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 all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What is Jazeta Novum and what is it used for
• 2. Before you take 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 reduces blood sugar levels in adults with type 2 diabetes. This medicine helps to increase the amount of insulin produced after a meal and decreases the amount of sugar made by the body. Your doctor has prescribed this medicine to lower your blood sugar levels, which are too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas or glitazones) that lower blood sugar, which you may already be taking for your diabetes, together with diet and exercise.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin that your body produces does not work as well as it should. Your body may also produce too much sugar. If this happens, sugar (glucose) builds up in your blood. This can lead to serious diseases such as heart disease, kidney disease, blindness, and amputation.

2. Before you take Jazeta Novum

Do not 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

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4). If you get severe and persistent stomach pain, you should contact your doctor immediately as this could be a sign of an inflamed pancreas. If you get blisters, consult your doctor as this could be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Jazeta Novum. Tell your doctor if you have or have had:

• pancreatitis (inflammation of the pancreas);
• gallstones, alcohol dependence or very high levels of triglycerides (a type of fat) in your blood. In these cases, the risk of pancreatitis may be increased (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting);
• any kidney problems in the past or present;
• an allergic reaction to sitagliptin (see section 4).

Because this medicine does not work when your blood sugar is low, it is unlikely to cause low blood sugar. However, if you take this medicine with a sulphonylurea or insulin, you may get low blood sugar (hypoglycaemia). Your doctor may reduce the dose of your sulphonylurea 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 from 10 to 17 years of age. It is not known if this medicine is safe and effective in children under 10 years of age.

Jazeta Novum with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, you should tell your doctor if you are taking digoxin (a medicine used to treat heart failure and irregular heartbeats). When taking Jazeta Novum with digoxin, your doctor will check the level of digoxin in your blood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine if you are pregnant. It is not known if this medicine passes into breast milk. Do not take this medicine if you are breast-feeding or plan to breast-feed.

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 your ability to drive or use machines. Taking this medicine with a sulphonylurea or insulin may cause low blood sugar (hypoglycaemia), which may affect your ability to drive or use machines or perform tasks that require you to be alert.

Jazeta Novum contains sodium

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

3. How to take Jazeta Novum

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

• one 100 mg film-coated tablet;
• once a day;
• taken by mouth.

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

If you take more Jazeta Novum than you should

If you take more than the prescribed dose, contact your doctor immediately.

If you forget to take Jazeta Novum

If you miss a dose, take it as soon as you remember. 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 control your blood sugar, you should continue to take this medicine as long as your doctor prescribes it to you. Do not stop taking this medicine without talking to your doctor first. If you have any further questions on the use of this product, 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 stomach pain (which may radiate to your back) with nausea and vomiting or not - this could be a sign of pancreatitis (frequency not known: cannot be estimated from the available data).
• serious allergic reactions, including severe skin rashes, hives, blisters, or peeling skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty in breathing or swallowing.

Your doctor may prescribe a medicine to treat an allergic reaction and another medicine to treat your diabetes (frequency not known: cannot be estimated from the available data). In some patients, sitagliptin, in combination with metformin, has caused the following side effects:

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

• low blood sugar;
• nausea;
• bloating;
• vomiting;
• stomach discomfort after starting sitagliptin in combination with metformin.

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

• stomach pain;
• diarrhoea;
• constipation;
• drowsiness.

In some patients, sitagliptin, in combination with a sulphonylurea and metformin, has caused the following side effects:

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, sitagliptin, in combination with pioglitazone, has caused the following side effects:

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

• bloating;
• swelling of the hands or feet.

In some patients, sitagliptin, in combination with pioglitazone and metformin, has caused the following side effects:

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

• swelling of the hands or feet.

In some patients, sitagliptin, in combination with insulin (with or without metformin), has caused the following side effects:

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

• flu.

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

• dry mouth.

In some patients, sitagliptin, alone or in combination with other anti-diabetic medicines, has caused the following side effects:

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

• low blood sugar;
• headache;
• upper respiratory tract infections;
• stuffy or runny nose;
• sore throat;
• joint 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 number of platelets in the blood.

Frequency not known: cannot be estimated from the available data

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the websiteor contact your local health authority for further information. 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. Store in the original package in order to protect from moisture.

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 sitagliptin. Jazeta Novum 50 mg film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg sitagliptin. Jazeta Novum 100 mg film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin. The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, silicon dioxide, 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 is a round, biconvex, pink film-coated tablet with a diameter of about 5.6 mm. Jazeta Novum 50 mg is a round, biconvex, beige film-coated tablet with a diameter of about 7.1 mm with the inscription "Z" on one side. Jazeta Novum 100 mg is a round, biconvex, orange to brown film-coated tablet with a diameter of about 9.1 mm. PVC/PVDC/Aluminium blister. PVC/PE/PVDC/Aluminium blister. 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.

This medicine 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 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 any information about this medicine, please 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.

Date of last revision of the leaflet: