Sitagliptin + Metformin Medreg

Leaflet accompanying the packaging: patient information

Sitagliptin + Metformin Medreg, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

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

1. What is Sitagliptin + Metformin Medreg and what is it used for

Sitagliptin + Metformin Medreg 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 substances leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body. The medicine, used in conjunction with diet and physical exercise, helps to reduce blood sugar levels. This medicine may 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?

Type 2 diabetes is a disease in which 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) 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 Sitagliptin + Metformin Medreg

When not to take Sitagliptin + Metformin Medreg

• if you are allergic to sitagliptin or metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have severely reduced kidney function
• 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 disease in which substances called ketone bodies accumulate in the blood and which can lead to a diabetic pre-coma state. The 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 going to have a radiological examination with intravenous administration of a contrast agent. You should stop taking Sitagliptin + Metformin Medreg during the radiological examination and for 2 or more days after the examination, according to your doctor's recommendations, depending on your kidney function.
• if you have recently had a heart attack or have had severe circulatory problems, such as shock or breathing difficulties
• if you have liver disease
• if you drink excessive amounts of alcohol (either daily or only from time to time)
• if you are breastfeeding

You should not take Sitagliptin + Metformin Medreg if you have any of the above contraindications. You should consult your doctor to determine other methods of controlling diabetes. In case of doubts, before taking Sitagliptin + Metformin Medreg, you should discuss it with your doctor or pharmacist.

Warnings and precautions

In patients taking Sitagliptin + Metformin Medreg, cases of pancreatitis (see section 4) have been reported. If you experience blisters on your skin, it may be a sign of a disease called pemphigoid blisters. Your doctor may recommend that you stop taking Sitagliptin + Metformin Medreg.

Risk of lactic acidosis

Sitagliptin + Metformin Medreg 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 cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed 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, you should consult your doctor for additional instructions.

You should stop taking Sitagliptin + Metformin Medreg for a short time if you

have a medical condition that may lead to dehydration(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for additional instructions.

You should stop taking Sitagliptin + Metformin Medreg and immediately contact your doctor or the nearest hospital if you

experience any symptoms of lactic acidosis, as this condition can lead to coma. The symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general feeling of being unwell, accompanied by severe fatigue
• breathing difficulties
• low body temperature and slow heart rate

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. You should contact your doctor immediately to receive 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.
• after starting metformin, you experience any of the following symptoms: seizures, worsening of cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Before taking Sitagliptin + Metformin Medreg, you should discuss it with your doctor or pharmacist:

• if you have or have had pancreatitis (e.g., pancreatitis)
• if you have or have had gallstones, alcohol dependence, or very high triglyceride levels in your 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 Sitagliptin + Metformin Medreg (see section 4)
• if you are taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sitagliptin + Metformin Medreg, as this may lead to excessive reduction of blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

If you are going to have a major surgical procedure, you should not take Sitagliptin + Metformin Medreg during the procedure and for some time after it. Your doctor will decide when you should stop and resume treatment with Sitagliptin + Metformin Medreg. In case of doubts, before taking Sitagliptin + Metformin Medreg, you should discuss it with your doctor or pharmacist. During treatment with Sitagliptin + Metformin Medreg, your doctor will monitor your kidney function at least once a year or more often if you are elderly and/or have deteriorating kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under the age of 18. 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 when used in children under the age of 10.

Sitagliptin + Metformin Medreg and other medicines

If you are going to have a contrast agent containing iodine injected into your bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Sitagliptin + Metformin Medreg before or at the latest at the time of the injection. Your doctor will decide when you should stop and resume treatment with Sitagliptin + Metformin Medreg. You should 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 and kidney function tests or dose adjustments of Sitagliptin + Metformin Medreg by your doctor. It is especially 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)
• 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 agents 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 diseases). When taking Sitagliptin + Metformin Medreg with digoxin, you should have your digoxin levels checked.

