JAZETA 50 mg FILM-COATED TABLETS

2. What you need to know before you take Jazeta

Do not take Jazeta

• 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 treated with sitagliptin (see section 4).

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

Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the 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 have now or have had in the past
• an allergic reaction to sitagliptin (see section 4)

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

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Jazeta

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your doctor may need to check the level of digoxin in your blood if you are taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not be taken during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

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

Also, taking this medicine with sulfonylureas or insulin may cause low blood sugar (hypoglycemia), which may affect your ability to drive or use machines or work without a safe support.

This medicine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this 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 some sugars, consult with them before taking this medicine.

3. How to take Jazeta

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended 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 medicine with or without food and drinks.

Your doctor may prescribe this medicine alone or with other medicines that also reduce blood sugar levels.

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

If you take more sitagliptin than you should

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

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

If you forget to take this medicine

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 make up for the missed doses.

If you stop taking this medicine

Keep taking this medicine while your doctor prescribes it for you to continue helping control your blood sugar levels. You should not stop taking this medicine without consulting your doctor first.

If you have any other questions about 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 this medicine and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area) that may radiate to the back with or without nausea and vomiting, as these may be signs of pancreatitis (frequency not known: cannot be estimated from the available data).
• Severe allergic reaction, including skin rash, hives, blisters on the skin/exfoliative dermatitis, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing. Your doctor will prescribe a medicine to treat the allergic reaction and change your diabetes medicine (frequency not known: cannot be estimated from the available data).

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

Common:may 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

Uncommon:may affect up to 1 in 100 people

• stomach pain
• diarrhea
• constipation
• somnolence

Some patients experienced the following side effects while taking sitagliptin in combination with a sulfonylurea 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

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

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

• flatulence
• swelling of hands or feet

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

Common:may affect up to 1 in 10 people

• swelling of hands or feet

Some patients experienced the following side effects while taking sitagliptin 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

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

Common:may affect up to 1 in 10 people

• low blood sugar
• headache
• upper respiratory tract infection
• nasal congestion or runny nose
• sore throat
• arthrosis
• pain in the arm or leg

Uncommon:may affect up to 1 in 100 people

• dizziness
• constipation
• itching

Rare:may affect up to 1 in 1,000 people

• reduction in the number of platelets

Frequency not known:cannot be estimated from the available data

• kidney problems (which may require dialysis)
• vomiting
• joint pain
• muscle pain
• back pain
• interstitial lung disease
• bullous pemphigoid (a type of skin blister)

Reporting of side effects

If you experience 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 to the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Jazeta

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 blister and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 further information

Composition of Jazeta

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

• The other ingredients are:

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

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

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

Appearance of the product and pack contents

Jazeta 25 mg is a film-coated tablet, round, biconvex with a diameter of approximately 6 mm, pink, engraved with "LC" on one side and without engraving on the other.

Jazeta 50 mg is a film-coated tablet, round, biconvex with a diameter of approximately 8 mm, orange, engraved with "C" on one side and without engraving on the other.

Jazeta 100 mg is a film-coated tablet, round, biconvex with a diameter of approximately 9.8 mm, beige, engraved with "L" on one side and without engraving on the other.

Opaque blisters (PVC/PVDC-Alu).

Pack sizes: 14, 28, 30, 56, 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Zentiva k.s.

U Kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo 7

Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

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

28224 Pozuelo de Alarcón, Madrid

Spain

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

Date of last revision of this leaflet:November 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.