Brand Name Choices
No generic medication is available for Eucreas (Vildagliptin/Metformin Hydrochloride)
What Eucreas is and what it is used for
The active substances of Eucreas, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. Eucreas is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as noninsulin-dependent diabetes mellitus. Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the body produces too much glucagon. Both insulin and glucagon are made in the pancreas. Insulin helps to lower the level of sugar in the blood, especially after meals. Glucagon triggers the liver to make sugar, causing the blood sugar level to rise. How Eucreas works Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood. The substance vildagliptin works by making the pancreas produce more insulin and less glucagon. The substance metformin works by helping the body to make better use of insulin. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes.
How to take Eucreas
The amount of Eucreas that people have to take varies depending on their condition. Your doctor will tell you exactly the dose of Eucreas to take. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 4 if you are not sure. 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. When and how to take Eucreas
•Swallow the tablets whole with a glass of water,
•Take one tablet in the morning and the other in the evening with or just after food. Taking the tablet just after food will lower the risk of an upset stomach. Continue to follow any advice about diet that your doctor has given you. In particular, if you are following a diabetic weight control diet, continue with this while you are taking Eucreas. If you take more Eucreas than you should If you take too many Eucreas tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately. Medical attention may be necessary. If you have to go to a doctor or hospital, take the pack and this leaflet with you. If you forget to take Eucreas If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway. Do not take a double dose (two tablets at once) to make up for a forgotten tablet. If you stop taking Eucreas Continue to take this medicine as long as your doctor prescribes it so that it can continue to control your blood sugar. Do not stop taking Eucreas unless your doctor tells you to. If you have any questions about how long to take this medicine, talk to your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. You should stop taking Eucreas and see your doctor immediately if you experience the following side effects:
• Lactic acidosis (very rare: may affect up to 1 user in 10,000): Eucreas may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Eucreas and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
• 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, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
• 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. 5
Other side effects Some patients have experienced the following side effects while taking Eucreas:
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 Eucreas and a sulphonylurea:
Common: dizziness, tremor, weakness, low blood glucose, excessive sweating. Some patients have had the following side effects while taking Eucreas and insulin:
Common: headache, chills, nausea (feeling sick), low blood glucose, heartburn.
Uncommon: diarrhoea, flatulence. Since this product has been marketed, the following side effects have also been reported:
• Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
How to Store Eucreas
Keep this medicine out of the sight and reach of children.
•Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
•Do not store above 30°C.
•Store in the original package (blister) in order to protect from moisture.
2 to 3 weeks on average
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