Depepsit Met

Leaflet accompanying the packaging: patient information

Depepsit Met, 50 mg + 500 mg, tablets with modified release

Depepsit Met, 50 mg + 1000 mg, tablets with modified release

Depepsit Met, 100 mg + 1000 mg, tablets with modified release

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 in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• 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 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 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 packaging 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 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 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? In type 2 diabetes, 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 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 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, 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 disease in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state. 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. Depepsit Met should be discontinued 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 (daily or from time to time)
• if the patient is breastfeeding.

Depepsit Met should not be taken if any of the above contraindications are present. The doctor should be consulted to determine other methods of controlling diabetes. In case of doubts, before taking Depepsit Met, it should be discussed with the doctor, pharmacist, or nurse.

Warnings and precautions

Before starting to take Depepsit Met, it should be discussed with the doctor or pharmacist. In patients taking Depepsit Met, 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. The doctor may recommend discontinuing Depepsit Met.

Risk of lactic acidosis

Depepsit Met may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see additional information below), liver function disorders, and any conditions in which any part of the body is not sufficiently supplied with oxygen (such as acute severe heart disease). If any of the above situations apply to the patient, they should consult their doctor for further instructions.

It is necessary to immediately contact the doctor for further instructions if:

• the patient has 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).
• the patient has experienced any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

It is necessary to temporarily discontinue Depepsit Met if the patient has a condition that may be associated with 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 doctor should be consulted for further instructions.

It is necessary to discontinue Depepsit Met and immediately contact the 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 malaise with severe fatigue
• breathing difficulties
• low body temperature and slow heart rate

Lactic acidosis is a life-threatening condition that requires hospital treatment. Before starting to take Depepsit Met, it should be discussed with the 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 sometimes called insulin-dependent diabetes
• if the patient has currently or has had an allergic reaction to sitagliptin, metformin, or Depepsit Met (see section 4)
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Depepsit Met, as it may lead to excessive lowering of blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin

If the patient is to undergo major surgery, they must discontinue Depepsit Met during and after the surgery. The doctor will decide when the patient should discontinue and resume Depepsit Met treatment. In case of doubts, whether any of the above situations apply to the patient, before taking Depepsit Met, it should be discussed with the doctor or pharmacist. During Depepsit Met treatment, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and (or) has deteriorating 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.

Depepsit Met and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they must discontinue Depepsit Met before or at the latest at the time of such injection. The doctor will decide when the patient should discontinue and resume Depepsit Met treatment. The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The patient may require more frequent blood sugar level checks and kidney function assessments or dose adjustments of Depepsit Met by the doctor. It is particularly important to inform about the following medicines:

• medicines (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma and 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 (beta-sympathomimetic drugs)
• 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 pectoris
• dolutegravir, a medicine used to treat HIV infection
• vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid carcinoma)
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Depepsit Met with digoxin, the digoxin level in the blood should be monitored.

Depepsit Met and alcohol

Excessive alcohol consumption should be avoided while taking Depepsit Met, 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 child, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be taken during pregnancy or breastfeeding. See section 2 "When not to take Depepsit Met".

Driving and using machines

This medicine does not affect or has negligible effects on the ability to drive and use machines. However, during sitagliptin treatment, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines. Taking this medicine in combination 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.

Depepsit Met 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 Depepsit Met

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. The doctor will inform the patient about the number of Depepsit Met tablets to take and when to take them. The maximum daily dose is 100 milligrams of sitagliptin and 2000 milligrams of metformin. The tablets are usually taken once a day with an evening meal. In some cases, the doctor may recommend taking the tablets twice a day. The tablets should always be taken with food to reduce the risk of stomach upset. The tablets should be swallowed whole, with a glass of water, without chewing. The doctor may increase the dose of the medicine to control blood sugar levels. If the patient has reduced kidney function, the doctor may prescribe a lower dose. During Depepsit Met treatment, the patient should continue to follow the diet recommended by the doctor and pay attention to the uniform intake of 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, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Depepsit Met than recommended

In case of taking a higher dose of this medicine than recommended, the doctor should be contacted immediately. The patient should go to the hospital if symptoms of lactic acidosis occur, such as a feeling of cold or discomfort, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Depepsit Met

In case of missing a dose, it should be taken as soon as possible. If the patient does not remember the missed dose until the next dose is taken, the missed dose should be skipped, and the regular dosing schedule should be resumed. A double dose should not be taken to make up for the missed dose.

Discontinuing Depepsit Met

The patient should continue taking this medicine for as long as the doctor recommends to maintain blood sugar control. Depepsit Met should not be discontinued without prior consultation with the doctor. Discontinuing Depepsit Met may cause blood sugar levels to rise again. In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Depepsit Met can cause side effects, although not everybody gets them. The patient should STOP taking Depepsit Met and immediately contact their doctor if 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, as it may be a sign 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 occurs, the patient should STOP taking Depepsit Met 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, cannot be estimated from the available data), including rash, hives, blisters on the skin, and (or) peeling skin, as well as swelling of the face, lips, tongue, and throat, which can cause difficulty breathing or swallowing, Depepsit Met should be discontinued, and the doctor should be contacted immediately. 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 affect up to 1 in 10 people): low blood sugar, 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). Some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, have experienced the following side effects: Very common (may affect more than 1 in 10 people): low blood sugar. Common: constipation. Some patients taking this medicine in combination with pioglitazone have experienced the following side effects: Common: swelling of the hands or feet. Some patients taking this medicine in combination with insulin have experienced the following side effects: Very common: low blood sugar. Uncommon: dry mouth, headache. During clinical trials, some patients taking sitagliptin (one of the active substances of Depepsit Met) alone or after marketing authorization, during Depepsit Met or sitagliptin treatment, alone or with other anti-diabetic medicines, have experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or runny nose, and sore throat, osteoarthritis, pain in the hands or feet. Uncommon: dizziness, constipation, itching. Rare (may affect up to 1 in 1,000 people): decreased platelet count. Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid (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 may occur at the beginning of metformin treatment and usually disappear. Common: metallic taste in the mouth. Very rare: decreased vitamin B12 levels, liver inflammation (liver disease), hives, skin redness (rash), or itching.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 the medicine.

5. How to store Depepsit Met

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiration date stated on the blister pack and carton after "EXP". The expiration date refers to the last day of the month. The medicine should not be stored above 25°C. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Depepsit Met contains

The active substances of Depepsit Met are sitagliptin and metformin. Depepsit Met, 50 mg + 500 mg: Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin, and 500 mg of metformin hydrochloride. Depepsit Met, 50 mg + 1000 mg: Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride. Depepsit Met, 100 mg + 1000 mg: Each tablet contains sitagliptin hydrochloride 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 hydrogen phosphate, microcrystalline cellulose, sodium stearylfumarate, sodium croscarmellose (see section 2 "Depepsit Met contains sodium").
• In addition, 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. Blisters of PVC/PVDC/Aluminum in a cardboard box. Packs of 28, 30, 56, 60 modified-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 for use in the Member States of the European Economic Area under the following trade names:

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

Date of the last revision of the leaflet: 07.2025