Iuzimette

Before taking Juzimette, consult your doctor if you have or have had: pancreatitis (inflammation of the pancreas); gallstones, alcohol dependence, or high levels of triglycerides (a type of fat) in the blood; type 1 diabetes; allergic reactions to sitagliptin, metformin, or Juzimette (see section 4); or if you are taking sulfonylureas or insulin, as you may be at risk of hypoglycemia (low blood sugar). Your doctor may adjust the dose of sulfonylureas or insulin.

Children and adolescents

Juzimette 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 if the medicine is safe and effective in children under 10 years of age.

Juzimette with other medicines

If you are going to have an injection of a contrast agent containing iodine (e.g., for an X-ray or CT scan), you should stop taking Juzimette before or at the time of the injection. Your doctor will decide when you should stop and restart Juzimette. 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 sugar checks or kidney function tests, or your doctor may need to adjust the dose of Juzimette. It is especially important to inform your doctor about the following medicines: oral, inhaled, or injected corticosteroids; diuretics; non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., ibuprofen or celecoxib); certain medicines for high blood pressure (ACE inhibitors or angiotensin II receptor antagonists); beta-sympathomimetics (for asthma); iodine-containing contrast agents or alcohol-containing medicines; certain medicines for stomach disorders (e.g., cimetidine); ranolazine (for angina); dolutegravir (for HIV infection); vandetanib (for a certain type of thyroid cancer); digoxin (for heart rhythm disorders or other heart conditions). Your doctor may need to monitor your digoxin levels while you are taking Juzimette.

Juzimette with alcohol

Avoid excessive alcohol consumption while taking Juzimette, as it 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 if you are pregnant or 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 in patients taking sitagliptin, which may affect the ability to drive and use machines. Taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect the ability to drive and use machines or work without safe support for your feet.

Juzimette contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Juzimette

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 gastrointestinal upset.
• Your doctor may increase the dose of Juzimette to control your blood sugar levels.
• 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 a regular carbohydrate intake throughout the day. It is unlikely that this medicine will cause low blood sugar (hypoglycemia) when taken alone. Low blood sugar may occur when this medicine is taken with a sulfonylurea or insulin - in this case, your doctor may reduce the dose of sulfonylurea or insulin.

Taking a higher dose of Juzimette than recommended

If you take more Juzimette 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, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Juzimette

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 Juzimette

To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first. Stopping Juzimette may cause your blood sugar levels to rise. If you have any further questions on the use of 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 Juzimette 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.

Juzimette may very rarely cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If you experience this, you should STOP taking Juzimette and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. In patients taking metformin, the following side effects have been reported: very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually resolve on their own. Common (may affect up to 1 in 10 people): metallic taste, reduced or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, or redness of the tongue, numbness or tingling, or pale or yellowish skin). Your doctor may order tests to determine the cause of these 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 you experience any side effects, including any not listed in this package leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects 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. 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 Juzimette

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. Store in a temperature below 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 Juzimette contains

The active substances are sitagliptin and metformin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin, and 850 mg metformin hydrochloride, equivalent to 660 mg metformin. The other ingredients are: tablet core: microcrystalline cellulose, type 101, povidone K29/32, sodium stearyl fumarate, sodium lauryl sulfate; coating: polyvinyl alcohol, partially hydrolyzed, macrogol 3350, talc, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172).

What Juzimette looks like and contents of the pack

Pink (white or almost white) film-coated tablet, oblong (approximately 17.7 mm long, 10.0 mm wide), biconvex. The tablet has "AE3" engraved on one side and is blank on the other. The film-coated tablets are packaged in white, non-transparent blisters made of PVC/PE/PVDC/Aluminum. The blisters are packaged in a carton containing 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/850 mg, film-coated tablets; Czech Republic: Juzimette; Estonia: Juzimette; Hungary: Juzimette 50 mg/850 mg, film tablet; Latvia: Juzimette 50 mg/850 mg, film-coated tablets; Poland: Juzimette; Romania: Juzimette 50 mg/850 mg, film-coated tablets; Slovakia: Juzimette 50 mg/850 mg, film-coated tablets

Date of last revision of the package leaflet: April 2024