Iansitin Duo

Package Leaflet: Information for the Patient

Jansitin Duo, 50 mg + 1000 mg, Film-Coated Tablets

Sitagliptin + Metformin Hydrochloride
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

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 a type of diabetes known as "type 2 diabetes". This medicine helps to achieve higher insulin levels after meals and reduces 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 severely reduced kidney function;
• If you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, rapid 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 ketoacidosis.

If you experience any of the following symptoms, this could be a sign of lactic acidosis or ketoacidosis: abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth;

• If you have a severe infection or dehydration;
• If you are going to have a radiological examination with intravascular contrast agents. You should stop taking Jansitin Duo during the examination and for 2 days or more 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 problems, such as stroke or difficulty breathing;
• If you have liver disease;
• If you drink excessive amounts of alcohol (either regularly or from time to time);
• If you are breastfeeding.

Do not take Jansitin Duo if any of the above applies to you. You should consult your doctor to determine other methods of controlling your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before taking Jansitin Duo.

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking Jansitin Duo (see section 4). If you experience blisters on your skin, this could be a sign of a condition 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 with 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 the above applies to you, you should 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, high temperature, or if you drink less fluid than usual. You should 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

because this condition can lead to death. Symptoms of lactic acidosis include:

• Vomiting
• Abdominal pain
• Muscle cramps
• General feeling of being unwell, together 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. You should contact your doctor immediately to receive further instructions if:

• You have a genetically inherited disease affecting the mitochondria (energy-producing structures within cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.

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

Before taking Jansitin Duo, you should discuss the following with your doctor or pharmacist:

• If you have or have had pancreatitis (inflammation of the pancreas);
• If you have or have had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood. In these situations, the risk of pancreatitis (see section 4) may increase.
• If you have type 1 diabetes. This is sometimes called insulin-dependent diabetes;
• If you have or have had allergic reactions to sitagliptin, metformin, or Jansitin Duo (see section 4);
• If you are taking a sulfonylurea or insulin, anti-diabetic medicines taken at the same time as Jansitin Duo, as this may lead to excessively low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

If you are going to have a major surgical procedure, you should not take Jansitin Duo during the procedure and for some time after it. Your doctor will decide when you should stop and restart treatment with Jansitin Duo. If you are unsure whether any of the above applies to you, you should consult 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 when used in children under 10 years of age.

Jansitin Duo and other medicines

If you are going to have an intravascular contrast agent (e.g., for an X-ray or CT scan), you should stop taking Jansitin Duo before or at the time of the injection. Your doctor will decide when you should stop and restart treatment with Jansitin Duo. You should 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 monitoring, kidney function tests, or dose adjustments of Jansitin Duo by your doctor. It is particularly important to inform your doctor about the following medicines:

• Medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions, 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 problems, 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 conditions). When taking Jansitin Duo with digoxin, your doctor should monitor your digoxin blood levels.

Jansitin Duo and alcohol

You should avoid excessive alcohol consumption while taking Jansitin Duo, as this 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 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 if you are 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 in patients taking 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 is essentially "sodium-free".

3. How to take Jansitin Duo

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

• You should take one tablet:
• twice a day, orally
• with meals to reduce the likelihood of gastrointestinal upset.
• Your doctor may increase the dose of Jansitin Duo to control your 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 distributed carbohydrate intake throughout the day. It is unlikely that this medicine will cause abnormally low blood sugar levels (hypoglycemia) when taken alone. Low blood sugar levels can occur when this medicine is taken with a sulfonylurea or insulin - in this case, your doctor may reduce the dose of the sulfonylurea or insulin. The score line on the tablet is not intended for breaking the tablet.

Overdose of Jansitin Duo

If you have taken more than the prescribed dose of this medicine, 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 "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 your 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 treatment with Jansitin Duo may lead to increased blood sugar levels. If you have any further questions about taking this medicine, ask 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 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 - this could be a sign of pancreatitis.

Jansitin Duo 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 you, you should STOP taking Jansitin Duo and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to death. In the 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, you should stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat your 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): stomach pain, diarrhea, constipation, drowsiness. Some patients experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting treatment with sitagliptin in combination with metformin (common). Some patients taking this medicine in combination 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 in combination with pioglitazone experienced the following side effects: Common: swelling of the hands or feet. Some patients taking this medicine in combination with insulin experienced the following side effects: Very common: low blood sugar levels. Uncommon: dry mouth, headache. In clinical trials, some patients taking sitagliptin alone (one of the active substances in Jansitin Duo) or after marketing authorization of Jansitin Duo or sitagliptin alone or with other anti-diabetic medicines experienced the following side effects: Common: low blood sugar levels, headache, upper respiratory tract infection, sore throat, or cough. Uncommon: dizziness, constipation, itching. Rare (may affect up to 1 in 1,000 people): 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 blister on the skin). Some patients taking metformin alone experienced the following side effects: Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually disappear after starting metformin. Common: metallic taste, reduced 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 your 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 any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Post-Marketing Surveillance, 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, which is stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. Store in a temperature not exceeding 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 are sitagliptin and metformin. 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: 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).

What Jansitin Duo looks like and contents of the pack

Red to brownish-red, elongated, oval film-coated tablets with a score line between the markings "S" and "B" on one side and a score line on the other side. Tablet length: 21.3 mm ± 0.5 mm. Blisters of PVC/PVDC/Aluminum 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, biuro@gl-pharma.pl

Date of last revision of the leaflet: 26.05.2025