Prospecto:information for the user

Sitagliptin/Metformin Aurovitas Spain 50 mg/850 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

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

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenif they are not listed in this prospectus. See section 4.

1.What isSitagliptin/Metformin Aurovitas Spainand for what it is used

2.What you need to knowbeforestarting totakeSitagliptin/Metformin Aurovitas Spain

3.How to takeSitagliptin/Metformin Aurovitas Spain

4.Possible adverse effects

5Storage ofSitagliptin/Metformin Aurovitas Spain

6.Contents of the package and additional information

Sitagliptina/Metformina Aurovitas Spain contains two different medicines, called sitagliptin and metformin.

• Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformin belongs to a class of medicines called biguanides.

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

Along with a diet and exercise, this medicine helps to lower your blood sugar level. This medicine can be used alone or with certain diabetes medicines (insulin, sulfonylureas or thiazolidinediones).

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin and the insulin that your body produces does not work as well as it should. Your body may also produce too much sugar. When this occurs, sugar (glucose) accumulates in the blood. This can lead to serious medical problems, such as heart diseases (cardiovascular), kidney diseases (renal), blindness and amputations.

Do not take Sitagliptina/Metformina Aurovitas Spain:

• if you are allergic to sitagliptin, metformin, or any of the other components of this medication (listed in section 6)
• if you have severe kidney function reduction
• if you have uncontrolled diabetes, 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 condition in which substances called "ketone bodies" accumulate in the blood, which can lead to diabetic precoma. The symptoms include abdominal pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor
• if you have a severe infection or are dehydrated
• if you are about to undergo a radiography that requires the injection of a contrast agent. You will need to stop taking this medication at the time of the radiography and for 2 or more days afterwards, as instructed by your doctor, depending on the functioning of your kidneys
• if you have recently had a heart attack or have severe circulatory problems, such as "shock" or difficulty breathing
• if you have liver problems (hepatic)
• if you drink excessive alcohol (whether daily or occasionally)
• if you are breastfeeding

Do not take this medication if any of the above circumstances affect 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

Cases of pancreatitis have been reported in patients treated with sitagliptin/metformin (see section 4).

If you observe 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

Sitagliptin/metformin may cause a 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 acute and severe heart disease).

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

Stop taking sitagliptin/metformin for a short period if you have a condition that may be associated with dehydration (significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less liquid than normal. Consult your doctor for further instructions.

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

The symptoms of lactic acidosis include:

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

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

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

• if you have or have had pancreatitis
• if you have or have had gallstones, alcohol addiction, or have very high levels of triglycerides (a type of fat) in your blood. 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 or have had an allergic reaction to sitagliptin, metformin, or this medication (see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience low blood sugar (hypoglycemia). Your doctor may consider reducing the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, you should stop taking this medication while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with this medication and when to restart it.

If you are unsure whether any of the above circumstances affect 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 deteriorating.

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/Metformina Aurovitas Spain

If you need to receive an injection of a contrast agent containing iodine, such as during a radiography or examination, you should stop taking sitagliptin/metformina before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with this medication and when to restart it.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to 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 sitagliptin/metformina. It is especially important to mention the following:

• medications (taken orally, inhaled, or injected) used to treat inflammatory diseases, 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)
• specific medications used to treat bronchial asthma (β-adrenergic agonists)
• 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 (to treat irregular heartbeat and other heart problems). You may need to have your digoxin blood level checked if you are taking sitagliptin/metformina.

Taking Sitagliptina/Metformina Aurovitas Spain with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy or while breastfeeding. See section 2, Do not take this medication.

Driving and operating machinery

The influence of this medication on your ability to drive and operate machinery is negligible or insignificant. However, cases of dizziness and somnolence have been reported during treatment with sitagliptin, which may affect your ability to drive and operate machinery.

Taking this medication with medications called sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Sitagliptina/Metformina Aurovitas Spain contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per 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.

• Take one tablet:

• twice a day by mouth
• with food to reduce the likelihood of stomach discomfort

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

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

It is unlikely that treatment with this medication alone will cause an abnormal drop in blood sugar (hypoglycemia). A drop in blood sugar may occur when this medication is taken with a medication containing sulfonylurea or insulin, so your doctor may need to reduce 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 Toxicological 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 have symptoms of lactic acidosis such as feeling cold or unwell, intense nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or agitated 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 regular treatment. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Sitagliptina/Metformina Aurovitas Spain

Continue taking this medication as long as your doctor tells you to, to help control your blood sugar level. Do not stop taking this medication without first consulting your doctor. If you stop treatment with this medication, your blood sugar may rise again.

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/metformin and see your doctor immediately if you notice any of the following serious side effects:

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

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

because lactic acidosis can lead to coma.

If you have a severe allergic reaction (frequency unknown), including skin rash, urticaria, blisters on the skin/skin peeling 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 the medicine for diabetes treatment.

Some patients taking metformin have experienced the following side effects after starting treatment with sitagliptin:

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

Rare (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 side effects when taking this medicine with a sulfonylurea such as glimepiride:

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

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

Frequent: swelling of hands or feet

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

Very frequent: low blood sugar Rare: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines contained in 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, congestion or nasal mucosity, and throat pain, arthritis, arm or leg pain

Rare: dizziness, constipation, itching

Very rare: reduction in platelet count

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

Some patients have experienced the following side 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,decrease or low levels of vitamin B12 in the 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 may also be caused by diabetes and other unrelated health problems

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

Reporting of side effects

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

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. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre point of your pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition ofSitagliptina/Metformina Aurovitas Spain

• The active principles are sitagliptin and metformin.

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

• The other componentsare:

Tablet core:microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, and magnesium stearate.

Covering:copolymer of graft macrogol and poly(vinyl alcohol) (E1209), talc (E553b), titanium dioxide (E171), monoglycerol caprate (type I) (E471), poly(vinyl alcohol) (E1203)and red iron oxide (E172).

Appearance of the product and contents of the package

Sitagliptina/Metformina Aurovitas Spain 50 mg/850 mg are film-coated, oval, biconvex tablets, approximately 20.5 mm x 9.5 mm, pink, and with “S476” engraved on one of its faces.

It is packaged in:

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Responsible 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:

Last review date of thisleaflet:March 2025

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