Package Leaflet: Information for the Patient

Sitagliptina/Metformina Krka50 mg/850 mg Film-Coated Tablets EFG

Sitagliptina/Metformina Krka50 mg/1.000 mg Film-Coated Tablets EFG

sitagliptina/metformina hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Sitagliptina/Metformina Krka and what it is used for

2.What you need to know before you start taking Sitagliptina/Metformina Krka

3.How to take Sitagliptina/Metformina Krka

4.Possible side effects

5.Storage of Sitagliptina/Metformina Krka

6.Contents of the pack and additional information

Sitagliptina/Metformina Krka 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 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 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, kidney diseases, blindness, and amputations.

Do not takeSitagliptina/Metformina Krka

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medication (listed in section 6)
• if you have severe kidney function impairment
• if you have uncontrolled diabetes, 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" accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor on your breath
• if you have a severe infection or are dehydrated
• if you are scheduled to undergo a radiography that 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 your kidney function
• if you have recently had a heart attack or have severe circulatory problems, such as "shock" or difficulty breathing
• if you have liver problems
• if you drink excessive amounts of alcohol (either 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 with this medication (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 this medication.

Risk of lactic acidosis

This medication 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, alcohol consumption, dehydration (see below for more information), 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 liquid 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 pancreatitis
• if you have or have had gallstones, alcohol addiction, or have 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 this medication (see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience low blood sugar (hypoglycemia). Your doctor may need to reduce the dose of the sulfonylurea or insulin you are taking.

If you need to undergo major surgery, stop taking this medication while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with this medication and when to restart it.

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 with this medication, 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 Sitagliptina/Metformina Krka

If you need to receive an injection of a contrast agent containing iodine, such as during a radiography or examination, stop taking this medication before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with this medication and when to restart it.

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 this medication. 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 blood level checked if you are taking this medication.

Taking Sitagliptina/Metformina Krka 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, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy. Do not take this medication if you are breastfeeding. See section 2 "Do not take Sitagliptina/Metformina Krka".

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

Sitagliptina/Metformina Krka contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, 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 sulfonilurea or with insulin, so your doctor may consider reducing the dose of your sulfonilurea or insulin.

If you take more Sitagliptina/Metformina Krka 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").

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina/Metformina Krka

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 regular treatment. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Sitagliptina/Metformina Krka

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 this medicine 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 of the pancreas).

This medicine 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, 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 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: 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

Rare: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines contained in Sitagliptina/Metformina Krka) or during use after approval of this medicine or sitagliptin alone or with other diabetes medicines:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity, and throat pain, 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,decrease or low levels of vitamin B12 in the blood (symptoms can include extreme fatigue, pain and redness of the tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may request tests to determine 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 is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 packaging after CAD. The expiration date is the last day of the month indicated.

OPA/Alu/PVC//Alu Blister Packs:

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

PVC/PE/PVDC/PE/PVC//Alu Blister Packs:

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through the drains or in the trash. Deposit the packaging and unused medications at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Sitagliptin/Metformin Krka

• The active substances are sitagliptin and metformin hydrochloride.

Sitagliptin/Metformin Krka 50 mg/850 mg film-coated tablets

Each film-coated tablet contains 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

Sitagliptin/Metformin Krka 50 mg/1.000 mg film-coated tablets

Each film-coated tablet contains 50 mg of sitagliptin and 1.000 mg of metformin hydrochloride.

• The other components are: povidone, microcrystalline cellulose, mannitol, sodium lauryl sulfate and magnesium stearate in the core tablet and hypromellose, titanium dioxide (E171), talc, propylene glycol and iron oxide red (E172) in the film coating. See section 2 “Sitagliptin/Metformin Krka contains sodium”.

Appearance of the product and contents of the pack

Sitagliptin/Metformin Krka 50 mg/850 mg film-coated tablets:film-coated tabletsof pink colour, oval, biconvex and with the inscription “C4” on one side (approximate dimensions: 20 x 11 mm).

Sitagliptin/Metformin Krka 50 mg/1.000 mg film-coated tablets:film-coated tabletsof dark pink colour, oval, biconvex and with the inscription “C3” on one side (approximate dimensions: 21 x 11 mm).

They are presented in packs containing:

• 10, 14, 28, 30, 56, 60, 196 and 200 film-coated tablets in blisters.
• 14, 28, 56 and 196 film-coated tablets in calendarised blisters.

Only some pack sizes may be marketed.

Marketing authorisation holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer responsible

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz Lohmann Straße 5, 27472 Cuxhaven, Germany

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L. C/ Anabel Segura, 10, 28108, Alcobendas (Madrid), Spain

This medicinal product is authorised in the Member States of the European Economic Area with the following names:

Last update of the summary of product characteristics: February 2024

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