METFORMAX 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Metformax 500, 500 mg, tablets
   1. You should read the contents of the leaflet before using the medicine because it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Metformax 500 and what is it used for
   1. What is Metformax 500
   2. What is Metformax 500 used for
4. Important information before taking Metformax 500
   1. When not to take Metformax 500
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. The patient should contact their doctor immediately for further instructions if:
   5. The patient should temporarily stop taking Metformax 500 if they have
   6. The patient should stop taking Metformax 500 and contact their doctor or the nearest hospital immediately if they experience any of the symptoms of
   7. Metformax 500 and other medicines
   8. Metformax 500 and alcohol
   9. Pregnancy, breastfeeding, and fertility
   10. Driving and using machines
5. How to take Metformax 500
   1. How to take Metformax 500
   2. Taking a higher dose of Metformax 500 than recommended
   3. Missing a dose of Metformax 500
   4. Stopping treatment with Metformax 500
6. Possible side effects
7. How to store Metformax 500
8. Contents of the pack and other information
   1. What Metformax 500 contains
   2. What Metformax 500 looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: information for the user

Metformax 500, 500 mg, tablets

Metformin hydrochloride

You should read the contents of the leaflet before using the medicine because 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 to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Metformax 500 and what is it used for
• 2. Important information before taking Metformax 500
• 3. How to take Metformax 500
• 4. Possible side effects
• 5. How to store Metformax 500
• 6. Contents of the pack and other information

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

What is Metformax 500

Metformax 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 makes the body take in glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
If the patient has diabetes, the pancreas does not produce enough insulin or the body cannot use the insulin it produces properly. This leads to high blood sugar levels. Metformax 500 helps lower blood sugar levels to the most normal level possible.
If an adult patient has overweight, long-term use of Metformax 500 also helps reduce the risk of complications associated with diabetes.

What is Metformax 500 used for

Metformax 500 is used to treat patients with type 2 diabetes (also called "non-insulin-dependent diabetes") when diet and exercise alone have not achieved proper blood sugar control. It is used especially in patients with overweight.
Adult patients can take Metformax 500 alone or in combination with other oral anti-diabetic medicines (medicines taken orally or insulin).
Metformax 500 is used to treat impaired glucose tolerance (a pre-diabetic condition) when diet and exercise alone have not achieved proper blood sugar control.
Metformax 500 is used to treat polycystic ovary syndrome.

2. Important information before taking Metformax 500

When not to take Metformax 500

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient has uncontrolled diabetes, such as severe hyperglycemia or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called "ketone bodies" accumulate in the blood. Symptoms include rapid and deep breathing, weakness, abdominal pain, excessive thirst, and an unusual fruity odor from the mouth.
• Pre-coma state in diabetes.
• If the patient has lost too much water from the body (dehydration), e.g. due to prolonged or severe diarrhea or if the patient has vomited several times in a short period. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• If the patient has significantly reduced kidney function.
• If the patient has liver problems.
• If the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which 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.
• If the patient has a severe infection, such as pneumonia, respiratory or kidney infections. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• If the patient is taking medicines for heart failure, has recently had a heart attack, or has severe circulatory problems or breathing difficulties. This can lead to a lack of oxygen in the tissues, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• If the patient abuses alcohol.
• If the patient is breastfeeding.

If any of the above factors apply to the patient, they should consult a doctor before starting to take this medicine.
It is essential to consult a doctor if:

• The patient is to undergo an X-ray examination or an examination that requires the intravenous administration of a contrast agent containing iodine.
• The patient is to undergo surgery. The patient should stop taking Metformax 500 for a certain period before the examination or surgery and after it. The doctor will recommend alternative treatment if the patient's condition requires it. It is crucial to follow the doctor's instructions carefully.

Warnings and precautions

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

Risk of lactic acidosis

Metformax 500 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 increases in cases 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 circumstances apply to the patient, they should consult their doctor for more detailed instructions.

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 encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• The patient experiences any of the following symptoms after starting to take metformin: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or hearing loss.

The patient should temporarily stop taking Metformax 500 if they have

a condition that may be associated with dehydration(significant 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 500 and contact their doctor or the nearest hospital immediately if they experience any of the 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 along with extreme tiredness,
• 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 major surgery, they should not take Metformax 500 during and for some time after the surgery. The doctor will decide when the patient should stop and resume treatment with Metformax 500.
During treatment with Metformax 500, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has impaired kidney function.
During treatment with Metformax 500, the patient should continue to follow the dietary recommendations given by their doctor. The patient should have regular blood tests to assess changes in blood sugar levels.
If the patient experiences any infectious diseases, such as flu, respiratory or urinary tract infections, they should inform their doctor.
Treatment with Metformax 500 alone does not cause low blood sugar (hypoglycemia). However, when taking Metformax 500 in combination with other oral anti-diabetic medicines, hypoglycemia may occur (see the section "Driving and using machines"). In case of any of the above situations and in case of doubts about taking the medicine, the patient should consult their doctor.

Metformax 500 and other medicines

If the patient is to be given a contrast agent containing iodine intravenously, for example, for an X-ray examination or computed tomography, they should stop taking Metformax 500 before or at the latest at the time of such administration. The doctor will decide when the patient should stop and resume treatment with Metformax 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 monitoring of blood sugar levels and kidney function or modification of the Metformax 500 dose by the doctor. It is especially important to inform about the following medicines:

• beta-2-adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma),
• corticosteroids (used to treat a range of conditions, such as severe skin infections or asthma),
• diuretics (medicines that increase urine production),
• 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).

