Jazeta 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
Please read carefully all of this leaflet before taking this medicine, because it contains
important information for you.
Keep this leaflet, so that you can read it again if necessary.
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. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:

1. What Jazeta Novum is and what it is 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 Jazeta Novum is and what it is 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 glucose levels in adult patients with type 2 diabetes.
This medicine helps increase the amount of insulin 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 certain other glucose-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and an exercise programme.

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 may also produce too much glucose. When this occurs, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, loss of vision, and limb amputations.

2. Important information before taking Jazeta Novum

When not to take Jazeta Novum

• 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 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 Novum.
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 increase (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney disease currently or in the past;
• 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, low blood sugar (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea derivative or insulin.
Children and adolescents
This medicine must not be used 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 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 Jazeta Novum is taken together with digoxin, the concentration of digoxin in the blood should be monitored.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine.
This medicine must not be used during pregnancy.
It is not known whether the medicine passes into human breast milk. This medicine must not be used during breastfeeding or when planning to breastfeed.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylurea derivatives or insulin may lead to low blood sugar (hypoglycaemia), which may affect the ability to drive and operate machinery or work without secure foot support.
Jazeta Novum contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to take Jazeta Novum

This medicine should always be taken 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 recommend 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 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 Novum, it is important to follow the diet and perform the physical exercises
recommended by your doctor.
Taking more Jazeta Novum than prescribed
If you have taken more than the prescribed dose of this medicine, contact your doctor immediately.
Missing a dose of Jazeta Novum
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 treatment with Jazeta Novum
To maintain control of blood sugar levels, this medicine should be taken for as long as your doctor
advises. 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 will experience them.
DISCONTINUE Jazeta Novum and contact a 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 (frequency unknown: cannot be estimated based on available data).
• Severe allergic reactions, including skin rash, hives, skin blistering or peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.

The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes
(frequency unknown: cannot be estimated based on available data).
In some patients, when sitagliptin was added to metformin, the following adverse reactions occurred:
Common (may occur in less than 1 in 10 people):

• Low blood sugar levels,
• Nausea,
• Bloating,
• Vomiting,
• Various gastrointestinal discomforts after starting treatment with sitagliptin in combination with metformin.

Uncommon (may occur in less than 1 in 100 people):

• Stomach pain,
• Diarrhea,
• Constipation,
• Drowsiness.

In some patients, when sitagliptin was used in combination with a sulfonylurea and metformin, the following adverse reactions occurred:
Very common (may occur in more than 1 in 10 people):

• Low blood sugar levels.

Common (may occur in less than 1 in 10 people):

• Constipation.

In some patients, when sitagliptin was used together with pioglitazone, the following adverse reactions occurred:
Common (may occur in less than 1 in 10 people):

• Bloating,
• Swelling of hands or feet.

In some patients, when sitagliptin was used in combination with pioglitazone and metformin, the following adverse reactions occurred:
Common (may occur in less than 1 in 10 people):

• Swelling of hands or feet.

In some patients, when sitagliptin was used in combination with insulin (with or without metformin), the following adverse reactions occurred:
Common (may occur in less than 1 in 10 people):

• Influenza.

Uncommon (may occur in less than 1 in 100 people):

• Dry mouth.

In some patients, during clinical trials with sitagliptin alone, or during post-marketing use of sitagliptin alone and/or in combination with other antidiabetic medicines, the following adverse reactions occurred:
Common (may occur in less than 1 in 10 people):

• Low blood sugar levels,
• Headache,
• Upper respiratory tract infections,
• Nasal congestion or runny nose,
• Sore throat,
• Osteoarthritis,
• Pain in arm or leg.

Uncommon (may occur in less than 1 in 100 people):

• Dizziness,
• Constipation,
• Itching.

Rare (may occur in less than 1 in 1000 people):

• Decreased platelet count.

Frequency unknown: cannot be estimated based on 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, tell 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 Jazeta Novum

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following EXP. The expiry date refers to the last day of the stated month.
Blister made of PVC/PVDC/Aluminium foil
Store below 30°C. Keep in the original packaging to protect from moisture.
Blister made of PVC/PE/PVDC/Aluminium foil
No special storage temperature requirements for this medicine.
Keep in the original packaging to protect from moisture.
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 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 croscarmellose, 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 approximately 5.6 mm.
Jazeta Novum 50 mg are round, biconvex, beige film-coated tablets with a diameter of approximately 7.1 mm, imprinted with the code "Z" on one side.
Jazeta Novum 100 mg are round, biconvex, orange to brown film-coated tablets with a diameter of approximately 9.1 mm.
Blister made of PVC/PVDC/Aluminium.
Blister made of PVC/PE/PVDC/Aluminium.
Pack sizes: 14, 28, 30, 56, 60, 90, 98, 100 film-coated tablets.
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic, Poland: Jazeta Novum
Romania: Jazeta Novum 100 mg comprimate filmate
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 detailed information about this medicinal product, contact the local representative of the marketing authorisation holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00