Maimetsi

Package Leaflet: Information for the Patient

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

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

Sitagliptin + Metformin hydrochloride

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

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Maymetsi and what is it used for

Maymetsi contains two different active substances called sitagliptin and metformin.

• Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a group of medicines called biguanides.

The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with a type of diabetes known as "type 2 diabetes". This medicine helps achieve higher insulin levels after meals and reduces the amount of sugar produced by the body. The medicine, used in conjunction with diet and physical exercise, helps reduce blood sugar levels. This medicine can be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, or glitazones). What is type 2 diabetes? In type 2 diabetes, the body does not produce enough insulin, and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Maymetsi

When not to take Maymetsi

• if you are allergic to sitagliptin and metformin or any of the other ingredients of this medicine (listed in section 6),
• if you have significantly reduced kidney function,
• if you have uncontrolled diabetes, such as severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden 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 can lead to diabetic precoma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
• if you have a severe infection or dehydration,
• if you are scheduled to undergo a radiological examination with intravenous contrast medium administration. You should stop taking Maymetsi during the radiological examination and for 2 or more days, as recommended by your doctor, depending on your kidney function.
• if you have recently had a heart attack or have severe circulatory disorders, such as shock or breathing difficulties,
• if you have liver disease,
• if you consume excessive amounts of alcohol (either daily or from time to time),
• if you are breastfeeding.

Do not take Maymetsi if you have any of the above contraindications. Consult your doctor to determine other methods of controlling diabetes. If in doubt, before taking Maymetsi, discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking sitagliptin in combination with metformin, cases of pancreatitis (see section 4) have been reported. If you experience blisters on the skin, it may be a sign of a disease called pemphigoid blisters. Your doctor may advise you to stop taking Maymetsi.

Risk of lactic acidosis

Maymetsi may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in the case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of the above situations apply to you, consult your doctor for more detailed instructions.

Stop taking Maymetsi temporarily if you have a condition that may lead to dehydration

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

Stop taking Maymetsi 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 malaise with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Contact your doctor immediately for further instructions if:

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

Before taking Maymetsi, discuss it with your doctor or pharmacist:

• if you have or have had pancreatic disease (e.g., pancreatitis)
• if you have or have had gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase.
• if you have type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if you have or have had allergic reactions to sitagliptin, metformin, or Maymetsi (see section 4)
• if you are taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Maymetsi, as this may lead to excessively low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

If you are scheduled to undergo major surgery, you should not take Maymetsi during the surgery and for some time after it. Your doctor will decide when you should stop and resume taking Maymetsi. If in doubt, before taking Maymetsi, discuss it with your doctor or pharmacist. During treatment with Maymetsi, your doctor will monitor your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective in children under 10 years of age.

Maymetsi and other medicines

If you are going to have a contrast medium injected into your bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Maymetsi before or at the latest at the time of the injection. Your doctor will decide when you should stop and resume taking Maymetsi. Tell your doctor or pharmacist 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 blood sugar checks or kidney function tests, or your doctor may need to adjust the dose of Maymetsi. It is especially important to inform about the following medicines:

• medicines (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma or arthritis (corticosteroids),
• 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),
• specific medicines used to treat asthma (β-sympathomimetics),
• contrast media containing iodine or medicines containing alcohol,
• certain medicines used to treat stomach disorders, such as cimetidine,
• ranolazine, a medicine used to treat angina,
• dolutegravir, a medicine used to treat HIV infection,
• vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart conditions). When taking Maymetsi with digoxin, your doctor should monitor your digoxin blood levels.

Maymetsi and alcohol

Avoid consuming excessive amounts of alcohol while taking Maymetsi, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine. Do not take this medicine during pregnancy. This medicine cannot be used during breastfeeding. See section 2 "When not to take Maymetsi".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or operating machines, consider that dizziness and drowsiness have been reported in patients taking sitagliptin, which may affect the ability to drive and operate machines. Taking this medicine with sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and operate machines or work without safe foot support.

