Zomarist: detailed information

F Package leaflet: Information for the user
Zomarist 50 mg/850 mg film-coated tablets
Zomarist 50 mg/1000 mg film-coated tablets
vildagliptin/metformin hydrochloride
Please read this leaflet carefully before you start taking this medicine, as it contains
important information for you.

Keep this leaflet. 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 other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Zomarist is and what it is used for
What you need to know before taking Zomarist
How to take Zomarist
Possible side effects
How to store Zomarist
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 in combination with other antidiabetic medicines (insulin or sulphonylureas).
Type 2 diabetes develops when the body does not produce enough insulin, or when the insulin
produced by the body does not work properly. It may also develop when 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 stimulates the liver to produce sugar,
causing an increase in blood sugar levels.
How Zomarist works
Both active substances, vildagliptin and metformin, help control blood sugar levels. The substance vildagliptin acts by stimulating the pancreas to produce more insulin and less
glucagon. The substance metformin acts by helping the body make better use of insulin.
This medicine has been shown to reduce blood sugar levels. This may help prevent
complications arising from your diabetes.

2. What you need to know before taking 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 substances, consult your doctor before taking Zomarist.
if you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, and breath with an unusual fruity odour.
if you have recently had a heart attack or if you have heart failure, severe circulatory problems, or breathing difficulties that could be signs of heart problems.
if you have severely reduced kidney function.
if you have a serious infection or are severely dehydrated (your body has lost a lot of water).
if you are undergoing an X-ray examination with a contrast agent (a special type of X-ray involving injection of a dye). See also the information provided in the section “Warnings and precautions”.
if you have liver problems.
if you consume alcohol excessively (either on a daily basis 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 very serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, serious infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, and any other medical condition characterized by reduced oxygen supply to part of the body (such as severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.
Temporarily stop taking Zomarist if you develop a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Zomarist and contact your doctor or go to the nearest hospital immediately, because lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of being unwell associated with severe fatigue
difficulty breathing
reduced body temperature and slower heartbeat

Lactic acidosis is a medical emergency and must be treated in hospital.
Zomarist is not a substitute for insulin. Therefore, Zomarist must not be prescribed for the treatment of type 1 diabetes.
Consult your doctor, pharmacist, or nurse before taking Zomarist if you have or have had a disease of the pancreas.
Consult your doctor, pharmacist, or nurse before taking Zomarist if you are taking an antidiabetic medicine known as a sulphonylurea. If you take it together with Zomarist, your doctor may decide to reduce your dose of sulphonylurea to avoid low blood glucose levels (hypoglycaemia).
If you previously took vildagliptin but had to stop due to liver disease, you must not take this medicine.
Skin lesions are a common complication of diabetes. You are advised to follow the skin and foot care recommendations provided by your doctor or nurse.
You are also advised to pay particular attention to the development of new blisters or ulcers while taking Zomarist. If this occurs, contact your doctor immediately.
If you are scheduled for major surgery, you must stop taking Zomarist during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with Zomarist.
Before starting treatment with Zomarist, a test will be performed to assess liver function, which will be repeated every three months during the first year of treatment and periodically thereafter. This is to detect as early as possible any signs of increased liver enzymes.
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 kidney function worsens.
Your doctor will regularly 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 are scheduled to receive an intravenous injection of an iodine-containing contrast agent, for example for a radiographic examination, you must stop taking Zomarist before or during the injection. Your doctor will decide when to stop and when to restart treatment with Zomarist.
Inform your doctor if you are taking, have recently taken, or might take any other medicine. You may need to perform blood glucose and kidney function tests more frequently, or your doctor may decide to adjust the dose of Zomarist. It is particularly important to mention the following:

glucocorticoids, generally used to treat inflammation
beta-2 agonists, generally used to treat respiratory disorders
other medicines used to treat diabetes
medicines that increase urine production (diuretics)
medicines used for 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)
certain medicines acting on the thyroid
certain medicines acting on the nervous system
certain medicines used to treat angina (e.g., ranolazine)
certain medicines used to treat HIV infection (e.g., dolutegravir)
certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
certain medicines used to treat heartburn and peptic ulcers (e.g., cimetidine)

Zomarist and alcohol
Avoid excessive alcohol consumption during treatment with 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 become pregnant, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Zomarist during pregnancy.
Do not use 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 when taking Zomarist, do not drive or use machines.