Metformax 500 and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metformax 500, as this may increase the risk of lactic acidosis (see "Warnings and precautions").
It is recommended to take the medicine during or immediately after a meal, as this will help avoid gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
In case of planned pregnancy, the patient should consult their doctor. During pregnancy, diabetes should be treated with insulin. If the patient becomes pregnant or plans to become pregnant while taking Metformax 500, they should consult their doctor so that the doctor can implement alternative therapy.
Breastfeeding
Metformax 500 should not be taken during breastfeeding.
Fertility
Animal studies have not shown any effect of metformin on fertility.

Driving and using machines

Metformax 500 does not cause hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or use machines. However, Metformax 500 taken in combination with other anti-diabetic medicines (sulfonylurea derivatives, insulin, repaglinide, or other medicines that lower blood sugar) may cause hypoglycemia and impair physical and mental performance. Symptoms of hypoglycemia include fainting, confusion, excessive sweating, rapid heartbeat, headaches, dizziness, or difficulty concentrating.
The patient should not drive or use machines if they experience any of the above symptoms.

3. How to take Metformax 500

Metformax 500 should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.
Metformax 500 will not replace the benefits of a healthy lifestyle. The patient should follow the doctor's dietary recommendations and exercise regularly.
Usual dose
In diabetes
Adults:
The usual initial dose is one 500 mg or 850 mg metformin tablet, taken two or three times a day. The maximum dose of metformin is 3000 mg per day, given in 3 divided doses.
Elderly patients:
Due to the risk of kidney problems in elderly patients, the dose of metformin hydrochloride should be determined by the doctor based on kidney function parameters.
If the patient is also taking insulin, the doctor will inform them how to start taking Metformax 500.
In pre-diabetic condition
Metformax 500 is usually taken in a dose of 500 mg (1 tablet) twice a day.
In polycystic ovary syndrome
The usual dose is 500 mg (1 Metformax 500 tablet) three times a day or 850 mg (1 Metformax 850 tablet) twice a day.
Information for patients with impaired kidney function
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
Monitoring

• The doctor will adjust the dose of Metformax 500 according to the patient's blood sugar levels. The patient should regularly contact their doctor. This is especially important in elderly patients.
• The doctor will also check the patient's kidney function at least once a year. More frequent tests may be necessary if the patient is elderly or if their kidneys are not working properly.

How to take Metformax 500

The medicine should be taken during or after a meal. This will help avoid gastrointestinal side effects. The tablets should not be crushed or chewed. Each tablet should be swallowed with a glass of water.

• If the patient takes one dose per day, it should be taken in the morning (breakfast).
• If the patient takes 2 divided doses, they should be taken in the morning (breakfast) and evening (dinner).
• If the patient takes 3 divided doses, they should be taken in the morning (breakfast), at noon (lunch), and evening (dinner).

If after some time of taking the medicine, the patient thinks that the effect of Metformax 500 is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Metformax 500 than recommended

If the patient takes more Metformax 500 than they should, they may experience lactic acidosis. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general feeling of being unwell, extreme tiredness, and breathing difficulties. The patient should contact their doctor or pharmacist immediately.

Missing a dose of Metformax 500

The patient should not take a double dose to make up for a missed tablet. The next dose should be taken at the usual time.

Stopping treatment with Metformax 500

Usually, there are no side effects when stopping the medicine, but if diabetes is not treated further, complications may arise due to lack of treatment.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformax 500 can cause side effects, although not everybody gets them.
Metformax 500 may very rarely cause (may occur in up to 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Metformax 500 and contact their doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
The following side effects may occur during treatment:

• Very common side effects (occurring in more than 1 in 10 patients):
• Gastrointestinal problems such as nausea (nausea), vomiting, diarrhea, abdominal pain (stomach), and loss of appetite. These side effects are more common at the beginning of treatment with Metformax 500. It is helpful to take the doses at intervals during the day and if the tablets are taken with food or immediately after it. If the symptoms do not disappear, the patient should stop taking Metformax 500 and consult their doctor.

Common side effects (occurring in less than 1 in 10 patients):

• Taste disturbances.

Very rare side effects (occurring in less than 1 in 10,000 patients):

• Lactic acidosis. This is a rare but serious complication, occurring especially if the patient's kidneys are not working properly. If the patient experiences this side effect, they require immediate treatment. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general feeling of being unwell, extreme tiredness, breathing difficulties, decreased body temperature, and slowed heart rate .If the patient experiences any of these symptoms, they should stop taking Metformax 500 and contact their doctor or the nearest hospital immediately.
• Abnormal liver function test results or jaundice (liver inflammation, which can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, the patient should stop taking Metformax 500 and tell their doctor.
• Skin reactions such as redness and itching of the skin, hives.
• Decreased vitamin B levels in the blood.

Reporting side effects
If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell 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, PL-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 500

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
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 pack and other information

What Metformax 500 contains

One tablet contains:

• -active substance:metformin hydrochloride 500 mg;
• -excipients:povidone, talc, magnesium stearate.

What Metformax 500 looks like and contents of the pack

Tablets.
Available packs:

• 30 tablets in blisters and in a cardboard box,
• 60 tablets in blisters and in a cardboard box,
• 90 tablets in blisters and in a cardboard box,
• 120 tablets in blisters and in a cardboard box.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Date of last revision of the leaflet:February 2025