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 medicine, 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 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 as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 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 package 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 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 achieve higher insulin levels after meals and reduces the amount of sugar produced by the body. When taken with diet and exercise, this medicine helps lower blood sugar levels. This medicine can be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas, 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 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 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 breath odor.
• if the patient has a severe infection or dehydration,
• if the patient is scheduled to undergo a radiological examination with intravenous contrast medium administration. The patient should stop taking Metsigletic during the radiological examination and for at least 2 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 (either daily or from time to time),
• if the patient is breastfeeding.

Do not take Metsigletic if any of the above contraindications apply. Consult a doctor to determine other methods of diabetes control. In case of doubts, before taking Metsigletic, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting Metsigletic, discuss it with a doctor or pharmacist. In patients taking Metsigletic, 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 stopping Metsigletic.

Risk of lactic acidosis

Metsigletic 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 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., acute severe heart disease). If any of these situations apply to the patient, they should consult their doctor for more detailed instructions.

Temporarily stop taking Metsigletic if the patient has a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, high temperature, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

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

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Immediately consult a doctor for further instructions if::

• the patient has 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).
• the patient experiences any of the following symptoms after starting metformin: 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 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 also known as insulin-dependent diabetes.
• if the patient has or has had allergic reactions to sitagliptin, metformin, or Metsigletic (see section 4),
• if the patient is taking a sulfonylurea or insulin, diabetes medicines, at the same time as Metsigletic, as it may lead to low blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea or insulin.

If the patient is scheduled to undergo major surgery, they should stop taking Metsigletic during and after the surgery. The doctor will decide when the patient should stop and resume Metsigletic treatment. In case of doubts, before taking Metsigletic, discuss it with a doctor or pharmacist. During Metsigletic treatment, 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 worsening kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. The safety and efficacy of Metsigletic in children and adolescents under 18 years of age have not been established.

Metsigletic and other medicines

If the patient is to receive an intravenous contrast medium containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Metsigletic before or at the latest when the contrast medium is administered. The doctor will decide when the patient should stop and resume Metsigletic treatment. The patient should tell their doctor or pharmacist about all medicines they are 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 dose adjustments of Metsigletic by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or arthritis (corticosteroids),
• diuretics (medicines that increase urine production),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen or celecoxib),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• specific medicines used to treat asthma (β-sympathomimetics),
• iodine-containing contrast media or alcohol-containing medicines,
• 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 conditions). When taking Metsigletic with digoxin, the patient's digoxin blood levels should be monitored.

Taking Metsigletic with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metsigletic, as it 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 baby, 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 Metsigletic".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, the patient should consider that dizziness and drowsiness have been reported during sitagliptin treatment, which may affect the ability to drive and use machines. Taking this medicine with sulfonylureas 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 medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free". Metsigletic, 50 mg + 1000 mg, film-coated tablets The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Metsigletic

This medicine should always be taken exactly as the doctor has instructed. In case of doubts, the patient should consult their doctor or pharmacist.

• The patient should take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• To control blood sugar levels, the doctor may increase the dose of Metsigletic.
• If the patient has kidney problems, the doctor may prescribe a lower dose.

During treatment with this medicine, the patient should continue to follow the diet recommended by their 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 or insulin – in such cases, the doctor may reduce the dose of the sulfonylurea or insulin.

Taking a higher dose of Metsigletic than recommended

If the patient takes a higher dose of this medicine than recommended, they should immediately contact 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 Metsigletic

If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medicine as usual. The patient should not take a double dose of this medicine.

Stopping Metsigletic treatment

To maintain blood sugar control, the patient should take this medicine for as long as their doctor recommends. The patient should not stop taking this medicine without consulting their doctor first. Stopping Metsigletic treatment may lead to increased blood sugar levels. 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, Metsigletic can cause side effects, although not everybody gets them. The patient should STOP TAKING METSIGLETIC AND IMMEDIATELY CONTACT THEIR DOCTORif 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 – 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 "Warnings and precautions"). If this happens to the patient, they should STOP TAKING METSIGLETIC AND IMMEDIATELY CONTACT THEIR 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, or throat, which may cause difficulty breathing or swallowing, the patient should stop taking Metsigletic and immediately contact 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 sitagliptin experienced 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): abdominal pain, diarrhea, constipation, drowsiness. Some patients experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting sitagliptin in combination with metformin (common). Some patients taking this medicine with a sulfonylurea, such as glimepiride, experienced the following side effects: Very common (may affect more than 1 in 10 people): low blood sugar levels. 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 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 diabetes medicines experienced the following side effects: Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose, and 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 may occur after starting metformin and usually disappear. Common: metallic taste. Very rare: decreased vitamin B12 levels, liver inflammation (liver disease), hives, skin rash, or itching.

Reporting side effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should tell their 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, more information can be gathered on the safety of this medicine.

5. How to store Metsigletic

The medicine should be stored out of 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. 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. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the package 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