Metformax 850

Package Leaflet: Information for the User

Metformax 850, 850 mg, Tablets

Metformin Hydrochloride

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

• You should keep this leaflet, so you can read it again if you need to.
• 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 mentioned in this leaflet, or if any of the side effects become serious, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What Metformax 850 is and what it is used for
• 2. Important information 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 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 future use.
If you have diabetes, your pancreas does not produce enough insulin or your body is not able to use the insulin it produces properly. This leads to a high level of glucose in the blood. Metformax 850 helps to lower the level of glucose in the blood to a more normal level.
If you are an adult and have been diagnosed with overweight, long-term use of Metformax 850 also helps to reduce the risk of complications associated with diabetes.

What Metformax 850 is used for

Metformax 850 is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes) when diet and exercise alone have not been able to control blood sugar levels properly. It is particularly used in patients who are overweight.
Adult patients can take Metformax 850 alone or in combination with other oral anti-diabetic medicines (medicines taken by mouth or insulin).
To prevent type 2 diabetes in patients with a pre-diabetic condition.
To treat polycystic ovary syndrome.

2. Important information before taking Metformax 850

When not to take Metformax 850

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have uncontrolled diabetes, such as severe hyperglycemia or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies build up 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 you have lost too much water from your body (dehydration), for example due to prolonged or severe diarrhea or if you have 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 you have significantly reduced kidney function.
• if you have liver problems.
• if you have uncontrolled diabetes, such as severe hyperglycemia, nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies build up in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or a fruity odor from the mouth.
• if you have 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 you are taking medicines for heart failure, have recently had a heart attack or have 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 you abuse alcohol.
• if you are breastfeeding.

If any of the above applies to you, you should talk to your doctor before taking this medicine.
It is essential to consult your doctor if:

• You are going to have an X-ray or a test that requires the injection of a contrast agent containing iodine into a vein.
• You are going to have surgery (an operation). You should stop taking Metformax 850 for a certain period before the test or surgery and after it. Your doctor will advise you on alternative treatment if your condition requires it. It is crucial to follow your doctor's advice.

Warnings and precautions

You should discuss this with your doctor or pharmacist before taking Metformax 850.

Risk of lactic acidosis

Metformax 850 can 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 cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver problems, and any conditions in which a part of the body is not getting enough oxygen (e.g., severe heart disease).
If any of the above applies to you, you should consult your doctor for more detailed instructions.

You should contact your doctor immediately for further instructions if:

• you have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, 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, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

You should temporarily stop taking Metformax 850 if you have

a condition that may lead to dehydration(significant loss of water 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 850 and contact your doctor or the nearest hospital immediately if you experience any of the symptoms of

lactic acidosis, as this 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,
• lowered body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
If you are going to have major surgery, you should not take Metformax 850 during the surgery and for a certain period after it. Your doctor will decide when you should stop and restart Metformax 850.
During treatment with Metformax 850, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.
During treatment with Metformax 850, you should continue to follow the dietary advice given by your doctor. While taking the medicine, you should have regular blood tests to assess changes in blood sugar levels.
If you experience any infectious diseases, such as flu, respiratory or urinary tract infections, you should inform your doctor.
Treatment with Metformax 850 alone does not cause low blood sugar (hypoglycemia). However, when Metformax 850 is taken in combination with other oral anti-diabetic medicines, hypoglycemia may occur (see "Driving and using machines").
If you experience any of the above situations or have any doubts about taking the medicine, you should consult your doctor.

Metformax 850 with other medicines

If you are going to have a contrast agent containing iodine injected into a vein, for example for an X-ray or CT scan, you should stop taking Metformax 850 before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart Metformax 850.
You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent monitoring of blood sugar levels and kidney function or modification of the Metformax 850 dose by your doctor. It is especially important to inform your doctor 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 850 with alcohol

You should avoid excessive alcohol consumption while taking Metformax 850, as this can 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During pregnancy, diabetes should be treated with insulin. If you become pregnant or plan to become pregnant while taking Metformax 850, you should consult your doctor so that they can switch you to a substitute therapy.
Breastfeeding
You should not take Metformax 850 while breastfeeding.
Fertility
Animal studies have not shown any effect of metformin on fertility.

