Sitagliptin + Metformin hidrohloride Grindeks

Leaflet accompanying the packaging: patient information

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

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

Sitagliptin + Metformin hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 Grindeks is and what it is used for
• 2. Important information before taking Sitagliptin + Metformin hydrochloride Grindeks
• 3. How to take Sitagliptin + Metformin hydrochloride Grindeks
• 4. Possible side effects
• 5. How to store Sitagliptin + Metformin hydrochloride Grindeks
• 6. Contents of the pack and other information

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

Sitagliptin + Metformin hydrochloride Grindeks contains two different active substances called sitagliptin and metformin hydrochloride.
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Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
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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 anti-diabetic medicine 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 properly. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious diseases, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Sitagliptin + Metformin hydrochloride Grindeks

Grindeks

When not to take Sitagliptin + Metformin hydrochloride Grindeks

• 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, 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 ketone bodies 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 agent administration. The patient should stop taking Sitagliptin + Metformin hydrochloride Grindeks during the radiological examination and for at least 2 days or more, 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 Sitagliptin + Metformin hydrochloride Grindeks if any of the above contraindications occur, and consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Sitagliptin + Metformin hydrochloride Grindeks, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Sitagliptin + Metformin hydrochloride Grindeks, 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 Sitagliptin + Metformin hydrochloride Grindeks.

Risk of lactic acidosis

Sitagliptin + Metformin hydrochloride Grindeks 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 disease, 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 the above situations apply to the patient, they should consult their doctor for more detailed instructions.

Seek medical attention immediately 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 has experienced any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Temporarily stop taking Sitagliptin + Metformin hydrochloride Grindeks if:

the patient has a condition that may lead to dehydration(significant water loss 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 their doctor for more detailed instructions.

Stop taking Sitagliptin + Metformin hydrochloride Grindeks and seek medical attention immediately if:

any symptoms of lactic acidosis occur, 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.
Before taking Sitagliptin + Metformin hydrochloride Grindeks, the patient should discuss the following with their 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 may increase (see section 4).
• if the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if the patient has or has had allergic reactions to sitagliptin, metformin, or Sitagliptin + Metformin hydrochloride Grindeks (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sitagliptin + Metformin hydrochloride Grindeks, as this may lead to excessive blood sugar reduction (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is to undergo major surgery, they should not take Sitagliptin + Metformin hydrochloride Grindeks during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Sitagliptin + Metformin hydrochloride Grindeks.
If the patient is unsure whether any of the above statements apply to them before taking Sitagliptin + Metformin hydrochloride Grindeks, they should discuss it with their doctor or pharmacist.
During treatment with Sitagliptin + Metformin hydrochloride Grindeks, 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. 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 Grindeks and other medicines

If the patient is to receive an intravenous contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Sitagliptin + Metformin hydrochloride Grindeks before or at the latest at the time of such administration. The doctor will decide when the patient should stop and resume treatment with Sitagliptin + Metformin hydrochloride Grindeks.
The patient should tell their doctor or pharmacist about all medicines they are currently 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 assessments or dose adjustments of Sitagliptin + Metformin hydrochloride Grindeks 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 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 Sitagliptin + Metformin hydrochloride Grindeks with digoxin, the patient's digoxin levels should be monitored.

Taking Sitagliptin + Metformin hydrochloride Grindeks with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride Grindeks, as this 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 child, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy. This medicine should not be used during breastfeeding. See section 2, When not to take Sitagliptin + Metformin hydrochloride Grindeks.

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 with sitagliptin, which may affect the ability to drive and use machines.
Taking this medicine 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.

Sitagliptin + Metformin hydrochloride Grindeks contains sodium

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

3. How to take Sitagliptin + Metformin hydrochloride Grindeks

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
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The patient should take one tablet:
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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 kidney problems, the doctor may prescribe a lower dose.

While taking 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 abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when taking this medicine with a sulfonylurea derivative or insulin – in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Sitagliptin + Metformin hydrochloride Grindeks than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately consult their doctor. The patient should go to the hospital if symptoms of lactic acidosis occur, 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 Grindeks

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. The patient should not take a double dose of this medicine.

Stopping treatment with Sitagliptin + Metformin hydrochloride Grindeks

To maintain control of blood sugar levels, the patient should take the medicine for as long as the doctor recommends. The patient should not stop taking this medicine without consulting their doctor first.
Stopping Sitagliptin + Metformin hydrochloride Grindeks may lead to increased blood sugar levels.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should STOPtaking Sitagliptin + Metformin hydrochloride Grindeks and seek medical attention immediately if 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.

