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 Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their 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 pack 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 medication helps to increase the amount of insulin released after a meal and decrease the amount of sugar produced by the body. When taken in combination with diet and exercise, this medication helps to lower blood sugar levels. This medication can be used alone or in combination with certain other anti-diabetic medications (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 the patient is allergic to sitagliptin and metformin or any of the other ingredients of this medication (listed in section 6),
• if the patient has significantly reduced kidney function,
• if the patient has 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 coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
• if the patient has a severe infection or dehydration,
• if the patient is scheduled to undergo a radiological examination with intravenous administration of a contrast agent. The patient should stop taking Maymetsi during the radiological examination and for at least 2 days or more, as recommended by the doctor, depending on the patient's kidney function.
• if the patient has recently had a heart attack or has experienced severe circulatory disorders, such as shock or breathing difficulties,
• if the patient has liver disease,
• if the patient consumes excessive amounts of alcohol (either daily or from time to time),
• if the patient is breastfeeding.

Do not take Maymetsi if any of the above contraindications apply. Consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Maymetsi, discuss it with a 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 the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend stopping Maymetsi.

Risk of Lactic Acidosis

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

Temporarily Stop Taking Maymetsi if the Patient Experiences 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 the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

Stop Taking Maymetsi and Immediately Contact a Doctor or the Nearest Hospital if the Patient Experiences

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, accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. The patient should contact their doctor immediately for further instructions if:

• the patient has a genetically inherited 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 (MIDD).
• the patient experiences any of the following symptoms after starting metformin: seizures, decreased cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before starting Maymetsi, the patient should discuss the following with their doctor or pharmacist:

• if the patient has or has had pancreatitis (e.g., pancreatitis),
• if the patient has or has 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 the patient has type 1 diabetes. It is also known as insulin-dependent diabetes.
• if the patient has currently or has a history of allergic reactions to sitagliptin, metformin, or Maymetsi (see section 4),
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medications, at the same time as Maymetsi, as it may lead to hypoglycemia (low blood sugar levels). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is scheduled to undergo major surgery, they should not take Maymetsi during the surgery and for some time after it. The doctor will decide when the patient should stop and resume Maymetsi treatment. In case of doubts, before taking Maymetsi, the patient should discuss it with their doctor or pharmacist. During Maymetsi treatment, 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.

Children and Adolescents

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

Maymetsi and Other Medications

If the patient is to receive an intravenous contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Maymetsi before or at the latest at the time of the examination, and the doctor will decide when to resume Maymetsi treatment. The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. The patient may require more frequent blood glucose monitoring and kidney function tests or dose adjustments of Maymetsi by the doctor. It is especially important to inform about the following medications:

• medications (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma or arthritis (corticosteroids),
• medications that increase urine production (diuretics),
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
• certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• specific medications used to treat asthma (β-sympathomimetics),
• contrast agents containing iodine or medications containing alcohol,
• certain medications used to treat stomach disorders, such as cimetidine,
• ranolazine, a medication used to treat angina,
• dolutegravir, a medication used to treat HIV infection,
• vandetanib, a medication 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, the patient's digoxin blood levels should be monitored.

Maymetsi and Alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Maymetsi, as it may increase the risk of lactic acidosis (see "Warnings and Precautions").

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medication. This medication should not be used during pregnancy. This medication cannot be used during breastfeeding. See section 2 "When Not to Take Maymetsi"."

Driving and Using Machines

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

Maymetsi Contains Sodium

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

3. How to Take Maymetsi

This medication should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

• The patient should take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• The doctor may increase the dose of Maymetsi to control blood sugar levels.
• If the patient has kidney problems, the doctor may prescribe a lower dose.

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

Taking a Higher Dose of Maymetsi Than Prescribed

In case of taking a higher dose of this medication than prescribed, the patient should immediately contact their doctor. The patient should go to the hospital if they 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

In case of missing a dose, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medication as usual. The patient should not take a double dose of this medication.

Stopping Maymetsi Treatment

To maintain control of blood sugar levels, the patient should take this medication for as long as prescribed by their doctor. The patient should not stop taking this medication without consulting their doctor first. Stopping Maymetsi treatment may lead to increased blood sugar levels. In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Maymetsi can cause side effects, although not everybody gets them. The patient should STOP TAKING MAYMETSI AND IMMEDIATELY CONTACT THEIR DOCTORif they 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 this occurs, the patient should STOP TAKING MAYMETSI AND IMMEDIATELY CONTACT THEIR DOCTOR OR THE NEAREST HOSPITAL, as lactic acidosis can lead to coma. In case of 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, or throat, which may cause difficulty breathing or swallowing, the patient should stop taking Maymetsi and immediately contact their doctor. The doctor may prescribe a medication to treat the allergic reaction and another medication (change the medication) to treat diabetes. In some 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 Some patients have experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting sitagliptin in combination with metformin (common). Some patients taking Maymetsi with a sulfonylurea derivative, such as glimepiride, have experienced the following side effects: Very common (may occur in more than 1 in 10 patients): low blood sugar levels Common: constipation Some patients taking Maymetsi with pioglitazone have experienced the following side effects: Common: swelling of the hands or feet Some patients taking Maymetsi with insulin have experienced the following side effects: 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 medications have experienced the following side effects: Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, 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) Some patients taking metformin alone have experienced the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste, decreased or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness and tingling). The doctor may order certain tests to find the cause of the symptoms, 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 the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medication.

5. How to Store Maymetsi

The medication should be stored out of sight and reach of children. Do not use this medication after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. Blister pack (OPA/Aluminum/PVC/Aluminum): There are no special storage instructions 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. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack 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 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 Pack

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 packs 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 Medication 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