JUZINA 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. JUZINA, 100 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 Leaflet
3. What is JUZINA and what is it used for
4. Important information before taking JUZINA
   1. When not to take JUZINA
   2. Warnings and precautions
   3. Children and adolescents
   4. JUZINA and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. JUZINA film-coated tablets contain sodium
5. How to take JUZINA
   1. If you take more JUZINA than you should
   2. If you forget to take JUZINA
   3. If you stop taking JUZINA
6. Possible side effects
   1. Reporting side effects
7. How to store JUZINA
8. Contents of the pack and other information
   1. What JUZINA contains
   2. What JUZINA looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:
   6. Other sources of information

Package Leaflet: Information for the Patient

JUZINA, 100 mg, Film-Coated Tablets

Sitagliptin

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, 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is JUZINA and what is it used for

JUZINA contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. The medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which you have already been taking to treat diabetes, along with a suitable diet and exercise program.
What is type 2 diabetes?
Type 2 diabetes is a condition where 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, loss of vision, and limb amputation.

2. Important information before taking JUZINA

When not to take JUZINA

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In patients taking JUZINA, cases of pancreatitis (see section 4) have been reported.
If you develop blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking JUZINA.
Tell your doctor if you have or have had:

• pancreatic disease (e.g., pancreatitis);
• 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.
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney problems, past or present;
• an allergic reaction to JUZINA (see section 4).

Because this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels. However, if this medicine is taken with a sulfonylurea or insulin, low blood sugar levels (hypoglycemia) may occur. Your doctor may reduce the dose of the sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not take this medicine. This medicine is not effective in children and adolescents from 10 to 17 years of age. It is not known if this medicine is safe and effective in children under 10 years of age.

JUZINA and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking JUZINA with digoxin, your doctor may need to check your digoxin blood levels.

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.
It is not known if this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you plan to breastfeed.

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 observed, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which can affect the ability to drive and use machines or work without safe foot support.

JUZINA film-coated tablets contain sodium

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

3. How to take JUZINA

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet;
• once a day;
• taken orally.

If you have kidney problems, your doctor may prescribe a lower dose (e.g., 25 mg or 50 mg). A 50 mg dose can be achieved by dividing a 100 mg JUZINA tablet into two equal halves. A 25 mg dose of JUZINA cannot be obtained by dividing a 100 mg JUZINA tablet, and therefore, JUZINA is not suitable for patients with severe kidney problems. In these patients, other sitagliptin-containing products with a 25 mg dose should be used.
This medicine can be taken with or without food and drink.
Your doctor may advise you to take this medicine alone or with certain other medicines that lower blood sugar levels.
Diet and exercise help your body use the sugar in your blood. While taking JUZINA, it is important to follow the diet and exercise program recommended by your doctor.

If you take more JUZINA than you should

If you have taken more JUZINA than you should, contact your doctor immediately.

If you forget to take JUZINA

If you miss a dose, take it as soon as you remember. 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.

If you stop taking JUZINA

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.
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.
STOP taking JUZINA and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis.

In case 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, stop taking JUZINA and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients, when sitagliptin was added to metformin, the following side effects were observed:
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 experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).
In some patients, when sitagliptin was taken with a sulfonylurea and metformin, the following side effects were observed:
Very common (may affect more than 1 in 10 people): low blood sugar levels.
Common: constipation.
In some patients, when sitagliptin was taken with pioglitazone, the following side effects were observed:
Common: bloating, swelling of the hands or feet.
In some patients, when sitagliptin was taken with pioglitazone and metformin, the following side effects were observed:
Common: swelling of the hands or feet.
In some patients, when sitagliptin was taken with insulin (with or without metformin), the following side effects were observed:
Common: flu.
Uncommon: dry mouth.
In some patients, when sitagliptin was taken alone in clinical studies or alone or with other anti-diabetic medicines after marketing authorization, the following side effects were observed:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, joint pain, pain in the hands or feet.
Uncommon: dizziness, constipation, itching.
Rare: decreased platelet count.
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).
Children and adolescents
In children and adolescents with type 2 diabetes aged 10 to 17 years, the side effect profile was similar to that observed in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
Phone: +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 JUZINA

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicinal product.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of the month.
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 JUZINA contains

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
• The other ingredients are: Tablet core: Microcrystalline cellulose Calcium hydrogen phosphate Croscarmellose sodium Sodium stearyl fumarate Magnesium stearate

Coating:
Polyvinyl alcohol
Titanium dioxide (E 171)
Macrogol 4000
Talc
Yellow iron oxide (E 172)

What JUZINA looks like and contents of the pack

JUZINA film-coated tablets are yellow, round, biconvex, approximately 10.5 mm in diameter, with “AD3” engraved on one side and a score line on the other side. The tablet can be divided into two equal doses.
The film-coated tablets are packaged in white, non-transparent blisters of PVC/PE/PVDC//Aluminum, containing 28, 30, 56, 60, 84, 90, or 98 tablets. The blisters are packaged in a cardboard box, containing a patient information leaflet.
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
For further information on this medicine, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu