Zomarist 50 mg/1000 mg film-coated tablets

The active substances of Zomarist belong to a group of medicines called ?oral antidiabetics?.

Zomarist is used to treat patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus.

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

Both insulin and glucagon are made in the pancreas. Insulin helps to lower the level of sugar in the blood, especially after meals. Glucagon triggers the liver to make sugar, causing the blood sugar level to rise.

Zomarist contains two active substances called vildagliptin and metformin. Both of these substances help to control the level of sugar in the blood. The substance vildagliptin works by making the pancreas produce more insulin and less glucagon. The substance metformin works by helping the body to make better use of insulin.

Do not take Zomarist

• if you are allergic (hypersensitive) to vildagliptin, metformin or any of the other ingredients of Zomarist (listed in section 6). If you think you may be allergic to any of these, talk to your doctor before taking Zomarist.
• if you have or have had serious complications of your diabetes, such as diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea and/or vomiting) or diabetic coma.
• if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems.
• if you have kidney problems.
• if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body).
• if you are going to have a contrast x-ray (a specific type of x-ray involving an injectable dye). Please also see information about this in section ?Take special care with Zomarist?.
• if you have liver problems.
• if you drink alcohol excessively (whether every day or only from time to time).
• if you are breast-feeding (see also ?Pregnancy and breast-feeding?).

Take special care with Zomarist
Stop taking this medicine and talk to your doctor if you experience one or more of the following symptoms which may be related to a condition called ?lactic acidosis?:

• feeling cold or uncomfortable
• muscle pain
• severe nausea or vomiting
• pain in or around your stomach (abdominal pain)
• drowsiness or dizziness
• rapid breathing

If you have previously taken vildagliptin but had to stop taking it because of side effects (liver disease), you should not take this product.

Diabetic skin lesions are a common complication of diabetes. You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse. You are also advised to pay particular attention to new onset of blisters or ulcers while taking Zomarist. Should these occur, you should promptly consult your doctor.

If you have stopped using Zomarist due to surgery (you should stop at least 48 hours before planned surgery with general anesthesia and should not start again until at least 48 hours afterwards) or due to an x-ray involving an injectable dye, talk to your doctor before taking Zomarist again.

A test to determine your liver function will be performed before the start of Zomarist treatment, at three-month intervals for the first year and periodically thereafter. This is so that signs of increased liver enzymes can be detected as early as possible.

Elderly patients (65-74 years) taking Zomarist should have their kidney function monitored regularly. This will happen more often in patients with kidney problems. Zomarist is not recommended for patients aged 75 years or older.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important if you are already taking any medicine to treat a heart condition or problems with your blood sugar, kidneys or blood pressure such as medicines containing

• glucocorticoids generally used to treat inflammation
• beta-2 agonists generally used to treat respiratory disorders
• other medicines used to treat diabetes
• diuretics (also called water tablets)
• ACE inhibitors generally used to treat high blood pressure
• certain medicines affecting the thyroid, or
• certain medicines affecting the nervous system.

Taking Zomarist with food and drink
Take the tablets either with or just after food. This will lower the risk of an upset stomach.

Avoid alcohol while taking Zomarist since alcohol may increase the risk of lactic acidosis (please see section ?Possible side effects?).

Pregnancy and breast-feeding

• Tell your doctor if you are pregnant, if you think you might be pregnant, or if you are planning to become pregnant. Your doctor will discuss with you the potential risk of taking Zomarist during pregnancy.
• Do not use Zomarist if you are breast-feeding.

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 use any tools or machines.

Always take Zomarist exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take

The amount of Zomarist that people have to take varies depending on their condition. Your doctor will tell you exactly the dose of Zomarist to take.

When and 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 or just after food. Taking the tablet just after food will lower the risk of an upset stomach.

Continue to follow any advice about diet that your doctor has given you. In particular, if you are following a diabetic weight control diet, continue with this while you are taking Zomarist.

At least once a year, your doctor will check that your kidneys are working normally. Your doctor will test your blood and urine for sugar regularly.

If you take more Zomarist than you should

If you take too many Zomarist tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately. Medical attention may be necessary. If you have to go to a doctor or hospital, take 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 you are due to take one then anyway. Do not take a double dose (two tablets at once) to make up for a forgotten tablet.

If you stop taking Zomarist
Do not stop taking Zomarist unless your doctor tells you to. If you have any questions about how long to take this medicine, talk to your doctor.

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

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

These side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 patient in 10 common affects 1 to 10 patients in 100 uncommon affects 1 to 10 patients in 1,000 rare affects 1 to 10 patients in 10,000 very rare affects less than 1 patient in 10,000 not known frequency cannot be estimated from the available data.

Some symptoms need immediate medical attention

You should stop taking Zomarist and see your doctor immediately if you experience the following side effects:

• Angioedema (rare): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may indicate a reaction called ?angioedema?.
• Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).

Other side effects

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

• nausea
• vomiting
• diarrhoea
• pain in and around the stomach (abdominal pain)
• loss of appetite. Common:
• dizziness
• headache
• trembling that cannot be controlled
• metallic taste
• low blood glucose. Uncommon:
• joint pain
• tiredness
• constipation
• swollen hands, ankle or feet (oedema). Rare:
• signs of liver disease (hepatitis) Very rare:
• sore throat, runny nose, fever
• signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing.
• redness of the skin, itching
• decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or memory disturbances).

Since this product has been marketed, the following side effects have also been reported (frequency not known):

• itchy rash
• inflammation of the pancreas.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use Zomarist after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
• Store in the original package (blister) in order to protect from moisture.

What Zomarist contains

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

What Zomarist looks like and contents of the pack

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

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Laboratorios Dr. Esteve, S.A. Tel 34 93 446 60 00 Portugal Bialport-Produtos Farmacêuticos, S.A. Tel 351 22 986 61 00

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

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

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

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

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

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva

Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in