SITAGLIPTIN COMBIX 100 mg FILM-COATED TABLETS

2. What you need to know before taking Sitagliptina Combix

Do not take Sitagliptina Combix

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

Warnings and precautions

Cases of pancreatitis (inflammation of the pancreas) 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 disease called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin.

Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high blood triglyceride levels (a type of fat). 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 current or past kidney problems
• an allergic reaction to sitagliptin (see section 4)

It is unlikely that this medication will cause low blood sugar levels 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 levels (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medication.

Children and adolescents

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

Other medications and Sitagliptina Combix

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

In particular, tell your doctor if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood levels if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. This medication should not be taken during pregnancy.

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

Driving and using machines

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

Additionally, taking this medication with sulfonylureas or insulin may cause low blood sugar levels, which may affect your ability to drive and use machines or work without a secure support.

Sitagliptina Combix contains sodium and lactose

Sodium

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

Lactose (only for Sitagliptina Combix 25 mg)

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

3. How to take Sitagliptina Combix

Follow your doctor's instructions for taking this medication exactly. 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 medication with or without food and drinks.

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

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 sitagliptin.

If you take more Sitagliptina Combix than you should

If you take more 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina Combix

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 missed doses.

If you stop taking Sitagliptina Combix

Continue taking this medication while your doctor prescribes it to you to help control your blood sugar levels. You should not stop taking this medication without consulting your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

STOP taking sitagliptin and consult 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.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/exfoliative skin, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medication and consult your doctor immediately. Your doctor will prescribe a medication to treat the allergic reaction and change your diabetes medication.

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

Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, somnolence.

Some patients experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency classified as common).

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 levels

Common: constipation.

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

Common: flatulence, swelling of hands or feet.

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

Common: swelling of hands or feet.

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

Common: flu

Uncommon: dry mouth.

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

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

Uncommon: dizziness, constipation, itching

Rare: reduced platelet count

Frequency not known: kidney problems (which may require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sitagliptina Combix

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

Do not use this medication after the expiration date stated on the package 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 wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Sitagliptina Combix

• The active ingredient is sitagliptin:

• Each Sitagliptina Combix 25 mg film-coated tablet contains 25 mg of sitagliptin as sitagliptin hydrochloride.
• Each Sitagliptina Combix 50 mg film-coated tablet contains 50 mg of sitagliptin as sitagliptin hydrochloride.
• Each Sitagliptina Combix 100 mg film-coated tablet contains 100 mg of sitagliptin as sitagliptin hydrochloride.

• The other ingredients (excipients) are:

Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, and sodium fumarate.

Coating material (25 mg): lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, and iron oxide red (E172).

Coating material (50 mg and 100 mg): poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172), and iron oxide red (E172).

Appearance and package contents

Sitagliptina Combix 25 mg film-coated tablets EFG

Film-coated tablet, round, biconvex, approximately 6 mm in diameter, pink, marked with "LC" on one side and flat on the other.

Sitagliptina Combix 50 mg film-coated tablets EFG

Film-coated tablet, round, biconvex, approximately 8 mm in diameter, orange, marked with "C" on one side and flat on the other.

Sitagliptina Combix 100 mg film-coated tablets EFG

Film-coated tablet, round, biconvex, approximately 9.8 mm in diameter, beige, marked with "L" on one side and flat on the other.

Opaque PVC/PVDC-Alu blisters. Sitagliptina Combix 25 mg and 50 mg film-coated tablets are available in packages of 28 tablets, and Sitagliptina Combix 100 mg film-coated tablets are available in packages of 28 or 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the last revision of this package leaflet: April 2025

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