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

Introduction

Package Leaflet: Information for the Patient

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

Sitagliptin/Metformin hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What Sitagliptin/Metformin Alter is and what it is used for
2. What you need to know before taking Sitagliptin/Metformin Alter
3. How to take Sitagliptin/Metformin Alter
4. Possible side effects
5. Storage of Sitagliptin/Metformin Alter
6. Package contents and additional information

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

Sitagliptin/Metformin Alter contains two different medications, called sitagliptin and metformin.

• Sitagliptin belongs to a class of medications known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformin belongs to a class of medications known as 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 Sitagliptin/Metformin Alter

Do not take Sitagliptin/Metformin Alter

• if you are allergic to sitagliptin, metformin, 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 of the breath
• if you have a severe infection or are dehydrated
• if you are to undergo a radiography for which a contrast agent must be injected. You will need to stop taking this medication at the time of the radiography and for 2 or more days thereafter, as indicated 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

Consult your doctor, pharmacist, or nurse before starting to take sitagliptin/metformin.

Cases of pancreatitis have been reported in patients treated with sitagliptin/metformin (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 sitagliptin/metformin.

Risk of Lactic Acidosis

Sitagliptin/metformin 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 disorder in which a part of the body has a reduced oxygen supply (such as severe and acute heart diseases).

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

Stop taking this medication for a short period if you have a disorder 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 this medication and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this disorder 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
• decreased 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 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 likelihood 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 sitagliptin, metformin, or sitagliptin/metformin (see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, at the same time as sitagliptin/metformin, as you may experience low blood sugar levels (hypoglycemia). Your doctor may need to reduce the dose of your sulfonylurea or insulin

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

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 sitagliptin/metformin, 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.

Consult your doctor promptly to find out how to proceed 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 metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Children and Adolescents

Children and adolescents under 18 years of age should not use this medication. It is not known whether this medication is safe and effective when used in children and adolescents under 18 years of age.

Other Medications and Sitagliptin/Metformin Alter

If you need to be administered an iodine-containing contrast agent intravenously, for example, in the context of a radiography or examination, you should stop taking this medication before the injection or at the time of the injection. Your doctor will decide when you should stop and restart treatment with sitagliptin/metformin.

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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/metformin. 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 sitagliptin/metformin.

Taking Sitagliptin/Metformin Alter 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, 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 Sitagliptin/Metformin Alter.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is negligible or nonexistent. 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 medication with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which may affect your ability to drive and use machines or work without a secure support.

Sitagliptin/Metformin Alter contains sodium

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

3. How to Take Sitagliptin/Metformin Alter

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, 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 ensure that your carbohydrate intake is evenly distributed throughout the day.

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

If You Take More Sitagliptin/Metformin Alter Than You Should

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 a feeling of coldness or discomfort, nausea or severe vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section "Warnings and Precautions").

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If You Forget to Take Sitagliptin/Metformin Alter

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 of this medication.

If You Interrupt Treatment with Sitagliptin/Metformin Alter

Continue taking this medication for as long as your doctor indicates, to help control your blood sugar levels. Do not stop taking this medication without consulting your doctor first. If you interrupt treatment with sitagliptin/metformin, 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 this medicine 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).

This medicine 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 were taking 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 have experienced the following adverse effects while taking this medicine in combination with pioglitazone:

Frequent: swelling of hands or feet

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

Frequent: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose and sore throat, arthrosis, 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

Very rare: reduction in vitamin B12 levels, hepatitis (liver problem), hives, skin redness (rash) or itching

Reporting of Adverse Effects

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

5. Storage of Sitagliptina/Metformina Alter

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

Do not use this medicine 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.

Store below 25°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, 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 Sitagliptina/Metformina Alter

• The active ingredients are sitagliptin and metformin. Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
• The other ingredients are:

Core of the tablet: copolymer of polyvinyl alcohol and polyethylene glycol, sodium lauryl sulfate (see section 2), pregelatinized corn starch, silicified microcrystalline cellulose, and sodium stearyl fumarate.

Coating (OPADRY II 85F18422): partially hydrolyzed polyvinyl alcohol, macrogol 4000, titanium dioxide (E171), talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Package Contents

Film-coated tablet, red, oval, biconvex, scored on one side, approximately 21 x 10 mm.

The score line should not be used to divide the tablet.

PVC/PVDC-aluminum blisters.

Packaging of 28, 50, 56, and 60 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

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

Spain Sitagliptina/Metformina Alter 50 mg/1000 mg film-coated tablets EFG

France SITAGLIPTINE/METFORMINE ALTER 50 mg/1000 mg, film-coated tablet

Date of the Last Revision of this Leaflet:March 2025

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