JANSITIN 50 mg/850 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Jansitin Duo, 50 mg + 850 mg, Film-Coated Tablets
   1. Table of Contents of the Package Leaflet
3. What Jansitin Duo is and what it is used for
4. Important information before taking Jansitin Duo
   1. When not to take Jansitin Duo
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. You should temporarily stop taking Jansitin Duo if you have a condition that may lead to dehydration
   5. You should stop taking Jansitin Duo and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis
   6. Children and adolescents
   7. Jansitin Duo and other medicines
   8. Jansitin Duo and alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Jansitin Duo contains sodium
5. How to take Jansitin Duo
   1. Taking a higher dose of Jansitin Duo than recommended
   2. Missing a dose of Jansitin Duo
   3. Stopping treatment with Jansitin Duo
6. Possible side effects
   1. Reporting side effects
7. How to store Jansitin Duo
8. Contents of the pack and other information
   1. What Jansitin Duo contains
   2. What Jansitin Duo looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information about this medicine, contact the marketing authorization holder:
   6. Date of last revision of the leaflet: 26.05.2025

Package Leaflet: Information for the Patient

Jansitin Duo, 50 mg + 850 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 leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What Jansitin Duo is and what it is used for

Jansitin Duo contains two 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. When taken in combination with diet and exercise, this medicine helps to reduce blood sugar levels. This medicine can 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 diseases, such as heart disease, kidney disease, vision loss, and amputation of limbs.

2. Important information before taking Jansitin Duo

When not to take Jansitin Duo

• 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, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth;

If any of the above conditions apply to you, do not take Jansitin Duo. Consult your doctor to determine other methods of controlling diabetes. In case of doubt, before taking Jansitin Duo, discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Jansitin Duo, cases of pancreatitis (see section 4) have been reported. If you experience blisters on the skin, it may be a sign of a disease called pemphigoid blisters. Your doctor may advise you to stop taking Jansitin Duo.

Risk of lactic acidosis

Jansitin Duo 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 the case 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., severe heart disease). If any of the above situations apply to you, consult your doctor for more detailed instructions.

You should temporarily stop taking Jansitin Duo if you have a condition that may lead to dehydration

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

You should stop taking Jansitin Duo and contact your doctor or the nearest hospital immediately 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, difficulty breathing, decreased body temperature, and slow heart rate.

• Vomiting
• Abdominal pain
• Muscle cramps
• General feeling of being unwell along with severe fatigue
• Difficulty breathing
• Decreased body temperature and slow heart rate

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. You should contact your doctor immediately to receive 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 inherited diabetes and deafness (MIDD, maternal inherited diabetes and deafness).

If you experience any of the following symptoms after starting metformin: seizures, decreased cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or tingling), migraine, or hearing loss.

Before starting Jansitin Duo, discuss 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 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 Jansitin Duo (see section 4);
• If you are taking a sulfonylurea or insulin, anti-diabetic medicines, at the same time as Jansitin Duo, as it may lead to excessively low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of sulfonylurea or insulin.

If you are to undergo major surgery, you should not take Jansitin Duo during and for some time after the surgery. Your doctor will decide when you should stop and restart treatment with Jansitin Duo. If you are not sure whether any of the above applies to you, discuss it with your doctor or pharmacist before taking Jansitin Duo. During treatment with Jansitin Duo, your doctor will check 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 in children under 10 years of age.

Jansitin Duo and other medicines

If you are to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, you should stop taking Jansitin Duo before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Jansitin Duo. Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose checks and kidney function tests or a dose adjustment of Jansitin Duo by your doctor. It is especially important to inform about the following medicines:

• Medicines (taken orally, by inhalation, or by injection) used to treat diseases associated with inflammation, 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 gastrointestinal 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 specific type of thyroid cancer (medullary thyroid cancer);
• Digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Jansitin Duo with digoxin, digoxin levels in the blood should be monitored.

Jansitin Duo and alcohol

You should avoid consuming excessive amounts of alcohol while taking Jansitin Duo, as it 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy. You should not take this medicine while breastfeeding. See section 2, When not to take Jansitin Duo.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, 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.

Jansitin Duo contains sodium

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

3. How to take Jansitin Duo

Always take this medicine 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.
• Your doctor may increase the dose of Jansitin Duo to control blood sugar levels.
• 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 evenly distributing carbohydrates throughout the day. It is unlikely that this medicine, when used alone, will cause abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when this medicine is used with a sulfonylurea or insulin - in such cases, your doctor may reduce the dose of sulfonylurea or insulin. The line on the tablet is not intended to break the tablet.

Taking a higher dose of Jansitin Duo than recommended

If you take more Jansitin Duo than you should, contact your doctor immediately. 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 section "Warnings and precautions").

Missing a dose of Jansitin Duo

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 with your regular dosing schedule. Do not take a double dose of this medicine.

Stopping treatment with Jansitin Duo

To maintain control of blood sugar levels, you should take this medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first. Stopping Jansitin Duo may lead to increased blood sugar levels. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Jansitin Duo can cause side effects, although not everybody gets them. STOP taking Jansitin Duo and contact your doctor immediately 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.

Jansitin Duo may very rarely cause (may affect less than 1 in 10,000 people) a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If you experience it, stop taking Jansitin Duo and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. 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, 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 treatment with sitagliptin in combination with metformin (common). Some patients have experienced the following side effects when taking this medicine in combination with a sulfonylurea, such as glimepiride: Very common (may affect more than 1 in 10 people): low blood sugar. Common: constipation. Some patients have experienced the following side effects when taking this medicine in combination with pioglitazone: Common: swelling of the arms or legs. Some patients have experienced the following side effects when taking this medicine in combination with insulin: Very common: low blood sugar. Uncommon: dry mouth, headache. In clinical trials, some patients have experienced the following side effects when taking sitagliptin alone (one of the active substances of Jansitin Duo) or after marketing authorization, when taking Jansitin Duo or sitagliptin alone or with other anti-diabetic medicines: Common: low blood sugar, headache, upper respiratory tract infection, sore throat, or cough. Uncommon: dizziness, constipation, drowsiness. Rare (may affect less than 1 in 1,000 people): reduced platelet count. Unknown frequency: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blistering skin condition). Some patients have experienced the following side effects when taking metformin alone: Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur after starting metformin and usually disappear. Common: metallic taste, decreased or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness and tingling). 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 disease (liver disease), hives, skin rash, or itching.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects 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. You can also report side effects 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 Jansitin Duo

Keep this 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 stated. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Jansitin Duo contains

• The active substances of Jansitin Duo are sitagliptin and metformin. 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: povidone (K29/32), microcrystalline cellulose, crospovidone (Kollidon), sodium stearyl fumarate; Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172).

What Jansitin Duo looks like and contents of the pack

Oval, biconvex, film-coated tablets with a line on one side and "SA" on the other side. Tablet size: 19.5 mm ± 0.5 mm. PVC/PVDC/Aluminum blisters in a cardboard box. Packs of 56 film-coated tablets.

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Manufacturer

SAG MANUFACTURING S.L.U, Carretera Nacional I, Km 36, San Agustin de Guadalix, 28750 Madrid, Spain. GALenicUM HEALTH, S.L., Avda. Cornellá 144, 7º-1ª, Edificio Lekla, Esplugues de Llobregat, 08950 Barcelona, Spain

For more information about this medicine, contact the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o., Al. Jana Pawła II 61/313, 01-031 Warsaw, Poland. Tel: 022/ 636 52 23; 636 53 02, [email protected]

Date of last revision of the leaflet: 26.05.2025