Properties
What is it?
METFOGAMMA®500 Active ingredient: Metformin hydrochloride 500mg film-coated tablets Read the package leaflet carefully before using the medicine. - Keep the 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 personally. Do not pass it on to third parties, it may harm the patient, even if they have similar symptoms. - If you notice any of the side effects listed or if you experience any side effect not listed in the leaflet, inform your doctor or pharmacist. See section 4 The package leaflet contains the following information: 1. What is Metfogamma 500 and what is it used for? 2. What should you pay attention to before taking Metfogamma 500? 3. How is Metfogamma 500 used? 4. What side effects are possible? 5. How to store Metfogamma 500? 6. Further information 1. What is Metfogamma 500 and what is it used for? Metfogamma 500 contains metformin, a substance belonging to the group of biguanides, used to treat diabetes. Insulin is a hormone secreted by the islets of Langerhans in the pancreas that ensures glucose is transported from the blood into the cells. There, glucose is converted into energy or stored as reserves for later use. If you have diabetes, the pancreas does not produce enough insulin or the cells do not respond to it properly, leading to increased blood sugar levels. Metfogamma 500mg regulates blood sugar levels as much as possible. Metfogamma 500mg is recommended for long-term use in overweight adolescents to prevent diabetes-related complications. Metfogamma 500mg also helps regulate body weight. Metfogamma 500mg is used to treat non-insulin-dependent diabetes mellitus (type 2), especially in overweight patients where blood sugar levels cannot be controlled by diet or physical activity. In adults, your doctor may prescribe Metfogamma 500 alone (as monotherapy) or in combination with other blood sugar-lowering drugs or insulin. In adolescents and children over 10 years of age, your doctor may prescribe Metfogamma 500 alone (as monotherapy) or in combination with insulin. 2. What should you pay attention to before taking Metfogamma 500? Do not take Metfogamma 500 in the following cases: Hypersensitivity to metformin hydrochloride or to any of the other ingredients listed in section 6. Liver problems. Acute kidney failure. Hyperglycemia accompanied by nausea, vomiting, dehydration, sudden weight loss, lactic acidosis or ketoacidosis. Ketoacidosis is a precursor to diabetic coma, where ketone bodies are released into the blood. This condition is characterized by symptoms such as stomach pain, rapid and deep breathing, drowsiness, and a fruity odor to the breath. Dehydration, e.g., due to prolonged diarrhea or vomiting. Fluid loss can lead to kidney problems, which can result in lactic acidosis – an increase in lactic acid. (See section "Special Precautions"). Acute infection, e.g., of the lungs, bronchi, or kidneys. Acute infection can cause kidney problems, which in turn increases the risk of lactic acidosis. (See section "Special Precautions"). Recent heart treatment or heart attack, circulatory problems, or breathing difficulties that can lead to oxygen deficiency in the tissues, which in turn increases the risk of lactic acidosis. (See section "Special Precautions"). If you consume excessive amounts of alcohol. If any of the above criteria apply to you, consult your doctor before taking the preparation. Seek immediate medical attention if: You are planning to have an X-ray or other similar examination that requires the use of an iodine-containing contrast agent. You are planning to undergo surgery. You must stop taking Metfogamma before, during, and after surgery. Your doctor will adjust the timing of the end and continuation of your treatment. Special Precautions Risk of lactic acidosis: In patients with kidney problems, taking Metfogamma 500mg can lead to a rare but serious complication called lactic acidosis. Lactic acidosis can also develop due to improper diabetes treatment, prolonged fasting or alcohol consumption, dehydration caused by severe diarrhea or vomiting, liver problems, and medical conditions where the body receives less oxygen. If you notice such symptoms, seek immediate medical attention. Temporarily stop taking the preparation if you experience symptoms that cause dehydration, such as diarrhea, vomiting, high fever, chills, or unusually low fluid intake. Consult your doctor for advice. Since lactic acidosis can lead to coma, if symptoms appear, stop taking Metfogamma 500mg immediately and go to the nearest hospital. Symptoms of lactic acidosis include: Vomiting Abdominal pain Cramps General weakness Difficulty breathing Low body temperature and palpitations Lactic acidosis is a medical emergency and requires inpatient treatment. Metfogamma 500mg alone does not cause hypoglycemia, but if you take it in combination with other diabetes medications (sulfonylureas, insulin, glinides), there is a risk of hyperglycemia. Hyperglycemia is characterized by symptoms such as weakness, sweating, tachycardia, blurred vision, and reduced concentration. In such cases, you should consume food or drink containing sugar. During treatment with this preparation, your kidney function should be checked at least once a year, and more frequently in elderly patients or patients with kidney failure. Taking Metfogamma 500mg with other preparations If you are planning to have an X-ray or other similar examination that requires the use of an iodine-containing contrast agent, you should stop taking Metfogamma 500mg for a period before and after the examination. Your doctor will adjust the timing of the discontinuation and continuation of treatment. Inform your doctor if you are taking/have taken or plan to take other medications concurrently with Metfogamma 500mg. In such cases, you may need to monitor your blood sugar more frequently and control your kidney function, or your doctor will adjust the appropriate dose. It is important if you are taking medications such as: Diuretics Painkillers and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs and COX-2 inhibitors, such as ibuprofen and celecoxib) Blood pressure medications (ACE inhibitors and angiotensin II receptor