SITAGLIPTIN/METFORMIN SANDOZ FARMACEUTICA 50 mg/850 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Sitagliptin/Metformin Sandoz Pharmaceutical 50 mg/850 mg film-coated tablets EFG

Sitagliptin/Metformin Sandoz Pharmaceutical 50 mg/1,000 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

5 Storage of Sitagliptin/Metformin Sandoz Pharmaceutical

1. Package contents and additional information

1. What Sitagliptin/Metformin Sandoz Pharmaceutical is and what it is used for

This medication contains two different medications, called sitagliptin and metformin.

• sitagliptin belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• metformin belongs to a class of medications called biguanides.

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

Along with diet and exercise, this medication helps lower your blood sugar level. This medication can be used alone or with certain diabetes medications (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 disease, kidney disease, blindness, and amputations.

2. What you need to know before taking Sitagliptin/Metformin Sandoz Pharmaceutical

Do not take Sitagliptin/Metformin Sandoz Pharmaceutical:

• 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 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 substances called "ketone bodies" accumulate 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 on the breath,
• if you have a severe infection or are dehydrated,
• if you are to undergo an X-ray examination for which a contrast agent must be injected. You will need to stop taking sitagliptin/metformin at the time of the X-ray examination and for 2 or more days thereafter, 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 alcohol (either daily or occasionally),
• if you are breastfeeding.

Do not take sitagliptin/metformin 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 sitagliptin/metformin.

Warnings and precautions

There have been reports of pancreatitis in patients treated with sitagliptin/metformin (see section 4).

If you notice blisters on the 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 may cause a very 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, 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.

Consult your doctor immediately if:

• You know you have a genetic disorder 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: convulsions, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

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 symptoms of 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 (such as pancreatitis),
• if you have or have had gallstones, alcohol addiction, or have very high blood triglyceride levels (a type of fat). These medical conditions may 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 had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4),
• if you are taking a sulfonylurea or insulin, other diabetes medications, 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 sitagliptin/metformin during the procedure and for a period after it. Your doctor will decide when you should stop taking sitagliptin/metformin and when you can restart it.

If you are unsure whether any of the above circumstances apply to you, consult your doctor or pharmacist before starting to take 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 deteriorating.

Children and adolescents

Children and adolescents under 18 years of age should not use this medication. It is not effective in children and adolescents between 10 and 17 years of age. It is unknown whether this medication is safe and effective when used in children under 10 years of age.

Other medications and Sitagliptin/Metformin Sandoz Pharmaceutical

If you need to be administered an intravenous injection of a contrast agent containing iodine, for example, in the context of an X-ray examination or scan, you should stop taking sitagliptin/metformin before the injection 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 may 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 sitagliptin/metformin. It is especially important to mention the following:

• medications (taken orally, inhaled, or injected) used to treat diseases that cause inflammation, 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),
• certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• medications used to treat bronchial asthma (beta-sympathomimetics),
• iodinated contrast agents or medications containing alcohol,
• certain 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 (for treating irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood levels if you are taking sitagliptin/metformin.

Taking Sitagliptin/Metformin Sandoz Pharmaceutical with alcohol

Avoid excessive alcohol consumption 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 plan to become pregnant, consult your doctor or pharmacist before using this medication. You should not take this medication during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin Sandoz Pharmaceutical.

Driving and using machines

The effect of this medication on the ability to drive and use machines is negligible or nonexistent. 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 medication with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without a secure support.

Sitagliptin/Metformin Sandoz Pharmaceutical contains sodium.

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

3. How to take Sitagliptin/Metformin Sandoz Pharmaceutical

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, 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 medication and ensure that your carbohydrate intake is evenly distributed throughout the day.

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

If you take more Sitagliptin/Metformin Sandoz Pharmaceutical than you should

If you take more than the prescribed dose of this medication, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis, such as a feeling of coldness or discomfort, 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptin/Metformin Sandoz Pharmaceutical

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 missed doses.

If you stop taking Sitagliptin/Metformin Sandoz Pharmaceutical

Continue taking sitagliptin/metformin for as long as your doctor tells you to, to help control your blood sugar levels. You should not stop taking this medication 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 medication, 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 consult your 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.

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 took 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 with a sulfonylurea such as glimepiride:

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

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, headache, upper respiratory tract infection, nasal congestion or runny nose, 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 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.

