Sitagliptina/hlorovodorek metformini Polpharma

Leaflet accompanying the packaging: patient information

Sitagliptin/Metformin Hydrochloride Polpharma, 50 mg + 850 mg, film-coated tablets

Sitagliptin/Metformin Hydrochloride Polpharma, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin Hydrochloride

You should carefully read the contents of the leaflet before using 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 Polpharma is and what it is used for
• 2. Important information before taking Sitagliptin/Metformin Hydrochloride Polpharma
• 3. How to take Sitagliptin/Metformin Hydrochloride Polpharma
• 4. Possible side effects
• 5. How to store Sitagliptin/Metformin Hydrochloride Polpharma
• 6. Contents of the packaging and other information

1. What Sitagliptin/Metformin Hydrochloride Polpharma is and what it is used for

What it is used for
Sitagliptin/Metformin Hydrochloride Polpharma 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 is used in combination with diet and exercise to reduce blood sugar levels.
This medicine may be used alone or in combination with certain other anti-diabetic 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 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 Sitagliptin/Metformin Hydrochloride Polpharma

Polpharma

When not to take Sitagliptin/Metformin Hydrochloride Polpharma:

• 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 severely reduced kidney function,
• if the patient has uncontrolled diabetes, for example, 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 the patient has a severe infection or dehydration,
• if the patient is scheduled to have a radiological examination with intravenous contrast medium. The patient should stop taking Sitagliptin/Metformin Hydrochloride Polpharma 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 problems, 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 Sitagliptin/Metformin Hydrochloride Polpharma 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 Polpharma, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting to take Sitagliptin/Metformin Hydrochloride Polpharma, discuss it with a doctor or pharmacist. In patients taking Sitagliptin/Metformin Hydrochloride Polpharma, 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 the treatment with Sitagliptin/Metformin Hydrochloride Polpharma.

Risk of lactic acidosis

Sitagliptin/Metformin Hydrochloride Polpharma 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 sufficiently supplied with oxygen (e.g., acute severe heart disease).
If any of the above situations apply to the patient, they should consult a doctor for more detailed instructions.

Temporarily discontinue the use of Sitagliptin/Metformin Hydrochloride Polpharma

Polpharma 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 a doctor for more detailed instructions.

Discontinue the use of Sitagliptin/Metformin Hydrochloride Polpharma 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 treatment in a hospital.
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, symptoms of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before starting to take Sitagliptin/Metformin Hydrochloride Polpharma, 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 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 has had allergic reactions to sitagliptin, metformin, or Sitagliptin/Metformin Hydrochloride Polpharma (see section 4).
• if the patient is taking a sulfonylurea or insulin, anti-diabetic medicines, at the same time as Sitagliptin/Metformin Hydrochloride Polpharma, as it may lead to excessive reduction of blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea or insulin.

If the patient is to undergo a major surgical procedure, they should stop taking Sitagliptin/Metformin Hydrochloride Polpharma during the procedure and for some time after it. The doctor will decide when the patient should stop and resume treatment with Sitagliptin/Metformin Hydrochloride Polpharma.
In case of doubts, before taking Sitagliptin/Metformin Hydrochloride Polpharma, discuss it with a doctor or pharmacist.
During treatment with Sitagliptin/Metformin Hydrochloride Polpharma, 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 impaired kidney function.

Children and adolescents

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

Sitagliptin/Metformin Hydrochloride Polpharma and other medicines

If the patient is to be injected with a contrast medium containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Sitagliptin/Metformin Hydrochloride Polpharma 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 Polpharma.
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 monitoring of blood sugar levels and kidney function or dose adjustment of Sitagliptin/Metformin Hydrochloride Polpharma 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),
• medicines that increase urine production (diuretics),
• 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),
• contrast media 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 conditions). When taking Sitagliptin/Metformin Hydrochloride Polpharma with digoxin, the patient should have their digoxin levels monitored.

Taking Sitagliptin/Metformin Hydrochloride Polpharma with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Sitagliptin/Metformin Hydrochloride Polpharma, 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 a doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy or while breastfeeding. See section 2, "When not to take Sitagliptin/Metformin Hydrochloride Polpharma".

