Sitagliptin/metformin Tecnimede 50 mg/1.000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package Leaflet: Information for the Patient

Sitagliptin/metformin Tecnimede 50 mg/1.000 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Sitagliptina/metformina Tecnimede is and what it is used for
2. What you need to know before you start taking Sitagliptina/metformina Tecnimede
3. How to take Sitagliptina/metformina Tecnimede
4. Possible side effects
5. Storage of Sitagliptina/metformina Tecnimede
6. Contents of the pack and other 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 group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a group of medicines called biguanides.

They work together to control blood sugar levels in adult patients with a type of diabetes called "type 2 diabetes mellitus." This medicine helps to increase insulin levels produced after a meal and reduces the amount of sugar made by your body.

Together with diet and exercise, this medicine helps you lower your blood sugar level. This medicine may be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin and the insulin your body does produce 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 (cardiovascular) disease, kidney (renal) disease, blindness, and amputations.

2. What you need to know before 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 severely reduced kidney function,
• if you have uncontrolled diabetes, for example, with severe hyperglycemia (high blood glucose), 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or unusual fruity breath odor,
• if you have a serious infection or are dehydrated,
• if you are undergoing an X-ray procedure requiring injection of a contrast agent. You will need to stop taking sitagliptin/metformin at the time of the procedure and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning,
• 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 alcohol excessively (either daily or occasionally),
• if you are breastfeeding.

Do not take sitagliptin/metformin if any of the above apply to you, and consult your doctor about other ways to manage your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting sitagliptin/metformin.

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with sitagliptin/metformin (see section 4).

If you develop blisters on your skin, this may be a sign of a disease called bullous pemphigoid. Your doctor may instruct you to stop taking sitagliptin/metformin.

Risk of lactic acidosis

Sitagliptin/metformin may cause a very rare but serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting, alcohol consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body has a reduced oxygen supply (such as acute and serious heart conditions).

If any of the above apply to you, consult your doctor for further instructions.

Stop taking sitagliptin/metformin temporarily if you develop an illness that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.

STOP TAKING SITAGLIPTIN/METFORMIN AND CONTACT A DOCTOR OR GO TO THE NEAREST HOSPITAL IMMEDIATELY IF YOU EXPERIENCE ANY OF THE SYMPTOMS OF LACTIC ACIDOSIS, AS THIS CONDITION MAY LEAD TO COMA.

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• general feeling of discomfort with severe fatigue,
• difficulty breathing,
• reduction in body temperature and heart rate.
  Lactic acidosis is a medical emergency and must be treated in a hospital.

Contact your doctor immediately for advice on what to do if:

• You are known to have a genetic inherited disease affecting the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, 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: seizures, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Consult your doctor or pharmacist before starting this medicine:

• if you have or have had a disease of the pancreas (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 condition may also be called insulin-dependent diabetes,
• if you have ever had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4),
• if you are taking sitagliptin/metformina together with a sulfonylurea or insulin, or other antidiabetic medications, as you may experience low blood sugar levels (hypoglycemia).

Your doctor may consider reducing the dose of the sulfonylurea or insulin you are taking.

If you need to undergo major surgery, you must stop taking sitagliptin/metformin during the procedure and for some time afterward. Your doctor will decide when you should interrupt and when to restart treatment with sitagliptin/metformin.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before starting sitagliptin/metformin.

During treatment with sitagliptin/metformin, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

Children and adolescents

Children and adolescents under 18 years of age must not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether 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 receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or imaging scan, you must stop taking sitagliptin/metformin before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with sitagliptin/metformin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. You may require 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, by inhalation, or by injection) used to treat inflammatory conditions 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),
• specific medicines for bronchial asthma (β-sympathomimetics),
• iodinated contrast agents or medicines containing 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 (to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking sitagliptin/metformin.

Taking Sitagliptin/Metformin Tecnimede with alcohol

Avoid excessive alcohol intake while taking sitagliptin/metformin, 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin Tecnimede.

Driving and use of machines

The effect of this medicine on the ability to drive and operate machinery is negligible or none. However, dizziness and somnolence have been reported during treatment with sitagliptin, which may affect your ability to drive and use machinery.

Taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which could impair your ability to drive and operate machinery or work without secure support.

Sitagliptin/Metformin Tecnimede contains sodium.

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

3. How to take Sitagliptin/metformin Tecnimede

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• Take one tablet:
  • twice daily, orally
  • 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 kidney function, your doctor may prescribe you a lower dose.

You must continue the diet recommended by your doctor during treatment with this medicine and take care to evenly distribute carbohydrate intake throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar (hypoglycemia). However, low blood sugar may occur when this medicine is taken together with a medicine containing a sulfonylurea or with insulin; therefore, your doctor may consider it necessary to reduce the dose of your sulfonylurea or insulin.

The score line is not intended for dividing the tablet into equal doses.

If you take more Sitagliptina/metformina Tecnimede than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section “Warnings and precautions”).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Sitagliptin/metformin Tecnimede

If you forget to take a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptin/Metformin Tecnimede

Keep taking sitagliptin/metformin for as long as your doctor prescribes it, to help control your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. If you stop treatment with sitagliptin/metformin, your blood sugar levels may rise again.

If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

STOP taking sitagliptin/metformin and contact your doctor immediately if you notice any of the following serious adverse effects:

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

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 occurs, you must stop taking sitagliptin/metformin and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

If you experience a severe allergic reaction (frequency not known), including skin rash, hives, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and will switch your diabetes treatment to another medicine.

Some patients 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 levels, nausea, gas, vomiting.

Uncommon (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 together with a sulfonylurea such as glimepiride:

Very common (may affect more than 1 in 10 people): low blood sugar levels.

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

Some patients 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 legs.

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

Very common: low blood sugar levels.

Uncommon: dry mouth, headache.

Some patients experienced the following adverse effects during clinical studies while taking sitagliptin alone (one of the medicines contained in sitagliptin/metformin) or during post-approval use of sitagliptin/metformin or sitagliptin alone or with other diabetes medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, arm or leg pain.

Uncommon: 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 blistering skin condition).

Some patients have experienced the following adverse effects while taking metformin alone:

Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually resolve.

Frequent: metallic taste.

Very rare: reduction in vitamin B12 levels, hepatitis (a liver problem), hives, skin redness (rash), or itching.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide 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 expiry date stated on the blister and the carton following CAD/EXP. The expiry date refers to the last day of the stated month.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin/Metformin Tecnimede

The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptine 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 stearyl fumarate.

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

Product Appearance and Packaging Contents

Film-coated tablet, red-brown in colour, oval, oblong, with a breakline between "S" and "B" on one side and a breakline on the other side. Tablet diameter: 21.3 ± 0.5 mm.

PVC-PVDC/Aluminum blisters. Pack sizes of 14, 28 or 56 film-coated tablets.

Some pack sizes may not 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 most recent review of this leaflet: 10/2023

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