Package Leaflet: Information for the User

Eucreas 50mg/850mg Film-Coated Tablets

Eucreas 50mg/1000mg Film-Coated Tablets

vildagliptin/hydrochloride of metformin

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Eucreas and what it is used for

2.What you need to know before starting to take Eucreas

3.How to take Eucreas

4.Possible side effects

5.Storage of Eucreas

6.Contents of the pack and additional information

The active principles of Eucreas, vildagliptin and metformin,belong to a group of medications called “oral antidiabetics”.

Eucreasis used to treat adult patients with type2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus. Eucreas is used when diabetes cannot be controlled with diet and exercise alone and/or with other medications used to treat diabetes (insulin or sulfonylureas).

Type2 diabetes appears if the body does not produce enough insulin or if the insulin produced does not function properly. It can also appear if the body produces too much glucagon.

Insulin and glucagon are produced in the pancreas. Insulin helps to reduce blood sugar levels, especially after meals. Glucagon promotes the production of sugar by the liver and causes blood sugar levels to increase.

How Eucreas works

Both active principles, vildagliptin and metformin, help to control blood sugar levels. The active principle vildagliptin stimulates the pancreas to produce more insulin and less glucagon. The active principle metformin helps the body to use insulin better.This medication has been shown to reduce blood sugar levels, which will help to prevent complications of your diabetes.

Do not take Eucreas

• if you are allergic to vildagliptin, metformin or any of the other components of this medication (listed in section 6). If you think you may be allergic to any of these components, consult your doctor before taking Eucreas.
• if you have uncontrolled diabetes, 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 in which substances called "ketone bodies" accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or a fruity odor in your breath.
• if you have recently had a heart attack or if you have severe heart failure or circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have severe kidney function reduction.
• if you have a severe infection or severe dehydration (massive loss of body water).
• if you are undergoing a contrast radiology (a specific type of diagnostic test with X-rays and an injectable contrast medium). For more information, see the "Warnings and precautions" section.
• if you have liver problems.
• if you drink excessive alcohol (daily or occasionally).
• if you are breastfeeding (also see "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

Eucreas may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Eucreas for a short period of time if you have a condition that may be associated with dehydration (significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop taking Eucreas and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

Lactic acidosis is a medical emergency and should be treated in a hospital.

Eucreas is not a substitute for insulin. Therefore, do not take Eucreas for the treatment of type 1 diabetes.

Consult your doctor, pharmacist or nurse before starting to take Eucreas if you have or have had a pancreatic disease.

Consult your doctor, pharmacist or nurse before starting to take Eucreas if you are taking a diabetes medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with Eucreas to avoid low blood sugar (hypoglycemia).

If you have previously taken vildagliptin but had to stop taking it due to liver disease, do not take this medication.

Skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse for skin and foot care and pay special attention to the appearance of blisters or ulcers while taking Eucreas. If this occurs, you must consult your doctor immediately.

If you need to undergo major surgery, stop taking Eucreas while the procedure is performed and for a period of time afterwards. Your doctor will decide when to interrupt Eucreas treatment and when to restart it.

Liver function tests should be performed before starting Eucreas treatment, at three-month intervals during the first year and periodically thereafter. This is done to detect as soon as possible any sign of increased liver enzymes (transaminases).

During Eucreas treatment, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person and/or if your kidney function is deteriorating.

Your doctor will monitor your blood sugar levels and urine periodically.

Children and adolescents

The administration of Eucreas is not recommended in children and adolescents under 18 years old.

Other medications and Eucreas

If you need to be administered an injection of a contrast medium containing iodine, for example, in the context of a radiography or exploration, stop taking Eucreas before the injection or at the time of the injection. Your doctor will decide when to interrupt Eucreas treatment and when to restart it.

Inform your doctor if you are taking, have taken recently or may need to take any other medication. You may need more frequent blood sugar and kidney function tests, or your doctor may need to adjust the Eucreas dose. It is especially important to mention the following:

• corticosteroids, generally used to treat inflammation
• beta-2 agonists, generally used to treat respiratory disorders
• other active principles used to treat diabetes
• diuretics, which increase urine production
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medications used to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• substances that affect the thyroid
• substances that affect the nervous system
• substances used to treat angina pectoris (for example, ranolazine)
• substances used to treat HIV infection (for example, dolutegravir)
• substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (for example, vandetanib)
• substances used to treat stomach acid and peptic ulcers (for example, cimetidine)

Taking Eucreas with alcohol

Avoid excessive alcohol consumption while taking Eucreas, as this may increase the risk of lactic acidosis (see "Warnings and precautions" section).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

The dose of Eucreas that each person should take varies depending on their condition. Your doctor will tell you exactly the dose of Eucreas that you should take.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is a film-coated tablet of 50mg/850mg or 50mg/1000mg twice a day.

