Sitagliptin + Metformin hidrohloride Tzf

Leaflet accompanying the packaging: patient information

Sitagliptin + Metformin hydrochloride TZF, 50 mg + 850 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride TZF, 50 mg + 1000 mg, film-coated tablets

Sitagliptin+ Metformin hydrochloride

You should carefully read the contents of the leaflet before taking 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sitagliptin + Metformin hydrochloride TZF and what is it used for
• 2. Important information before taking Sitagliptin + Metformin hydrochloride TZF
• 3. How to take Sitagliptin + Metformin hydrochloride TZF
• 4. Possible side effects
• 5. How to store Sitagliptin + Metformin hydrochloride TZF
• 6. Contents of the packaging and other information

1. What is Sitagliptin + Metformin hydrochloride TZF and what is it used for

Sitagliptin + Metformin hydrochloride TZF 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 can be used as the only antidiabetic medicine or in combination with certain other antidiabetic 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 Sitagliptin + Metformin hydrochloride TZF

When not to take Sitagliptin + Metformin hydrochloride TZF:

• if you are allergic to sitagliptin or metformin, or any of the other ingredients of this medicine (listed in section 6),
• if you have significantly 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 ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic precoma. 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 scheduled to undergo a radiological examination with intravenous administration of a contrast agent. You should stop taking Sitagliptin + Metformin hydrochloride TZF during the radiological examination and for at least 2 days after the examination, as recommended by your doctor, depending on your kidney function.
• if you have recently had a heart attack or have had severe circulatory disorders, 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.

You should not take Sitagliptin + Metformin hydrochloride TZF if you have any of the above contraindications. You should consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Sitagliptin + Metformin hydrochloride TZF, you should discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Sitagliptin + Metformin hydrochloride TZF, cases of pancreatitis (see section 4) have been reported.
If you develop blisters on your skin, it may be a sign of a disease called pemphigoid blisters. Your doctor may recommend that you stop taking Sitagliptin + Metformin hydrochloride TZF.

Risk of lactic acidosis

Sitagliptin + Metformin hydrochloride TZF 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 disease, 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 you, you should consult your doctor for more detailed instructions.
You should contact your doctor immediately 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 (MIDD).
• after starting metformin, you have experienced any of the following symptoms: seizures, worsening of cognitive abilities, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

You should temporarily stop taking Sitagliptin + Metformin hydrochloride TZF if you

have 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 you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Sitagliptin + Metformin hydrochloride TZF 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 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.

Before taking Sitagliptin + Metformin hydrochloride TZF, you should 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 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 currently or in the past experienced allergic reactions to sitagliptin, metformin, or Sitagliptin + Metformin hydrochloride TZF (see section 4).
• if you are taking a sulfonylurea derivative or insulin, antidiabetic medicines, at the same time as Sitagliptin + Metformin hydrochloride TZF, as it may lead to excessive lowering of blood sugar (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

If you are going to have major surgery, you should not take Sitagliptin + Metformin hydrochloride TZF during the surgery and for some time after it. Your doctor will decide when you should stop and resume treatment with Sitagliptin + Metformin hydrochloride TZF.
In case of doubts whether any of the above statements apply to you, before taking Sitagliptin + Metformin hydrochloride TZF, you should discuss it with your doctor or pharmacist.
During treatment with Sitagliptin + Metformin hydrochloride TZF, your doctor will monitor 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 when used in children under 10 years of age.

Sitagliptin + Metformin hydrochloride TZF and other medicines

If you are going to have a contrast agent containing iodine injected into your bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Sitagliptin + Metformin hydrochloride TZF before or at the latest at the time of the injection. Your doctor will decide when you should stop and resume treatment with Sitagliptin + Metformin hydrochloride TZF.
You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You may need more frequent monitoring of blood sugar levels and kidney function or dose adjustment of Sitagliptin + Metformin hydrochloride TZF by your 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 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 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 TZF with digoxin, you should monitor your digoxin levels in the blood.

Sitagliptin + Metformin hydrochloride TZF with alcohol

You should avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride TZF, 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 baby, you should consult your doctor or pharmacist before taking this medicine.
You should not take this medicine during pregnancy or while breastfeeding. See section 2. When not to take Sitagliptin + Metformin hydrochloride TZF.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving and using machines, you should take into account that dizziness and drowsiness have been reported in patients taking sitagliptin, which may affect the ability to drive and use machines.
Taking this medicine at the same time as sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe support for your feet.

