Sitagliptin/metformin Aurovitas Spain 50 mg/1,000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptin/Metformin Aurovitas Spain 50 mg/1,000 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 others, 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 these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sitagliptin/Metformin Aurovitas Spain is and what it is used for
2. What you need to know before taking Sitagliptin/Metformin Aurovitas Spain
3. How to take Sitagliptin/Metformin Aurovitas Spain
4. Possible side effects
5. Storage of Sitagliptin/Metformin Aurovitas Spain
6. Contents of the pack and other information

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

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

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

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

Along with diet and exercise, this medicine helps lower your blood sugar level. It can be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas, or glitazones).

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 (cardiovascular) disease, kidney (renal) 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 sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have severely reduced kidney function
• if you have uncontrolled diabetes, for example with severe hyperglycemia (high blood glucose), 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, potentially leading to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or fruity-smelling breath
• if you have a serious infection or are dehydrated
• if you are undergoing an X-ray procedure requiring injection of a contrast agent. You will need to stop taking this medicine at the time of the scan and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning
• if you recently had a heart attack or have serious circulatory problems, such as “shock” or difficulty breathing
• if you have liver problems (hepatic)
• if you drink excessive amounts of alcohol (either daily or occasionally)
• if you are breastfeeding.

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

Warnings and precautions

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

If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may instruct you to stop taking this medicine.

Risk of lactic acidosis

Sitagliptin/metformin may cause a very rare but serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting, alcohol consumption, dehydration (see further information below), liver disorders, and any medical condition in which part of the body has a reduced oxygen supply (such as acute and serious heart conditions).

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

Temporarily stop taking sitagliptin/metformin if you develop a condition that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

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

Symptoms of lactic acidosis include:

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

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

Contact your doctor promptly if:

• You are known to have a genetic mitochondrial disorder (the components responsible for energy production within cells), such as MELAS syndrome (mitochondrial encephalopathy, 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 metformin: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Consult your doctor or pharmacist before starting this medicine:

• 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 levels of triglycerides (a type of fat). These medical conditions may increase your risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This condition may also be called insulin-dependent diabetes
• if you have or have had an allergic reaction to sitagliptin, metformin, or this medicine (see section 4)
• if you are taking a sulfonylurea or insulin, or other antidiabetic medicines along with this medicine, 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 must stop taking this medicine during the procedure and for a period afterwards. Your doctor will decide when to interrupt and when to restart treatment with this medicine.

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

During treatment with this medicine, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

Children and adolescents

Children and adolescents under 18 years of age should not use 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/Metformina Aurovitas Spain

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking sitagliptin/metformin before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with this medicine.

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

• medicines (taken orally, inhaled, or injected) used to treat inflammatory conditions such as asthma and arthritis (corticosteroids)
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines for bronchial asthma (β-sympathomimetics)
• iodinated contrast agents or medicines containing alcohol
• certain medicines used to treat stomach problems such as cimetidine
• ranolazine, a medicine used to treat angina pectoris
• dolutegravir, a medicine used to treat HIV infection
• vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (used to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking sitagliptin/metformin.

Taking Sitagliptina/Metformina Aurovitas Spain with alcohol

Avoid excessive alcohol intake while taking this medicine, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take this medicine.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is negligible or minor. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive and use machinery.

Taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may impair your ability to drive and use machinery or work without secure support.

Sitagliptina/Metformina Aurovitas Spain contains sodium

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

3. How to take Sitagliptina/Metformina Aurovitas Spain

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

• Take one tablet:

• twice daily by mouth

• with food to reduce the likelihood of stomach discomfort

• 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 the diet recommended by your doctor during treatment with this medicine and take care to evenly distribute carbohydrate intake throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar (hypoglycaemia). Low blood sugar may occur when this medicine is taken together with a medicine containing a sulphonylurea or with insulin; therefore, your doctor may consider it necessary to reduce the dose of your sulphonylurea or insulin.

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

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 take more than the prescribed dose of this medicine, contact your doctor immediately. Go to hospital if you experience symptoms of lactic acidosis such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section “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 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/Metformina Aurovitas Spain

Keep taking this medicine for as long as your doctor prescribes it, to help control your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. If you stop treatment with this medicine, your blood sugar levels may rise again.

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 experiences them.

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

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

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 occurs, you must stop taking this medicine and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

If you experience a severe allergic reaction (frequency not known), including skin rash, hives, skin blistering/skin peeling, 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 you to a different medicine for the treatment of diabetes.

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

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

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

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

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

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

Frequent: constipation

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

Frequent: swelling of hands or legs

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

Very frequent: low blood sugar levels
Uncommon: dry mouth, headache

Some patients experienced the following adverse effects during clinical studies while taking sitagliptin alone (one of the medicines contained in sitagliptin/metformin) or during post-approval use of sitagliptin/metformin or sitagliptin alone or in combination with other diabetes medicines:

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

Uncommon: dizziness, constipation, itching

Rare: reduction in platelet count

Frequency not known: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin rash)

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

Very frequent: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually resolve over time

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

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

Reporting of adverse effects

If you experience any 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina/Metformina Aurovitas Spain

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 blister pack and on the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the Sigre collection point at your pharmacy. 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 Sitagliptin/Metformin Aurovitas Spain

• The active substances are sitagliptin and metformin.

Each tablet contains 50 mg of sitagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride.

• The other components are:

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

Coating: polyethylene glycol-grafted copolymer and poly(vinyl alcohol) (E1209), talc (E1209), titanium dioxide (E171), glycerol monocaprylocaprate (type I) (E471), poly(vinyl alcohol) (E1203), iron oxide red (E172) and iron oxide black (E172).

Appearance of the product and contents of the pack

Sitagliptin/Metformin Aurovitas Spain 50 mg/1,000 mg are brown, film-coated, oval-shaped, biconvex tablets of approximately 21.5 mm x 10.0 mm, with “S477” engraved on one side.

Packaged in:

• PVC/PVdC-Aluminum opaque blisters containing 14, 28, 30, 56, 60, 196 and 210 tablets.
• White HDPE bottles with a compartment for silica gel desiccant in the cap containing 100 and 196 tablets.

Only certain pack 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the latest review of this leaflet: May 2025

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