Jazeta

Package leaflet: Information for the patient

Jazeta, 100 mg, coated tablets
Sitagliptin
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Jazeta is and what it is used for

Jazeta contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood glucose levels in adult patients 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. It may be used alone or in combination with other glucose-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and exercise.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced does not work properly, or the body produces too much glucose. As a result, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Information before taking Jazeta

When not to take Jazeta

• 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 (inflammation of the pancreas) have been reported in patients taking sitagliptin (see section 4).
If the patient develops skin blisters, this may be a symptom of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking Jazeta.
Inform the doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). 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;
• allergic reaction to sitagliptin (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, hypoglycaemia (low blood sugar) 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 in children under 10 years of age.
Jazeta with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 Jazeta together with digoxin, digoxin blood levels should be monitored.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy.
It is not known whether the medicine passes into human breast milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and using machines
This medicine has no effect or negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported, 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 low blood sugar (hypoglycaemia), which may affect the ability to drive and use machines or work without secure foot support.
Jazeta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered to be "sodium-free".

3. How to take Jazeta

This medicine should always be taken as prescribed by your doctor. If you have any doubts, 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 of sitagliptin (e.g. 25 mg or 50 mg).

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 Jazeta, it is important to follow the diet and perform the physical activities recommended by your doctor.

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

Missing a dose of Jazeta
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed tablet.

Stopping Jazeta
To maintain control of blood sugar levels, continue taking 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 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 everybody gets them.
STOP taking Jazeta and contact your doctor immediately if any of the following serious adverse reactions occur:

• Severe and persistent pain in the stomach area, possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis ( frequency unknown : cannot be estimated from available data)
• Severe allergic reactions, including rash, hives, skin blistering or peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing or swallowing. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes ( frequency unknown : cannot be estimated from available data).

The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:
Common (may affect up to 1 in 10 people):

• low blood sugar levels,
• nausea,
• flatulence,
• vomiting,
• various gastrointestinal discomforts after starting treatment with sitagliptin in combination with metformin

Uncommon (may affect up to 1 in 100 people):

• stomach pain,
• diarrhoea,
• constipation,
• drowsiness.

The following adverse reactions have been reported in some patients taking sitagliptin in combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people):

• low blood sugar levels

Common (may affect up to 1 in 10 people):

• constipation

The following adverse reactions have been reported in some patients taking sitagliptin and pioglitazone:
Common (may affect up to 1 in 10 people):

• flatulence,
• swelling of hands or feet

The following adverse reactions have been reported in some patients taking sitagliptin in combination with pioglitazone and metformin:
Common (may affect up to 1 in 10 people):

• swelling of hands or feet

The following adverse reactions have been reported in some patients taking sitagliptin in combination with insulin (with or without metformin):
Common (may affect up to 1 in 10 people):

• influenza-like illness

Uncommon (may affect up to 1 in 100 people):

• dry mouth

The following adverse reactions have been reported in some patients taking sitagliptin alone in clinical trials or after marketing authorization, either alone or in combination with other antidiabetic medicines:
Common (may affect up to 1 in 10 people):

• low blood sugar levels,
• headache,
• upper respiratory tract infections,
• stuffy or runny nose,
• sore throat,
• osteoarthritis,
• arm or leg pain

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 unknown: cannot be estimated from available data

• kidney disorders (sometimes requiring dialysis),
• vomiting,
• joint pain,
• muscle pain,
• back pain,
• interstitial lung disease,
• bullous pemphigoid (a type of blistering skin condition).

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 Reactions of Medicinal Products at 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 provide more information on the safety of the medicine.

5. How to store the medicine Jazeta

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
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 Jazeta contains
The active substance is sitagliptin.
Jazeta 100 mg film-coated tablets; each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
The other ingredients are:
Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, sodium stearyl fumarate.
Film-coating of the 100 mg tablet: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172), iron oxide red (E 172).

What Jazeta looks like and contents of the pack
Jazeta 100 mg film-coated tablets are beige, round, biconvex, approximately 9.8 mm in diameter, with the inscription "L" debossed on one side and smooth on the other.
Jazeta is available in PVC/PVDC/aluminum blister packs contained in a cardboard carton.
Pack sizes: 14, 28, 30, 56, or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10
Czech Republic
(logo of the marketing authorisation holder)

Manufacturer/Importer
Laboratorios Liconsa S.A.
Avenida Miralcampo 7
Poligono Industrial Miralcampo
Azuqueca De Henares
19200 Guadalajara
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact
the local representative of the marketing authorisation holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warszawa
tel.: +48 22 375 92 00