METSUNIX 50 MG/1.000 MG MODIFIED-RELEASE TABLETS

2. What you need to know before you take Metsunix

Do not take Metsunix

• 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 problems.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia, 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” build up in the blood, which can lead to a pre-diabetic coma. 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 radiograph for which you will be injected with a contrast agent. You will need to stop taking this medicine at the time of the radiograph and for 2 or more days afterwards, 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.
• if you drink excessive amounts of alcohol (either every day or only occasionally).
• if you are breast-feeding.

Do not take this medicine if any of the above applies to you and consult your doctor about other ways to control your diabetes. If you are not sure, consult your doctor, pharmacist, or nurse before taking this medicine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medicine.

There have been reports of pancreatitis in patients treated with this medicine (see section 4).

If you notice blisters on your skin, it may be a sign of a disease 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 very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased by uncontrolled diabetes, serious infections, prolonged fasting, or alcohol intake, dehydration (see below), liver problems, and any medical condition in which a part of your body has a reduced supply of oxygen (such as severe and acute 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 disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, 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 this medicine for a short period of time 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 this medicine and contact a doctor or the nearest hospital immediately if you experience any of the 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 taking this medicine:

• if you have or have had pancreatitis.
• if you have or have had gallstones, alcohol dependence, 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 disease is also known as insulin-dependent diabetes.
• if you have had an allergic reaction to sitagliptin, metformin, or the combination sitagliptin/metformin (see section 4).
• if you are taking a sulfonylurea or insulin, other diabetes medicines, 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 this medicine during the procedure and for some time afterwards. Your doctor will decide when you should stop taking this medicine and when you can restart it.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking 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 an elderly person 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 not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Metsunix

If you need to be given an injection of a contrast agent containing iodine into your bloodstream, for example, in the context of a radiograph or scan, you should stop taking this medicine before the injection or at the time of the injection. Your doctor will decide when you should stop taking this medicine and when you can restart it.

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 this medicine. It is especially important to mention the following:

• medicines (taken orally, inhaled, or injected) used to treat diseases that cause inflammation, 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).
• medicines used to treat bronchial asthma (beta-sympathomimetics).
• iodinated contrast agents or medicines that contain 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 (for treating irregular heartbeat and other heart problems). Your doctor may need to check the level of digoxin in your blood if you are taking this medicine.

Taking Metsunix with alcohol

Avoid excessive alcohol intake while taking this medicine, as this can increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or while breast-feeding. See section 2, “Do not take Metsunix”.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or non-existent. However, there have been reports of dizziness and somnolence during treatment with sitagliptin, which may affect your ability to drive or use machines.

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

Metsunix contains sodium

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

3. How to take Metsunix

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again. Your doctor will tell you how many tablets of this medicine to take and when to take them.

The maximum daily dose is 100 milligrams of sitagliptin and 2,000 milligrams of metformin.

Normally, you should take the tablets once a day, with your evening meal.

In some cases, your doctor may recommend that you take the tablets twice a day.

Always take the tablets with food to reduce the chance of stomach pain.

Swallow the tablets whole with a glass of water. Do not chew them.

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 medicine and be careful to distribute your carbohydrate intake evenly throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels can occur when this medicine is taken with a medicine that contains 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 Metsunix than you should

If you take more of this medicine than you should, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or unwell, 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, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Metsunix

If you forget to take a dose, take it as soon as you remember. If you do not remember until the time for your next dose, skip the missed dose and continue with your normal treatment schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Metsunix

Keep taking this medicine for as long as your doctor recommends. It will help to control your blood sugar levels. Do not stop taking this medicine without first talking to your doctor. If you stop taking this medicine, your blood sugar levels may increase again.

If you have any further questions on 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 all people suffer from them.

STOP taking this medicine and go to the 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 (inflammation of the pancreas).

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 happens to you, 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 since it cannot be estimated from the available data), including skin rash, hives, 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 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 along with a sulfonylurea such as glimepiride:

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

Frequent: constipation.

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

Frequent: swelling of hands or feet.

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

Very frequent: low blood sugar levels.

Infrequent: dry mouth, headache.

Some patients have experienced the following adverse effects during clinical studies while taking sitagliptin alone (one of the drugs that this medicine contains) or during use after the approval of this medicine or sitagliptin alone or with other diabetes medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infection, congestion or nasal stuffiness, and sore throat, arthritis, pain in the arm or leg.

Infrequent: dizziness, constipation, itching.

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

Frequency not known: kidney problems (which sometimes 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 does not appear 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 Metsunix

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. 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 Metsunix

The active ingredients are sitagliptin and metformin.

Metsunix 50 mg/500 mg: each tablet contains sitagliptin hydrochloride (equivalent to 50 mg of sitagliptin) and 500 mg of metformin hydrochloride.

Metsunix 50 mg/1,000 mg: each tablet contains sitagliptin hydrochloride (equivalent to 50 mg of sitagliptin) and 1,000 mg of metformin hydrochloride.

Metsunix 100 mg/1,000 mg: each tablet contains sitagliptin hydrochloride (equivalent to 100 mg of sitagliptin) and 1,000 mg of metformin hydrochloride.

The other components (excipients) are:

• Metformin prolonged-release layer:hypromellose, magnesium stearate.
• Sitagliptin immediate-release layer: calcium hydrogen phosphate, microcrystalline cellulose, sodium fumarate, and sodium croscarmellose (see section 2 "Metsunix contains sodium").
• In addition, the film coatingcontains:
• • Metsunix 50 mg/500 mg and Metsunix 100 mg/1,000 mg: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), and red iron oxide (E172).
  • Metsunix 50 mg/1,000 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, and talc.

Appearance of the Product and Package Contents

Metsunix 50 mg/500 mg: film-coated orange, oval, biconvex tablet, size 17.2 mm x 8.4 mm.

Metsunix 50 mg/1,000 mg: film-coated white, oval, biconvex tablet, size 22.2 mm x 10.8 mm, and marked with the number "50" on one face and "1000" on the other.

Metsunix 100 mg/1,000 mg: film-coated orange, oval, biconvex tablet, size 22.2 mm x 10.8 mm, marked with the number "100" on one face and "1000" on the other.

PVC/PVDC-Aluminum blisters. Packages of 28, 30, 56, and 60 modified-release tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

Date of the last revision of this prospectus: May 2025

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