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

You should carefully read the contents of the 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 necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 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 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? 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 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 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. Depepsit Met should be discontinued during the radiological examination and for at least 2 days or more, according to the doctor's recommendations, 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.

Do not take Depepsit Met if any of the above contraindications occur. Consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Depepsit Met, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting to take Depepsit Met, discuss it with a 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 that the patient 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 the patient has kidney function disorders. The risk of lactic acidosis also increases in cases 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 a doctor for further instructions.

Immediately consult a 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 inherited diabetes and deafness from the mother (MIDD, maternal inherited diabetes and deafness).
• the patient has experienced 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.

Temporarily discontinue Depepsit Met if the patient has 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 the patient drinks less fluid than usual. Consult a doctor for further instructions.

Discontinue Depepsit Met and immediately consult a doctor or the nearest hospital if the patient experiences any symptoms of lactic acidosis

because this condition can lead to a coma. Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of being unwell 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, discuss it with a doctor or pharmacist:

• if the patient has or has had pancreatic disease (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 in the past experienced 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 this 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 must discontinue and resume treatment with Depepsit Met. In case of doubts, whether any of the above situations apply to the patient, before taking Depepsit Met, discuss it with a doctor or pharmacist. During treatment with Depepsit Met, 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 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 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 must discontinue and resume treatment with Depepsit Met. Tell the doctor or pharmacist 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 need more frequent blood glucose monitoring and kidney function tests or dose adjustments of Depepsit Met by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, inhaled, or injected) used to treat diseases with inflammation, 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 cancer)
• 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

Avoid consuming excessive amounts of alcohol while taking Depepsit Met, 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 a doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy or breastfeeding. See section 2 "When not to 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 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 according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist. 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. Usually, the tablets should be 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 smaller dose. During treatment with this medicine, 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, immediately consult a doctor. 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, take it as soon as possible. If the patient does not remember the missed dose until the next dose is taken, skip the missed dose and return to the regular dosing schedule. Do not take a double dose to make up for the missed dose.

Stopping Depepsit Met

Continue taking this medicine for as long as the doctor recommends to maintain control of blood sugar levels. Do not stop taking this medicine without prior consultation with a doctor. Stopping Depepsit Met may cause blood sugar levels to rise again. In case of any further doubts about taking this medicine, consult a 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 immediately consult a doctor 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 occurs, STOP taking Depepsit Met and immediately consult a doctor or the nearest hospital, as lactic acidosis can lead to a 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 of the skin, as well as swelling of the face, lips, tongue, and throat, which can cause difficulty breathing or swallowing, STOP taking this medicine and immediately consult a doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the 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, nausea, bloating, vomiting Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness Some patients have 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 derivative, 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 (one of the active substances of Depepsit Met) alone or after marketing authorization of Depepsit Met or sitagliptin 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, bone and joint pain, 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 rash, or itching.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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, 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 stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the 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 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 phosphate, microcrystalline cellulose, sodium stearyl fumarate, 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 carton 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 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