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

Introduction

Package Leaflet: Information for the User

Sitagliptin/Metformin GLN 50 mg/850 mg film-coated tablets EFG

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

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

Sitagliptin/Metformin GLN 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 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 GLN

Do not take Sitagliptin/Metformin GLN:

• 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 on the breath
• if you have a severe infection or are dehydrated
• if you are to undergo an X-ray examination for which a contrast agent will be injected. You will need to stop taking Sitagliptin/Metformin GLN at the time of the X-ray examination 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
• if you drink excessive alcohol (either daily or occasionally)
• if you are breastfeeding.

Do not take Sitagliptin/Metformin GLN 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 taking Sitagliptin/Metformin GLN.

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with Sitagliptin/Metformin GLN (see section 4).

If you notice blisters on the skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptin/Metformin GLN.

Risk of lactic acidosis

Sitagliptin/Metformin GLN 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.

Consult your doctor immediately to determine 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 indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Stop taking Sitagliptin/Metformin GLN 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 Sitagliptin/Metformin GLN and contact a doctor or the nearest hospital immediately if you experience any 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
• reduced 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 Sitagliptin/Metformin GLN:

• 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 disease is also known as insulin-dependent diabetes
• if you have had an allergic reaction to sitagliptin, metformin, or Sitagliptin/Metformin GLN (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 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 Sitagliptin/Metformin GLN during the procedure and for a period after. Your doctor will decide when you should stop taking Sitagliptin/Metformin GLN and when to restart it.

If you are unsure whether any of the above circumstances apply to you, consult your doctor or pharmacist before taking Sitagliptin/Metformin GLN.

During treatment with Sitagliptin/Metformin GLN, 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 known if this medication is safe and effective when used in children and adolescents under 18 years of age.

Other medications and Sitagliptin/Metformin GLN

If you need to be administered an injection of a contrast agent containing iodine into your bloodstream, for example, in the context of an X-ray examination or scan, you should stop taking Sitagliptin/Metformin GLN before the injection or at the time of the injection. Your doctor will decide when you should stop taking Sitagliptin/Metformin GLN and when to restart it.

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 GLN. 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 medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• medications used to treat bronchial asthma (beta-sympathomimetics)
• iodinated contrast agents or medications that contain 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 GLN.

Taking Sitagliptin/Metformin GLN with alcohol

Avoid excessive alcohol consumption while taking Sitagliptin/Metformin GLN, 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 GLN.

Driving and using machines

The influence of this medication on the ability to drive and use machines is negligible or non-existent. 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 hypoglycemia, which may affect your ability to drive and use machines or work without a secure support.

Sitagliptin/Metformin GLN contains sodium

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

3. How to take Sitagliptin/Metformin GLN

Follow the instructions for taking 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 abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when this medication is taken with a medication that contains a sulfonylurea or with insulin, so your doctor may consider it necessary to reduce the dose of your sulfonylurea or insulin.

The score line is not intended to be used to break the tablet.

If you take more Sitagliptin/Metformin GLN than you should

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 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 GLN

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 of this medication.

If you stop taking Sitagliptin/Metformin GLN

Continue taking Sitagliptin/Metformin GLN for as long as your doctor tells you to, to help control your blood sugar levels. You should not stop taking this medication without consulting your doctor first. If you stop taking Sitagliptin/Metformin GLN, 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 Sitagliptina/Metformina GLN 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.

Sitagliptina/Metformina GLN 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 Sitagliptina/Metformina GLN 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 sitagliptina:

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 sitagliptina and metformina (frequency classified as frequent).

Some patients have experienced the following adverse effects when taking this medicine along 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 sitagliptina alone (one of the medicines that contains Sitagliptina/Metformina GLN) or during use after the approval of Sitagliptina/Metformina GLN or sitagliptina alone or with other diabetes medicines: Frequent: low blood sugar levels, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthrosis, pain in the arm or leg

Infrequent: dizziness, constipation, itching

Rare (may affect up to 1 in 1000 people): reduction of platelet count

Frequency not known: kidney problems (which occasionally 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: reduction of vitamin B12 levels, hepatitis (a liver problem), hives, skin redness (rash), or itching

Reporting of 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Sitagliptina/Metformina GLN

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister 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.

Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sitagliptina/Metformina GLN

• The active ingredients are sitagliptina and metformina. Each film-coated tablet (tablet) of Sitagliptina/Metformina GLN 50 mg/850 mg contains sitagliptina phosphate monohydrate equivalent to 50 mg of sitagliptina and 850 mg of metformina hydrochloride.
• The active ingredients are sitagliptina and metformina. Each film-coated tablet (tablet) of Sitagliptina/Metformina GLN 50 mg/1000 mg contains sitagliptina phosphate monohydrate equivalent to 50 mg of sitagliptina and 1000 mg of metformina hydrochloride.

• The other components are:
• Tablet core: povidone, microcrystalline cellulose, crospovidone, and sodium stearyl fumarate.
• The film coating contains:
• (Sitagliptina/Metformina GLN 50 mg/850 mg):
• Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).
• (Sitagliptina/Metformina GLN 50 mg/1000 mg):
• Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172), and black iron oxide (E172).

Appearance of Sitagliptina/Metformina GLN and Package Contents

Sitagliptina/Metformina GLN 50 mg/850 mg film-coated tablets

Film-coated tablets, oval shape, pink color with the inscription "SC" on one side and with a score line on the other.

Tablet diameter: 19.2 ± 0.5 mm

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Sitagliptina/Metformina GLN 50 mg/1000 mg film-coated tablets

Film-coated tablets, oval shape, reddish-brown color with a score line between the inscriptions "S" and "D" on one side and with a score line on the other.

Tablet diameter: 21.0 ± 0.5 mm

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Aluminum/Aluminum blisters

Packaging of 56, 112, and 196 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Galenicum Health, S.L.U.

Calle de San Gabriel, 50

08950 Esplugues de Llobregat

Barcelona, Spain

Manufacturer

SAG Manufacturing, S.L.U

Crtra. N-I, Km 36,

San Agustín de Guadalix

28750 Madrid

Spain

or

Galenicum Health, S.LU.

Calle de San Gabriel, 50

08950 Esplugues de Llobregat

Barcelona, Spain

Date of the Last Revision of this Prospectus: July 2025

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