METFORMAX 500 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Metformax SR 500, 500 mg, prolonged-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient
   2. Table of contents of the leaflet
3. What is Metformax SR 500 and what is it used for
4. Important information before taking Metformax SR 500
   1. When not to take Metformax SR 500
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. The patient should temporarily stop taking Metformax SR 500 if they experience
   5. The patient should stop taking Metformax SR 500 and immediately contact their doctor or the nearest hospital if they experience any symptoms of
   6. Children and adolescents
   7. Metformax SR 500 and other medicines
   8. Metformax SR 500 and alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
5. How to take Metformax SR 500
   1. Recommended dosage
   2. Information for patients taking Metformax SR 500 alone or in combination with other oral anti-diabetic medicines:
   3. Information for patients already taking metformin and switching to Metformax SR 500:
   4. Information for patients taking Metformax SR 500 in combination with insulin:
   5. Treatment monitoring
   6. How to take Metformax SR 500
   7. Taking a higher dose of Metformax SR 500 than recommended
   8. Missing a dose of Metformax SR 500
6. Possible side effects
   1. Metformax SR 500 and reporting side effects
   2. Reporting side effects
7. How to store Metformax SR 500
8. Contents of the packaging and other information
   1. What Metformax SR 500 contains
   2. What Metformax SR 500 looks like and what the packaging contains:
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
   7. Date of last revision of the leaflet: December 2023

Leaflet accompanying the packaging: patient information

Metformax SR 500, 500 mg, prolonged-release tablets

metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• 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 is Metformax SR 500 and what is it used for
• 2. Important information before taking Metformax SR 500
• 3. How to take Metformax SR 500
• 4. Possible side effects
• 5. How to store Metformax SR 500
• 6. Contents of the packaging and other information

1. What is Metformax SR 500 and what is it used for

Metformax SR 500 contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to take glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the produced insulin properly. This leads to an excessive increase in blood glucose levels. Metformax SR 500 helps reduce blood glucose levels to values as close to normal as possible.
In adults with overweight, long-term use of Metformax SR 500 also reduces the risk of complications associated with diabetes. Taking Metformax SR 500 is associated with maintaining body weight or moderate weight loss.
Metformax SR 500 is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes), when diet and physical exercise are not sufficient to achieve control over normal blood glucose levels. It is used especially in patients with overweight.
Adults can take Metformax SR 500 as the only medicine or in combination with other anti-diabetic medicines (oral medicines or insulin).

2. Important information before taking Metformax SR 500

When not to take Metformax SR 500

• If the patient is allergic to metformin hydrochloride or any of the other ingredients of the medicine (listed in section 6).
• If the patient has liver disease.
• If the patient has significantly reduced kidney function.
• If the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketonuria. Ketonuria 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 unusual fruity breath odor.
• In case of excessive water loss from the body (dehydration), e.g. due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below),
• In case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below),
• In case of treatment of acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. This can cause tissue hypoxia, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below),
• If the patient consumes large amounts of alcohol.
• If the patient is under 18 years old.

If any of the above situations occur, the patient should consult a doctor before taking this medicine.

Warnings and precautions

Before starting treatment with Metformax SR 500, the patient should discuss it with their doctor or pharmacist.

Risk of lactic acidosis

Metformax SR 500 may 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 sufficiently supplied with oxygen (e.g. acute severe heart disease).
If any of the above circumstances apply to the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Metformax SR 500 if they experience

a condition that may be associated with dehydration(excessive water loss from the body), such as severe vomiting, diarrhea, fever, exposure to 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 500 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 poor condition with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
If the patient is to undergo a major surgical procedure, they should not take Metformax SR 500 during the procedure and for some time after it. The doctor will decide when the patient should stop and resume treatment with Metformax SR 500.
Metformax SR 500 does not cause hypoglycemia (low blood glucose).
However, if Metformax SR 500 is taken in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heart rate, vision disturbances or concentration difficulties, eating or drinking a sugary drink usually helps.
During treatment with Metformax SR 500, 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 impaired kidney function.

Children and adolescents

Metformax SR 500 should not be used in children and adolescents.