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 take into account that dizziness and drowsiness have been reported during treatment with sitagliptin, 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.

Sitagliptin/Metformin Hydrochloride Polpharma contains sodium

Sitagliptin/Metformin Hydrochloride Polpharma, 50 mg + 850 mg film-coated tablets
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially "sodium-free".
Sitagliptin/Metformin Hydrochloride Polpharma, 50 mg + 1000 mg film-coated tablets
The 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 Polpharma

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.

• 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 the medicine.
• If the patient has impaired 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 the use of this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when this medicine is taken with a sulfonylurea or insulin - in such cases, the doctor may reduce the dose of the sulfonylurea or insulin.

Taking a higher dose of Sitagliptin/Metformin Hydrochloride Polpharma than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately contact a doctor. The patient should go to the hospital if symptoms of lactic acidosis occur, such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Sitagliptin/Metformin Hydrochloride Polpharma

In case of missing a dose, the patient 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. Do not take a double dose of this medicine.

Stopping the use of Sitagliptin/Metformin Hydrochloride Polpharma

To maintain control of blood sugar levels, the medicine should be taken for as long as the doctor recommends. Do not stop taking this medicine without consulting a doctor first.
Stopping the use of Sitagliptin/Metformin Hydrochloride Polpharma may lead to an increase in blood sugar levels.
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 Polpharma and immediately contact a doctorif the patient experiences 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.

Sitagliptin/Metformin Hydrochloride Polpharma may very rarely cause (may occur in up to 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Sitagliptin/Metformin Hydrochloride Polpharma and immediately contact a 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 of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking the 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:

• Frequently (may occur in up to 1 in 10 patients): low blood sugar, nausea, bloating, vomiting.
• Less frequently (may occur in up to 1 in 100 patients): stomach pain, diarrhea, constipation, drowsiness.

In some patients, diarrhea, nausea, bloating, constipation, stomach pain, or vomiting have occurred after starting treatment with sitagliptin in combination with metformin (frequently).
In some patients taking this medicine with a sulfonylurea, such as glimepiride, the following side effects have occurred:

• Very frequently (may occur in more than 1 in 10 patients): low blood sugar.
• Frequently: constipation.

In some patients taking this medicine with pioglitazone, the following side effects have occurred:

• Frequently: swelling of the hands or feet.

In some patients taking this medicine with insulin, the following side effects have occurred:

• Very frequently: low blood sugar.
• Less frequently: dry mouth, headache.

In clinical trials, in some patients taking sitagliptin alone (one of the active substances of Sitagliptin/Metformin Hydrochloride Polpharma) or after marketing authorization of Sitagliptin/Metformin Hydrochloride Polpharma or sitagliptin alone or with other anti-diabetic medicines, the following side effects have occurred:

• Frequently: low blood sugar, headache, upper respiratory tract infection, stuffy nose or sore throat, and joint or muscle pain.
• Less frequently: dizziness, constipation, itching.
• Rarely: 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 frequently: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear.
• Frequently: metallic taste.
• Very rarely: 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 Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sitagliptin/Metformin Hydrochloride Polpharma

Keep the 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.
The inscription on the packaging after the abbreviation "EXP" means the expiry date, and after the abbreviation "Lot/LOT" means the batch number.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 Polpharma contains

Sitagliptin/Metformin Hydrochloride Polpharma, 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), iron oxide black (E 172), iron oxide red (E 172).

Sitagliptin/Metformin Hydrochloride Polpharma, 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), iron oxide black (E 172), iron oxide red (E 172).

What Sitagliptin/Metformin Hydrochloride Polpharma looks like and contents of the pack

Sitagliptin/Metformin Hydrochloride Polpharma, 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.
Sitagliptin/Metformin Hydrochloride Polpharma, 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/PVDC blisters in a cardboard box.
Packaging contains 28, 56, or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

Farmaprojects S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 i 15
08028 Barcelona, Spain
Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact the local representative of the marketing authorization holder:

Polpharma Commercial Office Ltd.
Bobrowiecka 6, 00-728 Warsaw
Phone: 22 364 61 01
Date of last revision of the leaflet:March 2025