Vimetso

Package leaflet: Information for the patient

Vimetso, 50 mg + 850 mg, film-coated tablets
Vimetso, 50 mg + 1000 mg, film-coated tablets
Vildagliptinum + Metformini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Vimetso is and what it is used for
2. What you need to know 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 Vimetso is and what it is used for

The active substances in Vimetso are vildagliptin and metformin, which belong to a group of medicines called oral antidiabetic agents.
Vimetso is used in the treatment of adult patients with type 2 diabetes. This type of diabetes is also known as insulin-independent diabetes. Vimetso is used when diabetes cannot be controlled by diet and physical exercise alone and (or) when it is given in combination with other antidiabetic medicines (insulin or sulfonylureas).
Type 2 diabetes is a condition in which the body does not produce enough insulin or the insulin produced does not work properly. Type 2 diabetes may also occur when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood glucose levels, especially after meals. Glucagon is a substance that stimulates glucose production in the liver and causes an increase in blood glucose levels.
How Vimetso works
Both active substances, vildagliptin and metformin, help control blood glucose levels.
Vildagliptin works by stimulating the pancreas to produce insulin and by reducing glucagon production. Metformin helps the body use insulin more effectively.
The medicine has been shown to reduce blood glucose levels, which may help prevent complications associated with diabetes.

2. Important information before using Vimetso

When not to use Vimetso

• If the patient is allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If the patient suspects being allergic to any of these ingredients, they should inform their doctor before taking Vimetso.
• If the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketones accumulate in the blood and may lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or unusual fruity odour of the breath.
• If the patient has recently had a heart attack, or has heart failure, severe circulatory problems, or breathing difficulties which may be symptoms of heart failure.
• If the patient has significantly reduced kidney function.
• If the patient has a severe infection or is severely dehydrated (has lost a large amount of body fluid).
• If the patient is due to undergo a contrast radiological procedure (a special type of imaging requiring injection of a contrast agent). For further information, see section "Warnings and precautions".
• If the patient has liver disease.
• If the patient consumes excessive amounts of alcohol (either regularly or occasionally).
• If the patient is breastfeeding (see also section "Pregnancy and breastfeeding").

Warnings and precautions
Risk of lactic acidosis
Vimetso may cause a very rare but serious side effect called lactic acidosis, particularly if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see further details below), impaired liver function, and any condition in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, they should consult their doctor for further instructions.
The use of Vimetso should be temporarily discontinued if the patient develops an illness that may lead to dehydration (significant loss of body fluid), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for further instructions.
The patient must stop taking Vimetso and contact their doctor or the nearest hospital immediately if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• general malaise associated with profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
The patient should contact their doctor immediately for further instructions if:

• they have a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• after starting metformin, they experience any of the following symptoms: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Vimetso does not replace insulin. Therefore, Vimetso must not be used in the treatment of type 1 diabetes.
Before starting Vimetso, the patient should discuss with their doctor, pharmacist, or nurse if they have or have had any pancreatic disorders.
Before starting Vimetso, the patient should consult their doctor, pharmacist, or nurse if they are taking an antidiabetic medicine called a sulfonylurea. The doctor may wish to reduce the dose of the sulfonylurea taken together with Vimetso to avoid low blood glucose levels (hypoglycaemia).
If the patient previously took vildagliptin but had to discontinue it due to liver disease, they should not take this medicine.
Diabetic skin changes are a common complication of diabetes. The patient should follow the advice of their doctor or nurse regarding skin and foot care. The patient should also pay particular attention to the development of new blisters or ulcers while taking Vimetso. If these occur, the patient should consult their doctor promptly.
If the patient is undergoing major surgery, they must stop taking Vimetso during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Vimetso.
Before starting treatment with Vimetso and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows early detection of symptoms indicating increased liver enzyme activity.
During treatment with Vimetso, the doctor will monitor the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
The doctor will regularly assess blood and urine glucose levels.

Children and adolescents
Vimetso is not recommended for use in children and adolescents under 18 years of age.

