Label:Information for the Patient

Sitagliptina/Metformina Sandoz 50 mg/850 mg Film-Coated Tablets

Sitagliptina/Metformina Sandoz 50 mg/1.000 mg Film-Coated Tablets

sitagliptina/metformin hydrochloride

Read this label carefully before starting to take this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctor,pharmacistor nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist or nurse,evenif they do not appear in this label. See section 4.

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

2.What you need to knowbeforestarting totake Sitagliptina/Metformina Sandoz

3.How to take Sitagliptina/Metformina Sandoz

4.Possible adverse effects

5Storage of Sitagliptina/Metformina Sandoz

6.Contents of the package and additional information

Sitagliptina/Metformina Sandoz 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 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 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 Sandoz:

• 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 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 condition in which substances called “ketone bodies” accumulate in the blood, which can lead to diabetic precoma.The 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 a radiography that requires the injection of a contrast agent.You will need to stop taking sitagliptin/metformin 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 have severe circulatory problems, such as “shock” or difficulty breathing,
• if you have liver problems (hepatic),
• if you drink excessive alcohol (whether 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

Cases of pancreatitis have been reported in patients treated with sitagliptin/metformin (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 sitagliptin/metformin.

Risk of lactic acidosis

Sitagliptin/metformin may 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 diseases).

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 components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and hearing loss (MIDD).

• you experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with movement, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Stop taking sitagliptin/metformin for a short period of time 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 sitagliptin/metformin:

• if you have or have had pancreatitis,
• if you have or have had gallstones, alcohol addiction, or have very 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 disease is also known as insulin-dependent diabetes,
• if you have or 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, because 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 sitagliptin/metformin while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to stop and when to restart treatment with sitagliptin/metformin.

If you are unsure whether you are affected by any of the above circumstances, 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 older person and/or if your kidney function is deteriorating.

Children and adolescents

Children and adolescents under 18 years old should not use this medicine. It is not effective in children and adolescents between 10 and 17 years old. The safety and efficacy of this medicine in children under 10 years old are unknown.

Other medicines and Sitagliptina/Metformina Sandoz

If you need to receive an injection of a contrast agent containing iodine, such as in the context of a radiography or examination, stop taking sitagliptin/metformin before the injection or at the time of the injection. Your doctor will decide when to stop and when to restart treatment with sitagliptin/metformin.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. 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 inflammatory diseases, 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),
• specific medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• medicines specifically used to treat asthma (β-adrenergic agonists),
• contrast agents containing iodine or medicines containing alcohol,
• specific 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),

(thyroid medullary cancer),

• digoxin (to treat irregular heartbeat and other heart problems). You may need to have your digoxin blood level checked if you are taking sitagliptin/metformin.

Use of Sitagliptina/Metformina Sandoz 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, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not take this medicine during pregnancy or while breastfeeding. See section 2,Do not take Sitagliptina/Metformina Sandoz.

Driving and operating machines

The influence of this medicine on the ability to drive and use machines is negligible or insignificant. However, it should be taken into account when driving or using machines that have been reported to cause dizziness and somnolence with the use of sitagliptin.

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

Sitagliptina/Metformina Sandoz contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) 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 oral route
• with food to reduce the likelihood of stomach discomfort
• Your doctor may need to increase the dose to control blood sugar levels.
• Ifyouhave 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 sulfonilurea or insulin, so it is likely that your doctor will consider reducing the dose of your sulfonilurea or insulin.

If you take more Sitagliptina/Metformina Sandoz 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 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 immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina/Metformina Sandoz

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 doseto compensate for missed doses.

If you interrupt treatment with Sitagliptina/Metformina Sandoz

Continue taking sitagliptina/metformina at all times as indicated by your doctor to help control your blood sugar level. Do not stop taking this medication without first consulting your doctor. If you interrupt treatment with sitagliptina/metformina

, your blood sugar may increase again.

If you have any other questions about the use of 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 (pancreas 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" section). If this happens to you,you should 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 (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.

Infrequent(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(can affect up to 1 in 10 people): constipation.

Some patients presented the following side effects while taking this medicine in combination with pioglitazone:

Frequent:(can affect up to 1 in 10 people) 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.

Infrequent:dry mouth, headache.

