Metformax Sr 750

Leaflet accompanying the packaging: patient information

Metformax SR 750, 750 mg, prolonged-release tablets

Metformax SR 1000, 1000 mg, prolonged-release tablets

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 or pharmacist.
• 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Metformax SR 750 and Metformax SR 1000 are and what they are used for
• 2. Important information before taking Metformax SR 750 and Metformax SR 1000
• 3. How to take Metformax SR 750 and Metformax SR 1000
• 4. Possible side effects
• 5. How to store Metformax SR 750 and Metformax SR 1000
• 6. Contents of the packaging and other information

1. What Metformax SR 750 and Metformax SR 1000 are and what they are used for

Metformax SR 750 and Metformax SR 1000, prolonged-release tablets, contain metformin hydrochloride as the active substance and belong to a group of medicines called biguanides, used to treat type 2 diabetes (non-insulin-dependent diabetes). Metformax SR 750 and Metformax SR 1000 are used to treat type 2 diabetes when diet and physical exercise alone are not enough to control blood sugar levels. Insulin is a hormone that allows the body to take up glucose and use it for energy or store it for future use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced properly. This leads to high blood sugar levels, which can cause a number of serious long-term problems, so it is essential to continue taking the medicine, even if no symptoms are present. Metformax SR 750 and Metformax SR 1000 increase the body's sensitivity to insulin and help restore normal glucose use.

Taking Metformax SR 750 and Metformax SR 1000 is associated with maintaining or moderately reducing body weight.

Metformax SR 750 and Metformax SR 1000 are prolonged-release tablets that are specially designed to release the medicine slowly in the body and therefore differ from many other types of metformin tablets.

2. Important information before taking Metformax SR 750 and Metformax SR 1000

When not to take Metformax SR 750 and Metformax SR 1000

Warnings and precautions

Before taking Metformax SR 750 or Metformax SR 1000, consult your doctor.

Risk of lactic acidosis

Metformax SR 750 and Metformax SR 1000may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver function disorders, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease).

If any of the above conditions apply to the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Metformax SR 750 or Metformax SR 1000 if they experience a condition that may lead to dehydration

(excessive water loss 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 their doctor for more detailed instructions.

The patient should stop taking Metformax SR 750 or Metformax SR 1000 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, accompanied by extreme 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 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 encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• the patient experiences any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, symptoms of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If the patient is to undergo a major surgical procedure, they should not take Metformax SR 750 or Metformax SR 1000 during the procedure and for some time after it. The doctor will decide when the patient should stop and resume treatment with Metformax SR 750 or Metformax SR 1000.

Metformin used as the only medicine does not cause hypoglycemia (low blood sugar). However, if taken in combination with other anti-diabetic medicines (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur (such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating), the patient should eat or drink something that contains sugar.

During treatment with Metformax SR 750 or Metformax SR 1000, 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 impaired kidney function.

It may happen that the tablet coating is visible in the stool. The patient should not be concerned, as this is normal when taking this type of tablet.

The patient should follow the dietary recommendations given by their doctor and eat carbohydrates regularly throughout the day.

The patient should not stop taking this medicine without consulting their doctor.

Children and adolescents

Metformax SR 750 or Metformax SR 1000 should not be used in children and adolescents.

It is not known whether this medicine is safe and effective in children and adolescents under 18 years of age.

Metformax SR 750 and Metformax SR 1000 with 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 750 or Metformax SR 1000 before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Metformax SR 750 or Metformax SR 1000.

The patient should tell their doctor 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 750 or Metformax SR 1000 by their doctor. It is especially important to inform about the following medicines:

• diuretics (e.g., furosemide),
• medicines used to treat pain and inflammation [non-steroidal anti-inflammatory drugs (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),
• steroids, such as prednisolone, mometasone, beclometasone,
• sympathomimetic medicines, including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also part of some dental anesthetics.
• medicines that may change the levels of Metformax SR 750 or Metformax SR 1000 in the blood, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Metformax SR 750 and Metformax SR 1000 with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metformax SR 750 or Metformax SR 1000, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor to discuss any necessary changes in treatment or blood sugar monitoring.

Metformax SR 750 or Metformax SR 1000 should not be used during breastfeeding.

Before taking this medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Metformax SR 750 or Metformax SR 1000 taken as the only anti-diabetic medicine does not cause hypoglycemia (symptoms of low blood sugar or hypoglycemia, such as fainting, confusion, and excessive sweating), and therefore should not affect the ability to drive or operate machines.

However, if Metformax SR 750 or Metformax SR 1000 is taken in combination with other anti-diabetic medicines that may cause a risk of low blood sugar, the patient should be cautious when driving or operating machines.

Metformax SR 750 and Metformax SR 1000 contain 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 SR 750 and Metformax SR 1000

The doctor may prescribe Metformax SR 750 or Metformax SR 1000 as the only anti-diabetic medicine or in combination with other oral anti-diabetic medicines or insulin.

The medicine should always be taken according to the doctor's instructions.

In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

Treatment usually starts with one prolonged-release tablet containing 500 mg of metformin taken once a day. After about 2 weeks, based on blood sugar measurements, the doctor may adjust the dose. The maximum daily dose of metformin in prolonged-release tablets is 2000 mg.

If the patient has impaired kidney function, the doctor may prescribe a lower dose.

How to take the tablets

The tablets are usually taken once a day with the evening meal.

In some cases, the doctor may recommend taking the tablets twice a day. The tablets should always be taken with a meal.

The tablets should be swallowed whole with a glass of water, without chewing, breaking, or crushing them.

Taking a higher dose of Metformax SR 750 or Metformax SR 1000 than recommended

If the patient accidentally takes extra tablets, they should not be concerned, but if unusual symptoms occur, they should contact their doctor. If the overdose is large, it is more likely that lactic acidosis will occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), general feeling of being unwell, accompanied by extreme fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should seek medical help immediately, as lactic acidosis can lead to coma. The patient should stop taking Metformax SR 750 or Metformax SR 1000 and contact their doctor or go to the nearest hospital.

Missing a dose of Metformax SR 750 or Metformax SR 1000

The missed tablet should be taken as soon as the patient remembers. The tablet should be taken with a meal. The patient should not take a double dose to make up for the missed dose.

If the patient has further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformax SR 750 and Metformax SR 1000 can cause side effects, although not everybody gets them.

The following side effects may occur:

Metformax SR 750 and Metformax SR 1000 may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Metformax SR 750 or Metformax SR 1000 and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.

Metformax SR 750 and Metformax SR 1000 may cause changes in liver function test results and hepatitis, which can cause jaundice (may affect up to 1 in 10,000 people). If the patient experiences yellowing of the eyes and/or skin, they should contact their doctor immediately.

Other possible side effects are listed below by frequency of occurrence:

Very common: may affect more than 1 in 10 people

• Diarrhea, nausea, vomiting, abdominal pain, loss of appetite. If these symptoms occur, the patient should not stop taking the tablets, as they usually disappear after about 2 weeks. It may be helpful to take the tablets with a meal or immediately after a meal.

Common: may affect up to 1 in 10 people

• Taste disturbances
• Decreased or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pale or yellowish skin). The doctor may order several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Very rare: may affect up to 1 in 10,000 people

• Skin rash, including redness, itching, and hives.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.

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, 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 750 and Metformax SR 1000

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiration date, which is stated on the blister and carton after the abbreviation "EXP". The expiration date refers to the last day of the specified month.

There are no special precautions for storage.

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 750 and Metformax SR 1000 contain

• The active substance of the medicine is metformin hydrochloride. Each prolonged-release tablet contains 750 mg or 1000 mg of metformin hydrochloride, which corresponds to 585 mg or 780 mg of metformin, respectively.
• Other ingredients of the medicine are: magnesium stearate, colloidal silicon dioxide, sodium carmellose, and hypromellose.

What Metformax SR 750 and Metformax SR 1000 look like and contents of the pack:

Metformax SR 750, prolonged-release tablets, are white or almost white capsule-shaped tablets, 19.6 mm long, 9.3 mm wide, and 6.9 mm thick, with the inscription "SR 750" on one side and smooth on the other.

Metformax SR 1000, prolonged-release tablets, are white or almost white oval tablets, 22.0 mm long, 10.5 mm wide, and 8.9 mm thick, with the inscription "SR 1000" on one side and smooth on the other.

The tablets are available in blisters in a cardboard box containing 30 or 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer/Importer

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków

Poland

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State

Marketing authorization holder

Czech Republic

Metformin Teva XR

Hungary

Adimet XR 500 mg retard tabletta

Adimet XR 750 mg retard tabletta

Adimet XR 1000 mg retard tabletta

Poland

Metformax SR 750

Metformax SR 1000

Slovakia

Metformin Teva XR 500 mg

Metformin Teva XR 750 mg

Metformin Teva XR 1000 mg

United Kingdom (Northern Ireland)

Metformin Teva SR 500 mg, 750 mg & 1000 mg Prolonged-release Tablets

Date of last revision of the leaflet: March 2025