METFORMAX 50 mg/1000 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Metformax Combi, 50 mg + 850 mg, film-coated tablets
3. Metformax Combi, 50 mg + 1000 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Metformax Combi and what is it used for
5. Important information before taking Metformax Combi
   1. When not to take Metformax Combi:
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. Temporary discontinuation of Metformax Combi is recommended if the patient has a condition that may lead to dehydration
   5. Discontinue Metformax Combi and immediately contact a doctor or the nearest hospital if the patient experiences any symptoms of lactic acidosis
   6. Consult a doctor immediately for further instructions if:
   7. Children and adolescents
   8. Metformax Combi and other medicines
   9. Metformax Combi and alcohol
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Metformax Combi contains sodium
6. How to take Metformax Combi
   1. Taking a higher dose of Metformax Combi than recommended
   2. Missing a dose of Metformax Combi
   3. Stopping Metformax Combi treatment
7. Possible side effects
   1. Reporting side effects
8. How to store Metformax Combi
9. Contents of the packaging and other information
   1. What Metformax Combi contains
   2. What Metformax Combi looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: May 2025

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 achieve a higher concentration of insulin released after a meal and reduces the amount of sugar produced by the body. The medicine is used in combination with diet and physical exercise to help reduce blood sugar levels. This medicine may 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 a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Metformax Combi, discuss it with a 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 problems, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of the above situations apply to the patient, they should consult a doctor for more detailed instructions.

Temporary discontinuation of Metformax Combi is recommended if the patient has a condition that may lead to dehydration

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

Discontinue 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, accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

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

Consult a doctor immediately 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, worsening of cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss. Before starting Metformax Combi, discuss this with a 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 doubts, 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 frequently if the patient is elderly and/or has worsening kidney function.

Children and adolescents

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

Metformax Combi and other medicines

If the patient is to receive an intravenous 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 such administration. 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 glucose monitoring 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),
• 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 monitored.

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 a 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 and 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 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 doubts, the patient should consult a doctor or pharmacist.

• The patient should 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 the uniform intake of carbohydrates throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Hypoglycemia 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 a 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 Metformax Combi treatment

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 a doctor first. Stopping Metformax Combi treatment may lead to increased blood sugar levels. In case of any further doubts about taking this medicine, the patient should consult a 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 a 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 a 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 of the 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 a doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. Some patients taking metformin after starting sitagliptin experienced the following side effects: 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 Some patients experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting sitagliptin treatment in combination with metformin (common). Some patients taking this medicine in combination with a sulfonylurea derivative, such as glimepiride, experienced the following side effects: Very common (may occur in more than 1 in 10 patients): low blood sugar Common: constipation Some patients taking this medicine in combination with pioglitazone experienced the following side effects: Common: swelling of the hands or feet Some patients taking this medicine in combination with insulin experienced the following side effects: Very common: low blood sugar Uncommon: dry mouth, headache In clinical trials, 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 experienced the following side effects: 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) Some patients taking metformin alone experienced the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste Very rare: decreased vitamin B12 levels, liver inflammation (liver disease), hives, skin rash, or itching

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they 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 film-coated tablet of Metformax Combi, 50 mg + 850 mg, contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 850 mg of metformin hydrochloride.
• Each film-coated tablet of Metformax Combi, 50 mg + 1000 mg, 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 plant origin] (E470b) (see section 2 "Metformax Combi contains sodium").

Coating Opadry QX Pink (321A640002) for Metformax Combi, 50 mg + 850 mg, contains: copolymer of methacrylic acid and acrylic acid (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, contains: copolymer of methacrylic acid and acrylic acid (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 the imprint "S476" 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 the imprint "S477" 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