Iazeta

Package Leaflet: Information for the Patient

Jazeta, 100 mg, Coated Tablets

Sitagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult your doctor or pharmacist.
This medicine has been prescribed to you by your doctor. 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Jazeta and what is it used for
• 2. Important information 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 is Jazeta and what is it 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 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. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which may already be taken for diabetes, along with diet and exercise.
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 diseases, such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Jazeta

When not to take Jazeta

• 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 sitagliptin, cases of pancreatitis (see section 4) have been reported.
If you experience blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking Jazeta.
Tell your doctor if you have or have had in the past:

• 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 (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 disease that has occurred in the past or is currently present;
• allergic reaction to sitagliptin (see section 4).

Since 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 sulfonylurea derivatives or insulin, it may cause low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of sulfonylurea derivatives 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 and other medicines

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan 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 whether 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, cases of dizziness and drowsiness have been reported, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylurea derivatives or insulin may cause low blood sugar levels (hypoglycemia), which may affect the ability to drive and use machines or work without safe foot support.

Jazeta contains sodium

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

3. How to take Jazeta

Always take this medicine exactly as your doctor has told you.
In case of doubts, consult your doctor or pharmacist.
The recommended dose is:

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

If you have kidney problems, your doctor may prescribe a lower dose of sitagliptin (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may advise you to take only this medicine or this medicine and certain other medicines that lower blood sugar levels.
Diet and exercise help your body use the sugar in your blood better. While taking Jazeta, it is important to follow the diet and exercise recommended by your doctor.

Taking a higher dose of Jazeta than recommended

If you take more of this medicine than you should, 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 your 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 treatment with Jazeta

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 Jazeta 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 (frequency not known: cannot be estimated from the available data)
• Severe allergic reactions, including skin rash, hives, blisters, or peeling skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes (frequency not known: cannot be estimated from the available data).

In some patients, the following side effects have been reported when sitagliptin was added to metformin:
Common(may affect up to 1 in 10 people):

• -low blood sugar,
• -nausea,
• -bloating,
• -vomiting
• -various stomach discomforts after starting sitagliptin treatment in combination with metformin

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

• -stomach pain,
• -diarrhea,
• constipation,
• drowsiness.

In some patients, the following side effects have been reported when sitagliptin was taken in combination with sulfonylurea derivatives and metformin:
Very common(may affect more than 1 in 10 people):

• low blood sugar

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

• constipation

In some patients, the following side effects have been reported when sitagliptin and pioglitazone were taken:
Common(may affect up to 1 in 10 people):

• bloating,
• swelling of hands or feet

In some patients, the following side effects have been reported when sitagliptin, pioglitazone, and metformin were taken:
Common(may affect up to 1 in 10 people):

• swelling of hands or feet

In some patients, the following side effects have been reported when sitagliptin was taken in combination with insulin (with or without metformin):
Common(may affect up to 1 in 10 people):

• flu

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

• dry mouth

In some patients, the following side effects have been reported when sitagliptin was taken alone in clinical trials or when sitagliptin was taken alone or with other anti-diabetic medicines after the medicine was marketed:
Common(may affect up to 1 in 10 people):

• low blood sugar,
• headache,
• upper respiratory tract infections,
• stuffy or runny nose
• sore throat,
• inflammation of bones and joints,
• arm or leg pain

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

• dizziness,
• constipation,
• itching

Rare(may affect up to 1 in 1000 people):

• reduced platelet count

Frequency not known: cannot be estimated from the available data

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Jazeta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage precautions for this medicine.
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 Jazeta contains

The active substance is sitagliptin.
Jazeta, 100 mg, coated tablets; Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin.
The other ingredients are:
Tablet core; calcium hydrogen phosphate, microcrystalline cellulose, sodium carmellose, magnesium stearate, sodium stearyl fumarate
Coating 100 mg; polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Jazeta looks like and contents of the pack

Jazeta, 100 mg, coated tablets are beige, round, biconvex, approximately 9.8 mm in diameter with "L" engraved on one side and smooth on the other.
Jazeta is available in PVC/PVDC/Aluminum blisters in a carton.
Pack sizes: 14, 28, 30, 56, 98 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zentiva, k.s.
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10
Czech Republic
(logo of the marketing authorization holder)
Manufacturer/Importer
Laboratorios Liconsa S.A.
Avenida Miralcampo 7
Poligono Industrial Miralcampo
Azuqueca De Henares
19200 Guadalajara
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Spain: Jazeta
Bulgaria: Джазета / Jazeta

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

Date of last revision of the package leaflet: