EUCREAS. 50 mg. / 1000 mg. 60 tablets 

 EUCREAS WHAT IS AND WHAT IT IS USED

Eucreas is used to treat patients with type 2 diabetes. This type of diabetes is also known as insulin-dependent diabetes mellitus.

Eucreas contains two active substances called vildagliptin and metformin. Both of these substances help to control blood sugar levels. Substance vildagliptin works the pancreas to produce more insulin and less glucagon. Substance metformin works by helping the body use insulin better way.

 BEFORE YOU TAKE EUCREAS

Do not take Eucreas

 If you are allergic (hypersensitive) to vildagliptin, metformin or any of the other ingredients of Eucreas (listed in Section 6). If you think you are allergic to any of these, talk to your doctor before taking Eucreas.

If you have or have had a serious complication of diabetes such as diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea and / or vomiting) or diabetic coma.

 If you have recently had a heart attack or if you have severe heart failure or circulation problems or breathing difficulties that can be a sign of heart problems.

 If you have kidney problems.

If you have a severe infection or are seriously dehydrated (have lost a lot of water from your body).

 If you have a contrast x-ray (a specific type of X-ray, which involves injecting dye). Please also see information about this in section "Take special care with Eucreas".

 If you have liver problems.

 If you drink too much alcohol (either every day or only occasionally).

 If you are breastfeeding (see also "Pregnancy and lactation").

Take special care with Eucreas

Stop taking this medication and talk to your doctor if you experience one or more of the following symptoms may be associated with a condition called "lactic acidosis":

 Feeling cold or uncomfortable

 Muscle pain

 Severe nausea or vomiting

 Pain in or around your stomach (abdominal pain)

 Drowsiness or dizziness

 Shortness of breath

If you are receiving vildagliptin but had to stop taking it because of side effects (liver disease) should not take this medicine.

Diabetic skin lesions are a common complication of diabetes. Advised to follow the recommendations for care of the skin and feet that you get from your doctor or nurse. It is also advised to pay particular attention to the appearance of new blisters or ulcers while taking Eucreas. If you have these, you should immediately consult your doctor.

Cases of inflammation of the pancreas (pancreatitis) in patients taking Eucreas. Pancreatitis can be a serious, potentially life-threatening condition. Stop taking Eucreas and contact your doctor if you experience severe and persistent stomach pain with or without vomiting, because you may have pancreatitis.

If you have stopped taking Eucreas due to surgery (you should stop taking at least 48 hours before elective surgery with general anesthesia and should not start again for at least 48 hours afterwards) or by x-ray involving an injectable dye, talk to your doctor before again taking Eucreas.

In elderly patients taking Eucreas, you should regularly monitor renal function. This will happen more often in patients with kidney problems.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important if you are already taking medicines for heart disease or to treat problems with your blood sugar, kidney or blood pressure, and medicines containing:

Glucocorticoids, which are mainly used to treat inflammation

 Beta-2 agonists, which are mainly used for the treatment of respiratory diseases

 Other medicines used to treat diabetes

 Diuretics (also called water pills)

 ACE inhibitors, which are mainly used to treat high blood pressure

 Some medicines affecting the thyroid

 Some drugs acting on the nervous system.

Eucreas station with food and drink

Take tablets during or immediately after a meal. This will reduce the risk of an upset stomach.

Avoid drinking alcohol while taking Eucreas, since alcohol may increase the risk of lactic acidosis (please see "Possible side effects").

Pregnancy and lactation

 Tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant. Your doctor will discuss with you the possible risks of taking Eucreas during pregnancy.

 Do not take Eucreas, if you are breastfeeding.

Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery

If you feel dizzy while taking Eucreas, do not drive or operate any tools or machines.

 HOW TO TAKE EUCREAS

Always take Eucreas exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.

How much to take

The amount Eucreas, people have to take varies depending on their condition. Your doctor will tell you exactly how much to take Eucreas.

When and how to take Eucreas

 Swallow the tablet whole with a glass of water

Take one tablet in the morning and one in the evening during or immediately after a meal. Taking the tablet immediately after a meal will reduce the risk of an upset stomach.

Continue to follow any advice on diet, which is directed by your doctor. Especially if you are on a diet for weight control diabetes, continue to follow while taking Eucreas.

At least once a year, your doctor will check that your kidneys are working normally. Your doctor will test your blood and urine for sugar regularly.

If you take an overdose of Eucreas

If you take too many tablets Eucreas, or if someone else takes your tablets, contact your doctor or pharmacist. You may need medical attention. Take the carton and this leaflet with you if you need to see a doctor or go to hospital.

If you forget to take Eucreas

If you forget to take a tablet, take it to the next meal unless you then you should take next. Do not take a double dose (two tablets at a time) to make up the missed dose.

If you stop taking Eucreas

Do not stop taking Eucreas, unless your doctor tells you to. If you have questions about how to take this medicine, talk to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

 POSSIBLE SIDE EFFECTS

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

Some symptoms require immediate medical attention

You should stop taking Eucreas and contact your doctor immediately if you experience the following side effects:

Angioedema (rare): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden 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-colored urine that may indicate liver disease (hepatitis).

Other side effects

Some patients have experienced the following side effects while taking Eucreas:

Very common:

 Nausea;

 Vomiting;

 Diarrhea;

Pain in and around the abdomen (abdominal pain);

 Loss of appetite.

Common:

 Dizziness;

 Headache;

 Shivering, which can not be controlled;

 Metallic taste;

 Low blood sugar.

Uncommon:

 Joint pain;

 Fatigue;

 Constipation;

Swelling of hands, ankles or feet (edema).

Rare:

 Signs of liver disease (hepatitis).

Very rare:

 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 pulse or deep, rapid breathing; Redness, itching;

Low levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory impairment).

Since the product is marketed, also reported the following adverse reactions (frequency not known):

 Itchy rash;

 Inflammation of the pancreas.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

 HOW TO STORE EUCREAS

 Keep out of reach of children.

 Do not use Eucreas after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.

Store in original package (blister) in order to protect from moisture.

 ADDITIONAL INFORMATION

 What contains Eucreas

The active substances are vildagliptin and metformin hydrochloride.Each tablet Eucreas 50 mg/850 mg contains 50 mg vildagliptin and 850 mg metformin hydrochloride (equivalent to 660 mg of metformin). Each tablet Eucreas 50 mg / 1,000 mg contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (equivalent to 780 mg of metformin). The other ingredients are: hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.