If you have reduced renal function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking a diabetes medication known as a sulfonylurea.

Your doctor may prescribe this medication alone or in combination with certain medications that lower blood sugar levels.

How to Use Eucreas

• Swallow the tablets whole with a glass of water
• Take one tablet in the morning and the other at night with meals or after meals. Taking the tablet after meals will reduce the risk of digestive discomfort.

Follow your doctor's dietary advice. In particular, if you are following a weight control diet for diabetics, continue with the diet while taking Eucreas.

If You Take MoreEucreasThan You Should

If you have taken too many Eucreas tablets, or if someone else has taken your tablets,consult your doctor or pharmacist immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging and this leaflet with you.

If You Forget to TakeEucreas

If you forget to take a tablet, take it with the next meal, unless it is already time to take the usual dose. Do not take a double dose (two tablets at once) to make up for the missed doses.

If You Interrupt Treatment with Eucreas

Continue taking this medication as long as your doctor prescribes it for you so that they can continue to monitor your blood sugar levels. Do not stop taking Eucreas unless your doctor tells you to. If you have any doubts about the duration of treatment, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

You shouldstop taking Eucreas andimmediately consult your doctorif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to1in 10,000people):Eucreas may cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs,you should stop taking Eucreas and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
• Angioedema (rare:may affect up to 1 in 1,000people): symptoms that includeswollen face, tongue, or throat,difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (infrequent:may affect up to 1in 100people): symptoms that includeyellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (infrequent:may affect up to 1in 100people): symptoms that includeintense and persistent abdominal pain (stomach area), which may reach your back, as well as nausea and vomiting.

Other side effects

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

• Frequent (may affect up to 1in 10people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled tremor, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, abdominal pain, and stomach discomfort.
• Infrequent (may affect up to 1in 100people): fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite,swollen hands, ankles, or feet (edema), chills, pancreatitis, muscle pain.

• Very rare (may affect up to 1in 10,000people): signs of having high levels of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe vomiting and nausea, abdominal pain, irregular heartbeat or deep, rapid breathing; skin redness, itching; decreased levels of vitamin B12 (pale skin, fatigue, mental symptoms such as confusion or memory alterations).

Since the marketing of this product, the following side effects have also been reported:

• Unknown frequency (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or flat, pointed, red, and rounded patches under the skin's surface or bruises.

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect not listed in this leaflet.You can also report themdirectly through the national notification system included inAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Maintain this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging and blisterafter “CAD”/”EXP”. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Store in the original packaging (blister) to protect it from moisture.
• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Eucreas

• The active principles are vildagliptin and hydrochloride of metformin.
• Each Eucreas 50 mg/850 mg film-coated tablet contains 50 mg of vildagliptin and 850 mg of hydrochloride of metformin (corresponding to 660 mg of metformin).
• Each Eucreas 50 mg/1000 mg film-coated tablet contains 50 mg of vildagliptin and 1000 mg of hydrochloride of metformin (corresponding to 780 mg of metformin).
• The other components are: hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.

Appearance of the product and contents of the pack

Eucreas 50 mg/850 mg film-coated tablets are yellow, oval-shaped tablets with “NVR” on one side and “SEH” on the other.

Eucreas 50 mg/1000 mg film-coated tablets are dark yellow, oval-shaped tablets with “NVR” on one side and “FLO” on the other.

Eucreas is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multiple packs containing 120 (2 x 60), 180 (3 x 60) or 360 (6 x 60) film-coated tablets. It is possible that only some pack sizes and doses are marketed in your country.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible person for manufacturing

Lek d.d, PE PROIZVODNJA LENDAVA

Trimlini 2D

Lendava, 9220

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Novartis Pharmaceutical Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana

Slovenia

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can obtain further information about this medicinal product by contacting the representative of the marketing authorisation holder in your country:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu