Vimetso

Package Leaflet: Information for the Patient

Vimetso, 50 mg + 850 mg, film-coated tablets

Vimetso, 50 mg + 1000 mg, film-coated tablets

Vildagliptin and Metformin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Vimetso and what is it used for
• 2. Important information before taking Vimetso
• 3. How to take Vimetso
• 4. Possible side effects
• 5. How to store Vimetso
• 6. Contents of the pack and other information

1. What is Vimetso and what is it used for

The active substances of Vimetso are vildagliptin and metformin, which belong to the group of oral antidiabetic medicines.
Vimetso is used to treat adult patients with type 2 diabetes. This type of diabetes is also called non-insulin-dependent diabetes. Vimetso is used when diet and exercise alone are not enough to control blood sugar levels and when other antidiabetic medicines (insulin or sulfonylureas) are also being taken.
Type 2 diabetes is a condition where the body does not produce enough insulin or the insulin produced does not work properly. Type 2 diabetes can also occur when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps to lower blood sugar levels, especially after meals. Glucagon is a substance that stimulates the production of sugar in the liver and increases blood sugar levels.

How Vimetso works

Both active substances, vildagliptin and metformin, help to control blood sugar levels.
Vildagliptin works by stimulating the pancreas to produce more insulin and reducing the production of glucagon. Metformin helps the body to use insulin more effectively.
It has been shown that the medicine reduces blood sugar levels, which can help to prevent complications in diabetes.

2. Important information before taking Vimetso

When not to take Vimetso

• 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 ingredients, tell your doctor before taking Vimetso.
• If you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition where substances called ketones build up in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or unusual fruity odor from the mouth.
• If you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties, which may be a sign of heart failure.
• If you have significantly reduced kidney function.
• If you have a severe infection or are severely dehydrated (have lost a lot of water from your body).
• If you are going to have a contrast agent injected into your bloodstream, for example, for an X-ray or CT scan. See also section "Warnings and precautions" for more information.
• If you have liver disease.
• If you drink excessive amounts of alcohol (either regularly or from time to time).
• If you are breastfeeding (see also "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

Vimetso may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis also increases if you have uncontrolled diabetes, severe infection, prolonged fasting, or drink a lot of alcohol, dehydration (see more information below), liver problems, or any condition where part of your body is not getting enough oxygen (e.g., severe heart disease).
If any of these conditions apply to you, you should talk to your doctor for more detailed instructions.

You should temporarily stop taking Vimetso if you have a condition that may lead to dehydration

(significant loss of water from your body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should talk to your doctor for more detailed instructions.

You should stop taking Vimetso and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis

, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, together with severe tiredness,
• breathing difficulties,
• low body temperature and slow heart rate.

Lactic acidosis is a life-threatening condition that requires immediate medical treatment in a hospital.
You should contact your doctor immediately if:

• you have a hereditary disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• you have experienced any of the following symptoms after starting metformin: seizures, worsening of mental abilities, difficulty moving, symptoms of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Vimetso does not replace insulin. Therefore, you should not take Vimetso to treat type 1 diabetes.
Before taking Vimetso, you should discuss this with your doctor, pharmacist, or nurse if you have or have had pancreatitis.
Before taking Vimetso, you should tell your doctor, pharmacist, or nurse if you are taking a sulfonylurea, a type of antidiabetic medicine. Your doctor may want to reduce the dose of the sulfonylurea you are taking with Vimetso to avoid low blood sugar levels (hypoglycemia).
If you have taken vildagliptin before but had to stop due to liver disease, you should not take this medicine.
Diabetic skin changes are a common complication of diabetes. You should follow your doctor's or nurse's advice on skin and foot care. You should also pay special attention to the occurrence of new blisters or ulcers while taking Vimetso. If they occur, you should talk to your doctor as soon as possible.
If you are going to have a major surgical procedure, you will need to stop taking Vimetso during and for some time after the procedure. Your doctor will decide when you should stop and restart Vimetso.
Before and during treatment with Vimetso, and at 3-month intervals during the first year of treatment, and periodically thereafter, you should have your liver function tested. This will help to detect any increase in liver enzymes as soon as possible.
During treatment with Vimetso, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.
Your doctor will regularly check your blood sugar levels and urine.

Children and adolescents

Vimetso should not be used in children and adolescents under 18 years of age.

Vimetso with other medicines

If you are going to have a contrast agent injected into your bloodstream, for example, for an X-ray or CT scan, you will need to stop taking Vimetso before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart Vimetso.
You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent checks of your blood sugar levels or kidney function, or your doctor may need to adjust your dose of Vimetso. It is especially important to tell your doctor if you are taking:

• corticosteroids, which are often used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists, which are often used to treat respiratory disorders
• other antidiabetic medicines
• diuretics (water pills)
• 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 that affect the thyroid gland
• certain medicines that affect the nervous system
• certain medicines used to treat angina, such as ranolazine
• certain medicines used to treat HIV infection, such as dolutegravir
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer), such as vandetanib
• certain medicines used to treat heartburn and stomach ulcers, such as cimetidine.

Vimetso with alcohol

You should avoid drinking excessive amounts of alcohol while taking Vimetso, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Vimetso during pregnancy.
• You should not take Vimetso if you are pregnant or breastfeeding (see also "When not to take Vimetso").

Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

If you experience dizziness while taking Vimetso, you should not drive or operate machinery.

Vimetso contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Vimetso

The dose of Vimetso varies depending on your condition. Your doctor will decide what dose of Vimetso you should take.
You should always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet twice a day.
If you have kidney problems, your doctor may prescribe a lower dose. If you are taking a sulfonylurea, a type of antidiabetic medicine, your doctor may also prescribe a lower dose.
Your doctor may prescribe this medicine alone (as monotherapy) or with other medicines that lower blood sugar levels.

When and how to take Vimetso

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one tablet in the evening with a meal or shortly after a meal. Taking the tablet shortly after a meal will help to reduce the risk of stomach upset.

You should continue to follow your doctor's advice on diet while taking Vimetso. Diet is especially important when you are taking a weight-controlling diet.

What to do if you take more Vimetso than you should

If you accidentally take too many Vimetso tablets or if someone else takes your tablets, you should contact your doctor or pharmacist immediately. You may need medical attention. If you need to go to a doctor or hospital, take the package and this leaflet with you.

What to do if you forget to take Vimetso

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

What to do if you stop taking Vimetso

To keep your blood sugar levels under control, you should keep taking this medicine for as long as your doctor tells you to. Do not stop taking Vimetso without talking to your doctor first. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Vimetso can cause side effects, although not everybody gets them.
You should stop taking Vimetso and contact your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Vimetso may very rarely cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stop taking Vimetso and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
• Anaphylactic reaction (rare: may affect up to 1 in 1,000 people): Symptoms include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives. These may be signs of an allergic reaction.
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): Symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite, or dark-colored urine. These may be signs of liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): Symptoms include severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients who took Vimetso experienced the following side effects:

• Common (may affect up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled shaking, constipation, nausea, vomiting, diarrhea, bloating, heartburn, stomach pain (abdominal pain).
• Uncommon (may affect up to 1 in 100 people): tiredness, weakness, metallic taste in the mouth, low blood sugar levels, loss of appetite, swelling of the hands, feet, or ankles (edema), chills, pancreatitis, muscle pain.
• Rare (may affect up to 1 in 1,000 people): symptoms of high lactic acid levels in the blood (lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing; redness of the skin; itching; decreased levels of vitamin B12 (pallor, tiredness, mental symptoms such as confusion or memory problems).

After this medicine was marketed, the following side effects were also reported:

• Frequency not known (cannot be estimated from the available data): local skin peeling or blistering, vasculitis (inflammation of blood vessels), which can cause skin rash or purpura (red or purple spots on the skin).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system (see below for contact information). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vimetso

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.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vimetso contains

• The active substances are vildagliptin and metformin hydrochloride. Vimetso, 50 mg + 850 mg, film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride. Vimetso, 50 mg + 1000 mg, film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride.
• The other ingredients are: hydroxypropylcellulose, mannitol, sodium stearyl fumarate, and magnesium stearate in the tablet core, and hypromellose 2910, titanium dioxide (E 171), talc, propylene glycol, and yellow iron oxide (E 172) in the tablet coating.
  See section 2 "Vimetso contains sodium" for more information.

What Vimetso looks like and contents of the pack

Vimetso, 50 mg + 850 mg, film-coated tablets: brownish-yellow, oval, biconvex film-coated tablets with "V1" engraved on one side, approximately 20 mm x 11 mm in size.
Vimetso, 50 mg + 1000 mg, film-coated tablets: brownish-yellow, oval, biconvex film-coated tablets with "V2" engraved on one side, approximately 21 mm x 11 mm in size.
Vimetso is available in packs containing 10, 30, 60, 120, 180 film-coated tablets, and in multipacks containing 120 (2 packs of 60) and 180 (3 packs of 60) film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany
To obtain more detailed information on this medicine and its names in other EU Member States, please contact the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
tel. 22 57 37 500
Date of last revision of the leaflet:26.03.2025