Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zomarist

Document Subject

Generated Narrative: MedicinalProductDefinition mpdb0f7cad6eb30c65834f70206c7c6222

identifier: http://ema.europa.eu/identifier/EU/1/08/483/001-006

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Zomarist 50 mg/850 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-db0f7cad6eb30c65834f70206c7c6222

identifier: http://ema.europa.eu/identifier/EU/1/08/483/001-006

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - zomarist

Attesters

What is in this leaflet

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

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 sulphonylureas).

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.

How Zomarist works Both active substances, vildagliptin and metformin, 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. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes.

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, talk to your doctor before taking Zomarist.
• if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, 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 and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
• 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 severely reduced kidney function.
• 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 Warnings and precautions .
• 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 ).

Warnings and precautions

Risk of lactic acidosis Zomarist may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Zomarist for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Zomarist and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe tiredness
• difficulty in breathing
• reduced body temperature and heartbeat

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

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

Talk to your doctor, pharmacist or nurse before taking Zomarist if you have or have had a disease of the pancreas.

Talk to your doctor, pharmacist or nurse before taking Zomarist if you are taking an anti-diabetic medicine known as a sulphonylurea. Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Zomarist in order to avoid low blood glucose (hypoglycaemia).

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

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 need to have major surgery you must stop taking Zomarist during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Zomarist.

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.

During treatment with Zomarist, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.

Your doctor will test your blood and urine for sugar regularly.

Children and adolescents The use of Zomarist in children and adolescents up to 18 years of age is not recommended.

Other medicines and Zomarist If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Zomarist before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Zomarist.

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 dosage of Zomarist. It is especially 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 which increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain medicines affecting the thyroid
• certain medicines affecting 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 with alcohol Avoid excessive alcohol intake while taking Zomarist since this may increase the risk of lactic acidosis (please see section Warnings and precautions ).

Pregnancy and breast-feeding

• 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 discuss with you the potential risk of taking Zomarist during pregnancy.
• Do not use Zomarist if you are pregnant or breast-feeding (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 use any tools or machines.

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.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

If you have reduced kidney function, your doctor may prescribe a lower dose. Also if you are taking an anti-diabetic medicine known as a sulphonylurea your doctor may prescribe a lower dose.

Your doctor may prescribe this medicine alone or with certain other medicines that lower the level of sugar in your blood.

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.

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 Continue to take this medicine as long as your doctor prescribes it so that it can continue to control your blood sugar. 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 medicine, ask your doctor, pharmacist or nurse.

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

You should stop taking Zomarist and see your doctor immediately if you experience 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 you must stop taking Zomarist and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
• Angioedema (rare: may affect up to 1 in 1 000 people): 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) (uncommon: may affect up to 1 in 100 people): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (uncommon: may affect up to 1 in 100 people): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your 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, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, trembling that cannot be controlled, constipation, nausea (feeling sick), vomiting, diarrhoea, flatulence, heartburn, pain in and around the stomach (abdominal pain).
• Uncommon (may affect up to 1 in 100 people): tiredness, weakness, metallic taste, low blood glucose, loss of appetite, swollen hands, ankles or feet (oedema), chills, inflammation of the pancreas, muscle pain.
• Very rare (may affect up to 1 in 10 000 people): 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 (cannot be estimated from the available data): localised peeling of skin or blisters, blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 carton after EXP . The expiry date refers to the last day of that month.
• Do not store above 30 C.
• Store in the original package (blister) in order to protect from moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Lek d.d, PE PROIZVODNJA LENDAVA Trimlini 2D Lendava, 9Slovenia

Novartis Pharma GmbH Roonstrasse D-90429 Nuremberg Germany

Novartis Pharmaceutical Manufacturing LLC Verov kova ulica 1000 Ljubljana Slovenia

Novartis Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17
WIN MEDICA A.E. T : +30 210 74 88 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Esteve Pharmaceuticals, S.A. Tel: +34 93 446 60 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Bialport-Produtos Farmac uticos, S.A. Tel: +351 22 986 61 Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

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