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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

vildagliptin/metformin hydrochloride

Read the 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 other people 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.

Contents of the leaflet

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

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

The active substances in Vildagliptina/Metformina Vivanta, 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 medications used to treat diabetes (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 and causes blood sugar levels to rise.

How Vildagliptina/Metformina Vivanta 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 from your diabetes.

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

Do not take Vildagliptin/Metformin Vivanta

• 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 disorder 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 unusual odor on your breath.
• if you have recently had a heart attack, or if you have heart failure or severe circulatory problems or breathing difficulties that may be signs of heart problems.
• if you have severely reduced kidney function.
• if you have a severe infection or severe dehydration (massive loss of body water).
• if you are undergoing contrast radiology (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 (daily or even occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

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, severe 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 applies to you, consult your doctor for further instructions.

Stop taking Vildagliptin/Metformin Vivanta temporarily if you develop a condition that may 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 normal. Consult your doctor for further instructions.

Stop taking Vildagliptin/Metformin Vivanta 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 profound fatigue
• difficulty breathing
• decreased body temperature and reduced 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 hereditary disease affecting mitochondria (the energy-producing components inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• you develop 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 deafness.

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

Consult your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you have or have had a disease of the pancreas.

Consult your doctor, pharmacist, or nurse before starting this medicine if you are taking an antidiabetic medicine known as a sulfonylurea. Your doctor may wish to reduce your sulfonylurea dose when taken together with vildagliptin/metformin to prevent low blood glucose (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 vildagliptin/metformin. If this occurs, you must consult your doctor immediately.

If you require major surgery, you should 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, repeated every three months during the first year, and periodically thereafter. This is to detect as early as possible any signs indicating elevated liver enzymes.

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 Vivanta

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.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. 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 medicines 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 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 stomach acid and peptic ulcers (e.g., cimetidine)

Taking Vildagliptin/Metformin Vivanta 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 or breastfeeding, 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 Vivanta”).

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.

3. How to take Vildagliptin/Metformin Vivanta

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 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 another diabetes medicine such as a sulphonylurea.

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

How to take Vildagliptin/Metformin Vivanta

• 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 tablets after meals will reduce the risk of gastrointestinal discomfort.

Follow your doctor's dietary advice. In particular, if you are following a diabetic weight-control diet, continue with this diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin Vivanta than you should

If you have taken too many vildagliptin/metformin 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 medicine pack and this leaflet with you.

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

If you forget to take Vildagliptin/Metformin Vivanta

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 Vivanta

Continue taking this medicine for as long as your doctor prescribes it, to maintain control of your blood sugar levels. Do not stop treatment with vildagliptin/metformin unless your doctor tells you to. If you have any questions about the duration of 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 should 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 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 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 vildagliptin/metformin:

• 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, diarrhoea, flatulence, heartburn, stomach pain and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): fatigue, 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 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 vitamin B12 levels (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 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 Vivanta

• 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 "EXP". The expiry date refers to the last day of the month indicated.
• Store below 30°C.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin/Metformin Vivanta

• The active substances are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Vildagliptin/Metformin Vivanta 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 663 mg of metformin).
• Each film-coated tablet of Vildagliptin/Metformin Vivanta 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: tablet core: hydroxypropyl cellulose (E 463), magnesium stearate. Film coating: hypromellose (E464), yellow iron oxide (E 172), titanium dioxide (E 171), macrogol 8000 (E1521) and talc (E553b).

Appearance of the product and contents of the pack

Vildagliptin/Metformin Vivanta 50 mg/850 mg tablets are oval-shaped, yellow in colour, marked with "M" on one side and "V12" on the other.

Vildagliptin/Metformin Vivanta 50 mg/1,000 mg tablets are oval-shaped, dark yellow in colour, marked with "M" on one side and "V13" on the other.

Vildagliptin/Metformin Vivanta is available in packs containing 30, 60 or 180 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Vivanta Generics s.r.o
Trtinová 260/1, Cakovice,
19600, Prague 9
Czech Republic

Manufacturer

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola, PLA3000,
Malta

or

MSN Labs Europe Limited
KW20A Corradino Park, Paola, PLA3000,
Malta

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

Local representative:

Mabo-Farma S.A.
Calle Vía de los Poblados 3, Edificio 6
28033 Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names

Germany Vildaglitpin/Metformin-HCl Vivanta 50 mg/850 mg Filmtabletten
Vildaglitpin/Metformin-HCl Vivanta 50 mg/1000 mg Filmtabletten

Cyprus Vildagliptin/Metformin MSN 50 mg/850 mg, film-coated tablets
Vildagliptin/Metformin MSN 50 mg/1000 mg, film-coated tablets

Denmark Vildagliptin/Metformin Vivanta

Spain Vildagliptina/Metformina Vivanta 50 mg/850 mg comprimidos recubiertos con película EFG
Vildagliptina/Metformina Vivanta 50 mg/1,000 mg comprimidos recubiertos con película EFG

Finland Vildagliptin/Metformin Vivanta 50 mg/850 mg kalvopäällysteiset tabletit
Vildagliptin/Metformin Vivanta 50 mg/1000 mg kalvopäällysteiset tabletit

Norway Vildagliptin/Metformin Vivanta

Netherlands Vildagliptine/Metforminehydrochloride Vivanta 50 mg/850 mg, filmomhulde tabletten
Vildagliptine/Metforminehydrochloride Vivanta 50 mg/1000 mg, filmomhulde tabletten

Sweden Vildagliptin/Metformin Vivanta 50 mg/850 mg filmdragerade tabletter
Vildagliptin/Metformin Vivanta 50 mg/1000 mg filmdragerade tabletter

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

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