Vimetso with other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, they must stop taking Vimetso before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Vimetso.
The patient should inform their doctor about all medicines they are currently taking, have recently taken, or plan to take. They may require more frequent monitoring of blood glucose levels and kidney function, or a dose adjustment of Vimetso by their doctor. It is particularly important to inform the doctor about the following medicines:

• glucocorticoids, usually used to treat inflammatory conditions
• beta-2 adrenergic receptor agonists, usually used to treat breathing disorders
• other medicines used to treat diabetes
• diuretics (medicines that increase urine production)
• 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 gland
• 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.

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

Pregnancy and breastfeeding

• If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before taking this medicine. The doctor will discuss with her the potential risks associated with taking Vimetso during pregnancy.
• Vimetso must not be used during pregnancy or breastfeeding (see also "When not to use Vimetso").

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
If the patient experiences dizziness while taking Vimetso, they should not drive or operate machinery.

Vimetso contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Vimetso

The dose of Vimetso varies depending on the patient's condition. Your doctor will determine the appropriate dose of Vimetso to take.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet taken twice daily.
If the patient has impaired kidney function, the doctor may prescribe a lower dose. If the patient is taking an antidiabetic medicine called a sulfonylurea, the doctor may also prescribe a lower dose.
The doctor may prescribe this medicine to be taken alone (as monotherapy) or together with certain other medicines that reduce 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 in the evening, with a meal or immediately after a meal. Taking the tablet right after a meal may help reduce the risk of stomach disturbances.

Continue to follow any dietary advice given by your doctor. Following a diet is particularly important while taking Vimetso, especially if the patient is on a weight-control diet.

Taking more Vimetso than prescribed
If too many tablets of Vimetso are taken by accident, or if someone else takes these tablets, contact a doctor or pharmacist immediately. Medical attention may be required. If it is necessary to visit a doctor or hospital, bring the medicine pack and the leaflet with you.

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

Stopping Vimetso
To maintain control of blood sugar levels, continue taking this medicine for as long as your doctor recommends. Do not stop taking Vimetso without consulting your doctor. If you have any questions about how long to take this medicine, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Vimetso and immediately contact your doctor if any of the following adverse reactions occur:

• Lactic acidosis (very rare: may occur in no more than 1 in 10,000 patients): Vimetso may very rarely cause a serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Vimetso must be discontinued and medical advice must be sought immediately from a doctor or the nearest hospital, as lactic acidosis may lead to coma.
• Angioedema (rare: may occur in no more than 1 in 1,000 patients): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, breathing difficulties, sudden appearance of rash or hives. These may indicate a reaction known as "angioedema".
• Liver disease (hepatitis) (uncommon: may occur in up to 1 in 100 patients): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-coloured urine. These may indicate liver disease (hepatitis).
• Pancreatitis (uncommon: may occur in up to 1 in 100 patients): Symptoms include severe and persistent abdominal pain (around the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other adverse reactions
The following adverse reactions have been reported in some patients during treatment with Vimetso:

• Common (may affect up to 1 in 10 patients): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea, vomiting, diarrhoea, bloating, heartburn, stomach and perigastric pain (abdominal pain).
• Uncommon (may affect up to 1 in 100 patients): fatigue, weakness, metallic taste in the mouth, low blood glucose levels, loss of appetite, swelling of hands, ankles or feet (oedema), chills, pancreatitis, muscle pain.
• Very rare (may affect up to 1 in 10,000 patients): symptoms of high blood lactic acid levels (known as lactic acidosis), such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat, or deep, rapid breathing; skin redness, itching; decreased vitamin B12 levels (pallor, fatigue, psychiatric symptoms such as confusion or memory disturbances).

After the medicine was placed on the market, the following adverse reactions have also been reported:

• Frequency unknown (frequency cannot be estimated from available data): local skin peeling or blistering, vasculitis which may cause skin rash or small, flat, red, round spots under the skin or bruising.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Vimetso

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the word
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 (excipients) are: hydroxypropylcellulose, mannitol, sodium stearyl fumarate and magnesium stearate in the tablet core; and hypromellose type 2910, titanium dioxide (E 171), talc, propylene glycol and yellow iron oxide (E 172) in the tablet coating.
  See section 2, "Vimetso contains sodium".

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 the marking "V1" 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 the marking "V2" 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

For further information about this medicinal product and its names in other countries of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Poland
Tel. 22 57 37 500