Iuzimette

Leaflet attached to the packaging: patient information

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

sitagliptin + metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Juzimette and what is it used for

Juzimette 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 is used in combination with diet and exercise 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 properly. 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 Juzimette

When not to take Juzimette:

• 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, for example, severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis.

Lactic acidosis is a very rare but very serious side effect that can occur due to metformin accumulation. Symptoms of lactic acidosis include: vomiting, abdominal pain, muscle cramps, general feeling of being unwell, together with severe tiredness, difficulty breathing, and decreased body temperature and slow heart rate. Lactic acidosis is a medical emergency that requires immediate hospitalization.

Warnings and precautions

Patients taking Juzimette have reported cases of pancreatitis (see section 4). If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid. The doctor may advise the patient to stop taking Juzimette.

Risk of lactic acidosis

Juzimette 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 disease, and any conditions in which part of the body is not getting enough oxygen (e.g., acute severe heart disease). If any of these situations apply to the patient, they should consult their doctor for more detailed instructions.

Temporary discontinuation of Juzimette

The patient should temporarily stop taking Juzimette if they have a condition that may lead to dehydration (significant loss of body water), such as severe vomiting, diarrhea, fever, high temperature, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

Discontinuation of Juzimette and immediate contact with a doctor or hospital

The patient should stop taking Juzimette and immediately contact their doctor or the nearest hospital if they 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, together with severe tiredness, difficulty breathing, and decreased body temperature and slow heart rate.

Before starting to take Juzimette, the patient should discuss the following with their 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 levels of triglycerides (a type of fat) in the blood. In these situations, the risk of pancreatitis (see section 4) may increase. if the patient has type 1 diabetes. This is sometimes called insulin-dependent diabetes; if the patient has or has had allergic reactions to sitagliptin, metformin, or Juzimette (see section 4); if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Juzimette, as this may lead to low blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is going to have a major surgical procedure, they should not take Juzimette during the procedure and for some time after it. The doctor will decide when the patient should stop and restart treatment with Juzimette. If the patient is not sure whether any of the above applies to them, they should discuss it with their doctor or pharmacist before taking Juzimette. During treatment with Juzimette, the doctor will check 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. The medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether the medicine is safe and effective when used in children under 10 years of age.

Juzimette and other medicines

If the patient is going to have an intravenous contrast agent containing iodine injected into their bloodstream, for example, for an X-ray or CT scan, they should stop taking Juzimette before or at the latest at the time of the injection. The doctor will decide when the patient should stop and restart treatment with Juzimette. 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 blood glucose monitoring and kidney function tests or dose adjustments of Juzimette by their doctor. It is especially important to inform about the following medicines: oral, inhaled, or injected corticosteroids used to treat inflammatory conditions such as asthma or arthritis; diuretics; non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors, such as ibuprofen or celecoxib; certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists); beta-sympathomimetics used to treat asthma; iodine-containing contrast agents or alcohol-containing medicines; 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 Juzimette with digoxin, the patient's digoxin blood levels should be monitored.

Juzimette and alcohol

The patient should avoid excessive alcohol consumption while taking Juzimette, as this 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 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 Juzimette".

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 sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe support for their feet.

Juzimette 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 Juzimette

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

• The patient should take one tablet:
• twice a day, orally
• with meals to reduce the likelihood of stomach upset.
• The doctor may increase the dose of Juzimette to control blood sugar levels.
• 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 this medicine, when used alone, will cause low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when this medicine is used with a sulfonylurea derivative or insulin - in this case, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Juzimette 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, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Juzimette

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 Juzimette

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 Juzimette may cause an increase in 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 Juzimette 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.

Juzimette 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 the patient, they should STOP taking Juzimette and contact their 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, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking Juzimette 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. Some patients taking metformin after starting to take sitagliptin have reported 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 have reported 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 derivative, such as glimepiride, have reported the following side effects: Very common (may affect more than 1 in 10 people): low blood sugar levels Common (may affect up to 1 in 10 people): constipation. Some patients taking this medicine in combination with pioglitazone have reported the following side effects: Common (may affect up to 1 in 10 people): swelling of the hands or feet. Some patients taking this medicine in combination with insulin have reported the following side effects: Very common (may affect more than 1 in 10 people): low blood sugar levels Uncommon (may affect up to 1 in 100 people): dry mouth, headache. In clinical trials, some patients taking sitagliptin alone (one of the active substances of Juzimette) or after marketing authorization, during treatment with Juzimette or sitagliptin alone, or with other anti-diabetic medicines, have reported the following side effects: Common (may affect up to 1 in 10 people): low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, osteoarthritis, pain in the arms or legs Uncommon (may affect up to 1 in 100 people): dizziness, constipation, itching Rare (may affect up to 1 in 1,000 people): decreased platelet count Frequency not known (frequency cannot be estimated from the available data): kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid. Some patients taking metformin alone have reported the following side effects: Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur after starting to take metformin and usually disappear. Common (may affect up to 1 in 10 people): metallic taste, decreased or low levels of vitamin B in the blood (symptoms may include extreme tiredness, pain, and redness of the tongue, or numbness). The doctor may order tests to determine the cause of the symptoms, as some of them may also be caused by diabetes or other independent health problems. Very rare (may affect up to 1 in 10,000 people): liver inflammation (liver disease), hives, skin 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 collected on the safety of this medicine.

5. How to store Juzimette

The medicine should be stored out of 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. Store in a temperature below 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 Juzimette contains

The active substances of Juzimette are sitagliptin and metformin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin). The other ingredients are: Tablet core: Microcrystalline cellulose, type 101 Povidone K29/32 Sodium stearyl fumarate Sodium lauryl sulfate Film coating: Hypromellose, partially hydrolyzed Macrogol 4000 Talc Titanium dioxide (E 171) Iron oxide red (E 172) Iron oxide black (E 172)

What Juzimette looks like and contents of the pack

Brown (white or almost white) film-coated tablet, oblong (approximately 21.5 mm long, 10.0 mm wide), biconvex. The tablet has "AE4" engraved on one side and no markings on the other side. The film-coated tablets are packaged in white, non-transparent blisters made of PVC/PE/PVDC/Aluminum. The blisters are packaged in a carton, which includes a patient information leaflet. The cartons contain 28, 30, 56, 60, 98, or 120 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Poland

Manufacturer

Gedeon Richter România S.A., Str. Cuza-Vodă nr. 99-105, 540306 Târgu-Mureş, Romania Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

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

Bulgaria Juzimette 50 mg/1000 mg, филмирани таблетки Czech Republic Juzimette Estonia Juzimette Hungary Juzimette 50 mg/1000 mg, filmtabletta Latvia Juzimette 50 mg/1000 mg, apvalkotās tabletes Poland Juzimette Romania Juzimette 50 mg/1000 mg, comprimate filmate Slovakia Juzimette 50 mg/1000 mg, filmom obalené tablety

Date of last revision of the leaflet: April 2024