Vildagliptin/metformin Viatri 50 mg/1,000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin/Metformin Viatris 50mg/850mg film-coated tablets EFG

Vildagliptin/Metformin Viatris 50mg/1,000mg film-coated tablets EFG

vildagliptin/metformin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, as 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.

Package leaflet contents

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

1. What Vildagliptina / Metformina Viatris is and what it is used for

The active substances in this medicine, vildagliptin and metformin, belong to a group of medicines called "oral antidiabetics".

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

Vildagliptin/metformin is used when diabetes cannot be controlled by diet and exercise alone and/or with other antidiabetic medicines (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 lower blood sugar levels, especially after meals. Glucagon promotes sugar production by the liver and causes blood sugar levels to rise.

How Vildagliptin/Metformin 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 to use insulin more effectively. This medicine has been shown to reduce blood sugar levels, which will help prevent complications of your diabetes.

2. What you need to know before starting to take Vildagliptin/Metformin Viatris

Do not take Vildagliptin/Metformin Viatris

• 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 vildagliptin/metformin.
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, 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, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or a fruity 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 water from the body).
• if you are scheduled to undergo contrast radiography (a specific type of diagnostic X-ray test using an injectable contrast agent). For more information, see the 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

Talk to your doctor, pharmacist, or nurse before starting to take vildagliptin/metformin.

Risk of lactic acidosis

Vildagliptin/metformin 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 vildagliptin/metformin temporarily if you develop an illness 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 vildagliptin/metformin 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 malaise with severe fatigue
• difficulty breathing
• reduced 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 disease (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 metformin treatment: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Vildagliptin/metformin is not a substitute for insulin. Therefore, you should not take vildagliptin/metformin for the treatment of type 1 diabetes.

Talk to your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you have or have had a pancreatic disease.

Talk to your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you are taking an antidiabetic medicine known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin/metformin to prevent low blood glucose levels (hypoglycemia).

If you have previously taken vildagliptin but had to stop due to liver disease, you must 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 vildagliptin/metformin. If this occurs, you must consult your doctor immediately.

If you require major surgery, you must stop taking vildagliptin/metformin during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart treatment with vildagliptin/metformin.

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

During treatment with vildagliptin/metformin, 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 glucose levels.

Children and adolescents

The use of vildagliptin/metformin is not recommended in children and adolescents under 18 years of age.

Other medicines and Vildagliptin/Metformin Viatris

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 vildagliptin/metformin before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with vildagliptin/metformin.

Tell 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 the dose of Vildagliptin/Metformin. 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 high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain active substances affecting the thyroid gland, or
• 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 acid and peptic ulcers (e.g., cimetidine)

Taking Vildagliptin/Metformin Viatris with alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin, 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 vildagliptin/metformin during pregnancy.
• Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also “Do not take Vildagliptin/Metformin”).

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

If you feel dizzy while taking vildagliptin/metformin, do not drive or operate tools or machinery.

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This could be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is advisable to drive or operate machinery.

3. How to take/use Vildagliptin/Metformin Viatris

The dose of vildagliptin/metformin required varies from person to person, depending on individual circumstances. Your doctor will tell you exactly what dose of vildagliptin/metformin you should take.

Always follow exactly the instructions provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 50 mg/850 mg or 50 mg/1,000 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 sulfonamide sulfonylurea.

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

How to take Vildagliptin/Metformin

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening with meals or immediately 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 following a diabetic diet for weight control, continue this diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin than you should

If you have taken too many tablets of this medicine, 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 package and this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptin/Metformin

If you forget to take a tablet, take it with your next meal, unless it is almost time for your next scheduled dose. Do not take a double dose (two tablets at once) to make up for a missed dose.

If you stop taking Vildagliptin/Metformin

Continue taking this medicine for as long as your doctor prescribes it, to maintain control of your blood sugar. Do not stop treatment with vildagliptin/metformin unless your doctor tells you to. If you have any doubts about how long you should continue treatment, 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 experiences them.

You must stop taking vildagliptin/metformin 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):

Vildagliptin/metformin may cause a very rare but serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking vildagliptin/metformin and contact a doctor or go to 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 (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 vildagliptin/metformin:

• Frequent (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, diarrhoea, 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 (oedema), 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 blisters, inflammation of blood vessels (vasculitis), which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin / Metformin Viatris

• 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.
• This medicine does not require any special storage conditions.
• Store in the original packaging to protect from moisture.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin/Metformin Viatris

• The active substances are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Vildagliptin/Metformin Viatris 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 Vildagliptin/Metformin Viatris 50 mg/1,000 mg contains 50 mg of vildagliptin and 1,000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
• The other components are: microcrystalline cellulose, copovidone K 25-31, crospovidone (type B), hydroxypropylcellulose, hypromellose, magnesium stearate, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol/PEG 8000 and talc.

