Iazeta Novum

Package Leaflet: Information for the Patient

Jazeta Novum, 25 mg, Film-Coated Tablets

Jazeta Novum, 50 mg, Film-Coated Tablets

Jazeta Novum, 100 mg, Film-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 specifically. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Jazeta Novum and what is it used for

Jazeta Novum 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 certain other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which you may already be taking for diabetes, along with diet and a physical exercise program.
What is type 2 diabetes?
Type 2 diabetes is a disease in which 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 Novum

When not to take Jazeta Novum

• 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 Novum.
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 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, past or 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 you take this medicine with a sulfonylurea derivative or insulin, low blood sugar levels (hypoglycemia) may occur. Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age. 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 Novum and other medicines

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

Pregnancy and breastfeeding

If you are pregnant or 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, 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 Novum 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 Novum

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 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 physical exercise help your body make better use of the sugar in your blood.
While taking Jazeta Novum, it is important to follow the diet and exercise program recommended by your doctor.

If you take more Jazeta Novum than you should

If you take more of this medicine than you should, contact your doctor immediately.

If you forget to take Jazeta Novum

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 forgotten tablet.

If you stop taking Jazeta Novum

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 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 Novum 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 of the 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 an allergic reaction and another medicine to treat diabetes (frequency not known: cannot be estimated from the available data).
In some patients, after adding sitagliptin to metformin, the following side effects have occurred:
Common(may affect up to 1 in 10 people):

• low blood sugar levels,
• 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, after taking sitagliptin in combination with a sulfonylurea derivative and metformin, the following side effects have occurred:
Very common(may affect more than 1 in 10 people):

• low blood sugar levels.

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

• constipation.

In some patients, after taking sitagliptin and pioglitazone, the following side effects have occurred:
Common(may affect up to 1 in 10 people):

• bloating,
• swelling of the hands or feet.

In some patients, after taking sitagliptin in combination with pioglitazone and metformin, the following side effects have occurred:
Common(may affect up to 1 in 10 people):

• swelling of the hands or feet.

In some patients, after taking sitagliptin in combination with insulin (with or without metformin), the following side effects have occurred:
Common(may affect up to 1 in 10 people):

• flu.

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

• dry mouth.

In some patients, after taking sitagliptin alone in clinical trials or after taking sitagliptin alone and/or with other anti-diabetic medicines after the medicine was made available, the following side effects have occurred:
Common(may affect up to 1 in 10 people):

• low blood sugar levels,
• headache,
• upper respiratory tract infections,
• nasal congestion or runny nose,
• sore throat,
• joint or muscle pain,
• 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):

• 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 of side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jazeta Novum

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
PVC/PVDC/Aluminum blister
Store in a temperature below 30°C. Store in the original package to protect from moisture.
PVC/PE/PVDC/Aluminum blister
There are no special temperature storage conditions.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Jazeta Novum contains

The active substance is sitagliptin.
Jazeta Novum, 25 mg, film-coated tablets; Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Jazeta Novum, 50 mg, film-coated tablets; Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Jazeta Novum, 100 mg, film-coated tablets; Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
The other ingredients are:
Tablet core: microcrystalline cellulose type 112, calcium hydrogen phosphate, sodium carmellose, colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

What Jazeta Novum looks like and contents of the pack

Jazeta Novum, 25 mg, are round, biconvex, pink film-coated tablets with a diameter of about 5.6 mm.
Jazeta Novum, 50 mg, are round, biconvex, beige film-coated tablets with a diameter of about 7.1 mm with the inscription "Z" on one side.
Jazeta Novum, 100 mg, are round, biconvex, orange to brown film-coated tablets with a diameter of about 9.1 mm.
PVC/PVDC/Aluminum blister
PVC/PE/PVDC/Aluminum blister
Package sizes: 14, 28, 30, 56, 60, 90, 98, 100 film-coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
(marketing authorization holder's logo)

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

Czech Republic, Poland: Jazeta Novum
Romania: Jazeta Novum 100 mg film-coated tablets
Slovakia: Jazeta Novum 50 mg, Jazeta Novum 100 mg
Bulgaria: Jazeta Novum 100 mg film-coated tablets
Джазета Новум 100 mg филмирани таблетки

For more information about this medicine, contact your local representative of the marketing authorization holder:

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

Date of last revision of the package leaflet: