SITAGLIPTIN COMBIX 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sitagliptina Combix 25 mg film-coated tablets EFG

Sitagliptina Combix 50 mg film-coated tablets EFG

Sitagliptina Combix 100 mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Sitagliptina Combix and what is it used for
2. What you need to know before you take Sitagliptina Combix
3. How to take Sitagliptina Combix
4. Possible side effects
5. Storage of Sitagliptina Combix
6. Contents of the pack and further information

1. What is Sitagliptina Combix and what is it used for

Sitagliptina Combix contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

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

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

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce 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) builds up in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Sitagliptina Combix

Do not take Sitagliptina Combix

• 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 sitagliptin.

Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• gallstones, alcohol addiction, 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 problem 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 between 10 and 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 Sitagliptina Combix

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 sitagliptin.

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. You should not take this medicine 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 or nil. 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 secure support point.

Sitagliptina Combix contains sodium and lactose

Sodium

This medicine 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 some sugars, consult with them before taking this medicine.

3. How to take Sitagliptina Combix

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, 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 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 sitagliptin.

If you take more Sitagliptina Combix 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 Toxicological Information Service, phone 91 562 04 20, indicating the medicine 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 medicine as long as your doctor prescribes it to you to help 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 sitagliptin and contact your doctor immediatelyif 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 medicine and consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your diabetes medicine.

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.

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

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 and pioglitazone and metformin:

Common: swelling of hands or feet.

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

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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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. Storage of Sitagliptina Combix

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 after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sitagliptina Combix

• The active substance 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:

Core of the tablet: calcium hydrogen phosphate, microcrystalline cellulose, sodium carmellose, magnesium stearate, and sodium fumarate stearate.

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, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the pack

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 packs of 28 tablets, and Sitagliptina Combix 100 mg film-coated tablets are available in packs 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 last revision of this leaflet: April 2025

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