Sitagliptin + Metformin hidrohloride Apc

Leaflet attached to 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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• 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 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 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 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, e.g., severe hyperglycemia (high blood sugar levels), 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. 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. The patient should stop taking Sitagliptin + Metformin hydrochloride APC during the examination and for 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 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 only from time to time)
• if the patient is breastfeeding.

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

Warnings and precautions

Before starting to take Sitagliptin + Metformin hydrochloride APC, discuss it with your 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. 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 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 the patient, they should consult their doctor for further instructions.

Temporarily stop taking Sitagliptin + Metformin hydrochloride APC 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. The patient should consult their doctor for further instructions.

Stop taking Sitagliptin + Metformin hydrochloride APC and immediately consult a 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 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 your 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 levels of triglycerides (a type of fat) 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 had 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 major surgery, they must stop taking Sitagliptin + Metformin hydrochloride APC during and after the surgery for a certain period. The doctor will decide when the patient should stop and resume treatment with Sitagliptin + Metformin hydrochloride APC. In case of doubts, whether any of the above situations apply to the patient, before taking Sitagliptin + Metformin hydrochloride APC, discuss it with your 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 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 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 the injection. The doctor will decide when the patient should stop and resume treatment with Sitagliptin + Metformin hydrochloride APC. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or a dose adjustment 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 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-sympathomimetics)
• 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

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 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 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 the medicine is essentially "sodium-free".

3. How to take Sitagliptin + Metformin hydrochloride APC

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The doctor will tell 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 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 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

If a higher dose of this medicine is taken than recommended, the patient should immediately consult their doctor. The patient should go to the hospital if they 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 a dose is missed, the patient should take it as soon as possible. If the patient does not remember until it is time to take the next dose, they should skip the missed dose and return to their regular dosing schedule. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Sitagliptin + Metformin hydrochloride APC

The patient should continue to take this medicine for as long as the doctor recommends to maintain control of blood sugar levels. The patient should not stop taking this medicine without consulting their doctor first. Stopping treatment with Sitagliptin + Metformin hydrochloride APC may cause blood sugar levels to rise again. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The patient should STOPtaking Sitagliptin + Metformin hydrochloride APC and immediately consult 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 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 STOPtaking Sitagliptin + Metformin hydrochloride APC and IMMEDIATELYconsult 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 of the skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking this medicine and immediately consult their doctor. 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 to take sitagliptin reported the following side effects: Common (may affect up to 1 in 10 people): low blood sugar levels, 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). Some patients taking sitagliptin alone or in combination with other anti-diabetic medicines reported the following side effects: Common: low blood sugar levels, 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 (a type of blistering skin condition) Some patients taking metformin alone reported the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms may occur at the start 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, 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 storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 hydrogen 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. 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. 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 Sp. z o.o. 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 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