Metsigletic

Package Leaflet: Information for the Patient

Metsigletic, 50 mg + 850 mg, Film-Coated Tablets

Metsigletic, 50 mg + 1000 mg, Film-Coated Tablets

Sitagliptin + Metformin Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Metsigletic and what is it used for

Metsigletic contains two different active substances called sitagliptin and metformin.

• Sitagliptin belongs to a group of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a group of medications called biguanides.

The combined action of these medications leads to the normalization of blood sugar levels in adult patients with a type of diabetes known as "type 2 diabetes". This medication helps achieve higher insulin levels after meals and reduces the amount of sugar produced by the body. When used in conjunction with diet and exercise, this medication helps reduce blood sugar levels. It can be used as the only anti-diabetic medication or in combination with certain other anti-diabetic medications (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 properly. 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 Metsigletic

When not to take Metsigletic:

• if you are allergic to sitagliptin or metformin, or any of the other ingredients of this medication (listed in section 6),
• if you have significantly reduced kidney function,
• if you have uncontrolled diabetes, such as 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 condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic 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 undergo a radiological examination with intravenous administration of a contrast agent. You should stop taking Metsigletic 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 severe circulatory problems, such as shock or breathing difficulties,
• if you have liver disease,
• if you consume excessive amounts of alcohol (either daily or from time to time),
• if you are breastfeeding.

Do not take Metsigletic if you have any of the above contraindications. Consult your doctor to determine other methods of controlling diabetes. If in doubt, consult your doctor, pharmacist, or nurse before taking Metsigletic.

Warnings and precautions

Before starting Metsigletic, discuss it with your doctor or pharmacist. In patients taking Metsigletic, cases of pancreatitis (see section 4) have been reported. If you experience blisters on your skin, it may be a sign of a condition called pemphigoid. Your doctor may advise you to stop taking Metsigletic.

Risk of lactic acidosis

Metsigletic 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 cases 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.

Temporarily stop taking Metsigletic if you have a condition that may lead to dehydration

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

Stop taking Metsigletic and immediately contact 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, combined with extreme fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Immediately contact 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.
• after starting metformin, you experience any of the following symptoms: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before starting Metsigletic, 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 your blood. In such cases, the risk of pancreatitis (see section 4) may increase.
• if you have type 1 diabetes. It is also known as insulin-dependent diabetes.
• if you have or have had allergic reactions to sitagliptin, metformin, or Metsigletic (see section 4).
• if you are taking a sulfonylurea derivative or insulin, anti-diabetic medications, at the same time as Metsigletic, as this may lead to hypoglycemia (low blood sugar levels). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

If you are scheduled to undergo major surgery, you should stop taking Metsigletic during and after the surgery for a certain period. Your doctor will decide when you should stop and resume treatment with Metsigletic. If in doubt, consult your doctor or pharmacist before taking Metsigletic. During treatment with Metsigletic, your doctor will monitor your kidney function at least once a year or more frequently if you are elderly and/or have worsening kidney function.

Children and adolescents

This medication should not be used in children and adolescents under 18 years of age. The safety and efficacy of this medication in children and adolescents under 18 years of age are not known.

Metsigletic and other medications

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

• medications (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or arthritis (corticosteroids),
• medications that increase urine production (diuretics),
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen or celecoxib),
• certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• specific medications used to treat asthma (β-sympathomimetics),
• contrast agents containing iodine or medications containing alcohol,
• certain medications used to treat stomach disorders, such as cimetidine,
• ranolazine, a medication used to treat angina pectoris,
• dolutegravir, a medication used to treat HIV infection,
• vandetanib, a medication 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 Metsigletic with digoxin, monitor your digoxin blood levels.

Taking Metsigletic with alcohol

Avoid consuming excessive amounts of alcohol while taking Metsigletic, as this may increase the risk of lactic acidosis (see section "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 medication. Do not take this medication during pregnancy or breastfeeding. See section 2, "When not to take Metsigletic".

