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

2. What you need to know before you take Sitagliptin/Metformin Teva

Do not take Sitagliptin/Metformin Teva

• 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 where 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 if your breath develops an unusual fruity odor
• if you have a severe infection or are dehydrated
• if you are going to have an X-ray where you will be injected with a contrast agent. You will need to stop taking this medicine 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
• if you drink excessive amounts of alcohol (either every day or only occasionally)
• if you are breast-feeding.

Do not take this medicine 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 this medicine.

Warnings and precautions

Cases of pancreatitis have been reported in patients taking this medicine (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 this medicine.

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 with uncontrolled diabetes, serious infections, prolonged fasting, or alcohol intake, dehydration (see more information below), liver problems, and any medical condition where a part of your body has a reduced supply of oxygen (such as acute and severe heart diseases).

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, exposure to heat, 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 a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• 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 quickly if:

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

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

• if you have or have had a pancreatic disease (such as pancreatitis)
  • if you have or have had gallstones, alcohol dependence, or very high blood levels of triglycerides (a type of fat). These medical conditions can 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 this medicine (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 consider it necessary to reduce the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, you should stop taking this medicine during the procedure and for a period after it. Your doctor will decide when you should stop taking this medicine and when you can start taking it again.

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

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 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.

Other medicines and Sitagliptin/Metformin Teva

If you need to be given an injection of a contrast agent containing iodine into your bloodstream, for example, in the context of an X-ray or scan, you should 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 start taking it again.

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-2 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 irregular heartbeat and other heart problems). Your doctor may need to check the level of digoxin in your blood if you are taking this medicine.

Taking Sitagliptin/Metformin Teva with alcohol

Avoid excessive alcohol intake while taking this medicine, as this can increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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. Do not take this medicine if you are breast-feeding. (See section 2, Do not take Sitagliptin/Metformin Teva).

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or non-existent. However, cases of dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive or use machines.

Taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive or use machines or work without a safe support.

Sitagliptin/Metformin Teva contains sodium

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

3. How to take Sitagliptin/Metformin Teva

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

• Take one tablet:
• • twice a day by mouth
  • with food to reduce the chance 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 (hypoglycemia). Low blood sugar can occur when this medicine is taken with a sulfonylurea or insulin, so your doctor may consider it necessary to reduce the dose of your sulfonylurea or insulin.

If you take more Sitagliptin/Metformin Teva than you should

If you take more than 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, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section “Warnings and precautions”).

If you forget to take Sitagliptin/Metformin Teva

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

If you stop taking Sitagliptin/Metformin Teva

Keep taking this medicine for as long as your doctor recommends. This will help you to control your blood sugar levels. Do not stop taking this medicine without first talking to your doctor. If you stop taking this medicine, your blood sugar levels may increase again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine may 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 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 (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

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 along with a sulfonylurea such as glimepiride:

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

Frequent: constipation

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

Frequent: swelling of hands or feet

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

Very frequent: low blood sugar levels

Uncommon: dry mouth, headache

Some patients have experienced the following adverse effects during clinical trials while taking sitagliptin alone (one of the medicines that contains this medicine) or during the use after the approval of sitagliptin/metformin or sitagliptin alone or with other diabetes medicines:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal discharge, and sore throat, arthritis, pain in the arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduction in platelet count

Frequency not known: kidney problems (which may 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 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, low or decreased vitamin B12 levels in the blood (symptoms may include extreme fatigue, red and sore tongue, numbness or tingling, or pale or yellowish skin). Your doctor may schedule some tests to discover the cause of your symptoms because some of them can also be caused by diabetes or other health problems not related to the medicine.

Very rare: hepatitis (a liver problem), hives, skin redness (rash), or itching

Reporting 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 does not appear 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. Conservation of Sitagliptin/Metformin Teva

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 container after CAD. The expiration date is the last day of the month indicated.

Do not store above 30 ºC.

Medicines should not be thrown away through wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Sitagliptin/Metformin Teva

• The active ingredients are sitagliptin and metformin.
• 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:

Core of the tablet: microcrystalline cellulose, povidone, sodium lauryl sulfate, and magnesium stearate (Ph. Eur.) (vegetable origin) (E470b) (see section 2 "Sitagliptin/Metformin Teva contains sodium").

Film coating: titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), polyvinyl alcohol, macrogol 3350, and talc.

Appearance of the Product and Container Content

The film-coated tablets of Sitagliptin/Metformin Teva 50 mg/1,000 mg are oval, biconvex, approximately 21.5 mm x 10.0 mm, brown in color, and have the inscription "S477" on one side.

PVC-PVDC/aluminum blisters.

Containers of 14, 28, 30, 56, 60, 98, 112, and 196 film-coated tablets.

HDPE bottles with a desiccant gel silica container in the cap:

Containers of 196 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid

Spain

Manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Prospectus: March 2025

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/)

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86622/P_86622.html

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