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

Introduction

Package Leaflet:informationforthepatient

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

sitagliptin/metformin hydrochloride

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• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contentsoftheleaflet

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

5 Storage of Sitagliptin/metformin Tecnimede

1. Package contents and further information

1. What is Sitagliptin/metformin Tecnimede and what is it used for

This medicine 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 medicine helps increase the amount of insulin produced after a meal and reduces the amount of sugar produced by your body.

Along with diet and exercise, this medicine helps lower your blood sugar level. This medicine can be used alone or with certain diabetes medicines (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 (cardiac) problems, kidney (renal) problems, blindness, and amputations.

2. What you need to know before you start taking Sitagliptin/metformin Tecnimede

Do not take Sitagliptin/metformin Tecnimede:

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney problems,
• 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” build up 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 to your breath,

if you have a severe infection or are dehydrated,

if you are to have an X-ray where a contrast agent will be injected. You will need to stop taking sitagliptin/metformin at the time of the X-ray 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 (hepatic),
• if you drink excessive amounts of alcohol (either every day or only occasionally),
• if you are breastfeeding.

Do not take sitagliptin/metformin if any of the above applies to you and consult your doctor about other ways to control your diabetes. If you are not sure, consult your doctor, pharmacist, or nurse before taking sitagliptin/metformin.

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) 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 can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased by uncontrolled diabetes, serious infections, prolonged fasting, or alcohol intake, dehydration (see more information below), liver problems, and any medical condition in which a part of your body has a reduced supply of oxygen (such as severe and acute heart problems).

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 severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. 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 OF LACTIC ACIDOSIS, AS THIS CONDITION CAN LEAD TO COMA.

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• a general feeling of being unwell, with intense tiredness,
• difficulty breathing,
• reduced body temperature and heart rate, Lactic acidosis is a medical emergency and must be treated in a hospital.

Consult your doctor promptly if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, 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: seizures, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and deafness.

Consult your doctor or pharmacist before starting this medicine:

• if you have or have had pancreatitis (inflammation of the pancreas),
• if you have or have had gallstones, alcohol dependence, 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 condition 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 medicines, as you may experience low blood sugar levels (hypoglycemia).

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

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

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking sitagliptin/metformin.

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.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptin/metformin Tecnimede

If you need to be given an injection of a contrast agent containing iodine, for example, during an X-ray or scan, you will need to stop taking sitagliptin/metformin before or at the time of the injection. Your doctor will decide when you should stop taking sitagliptin/metformin and when you can restart it.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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:

• 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 medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• medicines used to treat bronchial asthma (beta-sympathomimetics),
• iodinated contrast agents or medicines that contain alcohol,
• certain medicines used to treat stomach problems, such as cimetidine,
• ranolazine, a medicine used to treat angina pectoris,
• dolutegravir, a medicine used to treat HIV infection,
• vandetanib, a medicine 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 levels if you are taking sitagliptin/metformin.

Taking Sitagliptin/metformin Tecnimede with alcohol

Avoid excessive alcohol intake while taking sitagliptin/metformin, as this can 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin Tecnimede.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, there have been reports of dizziness and drowsiness during treatment with sitagliptin, which may affect your ability to drive and use machines.

Taking this medicine 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 safe support.

Sitagliptin/metformin Tecnimede contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Sitagliptin/metformin Tecnimede

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, 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 medicine and be careful to distribute your carbohydrate intake evenly throughout the day.

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

The score line is not intended to break the tablet into equal doses.

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If you take more of the prescribed dose of this medicine, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or unwell, 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 your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Sitagliptina/etforminaT

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 medicine.

Sitagliptina/etforminaT

Continue taking sitagliptin/metformin for as long as your doctor tells you to, to help control your blood sugar levels. Do not stop taking this medicine without consulting your doctor first. If you stop taking sitagliptin/metformin, your blood sugar levels may increase again.

If you have any further questions about the use of this medicine, 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 sitagliptin/metformin 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).

Sitagliptin/metformin 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 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 not known), including skin rash, hives, blisters on the skin/peeling 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.

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 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(may affect more than 1 in 10 people): constipation.

Some patients have experienced the following adverse effects while taking this medicine in combination with pioglitazone:

Frequent(may affect more than 1 in 10 people): 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.

Infrequent: dry mouth, headache.

Some patients have experienced the following adverse effects during clinical studies while taking sitagliptin alone (one of the medicines that contains sitagliptin/metformin) or during use after the 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 nasal discharge, and sore throat, arthrosis, pain in the arm or leg.

Infrequent: dizziness, constipation, itching.

Rare: reduction in platelet count.

Frequency not known: kidney problems (which sometimes 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 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 (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 is not listed 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. Storage of Sitagliptin/Metformin Tecnimede

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 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 thrown down the drain or into the trash. 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 Sitagliptin/Metformin Tecnimede

The active ingredients 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 sodium starch glycolate.

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

Appearance of the Product and Package Contents

Red-brown film-coated tablet, oval, oblong, with a score line between "S" and "B" on one side and a score line on the other side. Tablet diameter: 21.3 ± 0.5 mm.

PVC-PVDC/aluminum blister packs. Packs of 14, 28, or 56 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer

SAG MANUFACTURING S.L.U.

Carretera Nacional I, Km 36

San Agustin de Guadalix 28750

Spain

Or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona,

Spain

Date of the last revision of this prospectus: 10/2023

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