Prospecto: information for the patient

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

Sitagliptin/Metformin Combix 50 mg/1000 mg film-coated tablets EFG

sitagliptin/metformin hydrochloride

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

1.What is Sitagliptin/Metformin Combix and for what it is used

2.What you need to know before starting to take Sitagliptin/Metformin Combix

3.How to take Sitagliptin/Metformin Combix

4.Possible adverse effects

5.Storage of Sitagliptin/Metformin Combix

6.Contents of the package and additional information

Sitagliptina/Metformina Combix 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 that 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 takeSitagliptin/Metformin Combix

• 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, 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, which can lead to diabetic precoma. 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 to undergo a radiography for which a contrast agent must be injected. 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/metforminif 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 withsitagliptin/metformin(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 takingsitagliptin/metformin.

Risk of lactic acidosis

Sitagliptin/metforminmay cause a very rare but serious side effect called lactic acidosis, especially if your kidneys do not function 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 disease).

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

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 takesitagliptin/metformin:

• if you have or have had a pancreatic disease (such as 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, orsitagliptin/metformin(see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience low blood sugar (hypoglycemia). Your doctor may consider reducing the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, you should stop takingsitagliptin/metforminwhile the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment withsitagliptin/metforminand when to restart it.

If you are unsure whether you are affected by any of the above circumstances, consult your doctor or pharmacist before starting to takesitagliptin/metformin.

During treatment withsitagliptin/metformin, 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 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. The safety and efficacy of this medicine in children under 10 years of age are unknown.

Other medicines and Sitagliptin/Metformin Combix

If you need to be administered an injection of a contrast agent containing iodine, such as in the context of a radiography or examination, you should stop takingsitagliptin/metforminbefore the injection or at the time of the injection. Your doctor will decide when to interrupt treatment withsitagliptin/metforminand when to restart it.

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 ofsitagliptin/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)
• certain medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines for treating asthma (beta-2 agonists)
• iodine-containing 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). You may need to have your digoxin level checked in your blood if you are takingsitagliptin/metformin.

Taking Sitagliptin/Metformin Combix with alcohol

Avoid excessive alcohol consumption while takingsitagliptin/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, consult your doctor before using this medicine. Do not take this medicine during pregnancy. Do not take this medicine if you are breastfeeding. See section 2,Do not takesitagliptin/metformin.

Driving and operating machinery

The influence of this medicine on your ability to drive and operate machinery is negligible or insignificant. However, cases of dizziness and somnolence have been reported during treatment with sitagliptin, which may affect your ability to drive and operate machinery.

Taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Sitagliptin/Metformin Combix contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which 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 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 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 medication containing sulfonylurea or with insulin, so your doctor may need to reduce the dose of your sulfonylurea or insulin.

If you take more Sitagliptina/Metformina Combix than you should

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

If you forget to take Sitagliptina/Metformina Combix

If you forget to take a dose, take it as soon as you remember. If you do not remember until your next scheduled dose, skip the missed dose and continue with your regular treatment. Do not take a double dose of this medication.

If you interrupt treatment with Sitagliptina/Metformina Combix

Continue taking this medication as directed by your doctor to help control your blood sugar levels. Do not stop taking this medication without first consulting your doctor. If you stop taking sitagliptin/metformin, your blood sugar levels may increase again.

If you have any other questions about using this product, ask your doctor or pharmacist.

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

STOP takingsitagliptin/metforminand 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 rare but serious side effect (affects up to 1 in 10,000 people), called lactic acidosis (see "Warnings and precautions"). If this happens to you, you muststop taking sitagliptin/metformina 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 medication to treat the allergic reaction and change the medication for diabetes treatment.

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

Frequent (affects up to 1 in 10 people): low blood sugar, nausea, gas, vomiting

Infrequent (affects 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 (affects more than 1 in 10 people): low blood sugar

Frequent: constipation

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

Frequent: 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 medications contained in Sitagliptina/Metformina Combix) or during use after approval of sitagliptin/metformina or sitagliptin alone or with other diabetes medications:

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: reduced platelet count

Unknown frequency: kidney problems (sometimes requiring dialysis), vomiting, joint pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

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, decrease or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may ask you to take some tests to find out the cause of your symptoms, as some of them can also be caused by diabetes or other unrelated health problems

Rare: hepatitis (liver problem), urticaria, skin redness (rash) or itching

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it's possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Sitagliptin/MetforminCombix

• The active ingredients are sitagliptin and metformin.
• • Sitagliptin/Metformin Combix 50 mg/850 mg film-coated tablets EFG: each tablet contains 50 mg of sitagliptin (as hydrochloride) and 850 mg of metformin hydrochloride.
  • Sitagliptin/Metformin Combix 50 mg/1000 mg film-coated tablets EFG: each tablet contains 50 mg of sitagliptin (as hydrochloride) and 1000 mg of metformin hydrochloride.
• The other components are:

Tablet core: microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, magnesium stearate.

Coating (50 mg/850 mg):polyvinyl alcohol partially hydrolyzed (E1209), talc (E553b), titanium dioxide (E171), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203) and iron oxide red (E172)

Coating (50 mg/1000 mg):polyvinyl alcohol partially hydrolyzed (E1209), talc (E553b), titanium dioxide (E171), iron oxide red (E172), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203) and iron oxide black (E172).

Appearance of the productand packaging content

Sitagliptin/Metformin Combix 50 mg/850 mg film-coated tablets EFG: film-coated tablet, oval, biconvex, approximately 20.5 mm x 9.5 mm in size, pink in color, engraved with “S476” on one side and flat on the other.

Sitagliptin/Metformin Combix 50 mg/1000 mg film-coated tablets EFG: film-coated tablet, oval, biconvex, approximately 21.5 mm x 10.0 mm in size, brown in color, engraved with “S477” on one side and flat on the other.

Sitagliptin/Metformin Combix 50 mg/850 mg film-coated tablets EFG are presented in

• Blister composed of PVC opaque/PVDC-Aluminum

Packaging of 14, 28, 30, 56, 60, 196 and 210 tablets.

• HDPE bottle white with silica gel desiccant contained in the screw cap

Packaging of 100 and 196 tablets.

Sitagliptin/Metformin Combix 50 mg/1000 mg film-coated tablets EFG are presented in

• Blister composed of PVC opaque/PVDC-Aluminum

Packaging of 14, 28, 30, 56, 60, 196 and 210 tablets.

• HDPE bottle white with silica gel desiccant contained in the screw cap

Packaging of 100 and 196 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Combix Laboratories, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

Laboratories Liconsa S.A.

Avda. Miralcampo, nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:January 2024

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