Sitagliptin + Metformin hidrohloride Apc

Leaflet accompanying the packaging: patient information

Sitagliptin + Metformin hydrochloride APC, 50 mg + 500 mg,

prolonged-release tablets

Sitagliptin + Metformin hydrochloride APC, 50 mg + 1000 mg, prolonged-release tablets

Sitagliptin + Metformin hydrochloride APC, 100 mg + 1000 mg, prolonged-release tablets

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 you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you specifically. 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 any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Sitagliptin + Metformin hydrochloride APC 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 can 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 Sitagliptin + Metformin hydrochloride APC

When not to take Sitagliptin + Metformin hydrochloride APC:

• if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6).
• if you have significantly 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 disease in which substances called ketone bodies accumulate in the blood and which can lead to a 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 scheduled to have a radiological examination with intravascular contrast agent administration. You should stop taking Sitagliptin + Metformin hydrochloride APC during the examination and for 2 or more days, as recommended by your doctor, depending on your kidney function.
• if you have recently had a heart attack or have had severe circulatory disorders, such as shock or breathing difficulties,
• if you have liver disease,
• if you consume excessive amounts of alcohol (daily or only from time to time)
• if you are breastfeeding.

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

Warnings and precautions

Before starting to take Sitagliptin + Metformin hydrochloride APC, you should discuss it with your doctor or pharmacist. In patients taking Sitagliptin + Metformin hydrochloride APC, 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 bullous pemphigoid. Your doctor may recommend that you stop taking Sitagliptin + Metformin hydrochloride APC.

Risk of lactic acidosis

Sitagliptin + Metformin hydrochloride APC 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 in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see additional information below), liver dysfunction, 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 you, you should consult your doctor for further instructions.

You should immediately consult your doctor 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, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

You should temporarily stop taking Sitagliptin + Metformin hydrochloride APC if you

have a condition that may lead to dehydration(significant water loss 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 further instructions.

You should stop taking Sitagliptin + Metformin hydrochloride APC and immediately consult your doctor or the nearest hospital if you

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 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 Sitagliptin + Metformin hydrochloride APC, 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 the blood. In such cases, the risk of pancreatitis may increase (see section 4)
• if you have type 1 diabetes. It is sometimes called insulin-dependent diabetes
• if you have currently or in the past experienced an allergic reaction to sitagliptin, metformin, or Sitagliptin + Metformin hydrochloride APC (see section 4)
• if you are taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sitagliptin + Metformin hydrochloride APC, as this may lead to excessive lowering of blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea derivative or insulin

If you are to undergo major surgery, you must stop taking Sitagliptin + Metformin hydrochloride APC during the surgery and for some time after it. Your doctor will decide when you should stop and resume treatment with Sitagliptin + Metformin hydrochloride APC. In case of doubts, whether any of the above situations apply to you, before taking Sitagliptin + Metformin hydrochloride APC, you should discuss it with your doctor or pharmacist. During treatment with Sitagliptin + Metformin hydrochloride APC, 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 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.

Sitagliptin + Metformin hydrochloride APC and 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 Sitagliptin + Metformin hydrochloride APC before or at the latest at the time of such injection. Your doctor will decide when you should stop and resume treatment with Sitagliptin + Metformin hydrochloride APC. You should tell your doctor or pharmacist about all medicines you are currently 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 hydrochloride APC by your 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 Sitagliptin + Metformin hydrochloride APC with digoxin, you should have your digoxin levels checked.

Sitagliptin + Metformin hydrochloride APC with alcohol

You should avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride APC, 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 or breastfeeding. See section 2 "When not to take Sitagliptin + Metformin hydrochloride APC".

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.

