Metformax 850

Package leaflet: Information for the user

Metformax 850, 850 mg, tablets
Metformini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Metformax 850 is and what it is used for
2. What you need to know before taking Metformax 850
3. How to take Metformax 850
4. Possible side effects
5. How to store Metformax 850
6. Contents of the pack and other information

1. What Metformax 850 is and what it is used for

What Metformax 850 is
Metformax 850 contains the active substance 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 which causes the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
If you have diabetes, your pancreas does not produce enough insulin or your body cannot use the insulin it produces effectively. This leads to high levels of glucose in the blood. Metformax 850 helps reduce blood glucose levels to values as close as possible to normal physiological levels.
If you are an overweight adult, long-term treatment with Metformax 850 also helps reduce the risk of diabetes-related complications.

What Metformax 850 is used for
Metformax 850 is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") when blood glucose levels have not been adequately controlled by diet and exercise alone. It is particularly used in overweight patients.
Adult patients may take Metformax 850 alone or in combination with other oral antidiabetic medicines (medicines taken by mouth) or insulin.
For the prevention of type 2 diabetes in patients with prediabetes.
In the treatment of polycystic ovary syndrome.

2. Important information before taking Metformax 850

When not to take Metformax 850

• if the patient is allergic to the active substance or to 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 rapid and deep breathing, weakness, abdominal pain, excessive thirst, and unusual fruity odour from the mouth.
• pre-coma state in diabetes.
• if the patient has lost too much water 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 may lead to a diabetic pre-comatose state. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or unusual fruity breath odour.
• 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 major circulatory problems 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 factors apply to the patient, contact a doctor before starting this medicine.
Consult a doctor if:

• The patient is scheduled for an X-ray or other imaging procedure requiring intravenous injection of an iodine-containing contrast agent.
• The patient requires surgery. Metformax 850 must be discontinued for a certain period before and after the procedure or examination. The doctor will recommend alternative treatment if necessary. It is important to strictly follow the doctor's instructions.

Warnings and precautions
Before starting Metformax 850, discuss this with your doctor or pharmacist.
Risk of lactic acidosis
Metformax 850 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, and any medical conditions in which part of the body is inadequately supplied with oxygen (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 (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, movement difficulties, signs of nerve damage (e.g. pain or numbness), migraine, or deafness.

Temporarily discontinue Metformax 850 if the patient develops a medical condition that may involve dehydration (significant loss of water from the body), 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.
Discontinue Metformax 850 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 combined with 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 850 must not be taken during and for some time after the procedure. The doctor will decide when to stop and restart treatment with Metformax 850.
During treatment with Metformax 850, 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.
While taking Metformax 850, continue to follow the dietary advice provided by the doctor. Regular blood tests should be performed during treatment to monitor blood glucose (sugar) levels.
If the patient develops any infectious diseases, such as influenza, respiratory or urinary tract infections, inform the doctor.
Treatment with Metformax 850 alone does not cause abnormally low blood sugar levels (hypoglycaemia). However, when Metformax 850 is used in combination with other oral antidiabetic medicines, hypoglycaemia may occur (see section "Driving and operating machinery").
If any of the above situations occur or if there are doubts about using the medicine, consult a doctor.

Metformax 850 and other medicines
If the patient receives an intravenous iodine-containing contrast agent, for example during an X-ray or CT scan, Metformax 850 must be discontinued before or at the latest at the time of injection. The doctor will decide when to stop and restart treatment with Metformax 850.
Inform the doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take. The patient may require more frequent blood glucose monitoring and kidney function assessments, or a dose adjustment of Metformax 850 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 to treat 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 850 and alcohol
Avoid consuming excessive amounts of alcohol while taking Metformax 850, 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 effects on 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 taking this medicine.
Pregnancy
During pregnancy, diabetes should be treated with insulin. If a woman becomes pregnant while being treated with Metformax 850, or plans to become pregnant, she must consult her doctor so that appropriate alternative therapy can be initiated.
Breastfeeding
Metformax 850 should not be used during breastfeeding.
Fertility
Animal studies have not shown any effect of metformin on fertility.

Driving and operating machinery
Metformax 850 does not cause hypoglycaemia (low blood glucose levels) and therefore does not affect the ability to drive or operate machinery. However, when Metformax 850 is used in combination with other antidiabetic medicines (sulfonylurea derivatives, insulin, repaglinide, or other blood glucose-lowering agents), hypoglycaemia may occur and impair psycho-physical performance. Symptoms of hypoglycaemia include: 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 850

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Metformax 850 does not replace the benefits of a healthy lifestyle. You should follow medical advice
regarding diet and regularly perform physical exercise.
Usual dose
In diabetes
Adults:
The usual starting dose in adults is one tablet of 500 mg or 850 mg 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 initiate treatment with Metformax 850.
Prediabetes (metformin monotherapy):
The usual target dose is 850 mg of metformin (1 tablet) twice daily, taken during or after a meal. A lower strength formulation is available on the market to allow appropriate dose adjustment (Metformax 500).
The doctor will decide whether to continue therapy based on regular assessment of blood glucose levels and coexisting risk factors.
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 850 according to the patient's blood glucose concentration. The patient should maintain regular contact with the doctor. 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 kidney function is impaired.

How to use Metformax 850
Take the medicine 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 on the medicine, the patient feels that the effect of Metformax 850 is too strong or too weak, contact the doctor or pharmacist.
Taking more Metformax 850 than prescribed
If the patient takes more Metformax 850 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 a doctor or pharmacist immediately.
Missing a dose of Metformax 850
Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time.
Stopping Metformax 850
Usually, there are no adverse effects associated with stopping the medicine. However, if diabetes is no longer treated, complications due to lack of treatment may arise.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

• The medicine Metformax 850 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, treatment with Metformax 850 must be discontinued and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.

The following adverse reactions may occur during treatment.
Very common (occurs 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 Metformax 850 treatment. Taking doses at intervals throughout the day and taking the tablets during or immediately after meals may help. If symptoms do not resolve, Metformax 850 should be discontinued and a doctor should be contacted.

Common (occurs in less than 1 in 10 treated patients):

• Taste disturbances.

Very rare (occurs 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. Immediate treatment is required if this adverse reaction occurs. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general malaise, severe fatigue, shortness of breath, decreased body temperature, and slowed heart rate. If any of these symptoms occur, Metformax 850 should be discontinued and immediate contact must be made with a doctor or the nearest hospital.
• 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 850 should be stopped immediately and the doctor informed.
• Skin reactions such as redness and itching of the skin, urticaria.
• Decreased blood concentration of vitamin B.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 this medicine.

5. How to store Metformax 850

Store below 25°C.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton, blister, or container after:
"Expiry date (EXP):" or "EXP:". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Metformax 850 contains
One tablet contains:

• active substance: metformin hydrochloride 850 mg;
• excipients: povidone, talc, magnesium stearate.

What Metformax 850 looks like and contents of the pack
Tablets.
Available pack sizes:

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

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