Zomarist 50 mg/1000 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zomarist 50mg/850mg film-coated tablets

Zomarist 50mg/1000mg film-coated tablets

vildagliptin/metformin hydrochloride

Read this entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Zomarist is and what it is used for
2. What you need to know before taking Zomarist
3. How to take Zomarist
4. Possible side effects
5. How to store Zomarist
6. Contents of the pack and other information

1. What Zomarist is and what it is used for

The active substances in 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 antidiabetic medications (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 may also occur when the body produces too much glucagon.

Insulin and glucagon are produced in the pancreas. Insulin helps reduce blood sugar levels, especially after meals. Glucagon promotes sugar production by the liver, thereby increasing 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 more effectively. This medicine has been shown to reduce blood sugar, which will help prevent complications of your diabetes.

2. What you need to know before starting to 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 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 disorder in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or a fruity, unusual odor on your breath.
• if you have recently had a heart attack or if you have heart failure, severe circulatory problems, or breathing difficulties that may be signs of heart problems.
• if you have severely reduced kidney function.
• if you have a serious infection or severe dehydration (massive loss of body water).
• if you are scheduled to undergo contrast radiography (a specific type of X-ray diagnostic test with an injectable contrast agent). For more information, see section “Warnings and precautions**”**.
• if you have liver problems.
• if you drink alcohol excessively (either daily or occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Risk of lactic acidosis

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

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

Stop taking Zomarist temporarily if you develop a condition that could be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking 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 symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with severe fatigue
• difficulty breathing
• decreased body temperature and heart rate

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

Contact your doctor promptly for guidance if:

• You are known to have a genetic mitochondrial disorder (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, 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: seizures, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or 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 Zomarist if you have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting Zomarist if you are taking an antidiabetic medicine known as a sulfonylurea. Your doctor may wish 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 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 must consult your doctor immediately.

If you need to undergo major surgery, you must stop taking Zomarist during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart treatment with Zomarist.

Liver function tests should be performed before starting treatment with Zomarist, every three months during the first year, and periodically thereafter. This is to detect as early as possible any signs of increased liver enzymes (transaminases).

During treatment with Zomarist, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

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

Children and adolescents

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

Other medicines and Zomarist

If you need to receive an injection of an iodine-containing contrast agent into your bloodstream, for example, during an X-ray or scan, you must stop taking Zomarist before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with Zomarist.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine. You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust your Zomarist 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 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 hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• certain active substances affecting the thyroid gland
• certain active substances affecting the nervous system
• certain active substances used to treat angina pectoris (e.g., ranolazine)
• certain active substances used to treat HIV infection (e.g., dolutegravir)
• certain active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• certain 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 plan to become pregnant, consult your doctor before using this medicine. Your doctor will inform you about the potential risks of taking Zomarist during pregnancy.
• Do not take Zomarist if you are pregnant or breastfeeding (see also “Do not take Zomarist”).

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

3. How to take Zomarist

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

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

If you have reduced kidney function, your doctor may prescribe you 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 together with certain other 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 one at night, with meals or after meals. Taking the tablet after meals will reduce the risk of gastrointestinal discomfort.

Follow your doctor's dietary advice. In particular, if you are on a diabetic weight-control diet, continue with this 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, contact your doctor or pharmacist immediately. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the packaging 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 next regular dose. Do not take a double dose (two tablets at the same time) to make up for a missed dose.

If you stop taking Zomarist

Continue taking this medicine for as long as your doctor prescribes it, so that your blood sugar remains under control. Do not stop treatment with Zomarist unless your doctor tells you to. If you have any doubts about how long you should take this medicine, consult your doctor.

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

4. Possible adverse effects

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

You must stop taking Zomarist and contact your doctor immediately if you experience any of the following adverse effects:

• Lactic acidosis (very rare: may affect up to 1 in 10,000 people): Zomarist may cause a very rare but serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must 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 1,000 people): symptoms including swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may indicate a reaction called "angioedema".

• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may indicate liver disease (hepatitis).

• Inflammation of the pancreas (pancreatitis) (uncommon: may affect up to 1 in 100 people): symptoms including severe and persistent abdominal pain (in the stomach area), which may radiate to your back, as well as nausea and vomiting.

Other adverse effects

Some patients have experienced the following adverse 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, uncontrollable tremor, constipation, nausea (feeling unwell), vomiting, diarrhea, flatulence, heartburn, stomach and abdominal pain.

• Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite, swollen hands, ankles or feet (edema), chills, inflammation of the pancreas, muscle pain.

• Very rare (may affect up to 1 in 10,000 people): signs of 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 (pallor, tiredness, mental symptoms such as confusion or memory disturbances).

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

• Frequency not known (cannot be estimated from available data): localized skin peeling or blistering, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots beneath the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Zomarist Storage

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and blister after "CAD"/"EXP". The expiry date refers to the last day of the month indicated.
• Do not store above 30 °C.
• Store in the original packaging (blister) to protect from moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Zomarist

• The active substances 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 (equivalent 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 (equivalent to 780 mg of metformin).
• The other components are: hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000, and talc.

Appearance of the product and pack contents

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

Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval-shaped tablets, marked with “NVR” on one side 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 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets. In your country, only certain pack sizes and strengths may be marketed.

Marketing Authorisation 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 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 more information about this medicinal product, you may contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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