Metsunix 100 mg/1,000 mg modified-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Metsunix 50 mg/500 mg modified-release tablets

Metsunix 50 mg/1,000 mg modified-release tablets

Metsunix 100 mg/1,000 mg modified-release tablets

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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What is Metsunix and what is it used for

Metsunix 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 insulin levels 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 level. 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 (cardiovascular) disease, kidney (renal) disease, blindness, and amputations.

2. What you need to know before taking 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 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 condition in which substances called “ketone bodies” build up in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or your breath developing an unusual fruity odor.
• 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 this medicine at the time of the procedure 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 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

Talk to your doctor, pharmacist, or nurse before starting this medicine.

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 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 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 consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body has 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 immediately for guidance if:

• You are known to have a hereditary 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: seizure, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or deafness.

Stop taking this medicine temporarily if you develop a condition 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 this medicine and contact a doctor or 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 extreme tiredness.
• difficulty breathing.
• reduced body temperature and heart rate.

Lactic acidosis is a medical emergency and must be treated in a hospital.

Talk to 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 called insulin-dependent diabetes.
• if you have had or have an allergic reaction to sitagliptin, metformin, or the combination of sitagliptin/metformin (see section 4).
• if you are taking a sulfonylurea or insulin, or other diabetes medications at the same time, 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 afterwards. Your doctor will decide when to interrupt and when to restart 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 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 between 10 and 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Metsunix

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking this medicine before or at the time of the injection. Your doctor will decide when to interrupt and when to restart 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 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, by inhalation, or 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 (to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking this medicine.

Taking Metsunix 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should not take this medicine during pregnancy or while breastfeeding. See section 2, “Do not take Metsunix”.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or none. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive and use machines.

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 secure support.

Metsunix contains sodium

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

3. How to take Metsunix

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how many tablets of this medicine you should take and when you should take them.

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

Usually, you should take the tablets once daily 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 possibility of stomach discomfort.

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

Your doctor may need to increase your dose to control your blood sugar levels.

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

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

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

If you take more Metsunix 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 Metsunix

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 a missed dose.

If you stop taking Metsunix

Continue taking this medicine for as long as your doctor prescribes it, to help control your blood sugar levels. You should not stop taking this medicine without first consulting your doctor. If you stop treatment with this medicine, 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 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 go to the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (frequency not known as it cannot be estimated from available data), including 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 medicine to treat the allergic reaction and will switch your diabetes treatment to another 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, 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 (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 active substances in this medicine) or during post-approval use of this medicine or sitagliptin alone or in combination 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 the number of platelets.

Frequency not known: kidney problems (which sometimes require 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), hives, skin redness (rash), or itching.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Metsunix

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

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

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metsunix

The active substances are sitagliptin and metformin.

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

Metsunix 50 mg/1.000 mg: each tablet contains sitagliptine hydrochloride monohydrate (equivalent to 50 mg of sitagliptin) and 1.000 mg of metformin hydrochloride.

Metsunix 100 mg/1.000 mg: each tablet contains sitagliptine hydrochloride monohydrate (equivalent to 100 mg of sitagliptin) and 1.000 mg of metformin hydrochloride.

The other components (excipients) are:

• Metformin extended-release layer: hypromellose, magnesium stearate.
• Sitagliptin immediate-release layer: calcium hydrogen phosphate, microcrystalline cellulose, sodium stearyl fumarate, sodium croscarmellose (see section 2 “Metsunix contains sodium”).
• In addition, the film coating contains:
  • Metsunix 50 mg/500 mg and Metsunix 100 mg/1.000 mg: partially hydrolysed 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 contents of the pack

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

Metsunix 50 mg/1.000 mg: white, oval, biconvex film-coated tablet, 22.2 mm x 10.8 mm in size, marked with the number “50” on one side and “1000” on the other.

Metsunix 100 mg/1.000 mg: orange, oval, biconvex film-coated tablet, 22.2 mm x 10.8 mm in size, marked with the number “100” on one side and “1000” on the other.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

Calle de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: February 2026

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.