Mifomet

Leaflet accompanying the packaging: patient information

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

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

Sitagliptin + Metformin hydrochloride

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Mifomet and what is it used for

Mifomet 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 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 derivative, or glitazones). What is type 2 diabetes? Type 2 diabetes is a disease in which the body does not produce enough insulin, and the produced insulin does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) accumulates 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 Mifomet

When not to take Mifomet:

• if the patient is allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6),
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, e.g., 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 disease in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor,

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 Mifomet during the radiological examination and for a period of 2 or more days, 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 Mifomet if any of the above contraindications occur. The patient should consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Mifomet, the patient should discuss it with their doctor, pharmacist, or nurse.

Warnings and precautions

Patients taking Mifomet have reported cases of pancreatitis (see section 4). If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend that the patient stop taking Mifomet.

Risk of lactic acidosis

Mifomet 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 also increases in cases 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 the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Mifomet if they experience a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, high temperature, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Mifomet and immediately contact their doctor or the nearest hospital if they 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, combined with extreme 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 if they experience any of the following:

• 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),

or if they experience any of the following symptoms after starting metformin: seizures, cognitive impairment, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

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

• if they have or have had pancreatitis (e.g., pancreatitis),
• if they 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 they have type 1 diabetes. It is sometimes called insulin-dependent diabetes,
• if they have or have had allergic reactions to sitagliptin, metformin, or Mifomet (see section 4),
• if they are taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Mifomet, as this may lead to excessively low blood sugar levels (hypoglycemia). 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 Mifomet during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Mifomet. If the patient is unsure whether any of the above applies to them, they should discuss it with their doctor or pharmacist before taking Mifomet. During treatment with Mifomet, 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 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.

Mifomet and other medicines

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

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or arthritis (corticosteroids),
• 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),
• specific medicines used to treat asthma (β-sympathomimetics),
• iodine-containing contrast agents or alcohol-containing medicines,
• certain medicines used to treat stomach disorders, such as cimetidine,
• ranolazine, a medicine used to treat angina pectoris,
• dolutegravir, a medicine used to treat HIV infection,
• vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Mifomet with digoxin, the patient's digoxin blood levels should be monitored.

Mifomet and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Mifomet, as this 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 child, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy. This medicine should not be used during breastfeeding. See section 2, When not to take Mifomet.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving and using machines, the patient should consider that dizziness and drowsiness have been reported with sitagliptin, which may affect the ability to drive and use machines. Taking this medicine 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.

Mifomet contains sodium

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

3. How to take Mifomet

This medicine should always be taken as directed by the doctor. 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.
• To control blood sugar levels, the doctor may increase the dose of Mifomet.
• If the patient has kidney problems, the doctor may prescribe a lower dose.

During treatment with this medicine, the patient should continue to follow the diet recommended by their doctor and pay attention to evenly distributing carbohydrate intake throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when taking this medicine 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 Mifomet than recommended

In case of taking a higher dose of this medicine than recommended, 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, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Mifomet

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 medicine as usual. The patient should not take a double dose of this medicine.

Stopping Mifomet treatment

To maintain control of blood sugar levels, the patient should take this medicine for as long as recommended by their doctor. The patient should not stop taking this medicine without consulting their doctor first. Stopping Mifomet treatment may cause blood sugar levels to rise again. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The patient should STOPtaking Mifomet and immediately contact their doctor in case of 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. Mifomet 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 Mifomet 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 skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking Mifomet and immediately contact their doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. Some patients taking metformin after starting sitagliptin have experienced the following side effects: 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): stomach pain, diarrhea, constipation, drowsiness. Some patients have experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting sitagliptin in combination with metformin (common). Some patients taking this medicine 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 this medicine with pioglitazone have experienced the following side effects: Common: swelling of the hands or feet. Some patients taking this medicine 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 Mifomet) or Mifomet, or after marketing authorization, have experienced the following side effects: Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy nose or sore throat, osteoarthritis, pain in the arms or legs. 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, stomach pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste, decreased or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pallor or yellowing of the skin). 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 any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Mifomet

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mifomet contains

The active substances of Mifomet are sitagliptin and metformin. Each film-coated tablet (tablet) of Mifomet, 50 mg + 850 mg, contains sitagliptin hydrochloride, equivalent to 50 mg of sitagliptin, and 850 mg of metformin hydrochloride. Each film-coated tablet (tablet) of Mifomet, 50 mg + 1000 mg, contains sitagliptin hydrochloride, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride. The other ingredients are: Tablet core: microcrystalline cellulose type 102, sodium carmellose, povidone (K30), sodium lauryl sulfate, and sodium stearyl fumarate. Coating Mifomet, 50 mg + 850 mg, film-coated tablets (Opadry Pink): polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), and iron oxide black (E172). Coating Mifomet, 50 mg + 1000 mg, film-coated tablets (Opadry Red): polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), and iron oxide black (E172).

What Mifomet looks like and contents of the pack

Mifomet, 50 mg + 850 mg, film-coated tablets are pink, capsule-shaped, film-coated tablets, 20.2 mm × 9.9 mm in size, with "L50" embossed on one side and smooth on the other. Mifomet, 50 mg + 1000 mg, film-coated tablets are red, capsule-shaped, film-coated tablets, 21.4 mm × 10.5 mm in size, with "H50" embossed on one side and smooth on the other. The tablets are packaged in PVC/PE/PVDC/Aluminum blisters in a cardboard box. The pack contains 56 film-coated tablets.

Marketing authorization holder

Bausch Health Poland sp. z o. o., ul. Przemysłowa 2, 35-959 Rzeszów, Poland, Tel.: +48 17 865 51 00

Manufacturer

Remedica Ltd., Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus, Bausch Health Poland sp. z o. o., ul. Kosztowska 21, 41-409 Mysłowice, Poland

Date of last revision of the leaflet: 03/2025