Sitagliptin/metformin Sandoz 50 mg/850 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

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

sitagliptin/metformin hydrochloride

Please read all of this leaflet carefully before you start taking this medicine, as 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, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Sitagliptin/Metformin Sandoz is and what it is used for
2. What you need to know before taking Sitagliptin/Metformin Sandoz
3. How to take Sitagliptin/Metformin Sandoz
4. Possible side effects
5. How to store Sitagliptin/Metformin Sandoz
6. Contents of the pack and other information

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

Sitagliptina/Metformina Sandoz contains two different medicines called sitagliptin and metformin.

• Sitagliptin belongs to a class of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a class of medicines known as biguanides.

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

Along with diet and exercise, this medicine helps you lower your blood sugar levels. This medicine can be used alone or in combination with certain diabetes medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin your body does produce 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

Do not take Sitagliptin/Metformin Sandoz:

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6),
• if you have severely reduced kidney function,
• if you have uncontrolled diabetes, for example, with severe hyperglycemia (high blood glucose), 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or a fruity odor on your breath,
• if you have a serious infection or are dehydrated,
• if you are undergoing an X-ray procedure requiring injection of a contrast agent. You will need to stop taking sitagliptin/metformin at the time of the scan and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning,
• if you have recently had a heart attack or have serious circulatory problems, such as “shock” or breathing difficulties,
• if you have liver problems (hepatic),
• if you drink alcohol excessively (either daily or occasionally),
• if you are breastfeeding.

Do not take sitagliptin/metformin if any of the above apply to you, and consult your doctor about other ways to manage your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting sitagliptin/metformin.

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with sitagliptin/metformin (see section 4).

If you develop blisters on your skin, this 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 very rare but serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting, alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which part of the body has a reduced oxygen supply (such as acute and severe heart conditions).

If any of the above apply to you, consult your doctor for further instructions.

Contact your doctor promptly for guidance if:

• You are known to have a genetic mitochondrial disease (components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, 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 decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or deafness.

Temporarily stop taking sitagliptin/metformin if you develop an illness that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking sitagliptin/metformin and contact a doctor or go to the nearest hospital immediately if you experience any symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• general feeling of discomfort with profound fatigue,
• difficulty breathing,
• decreased body temperature and heart rate,
• lactic acidosis is a medical emergency and must be treated in a hospital.

Consult your doctor or pharmacist before starting sitagliptin/metformin:

• if you have or have had a pancreatic disease (such as pancreatitis),
• if you have or have had gallstones, alcohol addiction, or 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 condition may also be called insulin-dependent diabetes,
• if you have had or currently have an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4),
• if you are taking a sulfonylurea or insulin, or other antidiabetic medications along with sitagliptin/metformin, as you may experience low blood sugar levels (hypoglycemia). Your doctor may consider reducing the dose of your sulfonylurea or insulin.

If you need to undergo major surgery, you must stop taking sitagliptin/metformin during the procedure and for a period afterwards. Your doctor will decide when to interrupt and when to restart treatment with sitagliptin/metformin.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before starting sitagliptin/metformin.

During treatment with sitagliptin/metformin, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is unknown whether this medicine is safe and effective in children under 10 years of age.

Other medicines and Sitagliptin/Metformin Sandoz

If you need to receive an injection of an iodine-containing contrast agent into your bloodstream, for example during an X-ray or imaging scan, you must stop taking sitagliptin/metformin before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with sitagliptin/metformin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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, by inhalation, or by injection) used to treat inflammatory conditions 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),
• specific medicines for bronchial asthma (β-sympathomimetics),
• iodinated contrast agents or medicines containing 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 (used to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking sitagliptin/metformin.

Taking Sitagliptin/Metformin 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin Sandoz.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or minor. However, you should be aware that dizziness and drowsiness have been reported with the use of sitagliptin.

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

Sitagliptin/Metformin Sandoz contains sodium.

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

3. How to take Sitagliptina/Metformina Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• Take one tablet:
• twice daily 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 kidney function, your doctor may prescribe a lower dose.

You should continue the diet recommended by your doctor during treatment with this medicine and ensure that carbohydrate intake is evenly distributed throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar (hypoglycaemia). Low blood sugar may occur when this medicine is taken together with a sulphonylurea or insulin; therefore, your doctor may consider it necessary to reduce the dose of your sulphonylurea or insulin.

If you take more Sitagliptina/Metformina Sandoz than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to hospital if you experience 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").

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine 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 it is time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Sitagliptina/Metformina Sandoz

Keep taking sitagliptina/metformina for as long as your doctor tells you, so that it can help you control your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. If you interrupt treatment with sitagliptina/metformina, your blood sugar levels may rise again.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

STOP taking sitagliptin/metformin and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area), which may radiate to the back with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (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 occurs, you must stop taking sitagliptin/metformin and contact a doctor or go to 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, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a treatment for the allergic reaction and switch you to another medicine for the treatment of diabetes.