Sitagliptin + Metformin hydrochloride APC contains sodium

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

3. How to take Sitagliptin + Metformin hydrochloride APC

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. Your doctor will tell you how many tablets of Sitagliptin + Metformin hydrochloride APC to take and when to take them. The maximum daily dose is 100 mg of sitagliptin and 2000 mg of metformin. You should usually 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. You should swallow the tablets whole, with a glass of water, without chewing. Your doctor may increase the dose of the 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 the even distribution of carbohydrates throughout the day. It is unlikely that taking this medicine alone will lead to low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when taking this medicine in combination 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 hydrochloride APC than recommended

If you take a higher dose of this medicine than recommended, you should immediately consult your doctor. 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 hydrochloride APC

If you miss a dose, you should take it as soon as possible. If you do not remember until it is time for your next dose, you should skip the missed dose and return to your regular dosing schedule. You should not take a double dose to make up for the missed dose.

Stopping treatment with Sitagliptin + Metformin hydrochloride APC

You should continue to take this medicine for as long as your doctor recommends to maintain control of your blood sugar levels. You should not stop taking this medicine without consulting your doctor first. Stopping treatment with Sitagliptin + Metformin hydrochloride APC may cause your blood sugar levels to rise again. 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 hydrochloride APC and immediately consult your 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.

Sitagliptin + Metformin hydrochloride APC 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 Sitagliptin + Metformin hydrochloride APC and immediately consult your 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 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 immediately consult your doctor. Your 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 In some patients, diarrhea, nausea, bloating, constipation, stomach pain, or vomiting have occurred after starting treatment with sitagliptin in combination with metformin (common). In some patients taking sitagliptin in combination 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, in some patients taking sitagliptin alone (one of the active substances of Sitagliptin + Metformin hydrochloride APC) or after marketing authorization of Sitagliptin + Metformin hydrochloride APC or sitagliptin alone or with other anti-diabetic medicines, the following side effects have occurred: Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or sore throat, and joint or muscle pain 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, bullous pemphigoid (a type of blistering skin disease) 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 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 not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported 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 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 Sitagliptin + Metformin hydrochloride APC

The medicine should be stored out of the 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 stated. There are no special storage instructions for this medicine. 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 hydrochloride APC contains

The active substances of the medicine are sitagliptin and metformin. Sitagliptin + Metformin hydrochloride APC, 50 mg + 500 mg: Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin and 500 mg of metformin hydrochloride. Sitagliptin + Metformin hydrochloride APC, 50 mg + 1000 mg: Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride. Sitagliptin + Metformin hydrochloride APC, 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, croscarmellose sodium (see section 2 Sitagliptin + Metformin hydrochloride APC contains sodium").
• Additionally, the coating contains: o in doses of 100 mg + 1000 mg and 50 mg + 500 mg: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172). o in the dose of 50 mg + 1000 mg: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc.

What Sitagliptin + Metformin hydrochloride APC looks like and contents of the pack

Sitagliptin + Metformin hydrochloride APC, 50 mg + 500 mg: orange, oval, biconvex, film-coated tablets with dimensions of 17.2 mm/8.4 mm. Sitagliptin + Metformin hydrochloride APC, 50 mg + 1000 mg: white, oval, biconvex, film-coated tablets with dimensions of 22.2 mm/10.8 mm with the engraving "50" on one side and "1000" on the other side. Sitagliptin + Metformin hydrochloride APC, 100 mg + 1000 mg: orange, oval, biconvex, film-coated tablets with dimensions of 22.2 mm/10.8 mm with the engraving "100" on one side and "1000" on the other side. Blisters of PVC/PVDC/Aluminum in a cardboard box. Packs of 10, 14, 28, 30, 56, 60, 98, 100, 112, 160, 168, 180, 196, or 200 prolonged-release tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

APC Institute Ltd. Al. Jerozolimskie 146C 02-305 Warsaw Poland Tel. +48 22 668 68 23

Manufacturer:

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

This medicine is authorized in the European Economic Area member states under the following trade names:

Cyprus

Sitagliptin+Metformin APC

Greece

Sitagliptin+Metformin APC

Poland

Sitagliptin + Metformin hydrochloride APC

Portugal

Mesiglic

Italy

Diesmit

Date of last revision of the leaflet:05/2025