Metformax 500

Package leaflet: Information for the user

Metformax 500, 500 mg, tablets
Metformini hydrochloridum
Read the entire leaflet carefully before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

What Metformax 500 is
Metformax 500 contains metformin, a medicine used in the treatment of diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that enables the patient's body to take up 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 either does not produce enough insulin or the body cannot properly use the insulin it produces. This leads to high levels of glucose in the blood. Metformax 500 helps reduce blood glucose levels to values closest to physiological levels.
If an adult patient has overweight, long-term use of Metformax 500 also helps reduce the risk of diabetes-related complications.

What Metformax 500 is used for
Metformax 500 is used in the treatment of patients with type 2 diabetes (also known as "insulin-independent diabetes") when proper blood glucose control cannot be achieved by diet and physical exercise alone. It is particularly used in patients who are overweight.
Adult patients may take Metformax 500 as monotherapy or in combination with other oral antidiabetic medicines (medicines taken by mouth) or insulin.
Metformax 500 is used in the treatment of impaired glucose tolerance (prediabetes) when normal blood glucose levels cannot be achieved by strict adherence to diet and physical exercise.
Metformax 500 is used in the treatment of polycystic ovary syndrome.

2. Important information before using Metformax 500

When not to use 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 hyperglycaemia or ketoacidosis. Ketoacidosis is a condition in which substances called "ketone bodies" accumulate in the blood. Symptoms include, among others, rapid and deep breathing, weakness, abdominal pain, excessive thirst, and unusual fruity odour from the breath.
• Pre-coma state in diabetes.
• If the patient has lost too much fluid from the body (dehydration), for example due to prolonged or severe diarrhoea, or if the patient has vomited several times in a short period. Dehydration may lead to impaired kidney function, which can increase the risk of lactic acidosis (see section "Warnings and precautions").
• If the patient has significantly reduced kidney function.
• If the patient has impaired liver function.
• If the patient has unbalanced diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which may lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or unusual fruity odour from the breath.
• If the patient has a severe infection, such as lung, respiratory, or kidney infections. Severe infections may lead to impaired kidney function, which can increase the risk of lactic acidosis (see section "Warnings and precautions").
• If the patient is taking medicines for heart failure, has recently had a heart attack, or has significant circulatory disorders or breathing difficulties. These conditions may lead to tissue hypoxia, increasing the risk of lactic acidosis (see section "Warnings and precautions").
• If the patient abuses alcohol.
• If the woman is breastfeeding.

If any of the above conditions apply, the patient should contact a doctor before starting treatment with this medicine.
The patient should consult a doctor if:

• The patient is scheduled for an X-ray examination or any procedure requiring intravenous administration of an iodine-containing contrast agent.
• The patient requires surgery. Metformax 500 must be discontinued for a certain period before and after the examination or surgical procedure. The doctor will recommend alternative treatment if necessary. It is important to strictly follow the doctor's instructions.

Warnings and precautions
Before starting treatment with Metformax 500, discuss this with a doctor or pharmacist.
Risk of lactic acidosis
Metformax 500 may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), impaired liver function, or any medical condition causing tissue hypoxia (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
Contact a doctor immediately for further instructions if:

• The patient has a genetically inherited mitochondrial disorder (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).
• After starting metformin treatment, the patient experiences any of the following symptoms: seizures, worsening cognitive function, movement difficulties, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Temporarily discontinue Metformax 500 if the patient develops a medical condition that may lead to dehydration (significant loss of body water),
such as severe vomiting, diarrhoea, fever, or exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.
Stop taking Metformax 500 and contact a doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
If the patient is undergoing major surgery, Metformax 500 must not be taken during and for some time after the procedure. The doctor will decide when the patient should stop and restart treatment with Metformax 500.
While taking Metformax 500, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
During treatment with Metformax 500, the patient should continue to follow the dietary recommendations provided by the doctor. Blood tests should be performed periodically to monitor blood glucose (sugar) levels.
If the patient develops any infectious diseases, such as flu, respiratory or urinary tract infections, inform the doctor.
Treatment with Metformax 500 alone does not cause excessively low blood sugar levels (hypoglycaemia). However, when Metformax 500 is used in combination with other oral antidiabetic medicines, hypoglycaemia may occur (see section "Driving and using machines").
If any of the above situations occur or if there are any doubts about using the medicine, consult a doctor.

