SITAGLIPTIN/METFORMIN Aurovitas Spain 50 mg/850 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Sitagliptina/Metformina Aurovitas Spain 50 mg/850 mg film-coated tablets EFG

sitagliptina/metformina hydrochloride

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

• 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.

Contents of the leaflet

1. What Sitagliptina/Metformina Aurovitas Spain is and what it is used for
2. What you need to know before taking Sitagliptina/Metformina Aurovitas Spain
3. How to take Sitagliptina/Metformina Aurovitas Spain
4. Possible side effects

5 Storage of Sitagliptina/Metformina Aurovitas Spain

1. Package contents and additional information

1. What Sitagliptina/Metformina Aurovitas Spain is and what it is used for

Sitagliptina/Metformina Aurovitas Spain contains two different medications, called sitagliptina and metformina.

• Sitagliptina belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformina belongs to a class of medications called biguanides.

They work together to control blood sugar levels in adult patients with a form of diabetes called "type 2 diabetes mellitus". This medication helps increase insulin production after a meal and reduces the amount of sugar produced by your body.

Along with diet and exercise, this medication helps lower your blood sugar level. This medication can be used alone or with certain diabetes medications (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin and the insulin your body 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 lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputations.

2. What you need to know before taking Sitagliptina/Metformina Aurovitas Spain

Do not take Sitagliptina/Metformina Aurovitas Spain:

• if you are allergic to sitagliptina, metformina, or any of the other ingredients of this medication (listed in section 6)
• if you have severe kidney function impairment
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a disorder in which substances called "ketone bodies" accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor in your breath
• if you have a severe infection or are dehydrated
• if you are going to have an X-ray for which you will be injected with a contrast agent. You will need to stop taking this medication at the time of the X-ray and for 2 or more days after, as directed by your doctor, depending on your kidney function
• if you have recently had a heart attack or have severe circulatory problems, such as "shock" or breathing difficulties
• if you have liver problems (hepatic)
• if you drink excessive alcohol (either daily or occasionally)
• if you are breastfeeding.

Do not take this medication if any of the above circumstances apply to you and consult your doctor about other ways to control your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting to take this medication.

Warnings and precautions

There have been reports of pancreatitis in patients treated with sitagliptina/metformina (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 this medication.

Risk of lactic acidosis

Sitagliptina/metformina may cause a very rare but serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as severe and acute heart disease).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking sitagliptina/metformina for a short period if you have a condition that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking sitagliptina/metformina and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• decreased body temperature and heart rate

Lactic acidosis is a medical emergency and should be treated in a hospital.

Consult your doctor promptly if:

• You know you have a genetic disorder that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformina: seizure, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Consult your doctor or pharmacist before starting to take this medication:

• if you have or have had a pancreatic disease (such as pancreatitis)
• if you have or have had gallstones, alcohol addiction, or very high blood triglyceride levels. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This disease is also known as insulin-dependent diabetes
• if you have had an allergic reaction to sitagliptina, metformina, or this medication (see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience low blood sugar levels (hypoglycemia). Your doctor may consider reducing the dose of your sulfonylurea or insulin

If you need to undergo major surgery, you should stop taking this medication during the procedure and for a period after. Your doctor will decide when to stop and restart treatment with this medication.

If you are unsure whether any of the above circumstances apply to you, consult your doctor or pharmacist before starting to take this medication.

During treatment with this medication, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person and/or if your kidney function is worsening.

Children and adolescents

Children and adolescents under 18 years of age should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. It is unknown whether this medication is safe and effective when used in children under 10 years of age.

Other medications and Sitagliptina/Metformina Aurovitas Spain

If you need to be administered an iodine-containing contrast agent injection into your bloodstream, for example, in the context of an X-ray or examination, you should stop taking sitagliptina/metformina before the injection or at the time of the injection. Your doctor will decide when to stop and restart treatment with this medication.

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of sitagliptina/metformina. It is especially important to mention the following:

• medications (taken orally, inhaled, or injected) used to treat diseases that cause inflammation, such as asthma and arthritis (corticosteroids)
• medications that increase urine production (diuretics)
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• medications specifically used to treat bronchial asthma (β-sympathomimetics)
• iodinated contrast agents or medications containing alcohol
• certain medications used to treat stomach problems, such as cimetidine
• ranolazine, a medication used to treat angina pectoris
• dolutegravir, a medication used to treat HIV infection
• vandetanib, a medication used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (for treating irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood levels if you are taking sitagliptina/metformina.

Taking Sitagliptina/Metformina Aurovitas Spain with alcohol

Avoid excessive alcohol consumption while taking this medication, as it may increase the risk of lactic acidosis (see "Warnings and precautions").

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. You should not take this medication during pregnancy or while breastfeeding. See section 2, "Do not take this medication".

