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 package 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 package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 reduces the amount of sugar produced by the body. The medicine, used in conjunction with diet and exercise, helps 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 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, for example, 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 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 2 or more days 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 shock or breathing difficulties,
• if you have liver disease,
• if you drink excessive amounts of alcohol (either every day 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 the patient develops blisters on the skin, it may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient 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 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 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 the patient, they should consult their doctor for more detailed instructions.

Temporarily stop taking Jamesi Novum if the patient has a condition

that may be associated with 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 Jamesi Novum and immediately contact your doctor or the nearest hospital if the patient

experiences 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, the patient should discuss it with their doctor or pharmacist:

• if the patient has or has had pancreatitis (e.g., inflammation of the pancreas).
• if the patient has or has had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) 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 currently or has had allergic reactions to sitagliptin, metformin, or Jamesi Novum (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Jamesi Novum, as it may lead to excessive lowering of blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

The patient should immediately contact their doctor 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 inherited diabetes and deafness from their mother (MIDD).
• the patient has experienced any of the following symptoms after starting to take metformin: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If the patient is to undergo major surgery, they must not take Jamesi Novum during the surgery and for some time after it. The doctor will decide when the patient should stop and resume taking Jamesi Novum. If in doubt, before taking Jamesi Novum, the patient should discuss it with their doctor or pharmacist. During treatment with Jamesi Novum, 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.

Jamesi Novum and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they must stop taking Jamesi Novum before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume taking Jamesi Novum. The patient should tell their doctor or pharmacist about all the medicines they are taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent monitoring of blood sugar levels and kidney function or modification of the Jamesi Novum dose by the doctor. It is particularly 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),

which may increase the risk of lactic acidosis (see section "Warnings and precautions").

• 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),
• iodine-containing contrast agents or alcohol-containing medicines,
• 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 diseases). When taking Jamesi Novum with digoxin, the patient's digoxin blood levels should be monitored.

Jamesi Novum and alcohol

The patient should avoid excessive alcohol consumption while taking Jamesi Novum, as it may increase the risk of lactic acidosis (see section "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 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 Jamesi Novum".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, while driving or using machines, the patient should take into account 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 Rarely, it may 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, 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 Novum than recommended

If the patient takes a higher dose of this medicine than recommended, they should immediately contact their doctor. The patient 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 section "Warnings and precautions").

Missing a dose of Jamesi Novum

If the patient misses a dose, they 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 Jamesi Novum

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 Novum may lead to increased blood sugar levels. If the patient has any further questions about taking this medicine, they should ask 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 Jamesi Novum and immediately contact their doctor 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 Novum may very rarely cause (may occur in less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to the patient, they should stop taking Jamesi Novum and immediately contact their doctor or the nearest hospital, 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, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, the patient should stop taking the medicine and immediately contact their doctor. 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 to take 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 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 derivative, such as glimepiride: Very common (may affect more than 1 in 10 people): low blood sugar levels Common: constipation Some patients have experienced the following side effects when taking this medicine in combination with pioglitazone: Common: swelling of the hands or feet Some patients have experienced the following side effects when taking this medicine in combination with insulin: Very common: low blood sugar levels 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 Jamesi Novum) or after marketing authorization of Jamesi Novum or sitagliptin alone or with other anti-diabetic medicines: Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, and 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, bullous pemphigoid (a type of blistering skin disease) Some patients have experienced the following side effects when taking metformin alone: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting to take metformin and usually go away. Common: metallic taste, decreased or low levels of vitamin B12 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 rash, or itching

Reporting side effects

If the patient experiences any side effects, including any not listed in this package 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. By reporting side effects, more information can be gathered 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 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. 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 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. Blisters of PVC/PVDC/Aluminum, 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 package leaflet:May 2025