Package Insert: Information for the User

Sitagliptin/Metformin Almus 50 mg/1,000 mg Film-Coated Tablets EFG

sitagliptin/metformin hydrochloride

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

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Sitagliptina/metformina contains two distinct 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 act 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 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 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 (cardiac), kidney diseases (renal), blindness, and amputations.

Do not take Sitagliptina/Metformina Almus

• if you are allergic to sitagliptin, metformin, or any of the other ingredients in 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 condition in which substances called "ketone bodies" accumulate in the blood, which can lead to diabetic precoma. 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 to undergo a radiography that requires the injection of a contrast agent. You will need to stop taking sitagliptin/metformin at the time of the radiography and for 2 or more days afterwards, 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 difficulty breathing

-if you have liver problems (hepatic)

-if you drink excessive amounts of alcohol (whether daily or occasionally)

-if you are breastfeeding

Do not take sitagliptin/metformin 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

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 condition 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 are not functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see 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 fluid 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

-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 takethis medication:

-if you have or have had a pancreatic disease (such as 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 sitagliptin/metformin (see section 4)

-if you are taking a sulfonylurea or insulin at the same time asthis medication, other diabetes medications, as you may experience 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 sitagliptin/metformina while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt and when to resume treatment with sitagliptin/metformin.

If you are unsure whether you are affected by any of the above circumstances, consult your doctor or pharmacist before starting to takethis 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 older person and/or if your kidney function is deteriorating.

Consult your doctor quickly if:

-you know you have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and hearing loss (MIDD).

-present any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Children and adolescents

Children and adolescents under 18 years old should not use this medication. It is not effective in children and adolescents aged 10-17 years. The safety and efficacy of this medication in children under 10 years old have not been established.

Other medications and Sitagliptina/Metformina

If you need to receive an intravenous injection of a contrast agent containing iodine, such as during a radiography or examination, you should stop takingthis medicationbefore the injection or at the time of the injection. Your doctor will decide when to interrupt and when to resume treatment with sitagliptin/metformin.

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 ofthis medication. 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)

• specific medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• medications specifically used to treat asthma (β-adrenergic agonists)
• iodinated contrast agents or medications containing alcohol
• specific 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/metformin.

Taking Sitagliptina/Metformina with alcohol

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, 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 Sitagliptina/Metformina Almus.

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 sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Sitagliptina/Metformina Almus contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, 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 with insulin, so your doctor may need to reduce the dose of your sulfonylurea or insulin.

The notch should not be used to break the tablet.

If you take more Sitagliptina/Metformina Almus 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 feeling cold or unwell, intense nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or agitated breathing (see "Warnings and precautions").

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina/Metformina Almus

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 interrupt treatment with Sitagliptina/Metformina Almus

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 interrupt treatment with sitagliptin/metformin, your blood sugar may rise again.

If you have any other questions about using 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:

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

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

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

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

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

Infrequent (can 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 (can 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

Infrequent: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines contained in this medicine) or during use after approval of sitagliptin/metformina 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

Infrequent: dizziness, constipation, itching

Rare: reduced 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 can 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 be caused by diabetes or other unrelated health problems.

Rare: hepatitis, urticaria, skin redness or itching

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By 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.

Store below 30 °C.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Sitagliptin/Metformin Almus

-The active principles are sitagliptin and metformin.

oEach film-coated tablet of Sitagliptin/Metformin Almus 50 mg/1.000 mg (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1.000 mg of metformin hydrochloride.

-The other components are:

oTablet core: povidone (E1201), microcrystalline cellulose PH 102 (E460), crospovidone type A and stearic acid sodium.

oFilm-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide red (E172) and iron oxide black (E172).

Appearance of the product and contents of the package

• The film-coated tablets of Sitagliptin/Metformin Almus 50 mg/1.000 mg are ofbrown reddish color, oblong and oval, with a groove between the inscription "S" and "B" on one side and with a groove on the other face.

Diameter of the tablet:21.3 ± 0.5mm

It is presented in PVC-PVDC and Aluminum blisters in packages of 56 and 98 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible manufacturer

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36,

28750 San Agustín de Guadalix (Madrid)

Spain

Galenicum Health, S.L.U.

Sant Gabriel 50,

Esplugues de Llobregat

08950 Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Malta: Sitagliptin/Metformin Diagonalis 50 mg/1.000 mg film-coated tablets

Netherlands: Sitagliptin/Metformin Diagonalis 50 mg /1.000 mg filmomhulde tablet

Poland: Sitagliptin/Metformin Diagonalis 50 mg /1.000 mg powlekana

Last review date of this leaflet: April 2025

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