Driving and using machines

This medication has no or negligible influence on the ability to drive and use machines. However, when driving and using machines, consider that dizziness and drowsiness have been reported during sitagliptin treatment, which may affect the ability to drive and use machines. Taking this medication 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.

Metsigletic contains sodium

Metsigletic, 50 mg + 850 mg, film-coated tablets The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free". Metsigletic, 50 mg + 1000 mg, film-coated tablets The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free".

3. How to take Metsigletic

Always take this medication exactly as your doctor 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.
• To control blood sugar levels, your doctor may increase the dose of Metsigletic.
• If you have kidney problems, your doctor may prescribe a lower dose.

During treatment with this medication, continue to follow the diet recommended by your doctor and pay attention to evenly distributing carbohydrate intake throughout the day. It is unlikely that taking this medication alone will lead to low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when taking this medication 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 Metsigletic than recommended

If you take a higher dose of this medication than recommended, immediately contact your doctor. Go to the hospital if you experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section "Warnings and precautions").

Missing a dose of Metsigletic

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 taking the medication as usual. Do not take a double dose of this medication.

Stopping Metsigletic treatment

To maintain control of blood sugar levels, take the medication for as long as your doctor recommends. Do not stop taking this medication without consulting your doctor first. Stopping Metsigletic treatment may lead to increased blood sugar levels. If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Metsigletic can cause side effects, although not everybody gets them. STOP taking Metsigletic and immediately contact your doctorif 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.

Metsigletic may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to you, stop taking Metsigletic and immediately contact your doctor or the nearest hospital, as lactic acidosis can lead to coma. In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking the medication and immediately contact your doctor. Your doctor may prescribe a medication to treat the allergic reaction and another medication (change the medication) 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 levels, 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 sitagliptin treatment in combination with metformin (common). In some patients taking this medication 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 levels. Common: constipation. In some patients taking this medication in combination with pioglitazone, the following side effects have occurred: Common: swelling of the hands or feet. In some patients taking this medication in combination with insulin, the following side effects have occurred: Very common: low blood sugar levels. Uncommon: dry mouth, headache. In clinical trials, some patients taking sitagliptin (one of the active substances of Metsigletic) alone or in combination with other anti-diabetic medications, or after marketing authorization of Metsigletic or sitagliptin, have experienced 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). In some patients taking metformin alone, the following side effects have occurred: Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste. Very rare: decreased vitamin B12 levels, liver inflammation (liver disease), hives, skin redness (rash), or itching.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety 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 medication.

5. How to store Metsigletic

Keep this medication out of the sight and reach of children. Do not use this medication after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month stated. The inscription on the packaging after the "EXP" abbreviation indicates the expiry date, and after the "Lot/LOT" abbreviation, it indicates the batch number. Do not store above 25°C. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Metsigletic contains

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

• The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 850 mg of metformin hydrochloride.
• The other ingredients are: tablet core: microcrystalline cellulose, povidone K30, sodium lauryl sulfate, sodium stearyl fumarate. The tablet coating also contains: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).

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

• The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride.
• The other ingredients are: tablet core: microcrystalline cellulose, povidone K30, sodium lauryl sulfate, sodium stearyl fumarate. The tablet coating also contains: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).

What Metsigletic looks like and contents of the pack

Metsigletic, 50 mg + 850 mg, film-coated tablets: oval, biconvex pink film-coated tablet, with "850" embossed on one side. The length of the tablet is 19.9-20.4 mm, and the width is 9.7-10.2 mm. Metsigletic, 50 mg + 1000 mg, film-coated tablets: oval, biconvex red film-coated tablet, with "1000" embossed on one side. The length of the tablet is 21.1-21.6 mm, and the width is 10.3-10.8 mm. Aluminum/PVC/PE/PVDC blisters in a cardboard box. Packs of 14, 28, 30, 56, 60, 90, 112, 168, 180, 196 film-coated tablets, collective packaging containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets. Packaging of 50 x 1 film-coated tablets in perforated single-dose blisters.

Marketing authorization holder and manufacturer

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01. Date of last revision of the package leaflet:March 2025.