Metformax Sr Combi

Leaflet accompanying the packaging: patient information

Metformax SR Combi, 50 mg + 500 mg, tablets with modified release

Metformax SR Combi, 50 mg + 1000 mg, tablets with modified release

Metformax SR Combi, 100 mg + 1000 mg, tablets with modified release

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.
• If you have any doubts, you should consult a 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 as yours.
• 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 SR Combi and what is it used for
• 2. Important information before taking Metformax SR Combi
• 3. How to take Metformax SR Combi
• 4. Possible side effects
• 5. How to store Metformax SR Combi
• 6. Contents of the packaging and other information

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

Metformax SR 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 reduce the amount of sugar produced by the body. The medicine is used in combination with diet and exercise to reduce blood sugar levels. This medicine can be used alone 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 diseases, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Metformax SR Combi

When not to take Metformax SR Combi:

• if the patient is allergic to sitagliptin or metformin, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, or lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.

Metformax SR 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 also increases in case 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 their doctor for more detailed instructions.

Warnings and precautions

In patients taking Metformax SR Combi, cases of pancreatitis (see section 4) have been reported. If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid. The doctor may advise the patient to stop taking Metformax SR Combi.

Risk of lactic acidosis

Metformax SR 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 also increases in case 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 their doctor for more detailed instructions.

The patient should temporarily stop taking Metformax SR Combi if they have 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.

The patient should stop taking Metformax SR Combi and immediately contact their doctor or the nearest hospital if they experience 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.

The patient should contact their doctor for further instructions if:

• they have 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).

Before taking Metformax SR Combi, the patient should discuss it with their doctor or pharmacist:

• if the patient has or has had pancreatitis (inflammation of the pancreas).
• if the patient has or has had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these situations, the risk of pancreatitis (see section 4) may increase.
• if the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if the patient has currently or has had allergic reactions to sitagliptin, metformin, or Metformax SR Combi (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Metformax SR Combi, as it may lead to excessively low blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin. If the patient is to undergo major surgery, they should not take Metformax SR Combi during the surgery and for some time after it. The doctor will decide when the patient should stop and restart Metformax SR Combi treatment.

In case of doubts about whether any of the above applies to the patient, they should discuss it with their doctor or pharmacist before taking Metformax SR Combi. During treatment with Metformax SR Combi, the doctor will check 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 in children under 10 years of age.

Metformax SR 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 SR Combi before or at the latest at the time of the injection. The doctor will decide when the patient should stop and restart Metformax SR Combi treatment. 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 SR 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 pectoris,
• 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 diseases). When taking Metformax SR Combi with digoxin, the patient's digoxin levels should be monitored.

Metformax SR Combi and alcohol

The patient should avoid excessive alcohol consumption while taking Metformax SR Combi, as it 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 taken during pregnancy or breastfeeding. See section 2, When not to take Metformax SR 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 a sulfonylurea derivative or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.

Metformax SR Combi contains sodium

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

3. How to take Metformax SR Combi

This medicine should always be taken exactly as the doctor has instructed. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will inform the patient about the dose of Metformax SR Combi they should take and when to take it. The maximum daily dose is 100 mg of sitagliptin and 2000 mg of metformin. Usually, the patient should take the tablets once a day with their evening meal. In some cases, the doctor may recommend taking the tablets twice a day. The tablets should always be taken with a meal to reduce the risk of stomach upset. The tablets should be swallowed whole, with a glass of water, without chewing. To control blood sugar levels, the doctor may increase the dose of the medicine. If the patient has reduced kidney function, the doctor may prescribe a lower dose. During treatment with this medicine, the patient should continue to follow the diet recommended by their 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). Low blood sugar levels may occur when taking this medicine with a sulfonylurea derivative or insulin - in this case, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Metformax SR 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 they experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Metformax SR 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 to make up for the missed dose.

Stopping treatment with Metformax SR Combi

To maintain control of blood sugar levels, the patient should take the medicine for as long as the doctor recommends. The patient should not stop taking this medicine without consulting their doctor first. Stopping treatment with Metformax SR Combi may cause blood sugar levels to rise again. 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 STOPtaking Metformax SR 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, as these may be symptoms of pancreatitis. Metformax SR Combi may very rarely cause (less than 1 in 10,000) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to the patient, they should stop taking Metformax SR 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, cannot be estimated from the available data), including rash, hives, blisters on the skin, and (or) peeling of the skin, as well as 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 to treat diabetes. In some patients taking metformin after starting sitagliptin, the following side effects have occurred: Common (may affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness Some patients have experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting sitagliptin treatment in combination with metformin (common). Some patients have experienced the following side effects when taking this medicine in combination with a sulfonylurea derivative, such as glimepiride: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation Some patients have experienced the following side effects when taking this medicine in combination with pioglitazone: Common: swelling of the hands or feet Some patients have experienced the following side effects when taking this medicine in combination with insulin: Very common: low blood sugar Uncommon: dry mouth, headache In clinical trials, some patients have experienced the following side effects when taking sitagliptin (one of the active substances of Metformax SR Combi) alone or in combination with other anti-diabetic medicines: Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose, and sore throat Uncommon: dizziness, constipation, itching Rare: reduced platelet count Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid (a type of blistering skin disease) Some patients have experienced the following side effects when taking metformin alone: Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur after starting metformin treatment and usually disappear. Common: metallic taste, reduced or low levels of vitamin B in the blood (symptoms may include extreme fatigue), tongue pain or redness (glossitis), feeling of tingling (paresthesia), or pale or yellowish skin discoloration. The doctor may order certain tests to identify the cause of the symptoms, as some of them may also be caused by diabetes or other health problems unrelated to treatment. Very rare: liver inflammation (liver disease), hives, skin redness (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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the 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 SR 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. There are no special precautions for storing the medicine. 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 SR Combi contains

The active substances of the medicine are sitagliptin and metformin. Metformax SR Combi, 50 mg + 500 mg: Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin, and 500 mg of metformin hydrochloride. Metformax SR Combi, 50 mg + 1000 mg: Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride. Metformax SR Combi, 100 mg + 1000 mg: Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of sitagliptin, and 1000 mg of metformin hydrochloride. The other ingredients are:

• the prolonged-release layer containing metformin: hypromellose K100M CR, hypromellose E50, magnesium stearate
• the immediate-release layer containing sitagliptin: calcium phosphate, microcrystalline cellulose, sodium stearyl fumarate, croscarmellose sodium (see section 2 "Metformax SR Combi contains sodium").

In addition, the tablet coating contains: Metformax SR Combi, 100 mg + 1000 mg and 50 mg + 500 mg (Opadry II orange): polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), red iron oxide (E172) Metformax SR Combi, 50 mg + 1000 mg (Opadry II white): polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc

What Metformax SR Combi looks like and contents of the pack

Metformax SR Combi, 50 mg + 500 mg: orange, oval, biconvex, film-coated tablets, 17.2 mm x 8.4 mm in size. Metformax SR Combi, 50 mg + 1000 mg: white, oval, biconvex, film-coated tablets with "50" engraved on one side and "1000" on the other, 22.2 mm x 10.8 mm in size. Metformax SR Combi, 100 mg + 1000 mg: orange, oval, biconvex, film-coated tablets with "100" engraved on one side and "1000" on the other, 22.2 mm x 10.8 mm in size. Blisters of PVC/PVDC/Aluminum in a carton. Packs of 14, 28, 30, 56, 60, 98, 112, 180, or 200 modified-release 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

Manufacturer

Adamed Pharma S.A. ul. Marszałka Józefa Piłsudskiego 5 95-200 Pabianice Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany

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

Austria: Sitagliptin/Metformin ratiopharm Bulgaria: Метформакс XR Комби Croatia: Gluformin Combi Czech Republic: Sitagliptin/Metformin Teva CR Spain: Estequen Luxembourg: Sitagliptin/Metformin-ratiopharm Germany: Sitagliptin/Metformin-ratiopharm Poland: Metformax SR Combi Portugal: Simedur Slovakia: Sitagliptin/Metformin XR Teva

Date of last revision of the leaflet: April 2025