ZOMARIST 50 mg/850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zomarist 50mg/850mg film-coated tablets

Zomarist 50mg/1000mg film-coated tablets

vildagliptin/metformin hydrochloride

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

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

if they have the same symptoms as you.

• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Zomarist and what is it used for

1. What you need to know before you take Zomarist
2. How to take Zomarist
3. Possible side effects
4. Storing Zomarist
5. Contents of the pack and further information

1. What is Zomarist and what is it used for

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

Zomarist is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus. Zomarist is used when diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulfonylureas).

Type 2 diabetes occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It can also occur when the body produces too much glucagon.

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

How Zomarist works

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

2. What you need to know before you take Zomarist

Do not take Zomarist

• 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, consult your doctor before taking Zomarist.
• if you have uncontrolled diabetes with, 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 disorder in which substances called “ketone bodies” accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor of the breath.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have severe kidney function impairment.
• if you have a severe infection or severe dehydration (massive water loss from the body).
• if you are going to have 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 only occasionally).
• if you are breastfeeding (see also “Do not take Zomarist”).

Warnings and precautions

Risk of lactic acidosis

Zomarist may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical disorder 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 if you have a disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. 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 disorder can lead to a coma.

The symptoms of lactic acidosis include:

vomiting

• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• decrease in body temperature and heart rate

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

Consult your doctor promptly to indicate how to proceed if:

• You know you have a genetic disorder that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

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

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

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

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

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care. 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, you should stop taking Zomarist while the procedure is being performed and for a period after it. Your doctor will decide when you should stop taking Zomarist and when you can restart it.

Liver function tests 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 any signs of increased liver enzymes (transaminases) as soon as possible.

During treatment with Zomarist, 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 worsening.

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

Children and adolescents

The administration of Zomarist is not recommended in children and adolescents under 18 years of age.

Other medicines and Zomarist

If you need to be administered an intravenous injection of a contrast medium containing iodine, for example, in the context of an X-ray or scan, you should stop taking Zomarist before the injection or at the time of the injection. Your doctor will decide when you should stop taking Zomarist and when you can restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Zomarist. It is especially important to mention the following:

• corticosteroids, usually used to treat inflammation
• beta-2 agonists, usually used to treat respiratory disorders
• other active substances used to treat diabetes
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific active substances that affect the thyroid
• specific active substances that affect the nervous system
• specific active substances used to treat angina (e.g., ranolazine)
• specific active substances used to treat HIV infection (e.g., dolutegravir)
• specific active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• specific active substances used to treat stomach acidity and peptic ulcers (e.g., 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

• 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 inform you of the potential risks of taking Zomarist during pregnancy.
• Do not take Zomarist if you are pregnant or breastfeeding (see also “Do not take Zomarist”).

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

Driving and using machines

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

3. How to take Zomarist

The dose of Zomarist that you should take varies depending on your condition. Your doctor will tell you exactly what dose of Zomarist you should take.

Follow the instructions for administering this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

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

If you have reduced 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 sulfonylurea.

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

How to take Zomarist

• Swallow the tablets whole with a glass of water
• Take one tablet in the morning and the other in the evening 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 follow a weight control diet for diabetics, continue with the diet while taking Zomarist.

If you take more Zomarist than you should

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 have to visit a doctor or go to the nearest hospital, take the package and this leaflet with you.

If you forget to take Zomarist

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

If you stop taking Zomarist

Continue taking this medicine while your doctor prescribes it to continue controlling your blood sugar. 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 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 Zomarist andgo to your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Zomarist may cause a very rare but very 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 a coma.

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): symptoms that include severe and persistent stomach pain (abdominal pain), which can radiate to the back, as well as nausea and vomiting.

Other side effects

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

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

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

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

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that can cause skin rashes or spots, flat, red, and round patches under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Zomarist

• 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 carton and blister after “EXP”. The expiry date refers to the last day of the month stated.
• Do not store above 30°C.
• Store in the original package (blister) to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Zomarist Composition

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

Product Appearance and Package Contents

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

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

Zomarist is available in packs of 10, 30, 60, 120, 180, or 360 film-coated tablets and in multipacks of 120 (2x60), 180 (3x60), or 360 (6x60) film-coated tablets. Not all pack sizes and strengths may be marketed in your country.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

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