Metformax Sr 1000

Leaflet accompanying the packaging: patient information

Metformax SR 750, 750 mg, prolonged-release tablets

Metformax SR 1000, 1000 mg, prolonged-release tablets

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 that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Metformax SR 750 and Metformax SR 1000 and what is it 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 is Metformax SR 750 and Metformax SR 1000 and what is it 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 exercise alone have not been able 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 important to continue taking the medicine, even if you do not have any obvious symptoms. Metformax SR 750 and Metformax SR 1000 increase the body's sensitivity to insulin and help restore proper glucose use. Taking Metformax SR 750 and Metformax SR 1000 is associated with either maintaining body weight or moderate weight loss. The medicine Metformax SR 750 and Metformax SR 1000 is in the form of prolonged-release tablets, which 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

• if you are allergic to metformin or any of the other ingredients of the medicine (listed in section 6). An allergic reaction may cause a rash, itching, or difficulty breathing.
• if you have liver problems,
• if you have severely reduced kidney function,
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
• in case of excessive fluid loss from the body (dehydration). Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of severe infection, such as pneumonia, bronchitis, or kidney infection. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of treatment for acute heart failure or recent myocardial infarction, severe circulatory disorders, or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• if you abuse alcohol,
• if you are under 18 years old.

Warnings and precautions

You should talk to your doctor before taking Metformax SR 750 and Metformax SR 1000.

Risk of lactic acidosis

Metformax SR 750 and Metformax SR 1000can cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis 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 adequately supplied with oxygen (e.g., acute severe heart disease). If any of the above conditions apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking Metformax SR 750 or Metformax SR 1000 if you have a condition that may lead to dehydration

(significant fluid loss from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Metformax SR 750 or Metformax SR 1000 and contact your doctor or the nearest hospital immediately if you 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 with severe fatigue, difficulty breathing, decreased body temperature, and slowed heart rate. Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

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

If you are to undergo a major surgical procedure, you should not take Metformax SR 750 or Metformax SR 1000 during or after the procedure. Your doctor will decide when you should stop and resume treatment with Metformax SR 750 or Metformax SR 1000. Metformin used alone does not cause hypoglycemia (low blood sugar levels). However, if taken in combination with other antidiabetic medicines (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia (such as weakness, dizziness, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating), you should eat or drink something that contains sugar. During treatment with Metformax SR 750 or Metformax SR 1000, your doctor will monitor your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function. It may happen that the tablet coating is visible in the stool. You should not be concerned, as this is normal when taking this type of tablet. You should follow the dietary recommendations given by your doctor and eat carbohydrates regularly throughout the day. You should not stop taking this medicine without consulting your 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 when used in children and adolescents under 18 years of age.

Metformax SR 750 and Metformax SR 1000 with 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 750 or Metformax SR 1000 before or at the latest at the time of injection. Your doctor will decide when you should stop and resume treatment with Metformax SR 750 or Metformax SR 1000. You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks and kidney function tests or dose adjustments of Metformax SR 750 or Metformax SR 1000 by your doctor. It is especially important to inform your doctor 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 and Metformax SR 1000 in the blood, especially if you have reduced 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

You 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 you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor to determine if any changes are needed in your treatment or blood sugar monitoring. You should not take Metformax SR 750 or Metformax SR 1000 if you are breastfeeding. Before taking this medicine, you should consult your doctor or pharmacist.

Driving and using machines

Metformax SR 750 or Metformax SR 1000 taken alone as an antidiabetic medicine does not cause hypoglycemia (symptoms of low blood sugar levels or hypoglycemia, such as fainting, confusion, and excessive sweating), and therefore should not affect your ability to drive or operate machinery. However, if you take Metformax SR 750 or Metformax SR 1000 in combination with other antidiabetic medicines that can cause a risk of low blood sugar levels, you should be careful when driving or operating machinery.

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

Your doctor may prescribe Metformax SR 750 or Metformax SR 1000 alone or in combination with other oral antidiabetic medicines or insulin. You should always take the medicine as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.

Recommended dose

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

How to take the tablets

The tablets are usually taken once daily with the evening meal. In some cases, your doctor may recommend taking the tablets twice daily. The tablets should always be taken with food. The tablets should be swallowed whole with a glass of water, without chewing, breaking, or crushing the tablets.

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

If you accidentally take extra tablets, you should not be concerned, but if you experience unusual symptoms, you should contact your doctor. If the overdose is large, it is more likely to cause lactic acidosis. The symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), general feeling of being unwell with severe fatigue, and difficulty breathing. Other symptoms include decreased body temperature and slowed heart rate. If you experience any of these symptoms, you should seek medical help immediately, as lactic acidosis can lead to coma. You should stop taking Metformax SR 750 or Metformax SR 1000 and contact your doctor or the nearest hospital immediately.

Missing a dose of Metformax SR 750 or Metformax SR 1000

Missed tablets should be taken as soon as you remember. The tablet should be taken with food. You should not take a double dose to make up for the missed dose. If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 you experience it, you should stop taking Metformax SR 750 or Metformax SR 1000 and contact your doctor or the nearest hospital immediately, 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 you experience yellowing of the eyes and/or skin, you should contact your 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 you experience such symptoms, you should not stop taking the tablets, as these symptoms usually resolve after about 2 weeks. It may be helpful to take the tablets with food or immediately after food.

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 paresthesia, or pale or yellowish skin). Your 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 you experience any side effects, including those not listed in this leaflet, you should tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Metformax SR 750 and Metformax SR 1000

The medicine should be stored out of sight and reach of children. You should not use this medicine after the expiry date, which is stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. There are no special storage precautions. Medicines should not be disposed of via wastewater or household waste. You should ask your 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 silica, sodium carmellose, and hypromellose.

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

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
Medicinal product name
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