Metformax 500 and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray examination or computed tomography, the patient must stop taking Metformax 500 before or at the latest at the time of administration. The doctor will decide when the patient should stop and restart treatment with Metformax 500.
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Metformax 500 by the doctor. It is especially important to inform the doctor about the following medicines:

• beta-2 adrenergic receptor agonists such as salbutamol or terbutaline (used in the treatment of asthma),
• corticosteroids (used in the treatment of various 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
Avoid consuming excessive amounts of alcohol while taking Metformax 500, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
It is recommended to take the medicine during or immediately after a meal, as this helps avoid gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
If planning pregnancy, consult a doctor. During pregnancy, diabetes should be treated with insulin. If a woman becomes pregnant or plans to become pregnant while being treated with Metformax 500, she must consult her doctor so that the doctor can initiate appropriate alternative therapy.
Breastfeeding
Metformax 500 should not be used during breastfeeding.
Fertility
Animal studies have not shown any effect of metformin on fertility.

Driving and using machines
Metformax 500 does not cause hypoglycaemia (low blood glucose levels) and therefore does not affect the ability to drive or operate machinery. However, when Metformax 500 is used in combination with other antidiabetic medicines (sulfonylurea derivatives, insulin, repaglinide, or other medicines that lower blood glucose), hypoglycaemia may occur and impair psycho-motor performance. Symptoms of hypoglycaemia include, for example: fainting, confusion, profuse sweating, rapid heartbeat, pain and dizziness, visual disturbances, or difficulty concentrating.
Do not drive or operate machinery if the patient experiences any of the above symptoms.

3. How to use Metformax 500

Metformax 500 should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Metformax 500 does not replace the benefits of a healthy lifestyle. You must follow your doctor's advice regarding diet and regularly perform physical exercise.

Typical dosage
In diabetes
Adults:
The usual starting dose for adults is one 500 mg or 850 mg tablet of metformin, taken two or three times daily. The maximum daily dose of metformin is 3000 mg, administered in three divided doses.
Elderly patients:
Due to the risk of impaired kidney function in elderly patients, the dose of metformin hydrochloride will be determined by the doctor based on kidney function parameters.
If the patient is also taking insulin, the doctor will inform the patient how to start treatment with Metformax 500.

In prediabetes
Metformax 500 is usually administered at a dose of 500 mg (1 tablet) twice daily.

In polycystic ovary syndrome
The usual dose is 500 mg (1 tablet of Metformax 500) three times daily or 850 mg (1 tablet of Metformax 850) twice daily.

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 glucose levels. The patient should contact the doctor regularly. This is particularly important for elderly patients.
• The doctor will also check at least once a year how well the patient's kidneys are functioning. More frequent monitoring may be necessary if the patient is elderly or if the kidneys are not working properly.

How to use Metformax 500
The medicine should be taken during or after a meal. This helps avoid gastrointestinal side effects. Do not crush or chew the tablets. Swallow each tablet whole with a glass of water.

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

If, after some time of using the medicine, the patient feels that the effect of Metformax 500 is too strong or too weak, contact the doctor or pharmacist.

Taking more Metformax 500 than prescribed
If the patient takes more Metformax 500 than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general malaise, severe fatigue, and shortness of breath. Contact your doctor or pharmacist immediately.

Missing a dose of Metformax 500
Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time.

Stopping Metformax 500
Usually, there are no adverse effects associated with stopping the medicine. However, if diabetes remains untreated, complications due to lack of treatment may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Metformax 500 may cause adverse reactions, although not everyone experiences them.
Metformax 500 may very rarely (may occur in up to 1 in 10,000 patients) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, the treatment with Metformax 500 must be discontinued and immediate contact must be made with a doctor or the nearest hospital, because lactic acidosis may lead to coma.

The following adverse reactions may occur during treatment:

Very common adverse reactions (occurring in more than 1 in 10 treated patients):

• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal (stomach) pain, and loss of appetite. These adverse reactions are more likely to occur at the beginning of treatment with Metformax 500. It may help to take the doses at intervals throughout the day and to take the tablets with or immediately after meals. If symptoms do not resolve, Metformax 500 should be discontinued and a doctor should be contacted.

Common adverse reactions (occurring in less than 1 in 10 treated patients):

• Taste disturbances.

Very rare adverse reactions (occurring in less than 1 in 10,000 treated patients):

• Lactic acidosis. This is a rare but serious complication, particularly if the patient's kidneys are not functioning properly. If this adverse reaction occurs, immediate treatment is required. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general malaise, severe fatigue, dyspnoea (shortness of breath), decreased body temperature, and slowed heart rate. If any of these symptoms occur, Metformax 500 should be discontinued immediately and a doctor or the nearest hospital should be contacted without delay.
• Abnormal liver function test results or jaundice (liver inflammation, which may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Metformax 500 should be discontinued immediately and the doctor should be informed.
• Skin reactions such as redness and itching of the skin, urticaria (hives).
• Decreased blood levels of vitamin B(_{12}).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Metformax 500

Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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 pack sizes:

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

Marketing Authorisation 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