Maymetsi contains sodium

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

3. How to take Maymetsi

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• Your doctor may increase the dose of Maymetsi to control blood sugar levels.
• If you have kidney problems, your doctor may prescribe a lower dose.

While taking this medicine, continue to follow the diet recommended by your doctor and pay attention to evenly distributing carbohydrates throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when taking this medicine with a sulfonylurea derivative or insulin - in such cases, your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Maymetsi than recommended

If you take more Maymetsi than you should, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Maymetsi

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue taking the medicine as usual. Do not take a double dose of the medicine.

Stopping treatment with Maymetsi

To maintain control of blood sugar levels, take the medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first. Stopping treatment with Maymetsi may cause an increase in blood sugar levels. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should STOP taking Maymetsi and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis.

Maymetsi may very rarely cause (may occur in less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If you experience it, stop taking Maymetsi and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking the medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. In patients taking metformin after starting sitagliptin, the following side effects have occurred: Common (may occur in less than 1 in 10 patients): low blood sugar levels, nausea, bloating, vomiting Uncommon (may occur in less than 1 in 100 patients): abdominal pain, diarrhea, constipation, drowsiness In some patients, the following side effects have occurred after starting sitagliptin in combination with metformin: Common: diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting. In some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, the following side effects have occurred: Very common (may occur in more than 1 in 10 patients): low blood sugar levels Common: constipation In some patients taking this medicine with pioglitazone, the following side effects have occurred: Common: swelling of the hands or feet In some patients taking this medicine with insulin, the following side effects have occurred: Very common: low blood sugar levels Uncommon: dry mouth, headache In clinical trials, some patients taking sitagliptin (one of the active substances of Maymetsi) alone or in combination with metformin or other anti-diabetic medicines have experienced the following side effects: Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy nose or sore throat, and joint or muscle pain Uncommon: dizziness, constipation, itching Rare: decreased platelet count Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin) In some patients taking metformin alone, the following side effects have occurred: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste, reduced or low vitamin B levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness and tingling). Your doctor may order certain tests to find the cause of the symptoms you are experiencing, as some of them may also be caused by diabetes or other unrelated health problems. Very rare: liver inflammation (liver disease), hives, skin redness (rash), or itching.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Maymetsi

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. Blister pack: OPA/Aluminum/PVC/Aluminum: There are no special storage precautions for the medicinal product. Store in the original packaging to protect from moisture. Blister pack: PVC/PE/PVDC/PE/PVC/Aluminum: Store below 30°C. Store in the original packaging 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 package and other information

What Maymetsi contains

• The active substances of Maymetsi are sitagliptin and metformin hydrochloride. Maymetsi, 50 mg + 850 mg, film-coated tablets Each film-coated tablet contains 50 mg of sitagliptin and 850 mg of metformin hydrochloride. Maymetsi, 50 mg + 1000 mg, film-coated tablets Each film-coated tablet contains 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• Other ingredients (excipients) are: povidone K30, microcrystalline cellulose, mannitol, sodium lauryl sulfate, magnesium stearate in the tablet core, and hypromellose type 2910 (6 cP), titanium dioxide (E 171), talc, propylene glycol, iron oxide red (E 172) in the tablet coating. See section 2 "Maymetsi contains sodium".

What Maymetsi looks like and contents of the package

Maymetsi, 50 mg + 850 mg, film-coated tablets Pink, oval, biconvex film-coated tablets with the marking C4 on one side of the tablet (dimensions: approximately 20 x 11 mm). Maymetsi, 50 mg + 1000 mg, film-coated tablets Dark pink, oval, biconvex film-coated tablets with the marking C3 on one side of the tablet (dimensions: approximately 21 x 11 mm). Maymetsi is available in packages containing:

• 10, 14, 28, 30, 56, 60, 90, 196, and 200 film-coated tablets in blisters,
• 14, 28, 56, and 196 film-coated tablets in blisters, in a calendar pack.

Not all pack sizes may be marketed.

Marketing authorization 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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet:26.03.2025