Prospecto: information for the patient

Sitagliptin Tecnimede 100 mg film-coated tablets

Read this prospectus carefully before starting to take this medicine, as it containsimportant information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, or pharmacist or nurse, even if they are not listed in this prospectus. See section 4.

Contentsof the prospectus

1. What Sitagliptin Tecnimede is and for what it is used
2. What you need to know before starting to take Sitagliptin Tecnimede
3. How to take Sitagliptin Tecnimede
4. Possible adverse effects
5. Storage of Sitagliptin Tecnimede
6. Contents of the package and additional information

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

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

Your doctor has prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and 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 disease that consists of your body not producing enough insulin, and the insulin it produces not functioning as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

Do not take Sitagliptina Tecnimede

Warnings and precautions

Cases of pancreatitis 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 condition called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin.

Inform your doctor if you have or have had:

• a pancreas disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides 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 does not work when blood sugar levels are low. However, when this medication is used in combination with a medication containing a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medication.

Children and adolescents

Children and adolescents under 18 years old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Sitagliptina Tecnimede

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

Particularly, inform 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 level if you are taking sitagliptin.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy.

The safety of this medication for use during breastfeeding is unknown. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and use of machines

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 hypoglycemia, which may affect your ability to drive and use machines or work without a secure support.

Sitagliptina Tecnimede contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual recommended dose is:

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 lower blood sugar. A diet and exercise can help your body use blood sugar better. It is essential to follow the diet and exercise recommended by your doctor while taking sitagliptin.

TakingmoreSitagliptinaTecnimededelayormore

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

IfyouforgottotakSitagliptinTecnimede

If you forget to take 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 of this medication.

IfyouinterrumpthetreatmentwithSitagliptinTecnimede

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

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

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

STOP taking Sitagliptin Tecnimede and see your doctor immediately if you notice any of the following serious side effects:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis inflammation.

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that can 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 medication.

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

Frequent (can affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomitingos

Rare (can affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced different types of stomach discomfort when they started taking sitagliptin and metformin together (classified as frequent).

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

Very frequent (can affect more than 1 in 10 people): low blood sugar

Frequent: constipation

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

Frequent: flatulence, swelling of hands or feet

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

Frequent: swelling of hands or feet

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

Frequent: flu

Rare: dry mouth

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

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthritis, arm or leg pain

Rare: dizziness, constipation, itching

Rare: reduced platelet count

Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin)

Reporting of suspected adverse reactions

It is essential to report suspected adverse reactions to the medicine after its authorization. This allows for continuous monitoring of the benefit-risk ratio of the medicine. Healthcare professionals are invited to report suspected adverse reactions through the

Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging 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 drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Sitagliptina Tecnimede

The active ingredient is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

The other components are:

In the tablet core: microcrystalline cellulose (E 460), calcium hydrogen phosphate, croscarmellose sodium (E 468), anhydrous colloidal silica, fumaric acid ester and sodium, 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).

Appearance of the product and content of the container

Beige, round film-coated tablets.

Sitagliptina Tecnimede is available in: Opaque blisters (PVC/PE/PVDC and aluminum)

Containers of 14, 28, and 56 film-coated tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, 13, 3rd floor.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

SAG MANUFACTURING, S.L.U.

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

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950

Barcelona, Spain

Last review date of this leaflet: November 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/