Sitagliptin Combix 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sitagliptin Combix 25 mg film-coated tablets EFG

Sitagliptin Combix 50 mg film-coated tablets EFG

Sitagliptin Combix 100 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Sitagliptin Combix is and what it is used for
2. What you need to know before taking Sitagliptin Combix
3. How to take Sitagliptin Combix
4. Possible side effects
5. How to store Sitagliptin Combix
6. Contents of the pack and other 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 increase insulin levels produced after a meal and reduces the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you lower your blood sugar, which is too high due to your type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) 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 condition in which your body does not produce enough insulin, and the insulin your body does produce 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 lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you start taking Sitagliptina Combix

Do not take Sitagliptina Combix

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

Warnings and precautions

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

If you notice blisters on the skin, this may be a sign of a condition 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 blood levels of triglycerides (a type of fat). These medical conditions may increase your likelihood of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes causing high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney problems you currently have 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 act when blood sugar levels are low. However, when this medicine is used in combination with a medicine containing 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 take this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether 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 need to 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). It may be necessary to monitor the level of digoxin in your blood if you are taking sitagliptin.

Pregnancy and breastfeeding

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

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

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is negligible or none. However, dizziness and drowsiness have been reported, which may affect your ability to drive or operate machinery.

In addition, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without secure support.

Sitagliptina Combix contains sodium and lactose

Sodium

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

Lactose (only for Sitagliptina Combix 25 mg)

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Sitagliptina Combix

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended usual dose is:

• one 100 mg film-coated tablet
• once daily
• by oral route

If you have kidney problems, your doctor may prescribe you lower doses (such as 25 mg or 50 mg).

You may take this medicine with or without food and drinks.

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

Diet and exercise can help the body use sugar more effectively. It is important that you follow the diet and exercise regimen recommended by your doctor while taking sitagliptin.

If you take more Sitagliptina Combix than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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 it is 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 missed dose.

If you stop taking Sitagliptina Combix

Keep taking this medicine for as long as your doctor continues to prescribe it, so it can continue helping you control your blood sugar. You should not stop taking this medicine without first consulting your doctor.

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

4. Possible adverse effects

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

STOP taking sitagliptin and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area) that may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

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

Some patients experienced the following adverse effects when sitagliptin was added to 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, drowsiness.

Some patients experienced various types of stomach discomfort when starting treatment with sitagliptin and metformin together (frequency classified as common).

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

Common: flatulence, swelling of hands or legs.

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

Common: swelling of hands or legs.

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

Common: influenza

Uncommon: dry mouth.

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

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

Uncommon: dizziness, constipation, itching.

Rare: reduction in platelet count.

Frequency not known: 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 adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Combix

• The active substance is sitagliptin:

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

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

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

• The other components (excipients) are:

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

Coating material (25 mg): lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, and red iron oxide (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 in colour, marked with "LC" on one side and plain on the other.

Sitagliptina Combix 50 mg film-coated tablets EFG

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

Sitagliptina Combix 100 mg film-coated tablets EFG

Film-coated tablet, round, biconvex, approximately 9.8 mm in diameter, beige in colour, marked with "L" on one side and plain 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. Sitagliptina Combix 100 mg film-coated tablets are available in packs of 28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 latest revision of this leaflet: April 2025

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