Very rare:reduction in vitamin B12 levels, 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 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 Sandoz Pharmaceutical

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.

PVC/PE/PVDC-aluminum opaque blister pack

Do not store at a temperature above 30°C

OPA/Alu/PVC-aluminum blister pack

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in 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 Sandoz Pharmaceutical

The active ingredients are sitagliptin and metformin hydrochloride.

Sitagliptin/Metformin Sandoz Pharmaceutical 50 mg/850 mg

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

Sitagliptin/Metformin Sandoz Pharmaceutical 50 mg/1,000 mg

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, sodium lauryl sulfate, microcrystalline cellulose, and magnesium stearate.

In addition, the coating contains:

50 mg/850 mg film-coated tablets

Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172), and black iron oxide (E172).

50 mg/1,000 mg film-coated tablets

Poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Sitagliptin/Metformin Sandoz Pharmaceutical 50 mg/850 mg

Film-coated tablet, pink, biconvex, capsule-shaped, engraved with "585" on one side and a break line on the other side.

Sitagliptin/Metformin Sandoz Pharmaceutical 50 mg/1,000 mg

Film-coated tablet, red, biconvex, capsule-shaped, engraved with "5100" on one side and a break line on the other side.

Sitagliptin/Metformin Sandoz Pharmaceutical is available in:

Opaque PVC/PE/PVDC-aluminum or OPA/Alu/PVC-aluminum blister pack, perforated or non-perforated.

Packages of 14, 28, 56, 100, 112, 168, 196 film-coated tablets, multiple packages containing 196 (2 packages of 98) and 168 (2 packages of 84) film-coated tablets.

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Rontis Hellas S.A.

Medical and Pharmaceutical Products

Products Area of Larissa, P.O. Box 3012

GR-41500 Larissa

Greece

or

PharOS MT Ltd

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

This medicine is authorized in the Member States of the European Economic Area with the following names:

Netherlands Sitagliptine/Metformine HCl Sandoz 50mg/850 mg, film-coated tablets

Sitagliptine/Metformine HCl Sandoz 50mg/1000 mg, film-coated tablets

Austria Sitagliptin/Metformin Sandoz GmbH 50 mg/850 mg – film-coated tablets

Sitagliptin/Metformin Sandoz GmbH 50 mg/1000 mg – film-coated tablets

Belgium Sitagliptin/Metformin Sandoz 50 mg/850 mg film-coated tablets

Sitagliptin/Metformin Sandoz 50 mg/1000 mg film-coated tablets

Czech Republic Sitagliptin/Metformin Sandoz GmbH

Estonia Metformin hydrochloride/Sitagliptin Sandoz

Greece Sitagliptin+ Metformin/Sandoz Επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο (50+850) mg

Sitagliptin+ Metformin/Sandoz Επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο (50+1000) mg

Finland Sitagliptin/Metformin Hexal 50 mg/850 mg tablet, film-coated

Sitagliptin/Metformin Hexal 50 mg/1000 mg tablet, film-coated

France SITAGLIPTINE/METFORMINE 50 mg/1000 mg GNR, film-coated tablet

Hungary Sitagliptin/Metformin 1 A Pharma 50 mg/850 mg film-coated tablet

Sitagliptin/Metformin 1 A Pharma 50 mg/1000 mg film-coated tablet

Lithuania Metformin hydrochloride/Sitagliptin Sandoz 850 mg/50 mg film-coated tablets

Metformin hydrochloride/Sitagliptin Sandoz 1000 mg/50 mg film-coated tablets

Latvia Metformin hydrochloride/Sitagliptin Sandoz 850 mg/50 mg film-coated tablets

Metformin hydrochloride/Sitagliptin Sandoz 1000 mg/50 mg film-coated tablets

Malta Sitagliptin / Metformin PharOS 50mg / 850mg film-coated tablets

Sitagliptin / Metformin PharOS 50mg / 1000mg film-coated tablets

Portugal Metformina + Sitagliptina Sandoz Farmacêutica

Slovakia Sitagliptin/Metformin Sandoz GmbH 50 mg/850 mg film-coated tablets

Sitagliptin/Metformin Sandoz GmbH 50 mg/1000 mg film-coated tablets

Date of the Last Revision of this Prospectus:April 2025

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