Sitagliptin + Metformin hydrochloride TZF contains sodium

Sitagliptin + Metformin hydrochloride TZF contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Sitagliptin + Metformin hydrochloride TZF

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

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

While taking this medicine, you should continue to follow the diet recommended by your doctor and pay attention to the even distribution of carbohydrates throughout the day.
It is unlikely that taking this medicine alone will lead to low blood sugar (hypoglycemia). Low blood sugar 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 Sitagliptin + Metformin hydrochloride TZF than recommended

If you take more of this medicine than you should, you should immediately contact your doctor.
You should 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 Sitagliptin + Metformin hydrochloride TZF

If you miss a dose, you should take it as soon as possible. If it is almost time for your next dose, you should skip the missed dose and continue taking the medicine as usual. You should not take a double dose of this medicine.

Stopping treatment with Sitagliptin + Metformin hydrochloride TZF

In order to maintain control of blood sugar levels, you should take the medicine for as long as your doctor recommends.
You should not stop taking this medicine without consulting your doctor first.
Stopping treatment with Sitagliptin + Metformin hydrochloride TZF may lead to an increase in blood sugar levels.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should STOP taking Sitagliptin + Metformin hydrochloride TZF and immediately contact your doctor 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.

Sitagliptin + Metformin hydrochloride TZF 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 you experience it, you should stop taking Sitagliptin + Metformin hydrochloride TZF 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 of the skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, you should stop taking the medicine and immediately contact your doctor. Your 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:

Common (may occur in up to 1 in 10 patients): low blood sugar, nausea, bloating, vomiting
Uncommon (may occur in up to 1 in 100 patients): abdominal pain, diarrhea, constipation, drowsiness
In some patients, diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting have occurred after starting treatment with sitagliptin in combination with metformin (common).

In some patients taking this medicine at the same time as a sulfonylurea derivative, such as glimepiride, the following side effects have occurred:

Very common (may occur in more than 1 in 10 patients): low blood sugar
Common: constipation

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

Common: swelling of the hands or feet

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

Very common: low blood sugar
Uncommon: dry mouth, headache

In clinical trials, in some patients taking only sitagliptin (one of the active substances of Sitagliptin + Metformin hydrochloride TZF) or after marketing authorization, during treatment with Sitagliptin + Metformin hydrochloride TZF or sitagliptin or with other antidiabetic medicines, the following side effects have occurred:

Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose 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)

In some patients taking only metformin, the following side effects have occurred:

Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms may occur after starting metformin and usually disappear.
Common: metallic taste, decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pallor or yellowing of the skin). 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 redness (rash), or itching.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell 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
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin + Metformin hydrochloride TZF

The medicine should be stored 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.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 TZF contains

The active substances of the medicine are sitagliptin and metformin.
Sitagliptin + Metformin hydrochloride TZF, 50 mg + 850 mg, film-coated tablets
Each film-coated tablet contains 50 mg of sitagliptin as sitagliptin phosphate monohydrate and 850 mg of metformin as metformin hydrochloride.
Sitagliptin + Metformin hydrochloride TZF, 50 mg + 1000 mg, film-coated tablets
Each tablet contains 50 mg of sitagliptin as sitagliptin phosphate monohydrate and 1000 mg of metformin as metformin hydrochloride.
Other ingredients are:
Tablet core: povidone K29/32, microcrystalline cellulose type 102, crospovidone, sodium stearyl fumarate
Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172) - only for the 50 mg + 850 mg strength

What Sitagliptin + Metformin hydrochloride TZF looks like and contents of the pack

Sitagliptin + Metformin hydrochloride TZF, 50 mg + 850 mg
Pink, elongated, oval film-coated tablet with a dividing line on one side and 'SA' on the other side. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Tablet dimensions: 19.5 ± 0.5 mm.
Sitagliptin + Metformin hydrochloride TZF, 50 mg + 1000 mg
Red to brown, elongated, oval film-coated tablet, with a dividing line between 'S' and 'B' on one side and a dividing line on the other side. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Tablet dimensions: 21.3 ± 0.5 mm.

Packaging

PVC/PVDC/Aluminum blister.
56 film-coated tablets packed with a leaflet in a carton.

Marketing authorization holder and manufacturer

Marketing authorization holder
Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
In order to obtain more detailed information about this medicine, you should contact the marketing authorization holder.
Manufacturer
Galenicum Health S.L.
Calle De San Gabriel 50
08950 Esplugues de Llobregat
Spain
SAG Manufacturing S.L.
Carretera Nacional 1 Km 36
28750 San Augustin del Guadalix
Spain
Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw

Date of last revision of the leaflet: March 2025