Package Insert: Information for the Patient

Sitagliptina/Metformina Teva 50mg/1,000mg Film-Coated Tablets

sitagliptin/metformin hydrochloride

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

• Keep this package insert, as you may need to refer to 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 package insert. See section4.

1.What is Sitagliptina/Metformina Teva and how is it used

2.What you need to know before starting to take Sitagliptina/Metformina Teva

3.How to take Sitagliptina/Metformina Teva

4.Possible adverse effects

5.Storage of Sitagliptina/Metformina Teva

6.Contents of the package and additional information

Sitagliptina/Metformina Teva 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”.This medicine helps to increase the levels of insulin produced after a meal and reduces the amount of sugar produced by the body.

Along with diet and exercise, this medicine helps to lower your blood sugar level.This medicine 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 (cardiovascular), kidney diseases (renal), blindness, and amputations.

Do not take Sitagliptina/Metformina Teva

• if you are allergic to sitagliptin, metformin, or any of the other ingredients in this medication (listed in section6)
• 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 disorder in which 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 about to undergo a radiographythat 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 haveserious circulatory problems, such as “shock” or difficulty breathing
• if you have liver problems
• if you drink excessive alcohol (whether daily or occasionally)
• if you are breastfeeding.

Do not take this medication 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 this medication.

Warnings and precautions

Cases of pancreatitis have been reported in patients treated withthis medication(see section4).

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

Sitagliptin/metforminmay 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, or alcohol consumption, dehydration (see more information 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 disease).

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 intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. 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 that produce 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 take this 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 triglyceride levels (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section4)
• ifyou have type1 diabetes.This disease is also known asinsulin-dependent diabetes

• if you have or have had an allergic reaction to sitagliptin, metformin, or this medication (see section4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, because you may experience low blood sugar (hypoglycemia). Your doctor may consider reducing the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, stop takingthis medicationwhile the procedure is performed and for a period of time afterwards. Your doctor will decide when to stop and when to restart the treatment withthis medication.

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 withsitagliptin/metformin, 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 18years should not use this medication. It is not effective in children and adolescents aged 10 to 17years. The safety and efficacy of this medication in children under 10years are unknown.

Other medications and Sitagliptina/Metformina Teva

If you need to receive an injection of a contrast agent containing iodine, such as during a radiography or examination, you should stop takingsitagliptin/metforminabefore the injection or at the time of the injection.Your doctor will decide when to stop and when to restart the treatment withsitagliptin/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 ofsitagliptin/metformina. 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 (β-adrenergic 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 takingthis medication.

Taking Sitagliptina/Metformina Teva 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 breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.You should not take this medication during pregnancy. Do not take this medication if you are breastfeeding. (See section2,Do not takeSitagliptina/Metformina Teva).

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 drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive and operate machinery.

Taking this medication with medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Sitagliptina/Metformina Teva contains sodium

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

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

• Take one 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 with insulin, so it is likely that your doctor will consider reducing the dose of your sulfonylurea or insulin.

If you take more Sitagliptina/Metformina Teva than 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").

If you forget to take Sitagliptina/Metformina Teva

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 with Sitagliptina/Metformina Teva

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 taking this medication, your blood sugar levels may increase again.

If you have any other questions about using 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 (can affect up to 1 in 10,000 people), called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should 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 (unknown frequency), 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 medicine to treat the allergic reaction and change the medicine 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 levels,nausea, gas, vomiting

Rare (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 metformina:(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 levels

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 levels

Rare: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines containedin this medicine)or during use after approval ofsitagliptin/metforminaor sitagliptin alone or with other diabetes medicines:

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

Rare: dizziness, constipation, itching

Very rare: reduction in platelet count

Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint 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 can appear when you start taking metformin and usually disappear

Frequent:metallic taste, low or decreased vitamin B12 levels in the blood (symptoms can include extreme fatigue, red and painful tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may schedule some tests to find the cause of your symptoms because some of them can also be caused by diabetes or other unrelated health problems.

Very rare: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's possible side effects that don't appear in this prospectus.You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://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 30 °C.

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

Composition of Sitagliptin/Metformin Teva

• The active principles are sitagliptin and metformin.
• Each film-coated tablet containssitagliptin hydrochloride monohydrate equivalent to50mg of sitagliptin and 1,000mg of metformin hydrochloride.
• The other components are:

Core tablet: microcrystalline cellulose, povidone, sodium lauryl sulfate, and stearic acid and sodium (see section 2 “Sitagliptin/Metformin Teva contains sodium”).

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

Appearance of the product and contents of the package

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

PVC-PVDC/aluminum blisters.

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

HDPE bottles with a silica gel desiccant in the cap:

Packages of 196 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid

Spain

Responsible manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: June 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your 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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