Some patients taking metformin have experienced the following adverse effects after starting treatment with sitagliptin:

Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, gas, vomiting.

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.

Some patients have experienced diarrhoea, nausea, gas, constipation, stomach pain, or vomiting when starting treatment with the combination of sitagliptin and metformin (classified as common frequency).

Some patients have experienced the following adverse effects when taking this medicine in combination with a sulfonylurea such as glimepiride:

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

Common (may affect up to 1 in 10 people): constipation.

Some patients experienced the following adverse effects while taking this medicine in combination with pioglitazone:

Common: swelling of hands or legs.

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

Very common: low blood sugar levels.

Uncommon: dry mouth, headache.

Some patients experienced the following adverse effects during clinical studies while taking sitagliptin alone (one of the medicines contained in sitagliptin/metformin) or during post-approval use of sitagliptin/metformin or sitagliptin alone or with other diabetes medicines:

Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose and sore throat, osteoarthritis, arm or leg pain.

Uncommon: dizziness, constipation, itching.

Rare: reduction in the number of platelets.

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Some patients have experienced the following adverse effects after taking metformin alone:

Very common: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually go away over time.

Common: metallic taste, decreased or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling (paraesthesia), or pale or yellowish skin). Your doctor may order tests to determine the cause of your symptoms, as some of them may also be caused by diabetes or other unrelated health conditions.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, including any possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin/Metformin Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after EXP/CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Sitagliptin/Metformin Sandoz

• The active substances are sitagliptin and metformin hydrochloride.

Sitagliptin/Metformin Sandoz 50 mg/850 mg

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

Sitagliptin/Metformin Sandoz 50 mg/1,000 mg

Each tablet contains sitagliptin monohydrate monohydrochloride 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 pack contents

Sitagliptin/Metformin Sandoz 50 mg/850 mg

Light orange, oval-shaped, biconvex film-coated tablet (approximately 10 x 20 mm), engraved with the code "SM 2" on one side.

Sitagliptin/Metformin Sandoz 50 mg/1,000 mg

Light red, oval-shaped, biconvex film-coated tablet (approximately 10.5 x 21 mm), engraved with the code "SM 3" on one side.

This medicine is available in blisters (OPA/Aluminum/PVC//Aluminum or transparent PVC/PE/PVDC//Aluminum blister) packed in cardboard boxes.

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

Multiple packs of 168 (2 packs of 84) and 196 (2 packs of 98) film-coated tablets.

Perforated unit-dose blister packs 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 packs of 90 x 1), 196 x 1, 196 x 1 (2 packs of 98 x 1) film-coated tablets.

Only certain pack 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

Manufacturer responsible for manufacturing

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

Lek S.A.

Ul. Podlipie 16

95 010 Strykow

Poland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria Sitagliptin/Metformin Hexal 50 mg/850 mg Filmtabletten
Sitagliptin/Metformin Hexal 50 mg/1000 mg Filmtabletten

Belgium Sitagliptin/Metformin Sandoz 50 mg/850 mg filmomhulde tabletten
Sitagliptin/Metformin Sandoz 50 mg/1000 mg filmomhulde tabletten

Denmark Sitagliptin/Metformin Sandoz

Finland Sitagliptin/Metformin Sandoz 50 mg/850 mg tabletti, kalvopäällysteinen
Sitagliptin/Metformin Sandoz 50 mg/1000 mg tabletti, kalvopäällysteinen

France SITAGLIPTINE/METFORMINE SANDOZ 50 mg/1000 mg, comprimé pelliculé

Hungary Sitagliptin/Metformin Sandoz 50 mg/850 mg filmtabletta
Sitagliptin/Metformin Sandoz 50 mg/1000 mg filmtabletta

Ireland Sitagliptin/Metformin hydrochloride Rowex 50 mg/850 mg film-coated tablets
Sitagliptin/Metformin hydrochloride Rowex 50 mg/1000 mg film-coated tablets

Iceland Sitagliptin/Metformin Sandoz 50 mg/850 mg filmuhúðaðar töflur
Sitagliptin/Metformin Sandoz 50 mg/1000 mg filmuhúðaðar töflur

Netherlands Sitagliptine/Metformine HCl Sandoz 50/850 mg filmomhulde tabletten
Sitagliptine/Metformine HCl Sandoz 50/1000 mg, filmomhulde tabletten

Norway Sitagliptin/Metformin Sandoz

Portugal Metformina/Sitagliptina Sandoz 50 mg/850 mg comprimidos revestidos por película
Metformina/Sitagliptina Sandoz 50 mg/1000 mg comprimidos revestidos por película

Czech Republic Sitagliptin/Metformin Sandoz

Sweden Sitagliptin/Metformin Sandoz 50 mg/850 mg filmdragerade tabletter
Sitagliptin/Metformin Sandoz 50 mg/1000 mg filmdragerade tabletter

Date of latest revision of the leaflet: July 2025

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