Depepsit Met

Package Leaflet: Information for the Patient

Depepsit Met, 50 mg + 500 mg, prolonged-release tablets

Depepsit Met, 50 mg + 1000 mg, prolonged-release tablets

Depepsit Met, 100 mg + 1000 mg, prolonged-release tablets

Sitagliptin + Metformin hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Depepsit Met and what is it used for

Depepsit Met 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 to increase the amount of insulin released after a meal and reduces the amount of sugar produced by the body. The medicine is used in combination with diet and exercise to reduce blood sugar levels. This medicine can be used alone or in combination with certain other anti-diabetic medicines (insulin, sulfonylureas, 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 diseases such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Depepsit Met

When not to take Depepsit Met:

• 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, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or diabetic ketoacidosis. Diabetic ketoacidosis is a condition 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 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 intravascular administration of a contrast agent. You should stop taking Depepsit Met during the examination and for at least 2 days or more, 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 (daily or only occasionally).
• if you are breastfeeding.

Do not take Depepsit Met if any of the above contraindications apply to you. Consult your doctor to determine other methods of controlling diabetes. If in doubt, consult your doctor, pharmacist, or nurse before taking Depepsit Met.

Warnings and precautions

Before starting to take Depepsit Met, discuss it with your doctor or pharmacist. In patients taking Depepsit Met, cases of pancreatitis (see section 4) have been reported. If you develop blisters on your skin, it may be a sign of a disease called pemphigus. Your doctor may advise you to stop taking Depepsit Met.

Risk of lactic acidosis

Depepsit Met may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis also increases if you have uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see additional information below), liver problems, or any conditions in which any part of your body is not adequately supplied with oxygen (such as acute severe heart disease). If any of these situations apply to you, consult your doctor for further instructions.

You should 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, worsening of cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

You should temporarily stop taking Depepsit Met if you have a 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. Consult your doctor for further instructions.

You should stop taking Depepsit Met and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis

because this condition can lead to coma. Symptoms of lactic acidosis include: vomiting, abdominal pain, muscle cramps, general feeling of being unwell with severe fatigue, difficulty breathing, low body temperature, and slow heart rate. Lactic acidosis is a life-threatening condition that requires hospital treatment.

Before starting to take Depepsit Met, 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 levels of triglycerides (a type of fat) in the blood. In these situations, 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 currently or in the past had an allergic reaction to sitagliptin, metformin, or Depepsit Met (see section 4). if you are taking a sulfonylurea or insulin, anti-diabetic medicines, at the same time as Depepsit Met, as you may experience low blood sugar (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

If you are to undergo a major surgical procedure, you must stop taking Depepsit Met during and for some time after the procedure. Your doctor will decide when you should stop and restart Depepsit Met treatment. If in doubt, consult your doctor or pharmacist before taking Depepsit Met. During treatment with Depepsit Met, your doctor will check 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 when used in children under 10 years of age.

Depepsit Met with other medicines

If you are to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, you must stop taking Depepsit Met before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart Depepsit Met treatment. 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 a dose adjustment of Depepsit Met by your doctor. It is especially important to inform about the following medicines: oral, inhaled, or injected medicines used to treat diseases with inflammation, such as asthma and arthritis (corticosteroids). 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 (beta-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 certain type of thyroid cancer (medullary thyroid cancer). digoxin (used to treat heart rhythm disorders and other heart conditions). When taking Depepsit Met with digoxin, your doctor should monitor your digoxin blood levels.

Depepsit Met with alcohol

Avoid excessive alcohol consumption while taking Depepsit Met, as it 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine during pregnancy or while breastfeeding. See section 2 "Do not take Depepsit Met".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, during treatment with sitagliptin, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines. Taking this medicine in combination with sulfonylureas or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.

Depepsit Met contains sodium

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

3. How to take Depepsit Met

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will tell you how many tablets of Depepsit Met to take and when to take them. The maximum daily dose is 100 mg of sitagliptin and 2000 mg of metformin. You should take the tablets once a day with your evening meal. In some cases, your doctor may recommend taking the tablets twice a day. You should always take the tablets with food to reduce the risk of stomach upset. Swallow the tablets whole with a glass of water, do not chew. Your doctor may increase the dose of your medicine to control your blood sugar levels. If you have reduced kidney function, your doctor may prescribe a lower dose. During treatment with this medicine, you should 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 low blood sugar (hypoglycemia). Low blood sugar may occur if you take this medicine with a sulfonylurea or insulin - in this case, your doctor may reduce the dose of the sulfonylurea or insulin.

