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 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 Sitagliptin + Metformin hydrochloride APC is and what it is 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 Sitagliptin + Metformin hydrochloride APC is and what it is 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 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 Sitagliptin + Metformin hydrochloride APC

When not to take Sitagliptin + Metformin hydrochloride APC:

• 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 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 the patient has a severe infection or dehydration
• if the patient is scheduled to undergo a radiological examination with intravascular administration of a contrast agent. The patient should stop taking Sitagliptin + Metformin hydrochloride APC during the 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.

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

Warnings and precautions

Before starting to take Sitagliptin + Metformin hydrochloride APC, discuss it with a doctor or pharmacist. In patients taking Sitagliptin + Metformin hydrochloride APC, 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 blisters. The doctor may recommend that the patient 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 the patient has kidney function disorders. The risk of lactic acidosis also increases in the 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 a doctor for further instructions.

Immediately contact a doctor for further instructions if:

• the patient has a genetically inherited disease affecting 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 abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Temporarily stop taking Sitagliptin + Metformin hydrochloride APC 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. Consult a doctor for further instructions.

Stop taking Sitagliptin + Metformin hydrochloride APC and immediately contact a doctor or the nearest hospital if the patient experiences any of the

symptoms of lactic acidosis, as 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 Sitagliptin + Metformin hydrochloride APC, discuss it with a 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 in the past experienced an allergic reaction to sitagliptin, metformin, or Sitagliptin + Metformin hydrochloride APC (see section 4)
• if the patient is 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). The doctor may reduce the dose of the sulfonylurea derivative or insulin

If the patient is to undergo a major surgical procedure, the patient must stop taking Sitagliptin + Metformin hydrochloride APC during the procedure and for some time after it. The doctor will decide when the patient must stop and resume treatment with Sitagliptin + Metformin hydrochloride APC. In case of doubts, whether the patient is affected by any of the above situations, before taking Sitagliptin + Metformin hydrochloride APC, discuss it with a doctor or pharmacist. During treatment with Sitagliptin + Metformin hydrochloride APC, 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 the age of 18. This medicine is not effective in children and adolescents aged 10 to 17. It is not known whether this medicine is safe and effective in children under the age of 10.

Sitagliptin + Metformin hydrochloride APC 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 stop taking Sitagliptin + Metformin hydrochloride APC before or at the latest at the time of such injection. The doctor will decide when the patient must stop and resume treatment with Sitagliptin + Metformin hydrochloride APC. 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 sugar checks and kidney function assessments or dose adjustments of Sitagliptin + Metformin hydrochloride APC by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, inhaled, or injected) used to treat diseases involving 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, the digoxin blood level should be monitored.

Sitagliptin + Metformin hydrochloride APC with alcohol

Excessive alcohol consumption should be avoided while taking Sitagliptin + Metformin hydrochloride APC, 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 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 the medicine is considered "sodium-free".

3. How to take Sitagliptin + Metformin hydrochloride APC

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist. The doctor will inform the patient how many Sitagliptin + Metformin hydrochloride APC tablets to take and when to take them. The maximum daily dose is 100 mg of sitagliptin and 2000 mg 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 treatment with this medicine, the patient should continue the diet and pay attention to the uniform intake of carbohydrates throughout the day recommended by the doctor. 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, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Sitagliptin + Metformin hydrochloride APC than recommended

In case of taking a higher dose of this medicine than recommended, immediately contact a doctor. Go to the hospital in case of symptoms of lactic acidosis, 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 Sitagliptin + Metformin hydrochloride APC

In case of missing a dose, take it as soon as possible. If the patient does not remember about the missed dose until the time of taking the next dose, 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 treatment with Sitagliptin + Metformin hydrochloride APC

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 consulting a doctor first. Stopping treatment with Sitagliptin + Metformin hydrochloride APC 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. STOP TAKING Sitagliptin + Metformin hydrochloride APC AND IMMEDIATELY CONTACT A DOCTORin case of 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 occurs in the patient, they should STOP TAKING Sitagliptin + Metformin hydrochloride APC AND IMMEDIATELY CONTACT 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 may cause breathing or swallowing difficulties, stop taking this medicine and immediately contact 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 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, 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 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 side effects occur, including any side effects not listed in this leaflet, tell the 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, Jerozolimskie Avenue 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 this medicine.

5. How to store Sitagliptin + Metformin hydrochloride APC

Keep this medicine 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. There are no special precautions for storing this medicine. Medicines should not be disposed of via wastewater or household waste. Ask the 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 this 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 what the pack contains

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 a score line and engraved "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 a score line and engraved "100" on one side and "1000" on the other side. PVC/PVDC/Aluminum blisters in a carton box. The pack sizes are 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. Jerozolimskie Avenue 146C, 02-305 Warsaw, Poland, Tel. +48 22 668 68 23

Manufacturer:

Adamed Pharma S.A., 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:

Bulgaria Sophamet Duo XR Croatia Sitagliptin/metformin hydrochloride APC 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