Prospecto:informationforthepatient

Sitagliptin/metformin Tecnimede 50 mg/1,000 mg film-coated tablets

sitagliptin/metformin hydrochloride

Readtheentireprospectuscarefullybeforestartingtotakethismedicine,becauseitcontainsimportantinformationforyou.

• Keep this prospectus, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine 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 prospectus. See section 4.

Contentsoftheprospectus

1. What Sitagliptin/metformin Tecnimede is and for what it is used
2. What you need to know before starting to take Sitagliptin/metformin Tecnimede
3. How to take Sitagliptin/metformin Tecnimede
4. Possible adverse effects

5Storage of Sitagliptin/metformin Tecnimede

6.Contents of the package and additional information

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 work together 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.

Along with a diet and exercise, this medication helps to lower blood sugar levels. 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 the body does not produce enough insulin and the insulin that the body produces does not work as well as it should. The 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 (cardiovascular), kidney diseases (renal), blindness, and amputations.

Do not take Sitagliptina/Metformina Tecnimede:

• 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 reduction,
• 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 ketones 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,

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

Consult your doctor if:

• you have a severe infection or are dehydrated,
• you are about to have a radiography that requires the injection of a contrast agent. You will need to stop taking sitagliptin/metformina at the time of the radiography and for 2 or more days afterwards, as instructed by your doctor, depending on your kidney function,
• you have recently had a heart attack or have severe circulatory problems, such as shock or difficulty breathing,
• you have liver problems (hepatic),
• you drink excessive alcohol (either daily or occasionally),
• you are breastfeeding.

Do not take sitagliptin/metformina 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 sitagliptin/metformina.

Warnings and Precautions

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

Risk of Lactic Acidosis

Sitagliptin/metformina may cause a 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 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 diseases).

Consult your doctor for further instructions if any of the above apply to you.

Stop taking sitagliptin/metformina for 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 TAKING SITAGLIPTINA/METFORMINA 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,
• reduced body temperature and heart rate, Lactic acidosis is a medical emergency and should be treated in a hospital.

Consult your doctor immediately if:

• you know 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), migraine, and hearing loss.

Consult your doctor or pharmacist before starting to take this medication:

• if you have or have had 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 sitagliptin/metformina (see section 4),
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience hypoglycemia (low blood sugar).

Your doctor may need to adjust the dose of the sulfonylurea or insulin you are taking.

Stop taking sitagliptin/metformina before undergoing major surgery and for a period of time afterwards. Your doctor will decide when to stop and when to restart treatment with sitagliptin/metformina.

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

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 old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other Medications and Sitagliptin/Metformina Tecnimede

If you need to receive an injection of a contrast agent containing iodine, such as in the context of a radiography or examination, you should stop taking sitagliptin/metformina before the injection or at the time of the injection. Your doctor will decide when to stop and when to restart treatment with sitagliptin/metformina.

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 sitagliptin/metformina. It is especially important to mention the following:

• medications (taken orally, inhaled, or injected) used to treat inflammatory conditions, 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 (beta-2 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 level checked in your blood if you are taking sitagliptin/metformina.

Taking Sitagliptin/Metformina Tecnimede with Alcohol

Avoid excessive alcohol consumption while taking sitagliptin/metformina, as this may increase the risk of lactic acidosis (see section “Warnings and Precautions”).

Pregnancy and Breastfeeding

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 Sitagliptin/Metformina Tecnimede”.

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 safely without support.

Sitagliptin/Metformina Tecnimede contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; 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 a 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 insulin, so your doctor may consider reducing the dose of your sulfonylurea or insulin.

The notch is not intended to divide the tablet into equal doses.

What to do if you take too much

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

What to do if you forget to take

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

What to do if you stop treatment with

Continue taking sitagliptin/metformin as directed by your doctor to help control your blood sugar level. Do not stop taking this medication without first consulting your doctor. If you stop treatment with sitagliptin/metformina, your blood sugar may rise 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 sitagliptin/metformin 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 can be signs of pancreatitis inflammation.

Sitagliptin/metformin can cause a very rare but serious side effect (affecting up to 1 in 10,000 people), called lactic acidosis (see "Warnings and precautions"). 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 (frequency unknown), 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 medication to treat the allergic reaction and change the medication 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(can affect more than 1 in 10 people): constipation.

Some patients presented the following side effects while taking this medicine in combination with pioglitazone:

Frequent(can affect more than 1 in 10 people): 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 medications that contains sitagliptin/metformina) or during use after approval of sitagliptin/metformina 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, pain in the arm or leg.

Infrequent: dizziness, constipation, itching.

Rare:reduction in platelet count.

Unknown frequency:kidney problems (sometimes requiring 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 while 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), urticaria, skin redness (rash) or itching.

Reportingofadversereactions

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 the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse reactions, 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 box after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the medication that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Sitagliptina/metformina Tecnimede

The active principles are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

The other components are: Tablet core: povidone K29/32, microcrystalline cellulose PH 102, crospovidone type A, and stearic acid and sodium.

Additionally, the coating contains:poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), and iron oxide black (E172).

Appearanceof the productandcontent of thecontainer

Film-coated red-brown tablets, oval, oblong, with a groove between “S” and “B” on one face and a groove on the other face. Diameter of the tablet: 21.3 ± 0.5 mm

PVC-PVDC/aluminum blisters.Containers of 14, 28, or 56 film-coated tablets.

Only some container sizes may be commercially marketed.

Holderofthemarketing authorization

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, 13, 3rd floor.

28108 Alcobendas (Madrid)

Spain

Responsibleformanufacturing

SAG MANUFACTURING S.L.U

National Highway I, Km 36

San Agustin de Guadalix 28750

Spain

Or

GALENICUM HEALTH, S.L.U

Sant Gabriel.50

Esplugues de Llobregat

08950 Barcelona,

Spain

Last review date of this leaflet: 10/2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/