Metformax Combi

Leaflet attached to the packaging: patient information

Metformax Combi, 50 mg + 850 mg, film-coated tablets

Metformax Combi, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Metformax Combi and what is it used for
• 2. Important information before taking Metformax Combi
• 3. How to take Metformax Combi
• 4. Possible side effects
• 5. How to store Metformax Combi
• 6. Contents of the packaging and other information

1. What is Metformax Combi and what is it used for

Metformax Combi contains two different active substances called sitagliptin and metformin.

• Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a group of medicines called biguanides.

The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduces the amount of sugar produced by the body. The medicine, used in combination with diet and physical exercise, helps to reduce blood sugar levels. This medicine can be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, or glitazones). What is type 2 diabetes? In type 2 diabetes, the body does not produce enough insulin, and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Metformax Combi

When not to take Metformax Combi:

Do not take Metformax Combi if any of the above contraindications occur. Consult your doctor to determine other methods of controlling diabetes. In case of doubt, before taking Metformax Combi, discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Metformax Combi, cases of pancreatitis (see section 4) have been reported.

• 4.

If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend that the patient stop taking Metformax Combi.

Risk of lactic acidosis

Metformax Combi may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver disease, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., severe heart disease). If any of the above situations apply to the patient, they should consult their doctor for more detailed instructions.

Temporarily discontinue use of Metformax Combi if the patient has a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, high temperature, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

Discontinue use of Metformax Combi and immediately contact a doctor or the nearest hospital if the patient experiences any symptoms of lactic acidosis

, as this condition can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, combined with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

Immediately consult a doctor for further instructions if:

• the patient has a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• after starting metformin, the patient experiences any of the following symptoms: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss. Before starting Metformax Combi, discuss this with your doctor or pharmacist:

If the patient is scheduled to undergo major surgery, they should not take Metformax Combi during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Metformax Combi. In case of doubt, whether any of the above statements apply to the patient, before taking Metformax Combi, consult a doctor or pharmacist. During treatment with Metformax Combi, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has deteriorating kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Metformax Combi and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Metformax Combi before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume treatment with Metformax Combi. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of Metformax Combi by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or 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 used to treat asthma (β-sympathomimetics),
• contrast agents containing iodine or medicines containing alcohol,
• certain medicines used to treat stomach disorders, such as cimetidine,
• ranolazine, a medicine used to treat angina,
• dolutegravir, a medicine used to treat HIV infection,
• vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart conditions). When taking Metformax Combi with digoxin, the patient should have their digoxin levels checked.

Metformax Combi and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metformax Combi, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy or breastfeeding. See section 2, "When not to take Metformax Combi".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, the patient should take into account that dizziness and drowsiness have been reported during sitagliptin treatment, which may affect the ability to drive and use machines. Taking this medicine with sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.

Metformax Combi contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Metformax Combi

This medicine should always be taken as directed by the doctor. In case of doubt, consult a doctor or pharmacist.

• Take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• To control blood sugar levels, the doctor may increase the dose of the medicine.
• If the patient has kidney problems, the doctor may prescribe a lower dose.

During treatment with this medicine, the patient should continue to follow the diet recommended by the doctor and pay attention to evenly distributing carbohydrate intake throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when taking this medicine with a sulfonylurea derivative or insulin - in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Metformax Combi than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately contact their doctor. The patient should go to the hospital if symptoms of lactic acidosis occur, such as feeling cold or discomfort, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Metformax Combi

In case of missing a dose, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medicine as usual. The patient should not take a double dose of this medicine.

Stopping treatment with Metformax Combi

To maintain control of blood sugar levels, the medicine should be taken for as long as the doctor recommends. The patient should not stop taking this medicine without consulting their doctor. Stopping treatment with Metformax Combi may lead to increased blood sugar levels. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The patient should STOP taking Metformax Combi and immediately contact their doctor if they experience any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis.

Metformax Combi may very rarely cause (may occur in less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should STOP taking Metformax Combi and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma. In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking the medicine and immediately contact their doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. In some patients taking metformin, after starting sitagliptin, the following side effects have occurred: Common (may occur in less than 1 in 10 patients): low blood sugar, nausea, bloating, vomiting. Uncommon (may occur in less than 1 in 100 patients): abdominal pain, diarrhea, constipation, drowsiness. In some patients, diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting have occurred after starting sitagliptin treatment in combination with metformin (common). In some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, the following side effects have occurred: Very common (may occur in more than 1 in 10 patients): low blood sugar. Common: constipation. In some patients taking this medicine with pioglitazone, the following side effects have occurred: Common: swelling of the hands or feet. In some patients taking this medicine with insulin, the following side effects have occurred: Very common: low blood sugar. Uncommon: dry mouth, headache. In clinical trials, in some patients taking sitagliptin alone (one of the active substances of Metformax Combi) or after marketing authorization of the combined medicinal product containing sitagliptin and metformin in tablet form or sitagliptin alone or sitagliptin in combination with other anti-diabetic medicines, the following side effects have occurred: Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or sore throat, and joint or muscle pain. Uncommon: dizziness, constipation, itching. Rare: decreased platelet count. Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin). In some patients taking metformin alone, the following side effects have occurred: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms may occur after starting metformin and usually disappear. Common: metallic taste. Very rare: decreased vitamin B12 levels, liver inflammation (liver disease), hives, skin redness (rash), or itching.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Metformax Combi

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Metformax Combi contains

• The active substances of the medicine are sitagliptin and metformin hydrochloride.
• Each Metformax Combi, 50 mg + 850 mg film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 850 mg of metformin hydrochloride.
• Each Metformax Combi, 50 mg + 1000 mg film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride.
• Other ingredients are: Tablet core: microcrystalline cellulose (type 102), povidone (K29/32), sodium lauryl sulfate, and magnesium stearate (Ph.Eur) [of vegetable origin] (E470b) (see section 2, "Metformax Combi contains sodium").

Coating Opadry QX Pink (321A640002) for Metformax Combi, 50 mg + 850 mg tablet contains: copolymer of methacrylic acid and acrylic acid methyl ester (E 1209), talc (E 553b), titanium dioxide (E 171), glycerol monocaprylocaprate (E 471), polyvinyl alcohol (E 1203), iron oxide red (E 172). Coating Opadry QX Brown (321A265038) for Metformax Combi, 50 mg + 1000 mg tablet contains: copolymer of methacrylic acid and acrylic acid methyl ester (E 1209), talc (E 553b), titanium dioxide (E 171), iron oxide red (E 172), glycerol monocaprylocaprate (E 471), polyvinyl alcohol (E 1203), iron oxide black (E 172).

What Metformax Combi looks like and contents of the pack

Metformax Combi, 50 mg + 850 mg are oval, biconvex, film-coated tablets, approximately 20.5 mm x 9.5 mm in size, pink, with "S476" embossed on one side. Metformax Combi, 50 mg + 1000 mg are oval, biconvex, film-coated tablets, approximately 21.5 mm x 10.0 mm in size, brown, with "S477" embossed on one side. PVC/PVDC/Aluminum blisters in a cardboard box: Pack sizes: 30, 60, 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. 22 345 93 00, (logo of the marketing authorization holder).

Manufacturer

Laboratorios Liconsa S.A., Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares, Guadalajara, Spain.

Date of last revision of the leaflet: May 2025