Appearance of the medicinal product and contents of the container

Vildagliptin/Metformin Viatris 50 mg/850 mg film-coated tablets are yellow, oval-shaped, bevel-edged tablets, flat on both sides, with dimensions of approximately 20.7 × 8.8 mm.

Vildagliptin/Metformin Viatris 50 mg/1,000 mg film-coated tablets are dark yellow, oval-shaped, bevel-edged tablets, flat on both sides, with dimensions of approximately 21.3 × 10.1 mm.

Vildagliptin/Metformin Viatris is available in packs containing 10, 30, 56, 60, 120, 180 or 360 film-coated tablets, or in multiple packs containing 2 packs of 90 film-coated tablets.

Only certain pack sizes and strengths may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Bluepharma Industria Farmaceutica, S.A.

Sao Martinho do Bispo

3045-016 Coimbra

Portugal

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the EEA Member States under the following names:

Denmark Vildagliptin/Metformin Viatris

Spain Vildagliptin/Metformin Viatris 50 mg/850 mg film-coated tablets EFG

Vildagliptin/Metformin Viatris 50 mg/1,000 mg film-coated tablets EFG

France Vildagliptin/Metformin Viatris 50 mg/850 mg film-coated tablet

Vildagliptin/Metformin Viat游戏副本 50 mg/1000 mg film-coated tablet

Norway Vildagliptin/Metformin Viatis

Instructions for the patient

Vildagliptin/Metformin Viatris

Active substances: 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they have the same symptoms as you.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

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1. What Vildagliptin/Metformin Viatris is and what it is used for

Vildagliptin/Metformin Viatris is a medicine that contains two active substances: vildagliptin and metformin hydrochloride.

Vildagliptin/Metformin Viatris is used to treat type 2 diabetes in adults. It is used:

• when treatment with both vildagliptin and metformin is appropriate
• in patients already treated with separate tablets containing vildagliptin and metformin.

Type 2 diabetes is a condition in which your body does not produce enough insulin, or if the insulin your body produces does not work properly. This medicine helps control your blood glucose (sugar) levels.

Vildagliptin/Metformin Viatris contains two active substances:

• Vildagliptin, which increases the levels of insulin produced by your body after meals and reduces the amount of sugar produced by your liver.
• Metformin hydrochloride, which decreases the amount of sugar produced by your liver and improves your body's sensitivity to insulin.

Vildagliptin/Metformin Viatris is used in combination with diet and exercise.

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2. What you need to know before you take Vildagliptin/Metformin Viatris

Do not take Vildagliptin/Metformin Viatris

• if you are allergic to vildagliptin, metformin hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
• if you have diabetic ketoacidosis (a serious complication of diabetes that requires emergency treatment with insulin).
• if you have moderate or severe kidney problems or if you are undergoing dialysis.
• if you have liver disease.
• if you have a condition in which tissues do not get enough oxygen (tissue hypoxia), for example, heart or lung disease, recent heart attack, or severe infections with low blood pressure.
• if you drink large amounts of alcohol, either chronically or in episodes of binge drinking.

Warnings and precautions

Talk to your doctor before taking Vildagliptin/Metformin Viatris if:

• you are over 75 years old. Your doctor will check your kidney function before prescribing this medicine.
• you have mild kidney problems.
• you have heart failure (even if it is mild).
• you have liver disease.
• you are dehydrated (for example, due to severe diarrhea or vomiting).
• you have a serious infection.
• you drink alcohol excessively.
• you are scheduled for surgery with spinal, epidural, or general anesthesia.
• you are scheduled for imaging tests using contrast agents (such as iodine-containing contrast agents) administered by injection into a vein. In such cases, your doctor may ask you to temporarily stop taking Vildagliptin/Metformin Viatris.

