Eucreas 50 mg / 850 mg film-coated tablets
Eucreas 50 mg / 1,000 mg film-coated tablets
 
vildagliptin / metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Eucreas is and what it is used for 
2. What you need to know before taking Eucreas 
3. How to take Eucreas 
4. Possible side effects 
5. How to store Eucreas 6. Contents of the pack 
and other ingredients information

1. What Eucreas is and what it is used for

What is the medicine used for?

The active substances in Eucreas, vildagliptin, and metformin, belong to a group of medicines called ‘oral diabetes medicines.

Eucreas are used in the treatment of adult patients with type 2 diabetes. This type of diabetes is also called non-insulin-dependent diabetes mellitus.

Type 2 diabetes develops if the body does not produce enough insulin or if the insulin that the body produces does not work as well as it should. Diabetes can also develop if the body produces too much glucagon.

Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood sugar levels, especially after meals. Glucagon initiates sugar production in the liver, which causes blood sugar levels to rise.

How Eucreas works

Both the active substances, vildagliptin, and metformin, help to regulate blood sugar levels. The substance vildagliptin works by causing the pancreas to produce more insulin and less glucagon. The substance metformin works by helping the body to use insulin better. This medication has been shown to lower blood sugar, which can help prevent complications of your diabetes.

2. What you need to know before taking Eucreas

Do not take Eucreas

  • if you are allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these ingredients, do not take Eucreas without talking to a doctor.
  • if you have uncontrolled diabetes such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Lactic acidosis risk” below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies to accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or that your breath gets a different, fruity odor. 
  • If you have recently had a heart attack or if you have heart failure or severe problems with your blood circulation or difficulty breathing, it may be a sign of heart disease.
  • if you have severe renal impairment.
  • if you have a severe infection or if you are severely dehydrated (have lost a lot of water from your body).
  • if you are going to have a contrast X-ray (a special type of X-ray with a dye injection ). See also the information on this in the section “Warnings and precautions”.
  • if you have liver disease.
  • if you drink too much alcohol (either you do it every day or only periodically).
  • if you are breast-feeding (see also under “Pregnancy and breast-feeding”).

Warnings and cautions

Risk of lactic acidosis

Eucreas can cause the very rare, but very serious side effect of lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, long-term fasting or alcohol intake, dehydration (see more information below), liver problems, and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

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

Stop taking Eucreas for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to a doctor for further instructions.

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

Symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate.

Lactic acidosis is an acute medical condition that must be treated in a hospital.

Eucreas do not replace insulin. Therefore, you should not take Eucreas for the treatment of type 1 diabetes.

Talk to your doctor, pharmacist, or nurse before taking Eucreas if you have or have had a pancreatic disease.

Talk to your doctor, pharmacist, or nurse before taking Eucreas if you are taking a diabetes medicine known as a sulphonylurea. Your doctor may want to lower your dose of sulphonylurea when you take it with Eucreas to avoid low blood sugar (hypoglycemia).

If you have taken vildagliptin before but have had to stop taking it due to liver disease, you should not take this medicine.

Diabetic skin conditions are a common complication in diabetics. Therefore, it is recommended that you follow the advice given to you by your doctor or nurse for skin and foot care. You are also advised to pay special attention to the appearance of blisters or sores when taking Eucreas. Should any of these occur, contact a doctor as soon as possible.

If you are going to have a major operation, you must stop taking Eucreas during the operation and for a certain time after it. Your doctor will decide when to stop taking Eucreas and when to start taking it again.

Liver function tests will be performed before starting treatment with Eucreas, at three-month intervals during the first year and periodically thereafter. This is to detect elevated liver enzyme values ​​as early as possible.

During treatment with Eucreas, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

Your doctor will take regular blood and urine tests to check your blood sugar.

Children and young people

The use of Eucreas in children and adolescents up to 18 years of age is not recommended.

Other drugs and Eucreas

If you need to get an injection in the blood with contrast media that contain iodine, for example in connection with X-rays or computed tomography, you must stop taking Eucreas before or at the time of injection. The doctor will decide when to stop taking Eucreas and when to start taking that again.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Eucreas. You must mention the following:

  • glucocorticoids commonly used in the treatment of inflammation
  • beta-2 agonists are commonly used in the treatment of respiratory problems
  • another anti-diabetic
  • drugs that increase urine production ( diuretics )
  • drugs used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
  • certain medicines for high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists)
  • certain drugs that affect the thyroid gland or
  • certain drugs that affect the nervous system.

Eucreas with alcohol

Avoid high alcohol intake while taking Eucreas as alcohol may increase the risk of lactic acidosis (see section “Warnings and Precautions”).

Pregnancy and breastfeeding

  • 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 possible risks of taking Eucreas during pregnancy.
  • Do not take Eucreas if you are pregnant or breast-feeding (see also “Do not take Eucreas”).