Metformax SR 500 and other medicines

If the patient is to be injected with a contrast agent containing iodine, e.g. for an X-ray examination or computed tomography, they should stop taking Metformax SR 500 before or at the latest at the time of the injection.
The doctor will decide when the patient should stop and resume treatment with Metformax SR 500.
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 glucose checks and kidney function assessments or dose adjustments of Metformax SR 500 by the doctor. It is especially important to inform about the following medicines:

• 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).
• beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma),
• corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma),
• medicines that may change metformin levels 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 500 and alcohol

• The patient should avoid consuming excessive amounts of alcohol while taking Metformax SR 500, 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, as changes in treatment or blood glucose monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Metformax SR 500 does not cause hypoglycemia (low blood glucose). This means that it does not affect the patient's ability to drive or use machines.
However, the patient should be careful if they take Metformax SR 500 with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heart rate, vision disturbances or concentration difficulties. If such symptoms occur, the patient should not drive or operate machinery.

3. How to take Metformax SR 500

This medicine should always be taken according to the doctor's or pharmacist's instructions. If the patient has any doubts, they should consult their doctor or pharmacist. Metformax SR 500 does not replace the benefits of a healthy lifestyle. The patient should continue to follow their doctor's recommendations regarding diet and regular physical activity.

Recommended dosage

Information for patients taking Metformax SR 500 alone or in combination with other oral anti-diabetic medicines:

The recommended initial dose is one tablet per day. After 10 to 15 days, the dose should be adjusted based on blood glucose levels. The doctor may increase the dose to a maximum of 2000 mg of metformin hydrochloride per day (four Metformax SR 500 tablets per day).

Information for patients already taking metformin and switching to Metformax SR 500:

The recommended initial dose of Metformax SR 500 should be equal to the daily dose of metformin in immediate-release tablets.

Information for patients taking Metformax SR 500 in combination with insulin:

When Metformax SR 500 is taken in combination with insulin, the recommended initial dose is one tablet per day, while the insulin dose is adjusted based on blood glucose levels.

Treatment monitoring

• The doctor will prescribe regular blood glucose tests and adjust the dose of Metformax SR 500 based on blood glucose levels. The patient should regularly visit their doctor for check-ups. This is especially important for elderly patients.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary for elderly patients or those with impaired kidney function.

How to take Metformax SR 500

Metformax SR 500 should be taken with a meal or immediately after an evening meal.
The tablets should be swallowed whole with water. The prolonged-release tablet is a type of tablet that releases the medicine over a longer period than an immediate-release tablet.
Sometimes, the tablet coating may be present in the stool. This is a normal situation. If the patient has any additional questions, they should consult their doctor or pharmacist.

Taking a higher dose of Metformax SR 500 than recommended

If a higher dose of Metformax SR 500 is taken than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general poor condition with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical attention, as lactic acidosis can lead to coma.
The patient should stop taking Metformax SR 500 and contact their doctor or the nearest hospital immediately.

Missing a dose of Metformax SR 500

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.
If the patient has any doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformax SR 500 can cause side effects, although not everybody gets them.
The following side effect is very serious and if it occurs, the patient should immediately contact their doctor or the nearest hospital:
Very rare (may occur less often than in 1 in 10,000 people)

• Metformax SR 500 may very rarely cause a very serious side effect called lactic acidosis, especially if the kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions"). If this occurs, the patient should stop taking Metformax SR 500 and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.

The following other side effects may occur :
Very common (may occur more often than in 1 in 10 people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, loss of appetite. These side effects usually occur at the beginning of treatment with Metformax SR 500. Taking Metformax SR 500 with a meal or immediately after a meal may help. If the symptoms do not disappear, the patient should stop taking Metformax SR 500 and tell their doctor.

Common (may occur less often than in 1 in 10 people)

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

Very rare (may occur less often than in 1 in 10,000 people)

• Abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite and weight loss, as well as with or without yellowing of the skin and whites of the eyes). If such symptoms occur, the patient should stop taking Metformax SR 500 and tell their doctor.

Metformax SR 500 and reporting side effects

• Skin reactions, such as redness, itching or itchy rash.

Reporting side effects

If the patient experiences any side effects, including those 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, Poland, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Metformax SR 500

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date, which is stated on the blisters and outer packaging after "EXP" or "Expiry date". The expiry date refers to the last day of the given 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 500 contains

• The active substance of the medicine is metformin hydrochloride. Each prolonged-release tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
• Other ingredients of the medicine are: hypromellose (E454), ethylcellulose, microcrystalline cellulose and magnesium stearate.

What Metformax SR 500 looks like and what the packaging contains:

• Metformax SR 500 is an oval, white or almost white tablet, with the number "93" embossed on one side and "7267" on the other side.
• The tablets are available in packages containing 30, 60, 90 or 120 tablets.

Not all pack sizes are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw, Poland

Manufacturer

Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, Netherlands
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland Sp. z o.o.,ul. Mogilska 80, 31-546 Kraków, Poland

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

Date of last revision of the leaflet: December 2023