Children and adolescents

Vildagliptin/Metformin Viatris is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Vildagliptin/Metformin Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect the action of Vildagliptin/Metformin Viatris or be affected by it. These include:

• medicines used to treat high blood pressure or heart failure (such as cationic drugs eliminated by the kidneys, e.g., digoxin).
• medicines that may affect kidney function (e.g., cimetidine).
• medicines used to treat type 2 diabetes.
• medicines used to treat epilepsy (such as carbonic anhydrase inhibitors, e.g., topiramate, zonisamide).
• medicines used to treat high cholesterol (such as fibrates).
• medicines used to treat psychiatric disorders (such as phenothiazines).
• medicines used to treat Parkinson's disease (such as levodopa).
• medicines used to treat nausea and vomiting (such as ondansetron).
• medicines used to treat cancer (such as platinum compounds).
• medicines used to treat tuberculosis (such as isoniazid).
• medicines used to treat thyroid disorders.
• medicines used to treat asthma or chronic obstructive pulmonary disease (such as sympathomimetics).
• medicines used to treat depression (such as monoamine oxidase inhibitors).
• medicines used to treat infections (such as pentamidine, vancomycin, sulfonamides, trimethoprim, or antiviral drugs).
• medicines used to treat high blood pressure (such as thiazide diuretics, calcium channel blockers, beta-blockers).
• medicines used to treat mental disorders (such as corticosteroids, danazol).
• medicines used to treat allergies (such as H2-receptor antagonists, e.g., ranitidine, cimetidine).
• medicines used to treat stomach acid (such as proton pump inhibitors).
• medicines used to treat pain and inflammation (such as non-steroidal anti-inflammatory drugs, e.g., ibuprofen).
• medicines used to treat gout (such as colchicine).
• medicines used to treat malaria (such as malarial suppressants).
• medicines used to treat HIV (such as protease inhibitors).
• medicines used to treat organ transplant rejection (such as immunosuppressants).
• medicines used to treat epilepsy (such as phenytoin).
• medicines used to treat cancer (such as mTOR inhibitors).
• medicines used to treat high blood pressure (such as ACE inhibitors).
• medicines used to treat high blood pressure (such as angiotensin II receptor blockers).
• medicines used to treat high blood pressure (such as diuretics).
• medicines used to treat high blood pressure (such as beta-blockers).
• medicines used to treat high blood pressure (such as calcium channel blockers).
• medicines used to treat high blood pressure (such as alpha-blockers).
• medicines used to treat high blood pressure (such as vasodilators).
• medicines used to treat high blood pressure (such as centrally acting agents).
• medicines used to treat high blood pressure (such as aldosterone antagonists).
• medicines used to treat high blood pressure (such as renin inhibitors).
• medicines used to treat high blood pressure (such as endothelin receptor antagonists).
• medicines used to treat high blood pressure (such as alpha-2 agonists).
• medicines used to treat high blood pressure (such as alpha-1 blockers).
• medicines used to treat high blood pressure (such as potassium-sparing diuretics).
• medicines used to treat high blood pressure (such as thiazide-like diuretics).
• medicines used to treat high blood pressure (such as loop diuretics).
• medicines used to treat high blood pressure (such as carbonic anhydrase inhibitors).
• medicines used to treat high blood pressure (such as vasopressin antagonists).
• medicines used to treat high blood pressure (such as adrenergic neuron blockers).
• medicines used to treat high blood pressure (such as ganglionic blockers).
• medicines used to treat high blood pressure (such as direct vasodilators).
• medicines used to treat high blood pressure (such as peripheral vasodilators).
• medicines used to treat high blood pressure (such as central vasodilators).
• medicines used to treat high blood pressure (such as arterial vasodilators).
• medicines used to treat high blood pressure (such as venous vasodilators).
• medicines used to treat high blood pressure (such as mixed vasodilators).
• medicines used to treat high blood pressure (such as arterial dilators).
• medicines used to treat high blood pressure (such as venous dilators).
• medicines used to treat high blood pressure (such as mixed dilators).
• medicines used to treat high blood pressure (such as peripheral dilators).
• medicines used to treat high blood pressure (such as central dilators).
• medicines used to treat high blood pressure (such as arterial dilators).
• medicines used to treat high blood pressure (such as venous dilators).
• medicines used to treat high blood pressure (such as mixed dilators).
• medicines used to treat high blood pressure (such as peripheral dilators).
• medicines used to treat high blood pressure (such as central dilators).
• medicines used to treat high blood pressure (such as arterial dilators).
• medicines used to treat high blood pressure (such as venous dilators).
• medicines used to treat high blood pressure (such as mixed dilators).
• medicines used to treat high blood pressure (such as peripheral dilators).
• medicines used to treat high blood pressure (such as central dilators).

Your doctor will decide whether any dose adjustment is needed.

Taking Vildagliptin/Metformin Viatris with food and drink

Take Vildagliptin/Metformin Viatris during or after meals to reduce the risk of stomach problems.

Do not drink alcohol while taking this medicine. Drinking alcohol increases the risk of serious side effects, including lactic acidosis (a serious condition caused by a buildup of lactic acid in the blood).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor before taking this medicine.

Treatment of diabetes during pregnancy usually requires insulin. Your doctor may stop this medicine and switch you to insulin.

