Juzina

Patient Information Leaflet

JUZINA, 100 mg, film-coated tablets
Sitagliptin
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. 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 leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What JUZINA is and what it is used for
2. What you need to know 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 JUZINA is and what it is used for

JUZINA contains the active substance sitagliptin, which belongs to a class of medicines known as
DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood glucose levels in adults with type 2 diabetes.
This medicine helps increase insulin levels released after meals and reduces the amount of glucose produced by the body.
Your doctor has prescribed this medicine to help lower high blood glucose levels caused by type 2 diabetes.
The medicine may be used alone or in combination with other antidiabetic medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with an appropriate diet and exercise program.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin that is produced does not work as it should. The body may also produce too much glucose. When 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 amputations.

2. Important information before taking JUZINA

When not to take JUZINA

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

Warnings and precautions
Cases of pancreatitis have been reported in patients taking JUZINA (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking JUZINA.
Inform the doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis may be increased (see section 4).
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney disease in the past or currently;
• an allergic reaction to JUZINA (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar. However, if this medicine is taken together with a sulfonylurea derivative or insulin, low blood sugar (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea derivative 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 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.
JUZINA and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking JUZINA together with digoxin, blood levels of digoxin should be monitored.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and using machines
This medicine has no effect or a negligible effect 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 together with medicines called sulfonylurea derivatives or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and use machines or work without secure foot support.
JUZINA coated tablets contain sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take the medicine JUZINA

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual recommended dose is:

• one 100 mg coated tablet;
• once daily;
• taken orally.

If the patient has impaired kidney function, the doctor may prescribe a lower dose (e.g. 25 mg or 50 mg). A 50 mg dose can be obtained by splitting the JUZINA 100 mg tablet into two equal halves. However, a 25 mg dose of JUZINA cannot be obtained by splitting the 100 mg tablet, and therefore JUZINA is not suitable for patients with severe kidney impairment. In such patients, other medicines containing sitagliptin at a 25 mg dose should be used.

This medicine can be taken regardless of meals or drinks.

Your doctor may recommend taking only this medicine or this medicine in combination with other medicines that lower blood sugar levels.

Diet and physical exercise help the body to use blood sugar more effectively. While taking JUZINA, it is important to follow the diet and exercise regimen recommended by your doctor.

Taking more JUZINA than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately.

Missing a dose of JUZINA
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.

Stopping JUZINA treatment
To maintain control of your blood sugar levels, you should continue taking this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should DISCONTINUE the medicine JUZINA and contact your doctor immediately if any of the following serious adverse reactions occur:

• Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, you should stop taking the medicine 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, the following adverse reactions occurred when sitagliptin was added to metformin:

Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, flatulence, vomiting.

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.

Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar levels.

Common: constipation.

In some patients, the following adverse reactions occurred during treatment with sitagliptin and pioglitazone:

Common: flatulence, swelling of hands or feet.

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet.

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with insulin (with or without metformin):

Common: influenza-like illness.

Uncommon: dry mouth.

In some patients, the following adverse reactions occurred during clinical trials with sitagliptin used alone, or after marketing when used alone or in combination with other antidiabetic medicines:

Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, osteoarthritis, pain in hands or feet.

Uncommon: dizziness, constipation, itching.

Rare: decreased platelet count.

Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering).

Children and adolescents

In children and adolescents with type 2 diabetes aged 10 to 17 years, the adverse reaction profile was comparable to that observed in adults.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine JUZINA

Keep the medicine out of the sight and reach of children.
There are no special storage requirements 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What JUZINA contains

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

Coating:
Polyvinyl alcohol
Titanium dioxide (E 171)
Macrogol 4000
Talc
Iron oxide yellow (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 the imprint “AD3” on one side and a break line on the other side. The tablet can be divided into two equal doses.
The film-coated tablets are packed in white, opaque blisters made of PVC/PE/PVDC//Aluminum, containing 28, 30, 56, 60, 84, 90 or 98 tablets. The blisters are packed in a cardboard box containing a patient information leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation 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 about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel. +48 (22)755 96 48
[email protected]

Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website
http://www.ema.europa.eu