Asigefort

Package Leaflet: Information for the Patient

Asigefort, 50 mg + 850 mg, film-coated tablets

Asigefort, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Asigefort and what is it used for
• 2. Important information before taking Asigefort
• 3. How to take Asigefort
• 4. Possible side effects
• 5. How to store Asigefort
• 6. Contents of the pack and other information

1. What is Asigefort and what is it used for

Asigefort 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 effect 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 decrease the amount of sugar produced by the body. When taken in combination with diet and exercise, this medicine helps to lower blood sugar levels. This medicine can be used alone 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 health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Asigefort

When not to take Asigefort

• if you are allergic to sitagliptin and metformin or any of the other ingredients of this medicine (listed in section 6),
• if you have severely 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 condition in which substances called ketones accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth.
• if you have a severe infection or dehydration,
• if you are going to have a radiological examination with intravascular administration of a contrast agent. You should stop taking Asigefort during the radiological examination and for at least 2 days or more, as recommended by your doctor, depending on your kidney function.
• if you have recently had a heart attack or have had severe circulatory problems, such as shock or breathing difficulties,
• if you have liver disease,
• if you drink excessive amounts of alcohol (either regularly or from time to time),
• if you are breastfeeding.

Do not take Asigefort if any of the above contraindications apply to you. Consult your doctor to determine other methods of controlling diabetes. If in doubt, before taking Asigefort, discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking sitagliptin in combination with metformin, cases of pancreatitis (see section 4) have been reported. If you experience blisters on your skin, it may be a sign of a disease called pemphigoid blisters. Your doctor may advise you to stop taking Asigefort.

Risk of lactic acidosis

Asigefort may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in the case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver problems, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., severe heart disease). If any of the above situations apply to you, consult your doctor for more detailed instructions.

You should temporarily stop taking Asigefort if you have a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. Consult your doctor for more detailed instructions.

You should stop taking Asigefort and contact your doctor immediately or go to the nearest hospital if you experience any symptoms of lactic acidosis

as it can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell along with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Contact your doctor immediately if you experience any of the following:

• 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, worsening of cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before taking Asigefort, discuss with your doctor or pharmacist:

• if you have or have had pancreatitis (inflammation of the pancreas),
• if you have or have 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 you have type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if you have had allergic reactions to sitagliptin, metformin, or Asigefort (see section 4),
• if you are taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Asigefort, as it may lead to low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

If you are going to have a major surgical procedure, you should not take Asigefort during the procedure and for some time after it. Your doctor will decide when you should stop and restart treatment with Asigefort. If in doubt, before taking Asigefort, discuss it with your doctor or pharmacist. During treatment with Asigefort, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have 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 in children under 10 years of age.

Asigefort with other medicines

If you are going to have an intravascular injection of a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, you should stop taking Asigefort before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Asigefort. Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose checks and kidney function tests or dose adjustments of Asigefort by your doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma or 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 (β-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,
• 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 conditions). When taking Asigefort with digoxin, your doctor should monitor your digoxin blood levels.

Asigefort with alcohol

Avoid excessive alcohol consumption while taking Asigefort, as it 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, consult your doctor or pharmacist before taking this medicine. Do not take this medicine during pregnancy. This medicine must not be used during breastfeeding. See section 2 "When not to take Asigefort".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or operating machinery, consider that dizziness and drowsiness have been reported in patients taking sitagliptin, which may affect the ability to drive and operate machinery. Taking this medicine with sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and operate machinery or work without safe foot support.

Asigefort contains sodium

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

3. How to take Asigefort

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

• Take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• Your doctor may increase the dose of Asigefort to control your blood sugar levels.
• If you have kidney problems, your doctor may prescribe a lower dose.

While taking this medicine, continue to follow the diet recommended by your doctor and pay attention to evenly distributing 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 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 Asigefort than recommended

If you take more Asigefort than you should, contact your doctor immediately. 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 Asigefort

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.

Stopping treatment with Asigefort

To maintain control of your blood sugar levels, you should take this medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first. Stopping treatment with Asigefort may lead to an increase in blood sugar levels. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Asigefort can cause side effects, although not everybody gets them. You should STOP taking Asigefort and contact your doctor immediately 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 - these may be symptoms of pancreatitis.

Asigefort may very rarely cause (may occur in less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, stop taking Asigefort and contact your doctor immediately or go to the nearest hospital, as lactic acidosis can lead to coma. In the case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking Asigefort and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes. Some patients taking metformin after starting sitagliptin 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 experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting treatment with sitagliptin in combination with metformin (common). Some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, 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 with pioglitazone experienced the following side effects: Common: swelling of the hands or feet Some patients taking this medicine with insulin experienced the following side effects: Very common: low blood sugar Uncommon: dry mouth, headache In clinical trials, some patients taking sitagliptin (one of the active substances of Asigefort) alone or in combination with metformin or other anti-diabetic medicines experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, osteoarthritis, pain in the arms or legs 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) Some patients taking metformin alone experienced the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste in the mouth, decreased or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness or tingling). Your doctor may order certain tests to find the cause of the symptoms you are experiencing, as some of them may also be caused by diabetes or other unrelated health problems. Very rare: liver inflammation (liver disease), hives, skin rash, or itching.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. 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 Asigefort

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. Blister pack: OPA/Aluminum/PVC//Aluminum: There are no special storage instructions for the medicinal product. Store in the original packaging to protect from moisture. Blister pack: PVC/PE/PVDC/PE/PVC//Aluminum: Do not store above 30°C. Store in the original packaging to protect from moisture. 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 pack and other information

What Asigefort contains

• The active substances of Asigefort are sitagliptin and metformin hydrochloride. Asigefort, 50 mg + 850 mg, film-coated tablets Each film-coated tablet contains 50 mg of sitagliptin and 850 mg of metformin hydrochloride. Asigefort, 50 mg + 1000 mg, film-coated tablets Each film-coated tablet contains 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• The other ingredients (excipients) are: povidone K30, microcrystalline cellulose, mannitol, sodium lauryl sulfate, magnesium stearate in the tablet core, and hypromellose type 2910 (6 mPa∙s), titanium dioxide (E 171), talc, propylene glycol (E 1520), and red iron oxide (E 172) in the tablet coating. See section 2 "Asigefort contains sodium".

What Asigefort looks like and contents of the pack

Asigefort, 50 mg + 850 mg, film-coated tablets: pink, oval, biconvex film-coated tablets with the marking C4 on one side of the tablet (approximately 20 x 11 mm in size). Asigefort, 50 mg + 1000 mg, film-coated tablets: dark pink, oval, biconvex film-coated tablets with the marking C3 on one side of the tablet (approximately 21 x 11 mm in size). Asigefort is available in packs containing:

• 28, 56 film-coated tablets in blisters,
• 28, 56 film-coated tablets in a calendar pack.

Not all pack sizes may be marketed.

Marketing authorization holder

TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany

Manufacturer/Importer

KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany For more information about this medicine and its names in other EU member states, contact the representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw tel. 22 57 37 500 Date of last revision of the package leaflet:26.03.2025