Taking a higher dose of Depepsit Met than recommended

If you take more Depepsit Met than 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 Depepsit Met

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Depepsit Met

Continue to take this medicine for as long as your doctor recommends to maintain control of your blood sugar levels. Do not stop taking this medicine without consulting your doctor first. Stopping treatment with Depepsit Met may cause your blood sugar levels to rise again. If you have any further questions on the use of this product, ask 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 Depepsit Met 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, as these may be symptoms of pancreatitis.

Depepsit Met may very rarely cause (less than 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should STOP taking Depepsit Met and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. In the event of a severe allergic reaction (frequency not known, cannot be estimated from the available data), including rash, hives, blisters on the skin, and (or) peeling of the skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, you should stop taking this 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 affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting. Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness. Some patients experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting treatment with sitagliptin in combination with metformin (common). In some patients taking this medicine with a sulfonylurea, such as glimepiride, the following side effects have occurred: Very common (may affect more than 1 in 10 people): low blood sugar. Common: constipation. In some patients taking this medicine in combination with pioglitazone, the following side effects have occurred: Common: swelling of the hands or feet. In some patients taking this medicine in combination with insulin, the following side effects have occurred: Very common: low blood sugar. Uncommon: dry mouth, headache. During clinical trials, some patients taking sitagliptin alone (one of the active substances of Depepsit Met) or after marketing authorization, during treatment with Depepsit Met or sitagliptin alone or with other anti-diabetic medicines, experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose, and sore throat, osteoarthritis, pain in hands or feet. Uncommon: dizziness, constipation, itching. Rare (may affect up to 1 in 1,000 people): reduced platelet count. Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigus (a type of blistering skin condition). Some patients taking metformin alone experienced the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur at the beginning of metformin treatment and usually disappear. Common: metallic taste in the mouth. Very rare: reduced vitamin B12 levels, liver inflammation (liver disease), hives, skin rash, or itching.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. 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 Depepsit Met

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month. Do not store above 25°C. 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 pack and other information

What Depepsit Met contains

The active substances are sitagliptin and metformin. Depepsit Met, 50 mg + 500 mg: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 500 mg of metformin hydrochloride. Depepsit Met, 50 mg + 1000 mg: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride. Depepsit Met, 100 mg + 1000 mg: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg of sitagliptin, and 1000 mg of metformin hydrochloride. The other ingredients are: Metformin prolonged-release layer: hypromellose K100M CR, hypromellose E50, magnesium stearate. Sitagliptin immediate-release layer: calcium phosphate, microcrystalline cellulose, sodium stearyl fumarate, croscarmellose sodium (see section 2 "Depepsit Met contains sodium"). Additionally, the coating contains: in the 100 mg + 1000 mg and 50 mg + 500 mg doses: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172). in the 50 mg + 1000 mg dose: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 4000, talc.

What Depepsit Met looks like and contents of the pack

Depepsit Met, 50 mg + 500 mg: Orange, oval, biconvex, film-coated tablets, 17.2 mm/8.4 mm in size. Depepsit Met, 50 mg + 1000 mg: White, oval, biconvex, film-coated tablets, 22.2 mm/10.8 mm in size, with "50" engraved on one side and "1000" on the other. Depepsit Met, 100 mg + 1000 mg: Orange, oval, biconvex, film-coated tablets, 22.2 mm/10.8 mm in size, with "100" engraved on one side and "1000" on the other. PVC/PVDC/Aluminum blisters in a carton box. Pack sizes: 28, 30, 56, 60 prolonged-release tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Tel: +48 22 732 77 00.

Manufacturer

Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice.

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

Spain: Metsunix, Latvia: TIXULDA, Germany: Metsunix, Poland: Depepsit Met, Italy: Metsunix.

Date of last revision of the leaflet: 07.2025