Label: information for the patient

sitagliptin/metformin cinfamed 50 mg/1,000 mg film-coated tabletsEFG

sitagliptin/metformin hydrochloride

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

• Keep this label, as you may need to read 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 even if they 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 label. See section 4.

This medication 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 actconjointly to control blood sugar levels in adult patients with a form of diabetes called “type 2 diabetes mellitus”. This medication helps to increase the levels of insulin produced after a meal and reduces the amount of sugar produced by the body.

Together with diet and exercise, this medication helps to lower your blood sugar level. This medication 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 that 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 takesitagliptina/metformina cinfamed

• 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, 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 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 scheduled for a radiography that requires the injection of a contrast agent. You will need to stop taking this medication at the time of the radiography and for 2 or more days afterwards, as instructed by your doctor, depending on the functioning of your kidneys
• 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 only occasionally)
• if you are breastfeeding

Do not takethis medicationif 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 takethis medication.

Warnings and precautions

Cases of pancreatitis have been reported in patients treated withthis medication(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 takingthis medication.

Risk of lactic acidosis

This medicationmay 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, alcohol consumption, dehydration (see below for more information), 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.

Seek medical attention immediately if:

• you have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and deafness (MIDD).
• you experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with movement, symptoms indicative of nerve damage (e.g., pain or numbness), migraines, and hearing loss.

Stop takingsitagliptina/metformina cinfamedfor a short period of time 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 takingsitagliptina/metformina cinfamedand seek medical attention 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 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 condition is also known as insulin-dependent diabetes
• if you have or have had an allergic reaction to sitagliptin, metformin, or this medication (see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience low blood sugar (hypoglycemia). Your doctor may need to reduce the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, stop taking this medication while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with this medication and when to restart it.

If you are unsure whether you are affected by any of the above circumstances, consult your doctor or pharmacist before starting to take this medication.

During treatment with this medication, 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.

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 andsitagliptina/metformina cinfamed

If you need to receive an injection of a contrast agent containing iodine, such as during a radiography or examination, stop taking this medication before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with this medication and when to restart it.

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 of this 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 (sympathomimetic P)
• 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 this medication.

Concomitant use of sitagliptina/metformina cinfamed 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 lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy or while breastfeeding. See section 2,Do not takesitagliptina/metformina cinfamed.

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 cinfamedcontains sodium

sitagliptina/metformina cinfamed 50 mg/1,000 mg film-coated tabletsEFGEThis medication contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• Take one tablet:
• twice a day orally
• with food to reduce the likelihood of feeling 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 it is likely that your doctor will consider reducing the dose of your sulfonylurea or insulin.

If you take moresitagliptin/metformin cinfamedthan 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 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 the Toxicological Information Service. Phone 91 562 04 20.

If you forget to takesitagliptin/metformin cinfamed

If you forget to take a dose, take it as soon as you remember. If you do not remember until your next scheduled dose, skip the missed dose and continue with your regular treatment. Do not take a double dose of this medication.

If you interrupt treatment withsitagliptin/metformin cinfamed

Continue taking this medication as directed by your doctor to help control your blood sugar levels. Do not stop taking this medication without first consulting your doctor. If you stop treatment with this medication, your blood sugar levels may increase again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking this medicine and see your doctor immediately if you notice any of the following serious side effects:

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

This medicine can cause a very rare but serious side effect (may affect up to 1 in 10,000 people), called lactic acidosis (see "Warnings and precautions"). If this happens to you, you muststop 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 (unknown frequency), including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medication to treat the allergic reaction and change your medication for diabetes treatment.

Some patients taking metformin have experienced the following side 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 side effects when taking this medicine with a sulfonylurea such as glimepiride:

Very frequent (may 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 this medicine or sitagliptin alone or with other diabetes medications: 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: reduction in platelet count

Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin)

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

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

Reporting of 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 leaflet. You can also report them directly through theSpanish 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.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofsitagliptin/metformin cinfamed

sitagliptin/metformin cinfamed 50 mg/1,000 mg film-coated tabletsEFG

• The active ingredient is sitagliptinand metformin hydrochloride. Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and1,000 mg of metformin hydrochloride.
• The other components are: In the tablet core: microcrystalline cellulose, povidone, sodium lauryl sulfate, and sodium stearyl fumarate. Additionally, the film coating contains: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), iron oxide black (E172), and iron oxide red (E172).

Appearance of the product and contents of the package

sitagliptin/metformin cinfamed 50 mg/1,000 mg film-coated tabletsEFG

Film-coated tablets of red color, oval, biconvex, engraved with “1000” on one face. The length of the tablet is 21.1 to 21.6 mm and the width is 10.3 to 10.8 mm.

Blister packs(Aluminum/PVC/PVDC) in outer packaging. Packages of28, 56, 196film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization

Cinfa Laboratories, S.A

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

FARMAPROJECTS S.A.U.

Parc Cientific de Barcelona

C/ Baldiri Reixac, 4/12 i 15

08028 Barcelona, Spain

or

Polpharma S.A.

Pelplinska Street 19, 83-200 Starogard Gdanski

Poland

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

Poland:

Sitagliptyna/Chlorowodorek metforminyPolpharma

Sitagliptyna/Chlorowodorek metforminy Polpharma

Germany:

Sitagliptin/Metforminhydrochlorid Polpharma 50 mg/850 mg, filmtablettenSitagliptin/Metforminhydrochlorid Polpharma 50 mg/1000 mg, filmtabletten

France:

SITAGLIPTINE / METFORMINE POLPHARMA 50 mg/850 mg, coated tablet

SITAGLIPTINE / METFORMINE POLPHARMA 50 mg/1000 mg, coated tablet

Italy:

Sitagliptin e Metformina Polpharma

Portugal:

Sitagliptina/Cloridrato de metformina Polpharma 50 mg/850 mg film-coated tablets

Sitagliptina/Cloridrato de metformina Polpharma 50 mg/1000 mg film-coated tablets

Last review date of this leaflet:March 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.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/85858/P_85858.html

QR code to:https://cima.aemps.es/cima/dochtml/p/85858/P_85858.html