Sitagliptin + Metformin hydrochloride Grindeks 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 occurs, the patient should STOPtaking Sitagliptin + Metformin hydrochloride Grindeks and seek medical attention immediately, 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, or throat, which may cause difficulty breathing or swallowing, the patient should stop taking the medicine and seek medical attention immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients taking metformin, after starting sitagliptin, the following side effects have occurred:

• Frequently (may occur in less than 1 in 10 patients): low blood sugar, nausea, bloating, vomiting
• Less frequently (may occur in less than 1 in 100 patients): abdominal pain, diarrhea, constipation, drowsiness

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

• Frequently: swelling of the hands or feet

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

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

In clinical trials, some patients taking sitagliptin (one of the active substances in Sitagliptin + Metformin hydrochloride Grindeks) alone or in combination with other anti-diabetic medicines, or after marketing authorization of Sitagliptin + Metformin hydrochloride Grindeks or sitagliptin alone in combination 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: reduced 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, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear.
• Frequently: metallic taste, reduced or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pale or yellowish skin). The doctor may order tests to find the cause of the patient's symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
• Very rarely: hives, skin rash, or itching

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sitagliptin + Metformin hydrochloride Grindeks

The medicine should be stored out of sight and reach of children.
This medicine does not require special storage conditions.
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 stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin + Metformin hydrochloride Grindeks contains

• The active substances of the medicine are sitagliptin and metformin hydrochloride. Sitagliptin + Metformin hydrochloride Grindeks, 50 mg + 850 mg, film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

Sitagliptin + Metformin hydrochloride Grindeks, 50 mg + 1000 mg, film-coated tablets:
Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.

• Other ingredients are: Tablet core: povidone K30, sodium lauryl sulfate, microcrystalline cellulose, sodium stearyl fumarate
  Coating: 50 mg + 850 mg tablet:copolymer of methacrylic acid and ethyl acrylate (E 1209) Talc (E 553b) Titanium dioxide (E 171) Glycerol monocaprylocaprate type 1 (E 471) Polyvinyl alcohol (E 1203) Iron oxide yellow (E 172) Iron oxide red (E 172) 50 mg + 1000 mg tablet:copolymer of methacrylic acid and ethyl acrylate (E 1209) Talc (E 553b) Titanium dioxide (E 171) Glycerol monocaprylocaprate type 1 (E 471) Polyvinyl alcohol (E 1203) Iron oxide red (E 172) Iron oxide yellow (E 172) Iron oxide black (E 172)

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

Sitagliptin + Metformin hydrochloride Grindeks, 50 mg + 850 mg, film-coated tablets:
orange, oval, biconvex film-coated tablet, with "SM85" embossed on one side. The tablet size is approximately 20 mm x 6.7 mm.
Sitagliptin + Metformin hydrochloride Grindeks, 50 mg + 1000 mg, film-coated tablets: brown, oval, biconvex film-coated tablet, with "SM100" embossed on one side. The tablet size is approximately 21 mm x 7.2 mm.
Sitagliptin + Metformin hydrochloride Grindeks is available in blisters containing 28, 56, 98 film-coated tablets or in multipacks containing 196 (2 packs of 98) film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sweden
Sitagliptin/Metformin Grindeks
Austria
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg Filmtabletten
Belgium
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Bulgaria
Ситаглиптин/Метформин Гриндекс 50 mg/850 mg, 50 mg/1000 mg филмирани таблетки
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Croatia
Sitagliptin/metformin hydrochloride Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Czech Republic
Sitagliptin/Metformin Grindeks
Denmark
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Estonia
Metformin hydrochloride/Sitagliptin Grindeks
Finland
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
France
SITAGLIPTINE/METFORMINE GRINDEKS 50 mg/850 mg, film-coated tablets
SITAGLIPTINE/METFORMINE GRINDEKS 50 mg/1000 mg, film-coated tablets
Germany
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg Filmtabletten
Greece
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Hungary
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Ireland
Sitagliptin/Metformin hydrochloride Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Italy
Sitagliptin/Metformin Grindeks
Latvia
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Lithuania
Sitagliptin/Metformin hydrochloride Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Luxembourg
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Netherlands
Sitagliptine/Metformine Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Norway
Sitagliptin/Metformin Grindeks
Poland
Sitagliptin + Metformin hydrochloride Grindeks
Portugal
Metformina + Sitagliptina Grindeks 850 mg + 50 mg, 1000 mg + 50 mg film-coated tablets
Romania
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Slovakia
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Slovenia
Sitagliptin/metformin hydrochloride Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Spain
Sitagliptina/Metformina Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets EFG

Date of last revision of the leaflet: 03/2025