JAMESI 56.688 mg/850 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Jamesi, 50 mg + 850 mg, film-coated tablets
3. Jamesi, 50 mg + 1000 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Jamesi and what is it used for
5. Important information before taking Jamesi
   1. When not to take Jamesi
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. The patient should temporarily stop taking Jamesi if they experience a condition that may lead to dehydration
   5. The patient should stop taking Jamesi and immediately contact a doctor or the nearest hospital if they experience any symptoms of lactic acidosis
   6. Children and adolescents
   7. Jamesi and other medicines
   8. Jamesi and alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Jamesi contains sodium
6. How to take Jamesi
   1. Taking a higher dose of Jamesi than recommended
   2. Missing a dose of Jamesi
   3. Stopping treatment with Jamesi
7. Possible side effects
   1. Reporting side effects
8. How to store Jamesi
9. Contents of the packaging and other information
   1. What Jamesi contains
   2. What Jamesi looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. For more information, the patient should contact the representative of the marketing authorization holder:

Leaflet accompanying the packaging: patient information

Jamesi, 50 mg + 850 mg, film-coated tablets

Jamesi, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metforminhydrochloride

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 or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Jamesi and what is it used for

Jamesi 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, used in conjunction with diet and physical exercise, helps to reduce blood sugar levels. This medicine may 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 as it should. The body may also produce too much sugar. If this happens, sugar (glucose) accumulates 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 Jamesi

When not to take Jamesi

• 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 significantly reduced kidney function,
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss,

Lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor.

• if the patient has a severe infection or dehydration,
• if the patient is scheduled to undergo a radiological examination with intravascular administration of a contrast agent. The patient should stop taking Jamesi during the radiological examination and for a period of 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 experienced 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 Jamesi if any of the above contraindications are present. Consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Jamesi, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking sitagliptin + metformin, 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 that the patient stop taking Jamesi.

Risk of lactic acidosis

Jamesi 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.

The patient should temporarily stop taking Jamesi if they experience a condition that may lead to dehydration

(significant water loss), 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.

The patient should stop taking Jamesi and immediately contact a doctor or the nearest hospital if they experience any symptoms of lactic acidosis

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

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, along with extreme fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. The patient should contact a doctor immediately 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, worsening of cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before taking Jamesi, the patient should discuss the following 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 triglyceride levels 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 or has had allergic reactions to sitagliptin, metformin, or Jamesi (see section 4),
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Jamesi, as it may lead to hypoglycemia (low blood sugar levels). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is scheduled to undergo major surgery, they should not take Jamesi during the surgery and for some time after it. The doctor will decide when the patient should stop and resume taking Jamesi. In case of doubts, before taking Jamesi, the patient should discuss it with a doctor or pharmacist. During treatment with Jamesi, the doctor will monitor the patient's kidney function at least once a year or more frequently 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.

Jamesi and other medicines

If the patient is to receive an intravascular contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Jamesi before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume taking Jamesi. 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 tests or a dose adjustment of Jamesi 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),
• diuretics (medicines that increase urine production),
• 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 Jamesi with digoxin, the patient's digoxin levels should be monitored.

Jamesi and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Jamesi, 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. This medicine should not be used during pregnancy or breastfeeding. See section 2, "When not to take Jamesi".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, while driving and using machines, the patient should take into account that dizziness and drowsiness have been reported during sitagliptin treatment, 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.

Jamesi 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 Jamesi

The patient should always take this medicine exactly as their doctor has told them. If they are not sure, they should ask their doctor or pharmacist.

• The patient should 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 Jamesi.
• 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). Low blood sugar levels 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 Jamesi than recommended

If the patient takes a higher dose of this medicine than recommended, they should contact their doctor immediately. They should go to the hospital if they 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 Jamesi

If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, they 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 Jamesi

To maintain control of blood sugar levels, the patient should take this medicine for as long as their doctor recommends. The patient should not stop taking this medicine without consulting their doctor first. Stopping treatment with Jamesi may lead to increased blood sugar levels. If the patient has any further doubts about taking this medicine, they 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 STOP taking Jamesi and contact their doctor 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.

Jamesi 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 happens to the patient, they should stoptakingJamesiandcontacttheirdoctororthenearesthospitalimmediately, 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 Jamesi and contact their doctor immediately. 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: 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): abdominal pain, diarrhea, constipation, drowsiness. Some patients have experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting sitagliptin treatment in combination with metformin (common). Some patients taking this medicine in combination with a sulfonylurea derivative, such as glimepiride, have 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 have experienced the following side effects: Common: swelling of the hands or feet. Some patients taking this medicine in combination with insulin have experienced the following side effects: Very common: low blood sugar levels Uncommon: dry mouth, headache. In clinical trials, some patients taking sitagliptin (one of the active substances of Jamesi) alone or in combination with other anti-diabetic medicines have experienced the following side effects: Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy nose or sinusitis, and sore throat, osteoarthritis, pain in the arms or legs Uncommon: dizziness, constipation, itching Rare: decreased platelet count. Unknown frequency: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin). Some patients taking metformin alone have experienced the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste, decreased or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pallor or yellowing of the skin). The doctor may order certain tests to find the cause of the symptoms, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Jamesi

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. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Jamesi contains

• The active substances of Jamesi are sitagliptin and metformin.
• Jamesi, 50 mg + 850 mg: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Jamesi, 50 mg + 1000 mg: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• Other ingredients of the medicine are: Core - microcrystalline cellulose (type 102), povidone (K 29/32), sodium lauryl sulfate, and magnesium stearate; Coating Jamesi, 50 mg + 850 mg, film-coated tablets (Opadry QX Pink), macrogol (PEG) and polyvinyl alcohol copolymer (E1209), talc (E553b), titanium dioxide (E171), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), iron oxide red (E172) Coating Jamesi, 50 mg + 1000 mg, film-coated tablets (Opadry QX Brown), macrogol (PEG) and polyvinyl alcohol copolymer (E1209), talc (E553b), titanium dioxide (E171), iron oxide red (E172), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), iron oxide black (E172),

What Jamesi looks like and contents of the pack

Jamesi, 50 mg + 850 mg, film-coated tablets are oval, biconvex, approximately 20.5 mm x 9.5 mm in size, pink, with the inscription "S476" on one side and smooth on the other. Jamesi, 50 mg + 1000 mg, film-coated tablets are oval, biconvex, approximately 21.5 mm x 10.0 mm in size, brown, with the inscription "S477" on one side and smooth on the other. The medicinal product is packed in a cardboard box. Blister packs of PVC/PVDC/Aluminum. Pack sizes: 14, 28, 56, 60, and 196 film-coated tablets. HDPE container with a PP closure and a desiccant. Pack size: 196 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Zentiva, k.s. U kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic

Manufacturer/Importer:

Laboratorios Liconsa S.A. Avenida Miralcampo 7 Poligono Industrial Miralcampo Azuqueca De Henares 19200 Guadalajara Spain

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

Austria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Spain: Jamesi Bulgaria: Джамези/Jamesi

For more information, the patient should contact the representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 Date of last revision of the leaflet:May 2025