Driving and using machines

The influence of this medication on the ability to drive and use machines is negligible or non-existent. However, there have been reports of dizziness and drowsiness during treatment with sitagliptina, which may affect your ability to drive and use machines.

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/Metformina Aurovitas Spain contains sodium

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

3. How to take Sitagliptina/Metformina Aurovitas Spain

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

• Take one tablet:

• twice a day orally
• with food to reduce the likelihood of stomach upset

• Your doctor may need to increase the dose to control your blood sugar levels.
• If you have reduced kidney function, your doctor may prescribe a lower dose.

You should continue with the diet recommended by your doctor during treatment with this medication and be careful to distribute your carbohydrate intake evenly throughout the day.

It is unlikely that treatment with this medication alone will cause abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when this medication is taken with a medication containing a sulfonylurea or with insulin, so your doctor may consider reducing the dose of your sulfonylurea or insulin.

If you take more Sitagliptina/Metformina Aurovitas Spain than you should

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 take more than the prescribed dose of this medication, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis, such as feeling cold or unwell, nausea or severe vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

If you forget to take Sitagliptina/Metformina Aurovitas Spain

If you forget to take 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 usual treatment. Do not take a double dose to make up for missed doses.

If you stop taking Sitagliptina/Metformina Aurovitas Spain

Continue taking this medication for as long as your doctor tells you to, to help control your blood sugar levels. Do not stop taking this medication without consulting your doctor first. If you stop taking this medication, your blood sugar levels may increase again.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

STOP taking sitagliptin/metformin and go to the doctor immediately if you notice any of the following serious adverse effects:

• Severe 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 of the pancreas).

Sitagliptin/metformin may cause a very rare (may affect up to 1 in 10,000 people) but very serious adverse effect called lactic acidosis (see section "Warnings and Precautions"). If this happens to you, you must stop taking this medicine and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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 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 the medicine for the treatment of diabetes.

Some patients who took metformin have experienced the following adverse effects after starting treatment with sitagliptin:

Frequent (may affect up to 1 in 10 people): low blood sugar, nausea, gas, vomiting

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

Some patients have experienced diarrhea, nausea, gas, constipation, stomach pain, or vomiting when starting treatment with the combination of sitagliptin and metformin (frequency classified as frequent).

Some patients have experienced the following adverse effects when taking this medicine with a sulfonylurea, such as glimepiride:

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

Frequent: constipation

Some patients presented the following adverse effects while taking this medicine in combination with pioglitazone:

Frequent: swelling of hands or feet

Some patients presented the following adverse effects while taking this medicine in combination with insulin:

Very frequent: low blood sugar levels

Uncommon: dry mouth, headache

Some patients have experienced the following adverse effects during clinical trials while taking sitagliptin alone (one of the medicines that contains sitagliptin/metformin) or during use after approval of sitagliptin/metformin or sitagliptin alone or with other diabetes medicines:

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

Uncommon: dizziness, constipation, itching

Rare: reduction in 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)

Some patients have experienced the following adverse effects after taking metformin alone:

Very frequent: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may appear when you start taking metformin and usually disappear

Frequent: metallic taste, decreased or low vitamin B12 levels in blood (symptoms may include extreme fatigue, pain and redness of the tongue (glossitis), tingling (paresthesia); or pale or yellowish skin). Your doctor may request tests to determine the cause of your symptoms because some of them can also be caused by diabetes and other unrelated health problems

Very rare: hepatitis (a liver problem), hives, skin redness (rash) or itching

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Sitagliptin/Metformin Aurovitas Spain

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the container after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need at the Sigre point in the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofSitagliptin/Metformin Aurovitas Spain

• The active ingredients are sitagliptin and metformin.

Each tablet contains 50 mg of sitagliptin (as hydrochloride) and 850 mg of metformin hydrochloride.

• The other components are:

Core of the tablet:microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, and magnesium stearate.

Coating:macrogol and poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylate (type I) (E471), poly(vinyl alcohol) (E1203), and red iron oxide (E172).

Appearance of the Product and Package Contents

Sitagliptin/Metformin Aurovitas Spain 50 mg/850 mg are film-coated tablets, oval, biconvex, approximately 20.5 mm x 9.5 mm, pink, and with "S476" engraved on one of their faces.

It is packaged in:

• PVC/PVdC-Aluminum opaque blister pack with 14, 28, 30, 56, 60, 196, and 210 tablets.
• HDPE white bottle with a silicagel desiccant compartment in the cap with 100 and 196 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Manufacturer:

Laboratorio Liconsa, S.A.

Avenida de Miralcampo, 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

or

PUREN Pharma GmbH & Co. KG

Willy-Brandt-Allee 2

81829 Munich

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Date of the Last Revision of thisProspectus:May 2025

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