SITAGLIPTIN/METFORMIN Aurovitas 50 mg/1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

sitagliptin/metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Sitagliptin/Metformin Aurovitas is and what it is used for

Sitagliptin/Metformin Aurovitas 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 amount of insulin produced after a meal and reduces the amount of sugar produced by your body.

Along with diet and exercise, this medicine helps to lower your blood sugar. This medicine can be used alone or with certain other diabetes medicines (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 also may 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 (cardiac), kidney disease (renal), blindness, and amputations.

2. What you need to know before you take Sitagliptin/Metformin Aurovitas

Do not take Sitagliptin/Metformin Aurovitas

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems.
• 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 condition in which substances called “ketone bodies” build up in the blood, which can lead to diabetic precoma. Symptoms include stomach 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 going to have an X-ray test where you will be given an injection of a contrast agent. You will need to stop taking this medicine at the time of the X-ray test and for 2 or more days after, as instructed 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 amounts of alcohol (either every day or only from time to time).
• if you are breast-feeding.

Do not take this medicine if any of the above applies to you and consult your doctor about other ways to control your diabetes. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

There have been reports of pancreatitis in patients treated with this medicine (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 medicine.

Risk of lactic acidosis

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

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

Consult your doctor promptly to advise you on how to proceed if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, 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: seizure, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Stop taking sitagliptin/metformin for a short period of time 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 sitagliptin/metformin 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 coma.

The symptoms of lactic acidosis include:

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

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

Consult your doctor or pharmacist before taking this medicine:

• if you have or have had pancreatitis (inflammation of the pancreas).
• if you have or have had gallstones, alcohol dependence, 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 is also known as insulin-dependent diabetes.
• if you have had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4).
• if you are taking a sulfonylurea or insulin, other diabetes medicines, as you may experience low blood sugar (hypoglycemia). Your doctor may consider it necessary to reduce the dose of the sulfonylurea or insulin you are taking.

If you need to undergo major surgery, you should stop taking this medicine during the procedure and for some time after. Your doctor will decide when you should stop taking this medicine and when you can restart it.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

During treatment with this medicine, 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 medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptin/Metformin Aurovitas

If you need to be given an injection of a contrast agent that contains iodine, for example, in the context of an X-ray or scan, you should stop taking sitagliptin/metformin beforehand or at the time of the injection. Your doctor will decide when you should stop taking this medicine and when you can restart it.

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

• medicines (taken orally, inhaled, or injected) used to treat diseases that cause inflammation, 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).
• medicines used to treat bronchial asthma (β-sympathomimetics).
• iodinated contrast agents or medicines that contain 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 (for treating irregular heartbeat and other heart problems). It may be necessary to check the level of digoxin in your blood if you are taking sitagliptin/metformin.

Taking Sitagliptin/Metformin Aurovitas with alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or while breast-feeding. See section 2, Do not take Sitagliptin/Metformin Aurovitas.

Driving and using machines

The ability to drive and use machines may be unaffected or minimally affected by this medicine. However, cases of dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive and use machines.

Taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without a safe support.

Sitagliptin/Metformin Aurovitas contains sodium

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

3. How to take Sitagliptin/Metformin Aurovitas

Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

• Take one tablet:
  • twice a day by mouth.
  • with food to reduce the chance 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 medicine and be careful to distribute your carbohydrate intake evenly throughout the day.

It is unlikely that this medicine alone will cause you to have low blood sugar (hypoglycemia). Low blood sugar can occur when this medicine is taken with a medicine that contains a sulfonylurea or with insulin, so your doctor may reduce the dose of the sulfonylurea or insulin.

If you take more Sitagliptin/Metformin Aurovitas than you should

In case of overdose or accidental intake, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken. If you take more of this medicine than you should, contact your doctor immediately. Go to the hospital if you have 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 section “Warnings and precautions”).

If you forget to take Sitagliptin/Metformin Aurovitas

If you forget to take a dose, take it as soon as you remember. If you do not remember until the time for your next dose, skip the missed dose and continue with your normal treatment schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Sitagliptin/Metformin Aurovitas

Keep taking this medicine for as long as your doctor recommends. If you stop taking this medicine, your blood sugar levels may increase again.

If you have any further questions on 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 all people suffer from them.

STOP taking sitagliptin/metformin and consult your 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.

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.

Infrequent (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.

Infrequent: dry mouth, headache.

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

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

Infrequent: dizziness, constipation, itching.

Rare: reduction of 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 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, decrease or low levels of vitamin B12 in blood (symptoms may include extreme fatigue, pain and redness of the tongue, tingling, 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 or 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 or pharmacist, 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

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box, bottle, or blister pack after CAD. The expiration date is the last day of the month indicated.

For blister packs:

Store below 30°C.

For HDPE bottles:

This medicine does not require special storage conditions.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sitagliptin/Metformin Aurovitas

• The active ingredients are sitagliptin and metformin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• The other components are:

Core of the tablet:microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium croscarmellose, and sodium stearyl fumarate.

Coating of the tablet:partially hydrolyzed poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the Product and Package Contents

Red film-coated tablets, capsule-shaped, biconvex, with the marks "SL" on one face and "1000" on the other.

Sitagliptin/Metformin Aurovitas 50 mg/1000 mg film-coated tablets EFG are available in blister packs and HDPE bottles.

Package sizes

Blister:14, 28, 30, 50, 56, 60, 100, 112, 168, 180, and 196 film-coated tablets, multiple packages with 196 film-coated tablets (2 packages of 98) and 168 film-coated tablets (2 packages of 84). Package of 50 × 1 film-coated tablets in a single-dose perforated blister.

Bottle:30 and 500 film-coated tablets.

Not all 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

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the Member States of the European Economic Area with the following names:

Germany: Sitagliptin/Metformin PUREN 50 mg/1000 mg Filmtabletten

Belgium: Sitagliptin /Metformin AB 50 mg / 1000 mg filmomhulde tabletten /comprimés pelliculés / Filmtabletten

Spain: Sitagliptina/Metformina Aurovitas 50 mg/1.000 mg comprimidos recubiertos con película EFG

France: Sitagliptine/Metformine Arrow 50 mg/1000 mg, comprimé pelliculé

Sweden: Sitagliptin/Metformin Aurobindo

Date of the Last Revision of this Prospectus: June 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/).