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines that contains sitagliptin/metformin) or during use after approval of sitagliptin/metformin 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.

Infrequent: dizziness, constipation, itching.

Rare:reduction in platelet count.

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

Frequent: metallic taste.

Very rare: reduction of vitamin B12 levels, 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 theSpanish System for 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister pack and the boxafter CAD/EXP. The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Sitagliptin/Metformin Sandoz

• The active ingredients are sitagliptin and metformin hydrochloride.

Sitagliptin/Metformin Sandoz 50 mg/850 mg

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

Sitagliptin/Metformin Sandoz 50 mg/1.000 mg

Each 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 (E1201), sodium lauryl sulfate, microcrystalline cellulose (E460), sodium croscarmellose (E468), stearic acid fumarate and sodium.

Coating:hypromellose (E464), hydroxypropylcellulose (E463), triethyl citrate (E1505), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

Sitagliptin/Metformin Sandoz 50 mg/850 mg

Coated tablet with a clear orange film, oval and biconvex shape (approximately 10 x 20 mm), engraved with the inscription “SM 2” on one side.

Sitagliptin/Metformin Sandoz 50 mg/1.000 mg

Coated tablet with a clear red film, oval and biconvex shape (approximately 10.5 x 21 mm), engraved with the inscription “SM 3” on one side.

This medicine is available in blisters (OPA/Aluminum/PVC//Aluminum or in transparent PVC/PE/PVDC//Aluminum blisters) packaged in a cardboard box.

Packaging of 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 112, 168, 180, 196 coated tablets.

Multiple packaging of 168 (2 packaging of 84) and 196 (2 packaging of 98) and packaging of 196 (2 packaging of 98 inside a wrapper) coated tablets.

Perforated single-dose blister packaging of 14 x 1, 28 x 1, 50 x 1, 56 x 1, 60 x 1, 112 x 1, 168 x 1, 180 x 1 (2 packaging of 90 x 1), 196 x 1, 196 x 1 (2 packaging of 98 x 1) and 196 x 1 (2 packaging of 98 x 1 inside a wrapper) coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

Lek S.A.

Ul. Podlipie 16

95 010Strykow

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaSitagliptin/Metformin Hexal 50 mg/850 mg Filmtabletten

Sitagliptin/Metformin Hexal 50 mg/1000 mg Filmtabletten

BelgiumSitagliptin/Metformin Sandoz 50 mg/850 mg filmomhulde tabletten

Sitagliptin/Metformin Sandoz 50 mg/1000 mg filmomhulde tabletten

DenmarkSitagliptin/Metformin Sandoz

FinlandSitagliptin/Metformin Sandoz 50 mg/850 mg tabletti, kalvopäällysteinen

Sitagliptin/Metformin Sandoz 50 mg/1000 mg tabletti, kalvopäällysteinen

FranceSITAGLIPTINE/METFORMINE SANDOZ 50 mg/1000 mg, comprimé pelliculé

HungarySitagliptin/Metformin Sandoz 50 mg/850 mg filmtabletta

Sitagliptin/Metformin Sandoz 50 mg/1000 mg filmtabletta

IrelandSitagliptin/Metformin hydrochloride Rowex 50 mg/850 mg film-coated tablets

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

IcelandSitagliptin/Metformin Sandoz 50 mg/850 mg filmuhúðaðar töflur

Sitagliptin/Metformin Sandoz 50 mg/1000 mg filmuhúðaðar töflur

NetherlandsSitagliptine/Metformine HCl Sandoz 50/850 mg filmomhulde tabletten

Sitagliptine/Metformine HCl Sandoz 50/1000 mg, filmomhulde tabletten

NorwaySitagliptin/Metformin Sandoz

PortugalMetformina/Sitagliptina Sandoz 50 mg/850 mg comprimidos revestidos por película

Metformina/Sitagliptina Sandoz 50 mg/1000 mg comprimidos revestidos por película

Czech RepublicSitagliptin/Metformin Sandoz

SwedenSitagliptin/Metformin Sandoz 50 mg/850 mg filmdragerade tabletter

Sitagliptin/Metformin Sandoz 50 mg/1000 mg filmdragerade tabletter

Last review date of thisleaflet:April 2025

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