It is not known whether Vildagliptin/Metformin Viatris passes into breast milk. Do not breastfeed while taking this medicine.

Driving and using machines

Vildagliptin/Metformin Viatris has minor or no influence on the ability to drive and use machines. However, if you experience dizziness or drowsiness, do not drive or operate machinery.

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3. How to take Vildagliptin/Metformin Viatris

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

The usual dose is one tablet twice daily (morning and evening), taken during or after meals.

Your doctor may adjust your dose depending on your blood glucose levels.

Swallow the tablets whole with water. Do not crush or chew the tablets.

If you take more Vildagliptin/Metformin Viatris than you should

If you take more tablets than prescribed, contact your doctor or go to the nearest hospital immediately. Bring the medicine pack with you.

Symptoms of overdose may include nausea, vomiting, diarrhea, abdominal pain, and muscle pain. In severe cases, lactic acidosis may occur.

If you forget to take Vildagliptin/Metformin Viatris

Take the missed dose as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Vildagliptin/Metformin Viatris

Do not stop taking this medicine unless your doctor tells you to. Stopping treatment may cause your blood glucose levels to rise.

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

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4. Possible side effects

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

Serious side effects that require immediate medical attention:

• Severe allergic reaction (anaphylaxis): symptoms include difficulty breathing, swelling of the face, lips, tongue, or throat, rash, itching, or low blood pressure. Stop taking this medicine and seek immediate medical help.
• Severe skin reactions: such as skin blistering or peeling, rash with fever, or erythema multiforme. Stop taking this medicine and contact your doctor immediately.
• Lactic acidosis (a rare but serious condition caused by a buildup of lactic acid in the blood): symptoms include unusual muscle pain, difficulty breathing, stomach pain with nausea and vomiting, feeling cold, drowsiness, unusual sleepiness, slow heartbeat, or fainting. This is more likely in patients with kidney or liver problems, heart failure, or dehydration. Stop taking this medicine and seek immediate medical help.
• Pancreatitis (inflammation of the pancreas): symptoms include severe stomach pain that may spread to the back, with or without vomiting. Stop taking this medicine and contact your doctor immediately.
• Liver problems: symptoms include loss of appetite, nausea, vomiting, feeling unwell, stomach pain, dark urine, or yellowing of the skin or eyes (jaundice). Stop taking this medicine and contact your doctor immediately.

Common side effects (may affect up to 1 in 10 people):

• nausea
• vomiting
• diarrhea
• stomach pain
• indigestion
• loss of appetite

Uncommon side effects (may affect up to 1 in 100 people):

• headache
• dizziness
• constipation
• swollen hands, ankles, or feet (edema)
• skin rash
• itching

Rare side effects (may affect up to 1 in 1,000 people):

• low red blood cell count (anemia)
• low platelet count (thrombocytopenia)
• low white blood cell count (leukopenia)
• changes in liver function tests
• hepatitis (liver inflammation)
• liver failure
• increased sweating
• taste disturbance
• fatigue
• joint pain
• muscle pain
• back pain
• chest pain
• flu-like symptoms
• upper respiratory tract infection
• urinary tract infection
• fungal infection
• weight gain
• weight loss

If you get any side effects, talk to your doctor or pharmacist. This includes any 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.

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5. How to store Vildagliptin/Metformin Viatris

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 that month.

Store in the original package to protect from moisture.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

What Vildagliptin/Metformin Viatris contains

• The active substances are vildagliptin and metformin hydrochloride.
• Other ingredients: microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), and macrogol.

What Vildagliptin/Metformin Viatris looks like and contents of the pack

Vildagliptin/Metformin Viatris tablets are white, oval, film-coated tablets marked with "V" on one side and "50/850" on the other side.

The tablets are available in blister packs made of PVC/aluminum foil or PVC/PVDC/aluminum foil in cartons containing 28, 56, 60, 84, 90, 98, or 100 tablets.

Marketing Authorization Holder

Viatris Norway AS
Stortingsgata 22
0161 Oslo
Norway

Manufacturer

Accord Healthcare S.L.U.
Polígono Industrial Mas Blau II
Carrer de les Finques Blancas, 135
08850 Gavà, Barcelona
Spain

For any information about this medicine, contact the local representative of the Marketing Authorization Holder.

This medicine is authorized in the following EU Member States:

• Norway: Vildagliptin/Metformin Viatris

This leaflet was last approved in:

[Date]

Appendix V: Information on the national reporting system for side effects

[Country-specific information on how to report side effects]

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Portugal Vildagliptin/Metformin Mylan

Date of the most recent review of this leaflet: March 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/