SITAGLIPTIN TECNIMEDE 25 mg FILM-COATED TABLETS

Read the entire leaflet carefully before starting to takethis medication, as it containsimportantinformationfor you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contentsoftheleaflet

1. What Sitagliptina Tecnimede is and what it is used for
2. What you need to know before taking Sitagliptina Tecnimede
3. How to take Sitagliptina Tecnimede
4. Possible side effects
5. Storage of Sitagliptina Tecnimede
6. Package contents and additional information

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

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

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

Your doctor has prescribed this medication to help you reduce blood sugar levels, which are too high due to your type 2 diabetes. This medication can be used alone or in combination with other medications (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 taking Sitagliptina Tecnimede

Do not take Sitagliptina Tecnimede

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

Warningsandprecautions

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 pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high triglyceride levels 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 currently have or have had in the past
• an allergic reaction to sitagliptin (see section 4).

It is unlikely that this medication will cause low blood sugar because it only works when blood sugar levels are high. 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.

Childrenandadolescents

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.

Othermedicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 levels if you are taking sitagliptin.

Taking Sitagliptina Tecnimede with food and/or drinksYou can take this medication with or without food and drinks.

Pregnancy,breastfeedingandfertility

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. You should not take this medication 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.

Drivingandusingmachines

The influence of this medication 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.

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

SitagliptinaTecnimede contains sodium

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

3. How to take Sitagliptina Tecnimede

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
• orally.

If you have kidney problems, your doctor may prescribe a lower dose (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 to follow the diet and exercise recommended by your doctor while taking sitagliptina.

IfyoutakemoreSitagliptinaTecnimedethanyoushould

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.

SitagliptinaTecnimede

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

SitagliptinaTecnimede

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

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

4. Possible side effects

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

STOPtakingSitagliptinaTecnimedeandconsultyourdoctorimmediatelyifyounoticeanyofthefollowingserioussideeffects:

• 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 dermatitis, 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 medication for diabetes treatment.

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 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 suspected adverse reactions

It is essential to report suspected adverse reactions to the medication after its authorization. This allows for continuous monitoring of the benefit/risk ratio of the medication. Healthcare professionals are encouraged to report suspected adverse reactions through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

5. Storage of Sitagliptina Tecnimede

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

Do not use this medication after the expiration date stated on the blister pack and carton after CAD/EXP. 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. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package contents and additional information

Sitagliptina Tecnimede composition

The active ingredient is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.

The other ingredients are:

In the tablet core: microcrystalline cellulose (E 460), calcium hydrogen phosphate, sodium croscarmellose (E 468), anhydrous colloidal silica, sodium stearyl fumarate, and magnesium stearate (E470b).

The tablet coating contains: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of the product and package contents

Pink, round film-coated tablets

Opaque blisters (PVC/PE/PVDC and aluminum)

Pack sizes: 10, 28, 30, 60, and 98 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer

SAG MANUFACTURING, S.L.U.

Ctra. N-I, Km 36. 28750 San Agustin de Guadalix, Madrid (Spain)

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950

Barcelona, Spain

Date of the last revision of this leaflet:November 2023

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/