Driving and using machines

Metformax 850 does not cause hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or use machines. However, Metformax 850 taken in combination with other anti-diabetic medicines (sulfonylurea derivatives, insulin, repaglinide, or other medicines that lower blood sugar levels) may cause hypoglycemia and impair physical and mental performance. Symptoms of hypoglycemia include fainting, confusion, excessive sweating, rapid heartbeat, headaches, dizziness, or difficulty concentrating.
You should not drive or operate machinery if you experience any of the above symptoms.

3. How to take Metformax 850

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Metformax 850 will not replace the benefits of a healthy lifestyle. You should continue to follow your doctor's advice about diet and regular exercise.
Usual dose
In diabetes
Adults:
The usual starting dose is one 500 mg or 850 mg metformin tablet, taken 2 or 3 times a day. The maximum dose of metformin is 3000 mg per day, taken 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 you are also taking insulin, your doctor will tell you how to start taking Metformax 850.
Pre-diabetic state (metformin monotherapy):
The usual target dose is 850 mg metformin (1 tablet) twice a day during or after meals. There is a medicine on the market that allows for proper dose adjustment (Metformax 500).
Your doctor will decide whether to continue therapy based on regular assessment of blood sugar levels and co-existing risk factors.
In polycystic ovary syndrome
The usual dose is 500 mg (1 Metformax 500 tablet) 3 times a day or 850 mg (1 Metformax 850 tablet) twice a day.
Information for patients with kidney problems
If you have kidney problems, your doctor may prescribe a lower dose.
Monitoring

• Your doctor will adjust the dose of Metformax 850 according to your blood sugar levels. You should regularly contact your doctor. This is especially important for elderly patients.
• Your doctor will also check your kidney function at least once a year. More frequent tests may be necessary if you are elderly or if your kidneys are not working properly.

How to take Metformax 850

Take the medicine during or after a meal. This will help avoid gastrointestinal side effects. Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose a day, take it in the morning (breakfast).
• If you take 2 divided doses, take them in the morning (breakfast) and evening (dinner).
• If you take 3 divided doses, take them in the morning (breakfast), at noon (lunch), and evening (dinner).

If, after some time, you feel that the effect of Metformax 850 is too strong or too weak, you should talk to your doctor or pharmacist.

Taking a higher dose of Metformax 850 than recommended

If you take more Metformax 850 than you should, you 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. You should contact your doctor or pharmacist immediately.

Missing a dose of Metformax 850

Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time.

Stopping treatment with Metformax 850

There are usually no side effects when stopping the medicine, but if diabetes is not treated, complications may occur.
If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Metformax 850 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 this happens to you, you should stop taking Metformax 850 and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

During treatment, the following side effects may occur.
Very common (affects more than 1 in 10 people):

• Gastrointestinal problems such as nausea (feeling sick), vomiting, diarrhea, abdominal pain (stomach ache), and loss of appetite. These side effects are more common at the beginning of treatment with Metformax 850. It is helpful to take the doses at intervals during the day and to take the tablets with a meal or just after. If the symptoms do not improve, you should stop taking Metformax 850 and consult your doctor.

Common (affects less than 1 in 10 people):

• Taste disturbances.

Very rare (affects less than 1 in 10,000 people):

• Lactic acidosis. This is a rare but serious complication that occurs especially when the kidneys are not working properly. If you experience this side effect, you need immediate treatment. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general feeling of being unwell, extreme tiredness, breathing difficulties, lowered body temperature, and slowed heart rate. If you experience any of these symptoms, you should stop taking Metformax 850 and contact your doctor or the nearest hospital immediately .
• Abnormal liver function test results or jaundice (liver inflammation, which can cause fatigue, loss of appetite, weight loss, yellowing of the skin and whites of the eyes, or without). If such symptoms occur, you should stop taking Metformax 850 and tell your doctor.
• Skin reactions such as redness and itching of the skin, hives.
• Decreased levels of vitamin B12 in the blood.

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, 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, you can help provide more information on the safety of this medicine.

5. How to store Metformax 850

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or container after "EXP:" or "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 packs:

• 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 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