3. How to take Zomarist

The amount of Zomarist you should take varies depending on individual circumstances.
Your doctor will tell you exactly what dose to take.
Always take this medicine exactly as your doctor has instructed you. If you have any doubts, consult
your doctor or pharmacist.
The recommended dose is one 50 mg/850 mg or 50 mg/1000 mg film-coated tablet taken twice daily.
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 an antidiabetic medicine known as a sulfonilurea.
Your doctor may prescribe this medicine alone or in combination with other medicines that lower blood sugar levels.
When and how to take Zomarist

Take the tablets whole with a glass of water.
Take one tablet in the morning and one in the evening, with food or immediately after eating. Taking the tablet right after a meal will reduce the risk of stomach upset.

Continue to follow any dietary advice your doctor has given you. In particular, if you are on a diet for weight control related to diabetes, you must continue it during treatment with Zomarist.
If you take more Zomarist than you should
If you take too many Zomarist tablets, or if someone else takes your tablets, contact your doctor or pharmacist immediately. Medical treatment may be necessary. If you need to see a doctor or go to hospital, bring the pack 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 scheduled dose. Do not take a double dose (two tablets together) to make up for a missed tablet.
If you stop taking Zomarist
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep your blood sugar under control. Do not stop treatment with Zomarist unless your doctor tells you to. If you have any doubts about how long to take this medicine, consult your doctor.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You must stop taking Zomarist and contact your doctor immediately if you experience any of the following side effects:

Lactic acidosis (very rare: may occur in up to 1 in 10,000 people):
Zomarist may cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Zomarist and seek immediate medical attention at the nearest doctor’s office or hospital, as lactic acidosis can lead to coma.
Angioedema (rare: may occur in up to 1 in 1,000 people): symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of skin rash or hives, which may indicate a reaction called “angioedema”.
Liver disease (hepatitis) (uncommon: may occur in up to 1 in 100 people). Symptoms include yellowing of the skin or eyes, nausea, loss of appetite, or dark-coloured urine, which may indicate liver disease (hepatitis).
Inflammation of the pancreas (pancreatitis) (uncommon: may occur in up to 1 in 100 people). Symptoms include severe and persistent abdominal pain (in the stomach area), which may extend to the back, as well as nausea and vomiting.

Other side effects
While taking Zomarist, some patients have experienced the following side effects:

Common (may occur in up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea (feeling unwell), vomiting, diarrhoea, flatulence, heartburn, stomach pain and pain around the stomach (abdominal pain).
Uncommon (may occur in up to 1 in 100 people): fatigue, constipation, weakness, metallic taste, low blood glucose levels, loss of appetite, swelling of hands, ankles or feet (oedema), chills, inflammation of the pancreas, muscle pain.
Very rare (may occur in 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 nausea or vomiting, abdominal pain, irregular heartbeat or rapid deep breathing; skin redness, itching; reduced levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory disturbances).

During the marketing of this medicine, the following side effects have also been reported:

Frequency not known (cannot be estimated from the available data): localized peeling of the skin or blisters, inflammation of blood vessels (vasculitis), which may cause skin rash or round, red, flat, raised spots under the skin surface or bruising.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 blister and the outer carton after “EXP”/”Scad”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging (blister) to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zomarist contains

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.

Description of the appearance of Zomarist and pack contents
Zomarist 50 mg/850 mg film-coated tablets are yellow, oval-shaped, marked with “NVR” on one side and “SEH” on the other.
Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval-shaped, 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 multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Not all pack sizes 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 Nuremberg
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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
or
WIN MEDICA ΦΑΡΜΑΚΕΥΤΙΚΗ A.E.
Tηλ: +30 210 74 88 821

España Polska
Laboratorios Dr. Esteve, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 446 60 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Bialport-Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 22 986 61 00

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija United Kingdom (Northern Ireland)
SIA Novartis Baltics Novartis Ireland Limited
Tel: +371 67 887 070 Tel: +44 1276 698370

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