Prospect: information for the user

Zomarist 50mg/850mg film-coated tablets

Zomarist 50mg/1000mg film-coated tablets

vildagliptin/hydrochloride of metformin

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section4.

1.What is Zomarist and for what it is used

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

3.How to take Zomarist

4.Possible adverse effects

5.Storage of Zomarist

6.Contents of the package and additional information

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

Zomaristis used to treat adult patients with type2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus. Zomarist 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 Zomarist 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 Zomarist

• If you are allergic to vildagliptin, metformin, or any of the other components of this medication (including those listed in section 6). If you think you may be allergic to any of these components, consult your doctor before taking Zomarist.
• 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 section "Warnings and precautions".
• 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

Zomarist may cause a rare but 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 disease).

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

Stop taking Zomarist 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 Zomarist 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.

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

Consult your doctor, pharmacist, or nurse before starting to take Zomarist ifyou have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting to take Zomarist if you are taking a diabetes medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taking it with Zomarist 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 Zomarist. If this occurs, you should consult your doctor immediately.

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

Tests of liver function should be performed before starting treatment with Zomarist, at intervals of three months during the first year, and periodically thereafter. This is done to detect as soon as possible any sign of an increase in liver enzymes (transaminases).

During treatment with Zomarist, your doctor will check your kidney function at least once a year or more frequently if you are an older 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 Zomarist is not recommended in children and adolescents under 18years.

Other medications and Zomarist

If you need to be administered an injection of a contrast medium containing iodine, for example, in the context of a radiography or examination, stop taking Zomarist before the injection or at the time of the injection. Your doctor will decide when to interrupt Zomarist 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 dose of Zomarist. 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 medicationsused to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• Determinants of thyroid function
• Determinants of the nervous system
• Determinants used to treat angina pectoris (for example, ranolazine)
• Determinants used to treat HIV infection (for example, dolutegravir)
• Determinants used to treat a specific type of thyroid cancer (medullary thyroid cancer) (for example, vandetanib)
• Determinants used to treat stomach acid and peptic ulcers (for example, cimetidine)

Taking Zomarist with alcohol

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

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

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

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

Zomarist Usage Form

• 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 on a weight control diet for diabetics, continue with the diet while taking Zomarist.

If You Take Too Much Zomarist

If you have taken too many Zomarist 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 Take Zomarist

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

If You Interrupt Zomarist Treatment

Continue taking this medication as long as your doctor prescribes it for you to continue monitoring your blood sugar levels. Do not stop taking Zomarist 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 using this medication, ask your doctor, pharmacist, or nurse.

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

You shouldstop taking Zomarist andconsult your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to1in every10000people):Zomaristmay cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you,you should stop taking Zomarist and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Angioedema (rare:may affect up to 1 in every 1000people): 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 every 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 every 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 Zomarist:

• Frequent (may affect up to 1in every 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 pain.
• Infrequent (may affect up to 1in every 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 every 10000people): 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, red, rounded spots under the skin's surface or bruises.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep 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 the blister after “CAD”/”EXP”. The expiration date is the last day of the month indicated.
• Do not store above30°C.
• Store in the original packaging (blister) to protect it from moisture.
• Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Zomarist

• The active principles are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Zomarist 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
• Each film-coated tablet of Zomarist 50 mg/1000 mg contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (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

Zomarist 50 mg/850 mg film-coated tablets are yellow, oval-shaped tablets with "NVR" on one face and "SEH" on the other.

Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval-shaped tablets with "NVR" on one face and "FLO" on the other.

Zomarist 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 local representative of the marketing authorisation holder:

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