Taking Sitagliptin + Metformin Medreg with alcohol

You should avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin Medreg, 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 child, you should consult your doctor or pharmacist before taking this medicine. You should not take this medicine during pregnancy. You should not take this medicine while breastfeeding. See section 2, "When not to take Sitagliptin + Metformin Medreg".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, 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.

Sitagliptin + Metformin Medreg contains sodium

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

3. How to take Sitagliptin + Metformin Medreg

You should always take this medicine exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist. You should take one tablet:

• twice a day, orally
• with meals to reduce the likelihood of stomach upset.

To control blood sugar levels, your doctor may increase the dose of the medicine. If you have kidney problems, your doctor may prescribe a lower dose of the medicine. While taking this medicine, you should continue to follow the diet recommended by your doctor and pay attention to the even distribution of carbohydrates 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, your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Sitagliptin + Metformin Medreg than recommended

If you take more of this medicine than you should, you should contact your doctor immediately. You should 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 Sitagliptin + Metformin Medreg

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

Stopping treatment with Sitagliptin + Metformin Medreg

To maintain control of blood sugar levels, you should take the medicine for as long as your doctor recommends. You should not stop taking this medicine without consulting your doctor first. Stopping treatment with Sitagliptin + Metformin Medreg may lead to an increase in blood sugar levels. If you have any further doubts about taking this medicine, you should 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 STOPtaking Sitagliptin + Metformin Medreg and IMMEDIATELYcontact your doctor or the nearest hospital 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, as these may be symptoms of pancreatitis.

Sitagliptin + Metformin Medreg may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should STOPtaking Sitagliptin + Metformin Medreg and IMMEDIATELYcontact your 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, and throat, which may cause difficulty breathing or swallowing, you should stop taking the medicine and immediately contact your doctor. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes. In some patients taking metformin after starting sitagliptin, the following side effects have occurred: Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting. Uncommon (may affect up to 1 in 100 people): 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). In some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, the following side effects have occurred: Very common (may affect more than 1 in 10 people): 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 Sitagliptin + Metformin Medreg) alone or in combination with other anti-diabetic medicines, or after marketing authorization of Sitagliptin + Metformin Medreg, or sitagliptin alone, or with 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: reduced 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 may occur after starting metformin and usually disappear. Common: metallic taste, reduced 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). 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 leaflet, you should tell your doctor or pharmacist. You can 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 Sitagliptin + Metformin Medreg

You should keep this medicine out of the sight and reach of children. There are no special precautions for storing this medicine. Do not use this medicine after the expiry date stated on the blister pack and carton or label after: EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Sitagliptin + Metformin Medreg contains

• The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium lauryl sulfate, povidone K-90, sodium stearyl fumarate. Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), and yellow iron oxide (E 172)

What Sitagliptin + Metformin Medreg looks like and contents of the pack

Yellow film-coated tablets in the shape of a capsule, approximately 21.4 x 10.4 mm in size, 7.0 ± 0.4 mm thick, with the inscription "S19" and a dividing line on one side and "H" on the other side. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. The film-coated tablets are available in blisters of PVC/Aluminum/OPA/Aluminum in a cardboard box. Pack sizes: 20, 28, 30, 56, 60, 98, 100, 196, or 200 film-coated tablets. Not all pack sizes may be marketed. The film-coated tablets are also available in HDPE containers with a polypropylene cap with a child-resistant closure and a desiccant plug, in a cardboard box. Pack sizes: 30 or 60 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Medreg s.r.o. Na Florenci 2116/15 Nové Město 110 00 Prague 1 Czech Republic tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s. Průmyslová 961/16 747 23 Bolatice Czech Republic Pharmazet Group s.r.o. Třtinová 260/1 Čakovice 196 00 Prague 9 Czech Republic

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

Czech Republic: Sitagliptin/Metformin Medreg Poland: Sitagliptin + Metformin Medreg Slovakia: Sitagliptin/Metformin Medreg Romania: Sitagliptin/Metformin Gemax Pharma 50 mg/1000 mg film-coated tablets

Date of last revision of the leaflet: 04/2025