JUZIMETTE 50 mg/850 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. JUZIMETTE, 50 mg + 850 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Juzimette and what is it used for
4. Important information before taking Juzimette
   1. When not to take Juzimette:
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. Temporary discontinuation of Juzimette
   5. Stop taking Juzimette and contact your doctor or the nearest hospital immediately
   6. Children and adolescents
   7. Juzimette with other medicines
   8. Juzimette with alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Juzimette contains sodium
5. How to take Juzimette
   1. Taking a higher dose of Juzimette than recommended
   2. Missing a dose of Juzimette
   3. Stopping Juzimette
6. Possible side effects
   1. Reporting side effects
7. How to store Juzimette
8. Contents of the pack and other information
   1. What Juzimette contains
   2. What Juzimette looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the package leaflet: April 2024

Package Leaflet: Information for the Patient

JUZIMETTE, 50 mg + 850 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, pharmacist, or nurse.
• 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, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 pack 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 alone or in combination with certain other anti-diabetic medicines (insulin, sulfonylureas, 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 Juzimette

When not to take Juzimette:

• 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), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis.

Lactic acidosis is a rare but 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, respiratory distress, and decreased body temperature and heart rate. Lactic acidosis is a medical emergency that requires immediate hospitalization.

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking Juzimette (see section 4). If you experience blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Juzimette.

Risk of lactic acidosis

Juzimette may cause a very rare but serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases if you have uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see below), liver problems, or any condition that causes tissue hypoxia (e.g., acute severe heart failure). If any of these conditions apply to you, you should consult your doctor for further instructions.

Temporary discontinuation of Juzimette

If you have a condition that may lead to dehydration (e.g., severe vomiting, diarrhea, fever, high temperature, or reduced fluid intake), you should temporarily stop taking Juzimette. Consult your doctor for further instructions.

Stop taking Juzimette and contact your doctor or the nearest hospital immediately

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