known as a sulphonylurea your doctor may prescribe a lower dose.
• Your doctor may prescribe this medicine alone or with certain other medicines that lower the level of sugar in your blood.

¤ Risk of lactic acidosis:

 - Vilmet® may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration , liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart diseases).

 - If any of the above apply to you, talk to your doctor for further instructions.

¤ Stop taking Vilmet® for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.

¤ Stop taking Vilmet® and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.Symptoms of lactic acidosis include:vomiting , stomach ache (abdominal pain),muscle cramps, a general feeling of not being well with severe tiredness,difficulty in breathing and reduced body temperature and heartbeat. 

¤  A test to determine your liver function will be performed before the start of Vilmet® treatment, at three-month intervals for the first year and periodically thereafter. This is so those  signs of increased liver enzymes can be detected as early as possible.

¤ During treatment with Vilmet®, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.

• Vilmet® 50 mg/850 mg tablets: (Blister of 5 Tablets, Pack of 4 blisters). 
• Vilmet® 50 mg/1000 mg tablets: (Blister of 5 Tablets, Pack of 4 blisters).

• Vilmet® tablets store in a dry place at a temperature not exceeding 25°C.