Sitagliptin/metformin Kern Pharma 50 mg/1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Sitagliptin/Metformin Kern Pharma 50 mg/1.000 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

Read the entire 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Sitagliptina/Metformina Kern Pharma 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.

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

Together with diet and exercise, this medicine helps lower your blood sugar levels. This medicine can be used alone or in combination with certain other 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 (cardiovascular) disease, kidney (renal) disease, blindness, and amputations.

2. What you need to know before taking Sitagliptina/Metformina Kern Pharma

Do not take Sitagliptina/Metformina Kern Pharma:

• 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, 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, potentially leading to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or a fruity odor on the breath;
• if you have a serious infection or are dehydrated;
• if you are undergoing a radiographic procedure requiring injection of a contrast agent. You will need to stop taking this medicine at the time of the scan and for 2 or more days afterward, as directed by your doctor, depending on how well your kidneys are functioning;
• if you 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 alcohol excessively (either daily or occasionally);
• if you are breastfeeding.

Do not take this medicine 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 this medicine.

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with this medicine (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 this medicine.

Risk of lactic acidosis

This medicine 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 cases of uncontrolled diabetes, serious infections, prolonged fasting, alcohol consumption, dehydration (see further information below), liver problems, or any medical condition in which part of the body receives reduced oxygen supply (such as severe acute illnesses of the heart).

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 disorder (components responsible for energy production within 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 metformin treatment: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking sitagliptin/metformin temporarily if you develop an illness that could lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or reduced fluid intake. 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.

Symptoms of lactic acidosis include:

• vomiting;
• stomach pain (abdominal pain);
• muscle cramps;
• general feeling of discomfort with severe 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 this medicine:

• 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 levels of triglycerides (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 referred to as insulin-dependent diabetes;
• if you have or have had an allergic reaction to sitagliptin, metformin, or this medicine (see section 4);
• if you are taking a sulfonylurea or insulin, or other antidiabetic medicines, 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 this medicine during the procedure and for some time afterward. Your doctor will decide when to interrupt and resume treatment with this medicine.

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

During treatment with this medicine, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is worsening.

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 between 10 and 17 years. It is unknown whether this medicine is safe and effective in children under 10 years of age.

Other medicines and Sitagliptina/Metformina Kern Pharma

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or imaging scan, you must stop taking this medicine before or at the time of the injection. Your doctor will decide when to interrupt and resume treatment with this medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of this medicine. It is especially important to mention the following:

• medicines (taken orally, inhaled, or injected) 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 this medicine.

Taking Sitagliptina/Metformina Kern Pharma with alcohol

Avoid excessive alcohol consumption while taking this medicine, 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 medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptina/Metformina Kern Pharma.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is negligible or minor. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive and operate machinery.

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

Sitagliptina/Metformina Kern Pharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., essentially “sodium-free”.

3. How to take Sitagliptina/Metformina Kern Pharma

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 your blood sugar levels.

• If you have reduced kidney function, your doctor may prescribe you a lower dose.

You must continue the diet recommended by your doctor during treatment with this medicine and take care to evenly distribute carbohydrate intake throughout the day.

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

The score line should not be used to split the tablet.

If you take more Sitagliptina/Metformina Kern Pharma than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to the hospital if you have 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, consult your doctor or pharmacist or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Sitagliptina/Metformina Kern Pharma

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 of this medicine.

If you stop taking Sitagliptina/Metformina Kern Pharma

Keep taking this medicine for as long as your doctor tells you, so that it helps you control your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. If you stop taking this medicine, your blood sugar levels may rise again.

If you have any further questions about using 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 this medicine and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area) that may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

This medicine 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 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 (frequency not known), including skin rash, hives, skin blisters/desquamation, and swelling of the face, lips, tongue, and throat, which may 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 will switch your diabetes treatment to a different medicine.

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, flatulence, vomiting

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

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

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

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

Common: 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 Sitagliptina/Metformina Kern Pharma) or during post-approval use of this medicine or sitagliptin alone or with other diabetes medicines:

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

Uncommon: dizziness, constipation, itching

Rare (may affect up to 1 in 1,000 people): reduction in platelet count

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

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 problems.

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your usual pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin/Metformin Kern Pharma

• The active substances are sitagliptin and metformin. Each film-coated tablet (tablet) contains sitagliptine hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

• Other components are: In the tablet core: povidone K 29/32 (E1201), microcrystalline cellulose (E460), crospovidone Kollidon® and sodium stearyl fumarate. In addition, the film coating contains: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the container

Sitagliptin/Metformin Kern Pharma 50 mg/1,000 mg are film-coated tablets, reddish-brown in colour, oval and oblong, with a score line on one side and another score line on the opposite side with the imprint “S” and “B” on each side of it.

Tablet diameter: 21.3 ± 0.5 mm

Presented in PVC-PVDC/Aluminum blisters, in pack sizes of 14, 28, 50, 56, 112, 168 and 196 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

SAG MANUFACTURING S.L.U

Carretera Nacional I, Km 36

San Agustin de Guadalix 28750

Spain

Or

GALENICUM HEALTH, S.L.U.

Calle de Sant Gabriel, 50

08950 - Esplugues de Llobregat (Barcelona)

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Sitagliptin/Metformin Kern Pharma 50 mg/850 mg film-coated tablets EFG

Sitagliptin/Metformin Kern Pharma 50 mg/1000 mg film-coated tablets EFG

Malta: Sitagliptine/Metformine Kern Pharma 50 mg/850 mg film-coated tablets

Sitagliptine/Metformine Kern Pharma 50 mg/1000 mg film-coated tablets

Portugal: Metformin + Sitagliptin Pharmakern

Date of the most recent revision of this leaflet: July 2025

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