Iamesi Novum

Package Leaflet: Information for the Patient

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

Jamesi Novum, 50 mg + 1000 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 or pharmacist.
• 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Jamesi Novum and what is it used for

Jamesi Novum 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. 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, 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 Jamesi Novum

When not to take Jamesi Novum

• 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, 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 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 odor from the mouth.

• if you have a severe infection or dehydration,
• if you are going to have a radiological examination with intravascular administration of a contrast agent. You should stop taking Jamesi Novum 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 severe circulatory problems, such as shock or breathing difficulties,
• 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 Jamesi Novum if you have any of the above contraindications. Consult your doctor to determine other methods of controlling diabetes. If in doubt, before taking Jamesi Novum, discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking sitagliptin + metformin, 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 Jamesi Novum.

Risk of lactic acidosis

Jamesi Novum 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 detailed 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 you, consult your doctor for more detailed instructions.

You should temporarily stop taking Jamesi Novum if you have a condition that may lead to dehydration

(significant water loss), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. Consult your doctor for more detailed instructions.

You should stop taking Jamesi Novum 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,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Before starting to take Jamesi Novum, 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 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 or have had allergic reactions to sitagliptin, metformin, or Jamesi Novum (see section 4),
• if you are taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Jamesi Novum, as this may lead to hypoglycemia (low blood sugar). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Consult your doctor 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 experience any of the following symptoms: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If you are going to have a major surgical procedure, you should not take Jamesi Novum during the procedure and for some time after it. Your doctor will decide when you should stop and restart treatment with Jamesi Novum. If in doubt, before taking Jamesi Novum, discuss it with your doctor or pharmacist. During treatment with Jamesi Novum, 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.

Jamesi Novum with 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 Jamesi Novum before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Jamesi Novum. 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 and kidney function tests or dose adjustments of Jamesi Novum 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),

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, ranitidine, 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 conditions). When taking Jamesi Novum with digoxin, the digoxin blood level should be monitored.

Jamesi Novum with alcohol

Avoid excessive alcohol consumption while taking Jamesi Novum, 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. Do not take this medicine during pregnancy. Do not take this medicine while breastfeeding, see section 2 "When not to take Jamesi Novum".

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, consider that dizziness and drowsiness have been reported during treatment 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.

Jamesi Novum contains sodium and sulfite

Sodium This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free". Sulfite It may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Jamesi Novum

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.
• To control blood sugar levels, your doctor may increase the dose of Jamesi Novum.
• If you have kidney problems, your doctor may prescribe a lower dose.

While taking this medicine, continue to follow the diet recommended by your 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, your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Jamesi Novum than recommended

If you take more of this medicine than you should, contact your doctor immediately. 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 Jamesi Novum

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 Jamesi Novum

To maintain control of blood sugar levels, you should continue to take this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor. Stopping treatment with Jamesi Novum may lead to increased blood sugar levels. If you have any further questions on the use of this product, 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 Jamesi Novum 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.

Jamesi Novum 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 you, you should STOP taking Jamesi Novum and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. In the event 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, stop taking the medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat 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, 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 with a sulfonylurea derivative, such as glimepiride, experienced the following side effects: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation Some patients taking this medicine with pioglitazone experienced the following side effects: Common: swelling of the hands or feet Some patients taking this medicine with insulin experienced the following side effects: Very common: low blood sugar Uncommon: dry mouth, headache In clinical trials, some patients taking sitagliptin (one of the active substances of Jamesi Novum) alone or after marketing authorization, when taking Jamesi Novum or sitagliptin alone or with other anti-diabetic medicines, experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, joint or muscle pain 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) Some patients taking metformin alone experienced the following side effects: Very common: nausea, vomiting, diarrhea, stomach 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). 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 rash, or itching

Reporting side effects

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

5. How to store Jamesi Novum

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 that month. Do not store above 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 Jamesi Novum contains

• Jamesi Novum, 50 mg + 850 mg: The active substances are sitagliptin and metformin. Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Jamesi Novum, 50 mg + 1000 mg: 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.
• Other ingredients are: Core - microcrystalline cellulose type 102, povidone 30, sodium sulfate, sodium lauryl sulfate, and sodium stearyl fumarate. Coating - polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc Additionally for Jamesi Novum, 50 mg + 1000 mg, film-coated tablets: yellow iron oxide (E172), red iron oxide (E172).

What Jamesi Novum looks like and contents of the pack

Jamesi Novum, 50 mg + 850 mg, film-coated tablets are white to almost white, oval, approximately 21 mm x 10 mm in size, with a dividing line on both sides. 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. Jamesi Novum, 50 mg + 1000 mg, film-coated tablets are light pink, oval, approximately 21 mm x 10.0 mm in size, with a dividing line on both sides. 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. PVC/PVDC/Aluminum blisters in a cardboard box. Pack sizes: 28, 56, 60, and 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:

Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3 032266 Bucharest Romania

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

Bulgaria, Czech Republic, Poland, Romania, Slovakia: Jamesi Novum

For more information, 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