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

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

3. How to take Eucreas

Dos en Eucreas varies between different people depending on their disease state. Your doctor will tell you exactly what dose of Eucreas to take.

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is a film-coated tablet of either 50 mg / 850 mg or 50 mg / 1,000 mg twice daily.

If you have impaired kidney function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking a diabetes medicine known as a sulphonylurea.

Your doctor may prescribe this medicine alone or in combination with certain other medicines that lower your blood sugar level.

When and how to take Eucreas

  • Swallow the tablets whole with a glass of water.
  • Take one tablet in the morning and one in the evening with or shortly after a meal. If the tablet is taken shortly after a meal, the risk of stomach problems is reduced.

Continue to follow the dietary advice given to you by your doctor, especially if you are following a weight loss diet program. Continue with this when taking Eucreas.

If you take more Eucreas than you should

If you take more Eucreas than you should, or if someone else takes your tablet, contact your doctor or pharmacist immediately. You may need medical attention. If you have to go to a doctor or hospital, bring the medicine pack and this leaflet.

If you forget to take Eucreas

If you forget to take a tablet, take it at the next meal unless it is time to take your next dose. Do not take a double dose (two tablets at the same time) to make up for a forgotten tablet.

If you stop taking Eucreas

Keep taking this medicine for 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. Talk to your doctor if you have any questions about how long to take this medicine.

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

4. Possible side effects

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

You should stop taking Eucreas and see a doctor immediately if you get the following side effects:

  • Eucreas can cause very rare (may affect up to 1 in 10,000) but very serious side effects a lactic acidosis (see section “Warnings and Precautions”). If this happens to you, you must stop taking Eucreas and contact a doctor or nearest hospital immediately as lactic acidosis may lead to coma.
  • Angioedema (rare; affects up to 1 in 1,000 people): symptoms include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may be a sign of a reaction called ” angioedema ”.
  • Liver disease ( hepatitis ) (rare): symptoms include yellowing of the skin and whites of the eyes, nausea, decreased appetite, or dark urine, which may be signs of liver disease ( hepatitis ).
  • Inflammation of the pancreas ( pancreatitis ) (no known frequency): Symptoms include severe and persistent abdominal pain, which can reach the back of your back, as well as nausea and vomiting.

Other side effects are

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

  • Very common (affects more than 1 in 10 people): nausea, vomiting, diarrhea, pain in or around the abdomen (abdominal pain), loss of appetite.
  • Common (affects up to 1 in 10 people): dizziness, headache, uncontrollable tremors, metallic taste in the mouth, low blood sugar.
  • Uncommon (affects up to 1 in 100 people): joint pain, fatigue, constipation, swelling of the hands, ankles, or feet ( edema ).
  • Very rare (affects up to 1 in 10,000 people): sore throat, runny nose, fever; signs of high levels of lactic acid in the blood (so-called lactic acidosis ) such as fatigue or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deep, rapid breathing; redness, itching; decreased vitamin B12 level (pallor, fatigue, mental symptoms such as confusion and memory impairment).

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

  • Common: dizziness, tremors, weakness, low blood sugar, excessive sweating.

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

  • Common: headache, chills, nausea, low blood sugar, heartburn.
  • Uncommon: diarrhea, flatulence.

Following the marketing authorization of the medicine, the following side effects have also been reported:

  • No known frequency (can not be calculated from the available data): an itchy rash, inflammation of the pancreas, localized flaking of skin or blisters, muscle pain.

5. 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 or the carton after EXP. The expiration date is the last day of the specified month.
  • Do not store above 30 ° C.
  • Store in the original package (blister). Moisture sensitive.

6. Contents of the packaging and other information

Content declaration

  • The active substances are vildagliptin and metformin hydrochloride.
  • Each Eucreas 50 mg / 850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (equivalent to 660 mg metformin ).
  • Each Eucrea 50 mg / 1,000 mg film-coated tablet contains 50 mg vildagliptin and 1,000 mg metformin hydrochloride (equivalent to 780 mg metformin ).
  • The other ingredients are hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), Makrogol 4000, and talc.

What the medicine looks like and the contents of the pack

Eucreas 50 mg / 850 mg is a yellow, oval, film-coated tablet. One side is marked with “NVR” and the other side with “SEH”.

Eucreas 50 mg / 1,000 mg is a dark yellow, oval, film-coated tablet. One side is marked with “NVR” and the other side with “FLO”.

Eucreas are available in packs of 10, 30, 60, 120, 180, or 360 film-coated tablets and multiple packs containing 120 (2×60), 180 (3×60), or 360 (6×60) film-coated tablets.

Not all pack sizes and tablet strengths may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek dd, PE PROIZVODNJA LENDAVA

Trimlini 2D

Lendava, 9220

Slovenia

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

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