Label: information for the patient

Jazeta 25 mg film-coated tablets

Jazeta 50mg film-coated tablets

Jazeta 100mg film-coated tablets

sitagliptin

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

This medication contains the active ingredient sitagliptin, which belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adult patients with type 2 diabetes mellitus.type 2 diabetes mellitus.

This medication helps to increase the levels of insulin produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication may be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones), which reduce blood sugar and that you may already be taking for your diabetes along with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease that consists of your body not producing enough insulin, and the insulin it produces does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

Do not take Jazeta

• if you are allergic to sitagliptin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with sitagliptin (see section 4).

If you notice blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking this medication.

Inform your doctor if you have or have had:

• pancreatitis (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides in your blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any kidney problems you currently have or have had in the past
• a reaction to sitagliptin (see section 4)

It is unlikely that this medication will cause low blood sugar because it does not work when blood sugar levels are low. However, when this medication is used in combination with a medication that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medication.

Children and adolescents

Children and adolescents under 18 years old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Jazeta

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor if you are taking digoxin (a medication used to treat irregular heartbeats and other heart problems). Your doctor may need to check your digoxin blood levels if you are taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be taken during pregnancy.

The safety of this medication in breastfeeding women is unknown. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The effect of this medication on your ability to drive or operate machinery is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

Additionally, taking this medication with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

This medication contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Only for 25 mg:

Jazeta 25 mg contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended usual dose is:

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

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg). You can take this medication with or without food and drinks.

Your doctor may prescribe this medication alone or with other medications that also reduce blood sugar.

Diet and exercise can help your body use sugar better. It is essential that you follow the diet and exercise recommended by your doctor while taking this medication.

If you take more sitagliptin than you should

If you take more doses of this medication than prescribed, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take this medication

If you forget a dose, take it as soon as you remember. If you do not remember until the time of the next dose, then skip the missed dose and continue with your regular schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with this medication

Continue taking this medication as long as your doctor prescribes it for you to continue helping to control your blood sugar. You should not stop taking this medication without first consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking this medicine and see your doctor immediately if you notice any of the following serious side effects:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis (inflammation of the pancreas) (frequency not known: cannot be estimated from available data).
• Severe allergic reaction, including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing. Your doctor will prescribe a medicine to treat the allergic reaction and change the medicine for diabetes treatment (frequency not known: cannot be estimated from available data).

Some patients presented the following side effects after adding sitagliptin to treatment with metformin:

Frequent:can affect up to 1 in 10 people

• Low blood sugar
• Nausea
• Flatulence
• Vomiting
• Different types of stomach discomfort when starting the combination of sitagliptin and metformin together

Rare:can affect up to 1 in 100 people

• Abdominal pain
• Diarrhea
• Constipation
• Drowsiness

Some patients presented the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:

Very frequent:can affect more than 1 in 10 people

• Low blood sugar

Frequent:can affect up to 1 in 10 people

• Constipation

Some patients presented the following side effects while taking sitagliptin and pioglitazone:

Frequent(can affect up to 1 in 10 people):

• Flatulence
• Swelling of hands or feet

Some patients presented the following side effects while taking sitagliptin in combination with pioglitazone and metformin:

Frequent:can affect up to 1 in 10 people

• Swelling of hands or feet

Some patients presented the following side effects while taking sitagliptin in combination with insulin (with or without metformin):

Frequent:can affect up to 1 in 10 people

• Flu

Rare:can affect up to 1 in 100 people

• Dry mouth

Some patients presented the following side effects while taking only sitagliptin during clinical trials, or during use after approval alone and/or with other diabetes medications:

Frequent:can affect up to 1 in 10 people

• Low blood sugar
• Headache
• Upper respiratory tract infection
• Runny nose or nasal congestion
• Sore throat
• Arthritis
• Pain in the arm or leg

Rare:can affect up to 1 in 100 people

• Dizziness
• Constipation
• Itching

Very rare:can affect up to 1 in 1,000 people

• Reduced platelet count

Frequency not known: cannot be estimated from available data

• Kidney problems (which sometimes require dialysis)
• Vomiting
• Joint pain
• Muscle pain
• Back pain
• Pulmonary interstitial disease
• Bullous pemphigoid (a type of blister on the skin)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Jazeta

• The active ingredient is sitagliptin.
• Jazeta 25mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
• Jazeta 50mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
• Jazeta 100mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

• The other components are:

In the tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, stearate fumarate and sodium, magnesium stearate.

The film coating of Jazeta 25 mg tablets contains: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide (E172).

The film coating of Jazeta 50 mg and Jazeta 100mg tablets contains: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

Jazeta 25mg is a film-coated, round, biconvex tablet with an approximate diameter of 6mm, pink in color, engraved with “LC” on one side and unengraved on the other.

Jazeta 50mg is a film-coated, round, biconvex tablet with an approximate diameter of 8mm, orange in color, engraved with “C” on one side and unengraved on the other.

Jazeta 100mg is a film-coated, round, biconvex tablet with an approximate diameter of 9.8mm, beige in color, engraved with “L” on one side and unengraved on the other.

Opaque blisters (PVC/PVDC-Alu).

Packages of 14, 28, 30, 56, 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Responsible for manufacturing

Laboratorios Liconsa S.A.

Avda. Miralcampo 7

Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

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

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:November 2021

The information provided in this leaflet is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.