Metformax Sr Combi

Leaflet accompanying the packaging: patient information

Metformax SR Combi, 50 mg + 500 mg, prolonged-release tablets

Metformax SR Combi, 50 mg + 1000 mg, prolonged-release tablets

Metformax SR Combi, 100 mg + 1000 mg, prolonged-release tablets

Sitagliptin + Metformin hydrochloride

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 pack 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 a type of diabetes known as "type 2 diabetes". This medicine helps to achieve higher insulin levels after meals and reduces the amount of sugar produced by the body. When taken in combination with diet and exercise, this medicine helps to lower blood sugar levels. This medicine can be used alone or in combination with certain other anti-diabetic medicines (insulin, sulfonylureas, 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, loss of vision, and limb amputation.

2. Important information before taking Metformax SR Combi

When not to take Metformax SR Combi:

• if you are allergic to sitagliptin or metformin, or any of the other ingredients of this medicine (listed in section 6),
• if you have significantly reduced kidney function,
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar levels), 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.

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

Warnings and precautions

In patients taking Metformax SR Combi, cases of pancreatitis (see section 4) have been reported.
If you experience blisters on your skin, it may be a sign of a disease called pemphigoid blisters. Your doctor may advise you 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 you have kidney problems. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more detailed 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 you, consult your doctor for more detailed instructions.

You should temporarily stop taking Metformax SR Combi if you have a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. Consult your doctor for more detailed instructions.

You should stop taking Metformax SR Combi and immediately contact your doctor or the nearest hospital if you experience any symptoms of lactic acidosis

as it can lead to coma.
Symptoms of lactic acidosis include:

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

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

You should contact your doctor immediately for further instructions if:

• you 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).

• you experience any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before taking Metformax SR Combi, discuss it with your doctor or pharmacist:

• if you have or have had pancreatic disease (such as pancreatitis).
• if you have or have had gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase.
• if you have type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if you have currently or in the past experienced allergic reactions to sitagliptin, metformin, or Metformax SR Combi (see section 4).
• if you are taking a sulfonylurea or insulin, anti-diabetic medicines, at the same time as Metformax SR Combi, as it may lead to excessively low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin. If you are to undergo major surgery, you should not take Metformax SR Combi during the surgery and for some time after it. Your doctor will decide when you should stop and restart treatment with Metformax SR Combi.

In case of doubt, whether any of the above statements apply to you, before taking Metformax SR Combi, discuss it with your doctor or pharmacist.
During treatment with Metformax SR Combi, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have worsening 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 SR Combi and other medicines

If you are to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, you should stop taking Metformax SR Combi before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Metformax SR Combi.
Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. You may need more frequent blood glucose tests and kidney function tests or a dose adjustment of Metformax SR Combi by your 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 digoxin blood level should be monitored.

Metformax SR Combi and alcohol

You 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or while 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, you should take into account that dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect the ability to drive and use machines.
Taking this medicine with a sulfonylurea 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

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Metformax SR Combi

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will tell you how many tablets of Metformax SR Combi to take and when to take them.
The maximum daily dose is 100 mg of sitagliptin and 2000 mg of metformin.
Usually, you should take the tablets once a day with your evening meal.
In some cases, your doctor may recommend taking the tablets twice a day.
Tablets should always be taken with food to reduce the risk of stomach upset.
Swallow the tablets whole with a glass of water; do not chew them.
To control blood sugar levels, your doctor may increase the dose of Metformax SR Combi.
If you have reduced kidney function, your doctor may prescribe a lower dose.
While taking this medicine, you should continue to follow the diet recommended by your doctor and pay attention to evenly distributing 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 or insulin - in such cases, your doctor may reduce the dose of the sulfonylurea or insulin.

Taking a higher dose of Metformax SR Combi than recommended

If you take more of this medicine than you should, contact your doctor immediately. You should go to the hospital if you 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

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Metformax SR Combi

To maintain control of blood sugar levels, you should take this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor. Stopping treatment with Metformax SR Combi may cause your blood sugar levels to rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should STOPtaking Metformax SR Combi and contact your doctor immediately if you 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 it may be a sign 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 you, you should stop taking Metformax SR Combi and contact your doctor or the nearest hospitalimmediately, 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, you should stop taking the medicine and contact your doctor immediately. Your 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:

• Frequently (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
• Less frequently (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness

In some patients, diarrhea, nausea, bloating, constipation, stomach pain, or vomiting have occurred after starting treatment with sitagliptin in combination with metformin (frequently).
In some patients taking this medicine in combination with a sulfonylurea, such as glimepiride, the following side effects have occurred:

• Very frequently (may affect more than 1 in 10 people): low blood sugar levels
• Frequently: constipation

In some patients taking this medicine in combination with pioglitazone, the following side effects have occurred:

• Frequently: swelling of the hands or feet

In some patients taking this medicine in combination with insulin, the following side effects have occurred:

• Very frequently: low blood sugar levels
• Less frequently: dry mouth, headache

In clinical trials, some patients taking sitagliptin (one of the active substances of Metformax SR Combi) alone or in combination with other anti-diabetic medicines, or Metformax SR Combi after it was made available, or sitagliptin alone, or with other medicines, have experienced the following side effects:

• Frequently: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, joint pain or pain in the arms or legs
• Less frequently: dizziness, constipation, itching
• Rarely: 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 frequently: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear.
• Frequently: metallic taste, decreased or low vitamin B levels in the blood (symptoms may include extreme fatigue), pain and redness of the tongue (glossitis), feeling of tingling (paresthesia), or pale or yellowish skin discoloration). Your 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 rarely: liver disease (liver disease), hives, skin redness (rash), or itching.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Metformax SR Combi

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 carton after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Metformax SR Combi contains

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

• prolonged-release layer containing metformin: hypromellose K100M CR, hypromellose E50, magnesium stearate
• 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:
o 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)
o 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, elongated, biconvex, film-coated tablets, 17.2 mm x 8.4 mm in size.
Metformax SR Combi, 50 mg + 1000 mg: white, elongated, biconvex, film-coated tablets with "50" embossed 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, elongated, biconvex, film-coated tablets with "100" embossed 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 prolonged-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
phone: (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