blockers) Beta-2 agonists such as salbutamol or terbutaline (asthma medications) Corticosteroids (medications for asthma or skin inflammation) Other diabetes medications Taking Metfogamma 500mg with food and drinks You should avoid alcohol consumption while taking Metfogamma. Excessive alcohol increases the risk of lactic acidosis (see section "Special Precautions"). Pregnancy and lactation Diabetic patients who are planning to become pregnant or are pregnant should consult their doctor before taking this preparation. Insulin should be used to treat diabetes during pregnancy. Taking this medication during lactation is not recommended. Driving and operating machinery Metfogamma does not cause a decrease in blood sugar levels (hypoglycemia) and therefore does not affect the ability to drive or operate machinery. When used in combination with other blood sugar-lowering drugs (e.g., sulfonylureas, insulin, glinides), symptoms such as weakness, sweating, blurred vision, and reduced concentration may occur due to a decrease in blood sugar levels. Therefore, driving or operating machinery is not recommended in such cases. 3. How to take Metfogamma 500mg Take the preparation as prescribed by your doctor. For further questions, consult your doctor or pharmacist. Metfogamma cannot replace a healthy lifestyle. Eat according to your doctor's recommendations and exercise regularly. Recommended dosage Dosage in children and adolescents over 10 years of age Treatment usually starts with 500mg or 850mg of Metfogamma once a day. The maximum dose is 2000mg per day, divided into two or three doses. For children aged 10-12 years, consultation with a doctor is recommended, as studies in this age group are limited. Dosage for adults The recommended starting dose is 500mg or 850mg of Metfogamma two or three times a day. The maximum dose is 3000mg per day, divided into three doses. In patients with kidney failure, the starting dose is minimal. If you are also taking insulin, ask your doctor how to start treatment with Metfogamma tablets. Control Blood sugar tests should be performed regularly by a doctor, and the dose should be adjusted based on blood sugar levels. Medical supervision is particularly important for children, adolescents, and elderly patients. The doctor will check kidney function at least once a year. Elderly patients and patients with impaired kidney function will undergo examinations more frequently. How to take Metfogamma 500mg Take the preparation before or after meals. This will help you avoid gastrointestinal complications. Do not chew or crush the tablet. Swallow the tablet with a glass of water. - Take the preparation in the morning (with breakfast) if your daily dose is one. - Take the preparation in the morning (with breakfast) and in the evening (with dinner) if your daily dose is two. - Take the preparation in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner) if your daily dose is three. If after some time you notice that the preparation is acting weakly or strongly on you, consult your doctor or pharmacist. Overdose Taking an overdose can lead to lactic acidosis. Lactic acidosis is characterized by non-specific symptoms such as vomiting, abdominal pain, cramps, general weakness, difficulty breathing, as well as low body temperature and bradycardia. If such symptoms appear, stop taking the preparation and seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking the preparation and consult your doctor or the nearest hospital. If you forget to take the preparation If you forget to take a dose of Metfogamma, take it according to the schedule at the time of the next tablet. Do not take a double dose. For further questions, consult your doctor or pharmacist. 4. What side effects are possible? Like all medicines, this one can cause side effects, which do not occur in all patients. During treatment with this preparation, a very rare (1 in 10,000 patients) but very serious side effect, lactic acidosis, may occur (see section "Special Precautions"). If it occurs, discontinue treatment and go to the nearest hospital immediately, as lactic acidosis can lead to coma. Other possible side effects: Very common side effects (1 in 10 patients) - Gastrointestinal problems, such as vomiting, nausea, diarrhea, abdominal pain, loss of appetite. These reactions usually occur at the beginning of treatment; dividing the daily dose throughout the day and taking it after meals will help avoid these problems. If the complaints persist, consult your doctor. Common side effects (1 in 10 patients) - Reduced sense of taste Very rare side effects (1 in 10,000 patients) - Liver function test abnormalities or liver inflammation (hepatitis) (loss of appetite, weight loss, jaundice). If you notice such symptoms, stop taking the preparation and consult your doctor. - Skin reactions, such as redness, itching, and hives. - Low vitamin B12 concentration. There is limited data on side effects in children and adolescents. The frequency, type, and severity of side effects are similar to those in adults. Reporting of side effects If you experience any side effects, consult your doctor or pharmacist. Also consult your doctor if you notice any symptoms not listed in the leaflet. You can report side effects to the Federal Office for Medicines and Medical Products, Department of Pharmacovigilance. This will help you gather more information about side effects. 5. Storage conditions for Metfogamma 500mg Store the preparation out of reach of children. If the preparation is used by children, the parent or guardian should supervise the dosage regimen. The preparation does not require special storage conditions. Do not use the preparation after the expiry date indicated on the packaging. The preparation is valid until the last day of the indicated month. Do not dispose of the preparation with household waste. Ask your doctor or pharmacist about the disposal of the preparation. This will help protect the environment. 6. Further information What Metfogamma 500mg contains: - Active substance: Metformin hydrochloride. 1 film-coated tablet contains 500mg of metformin hydrochloride. - Excipients are: hypromellose, povidone K25, magnesium stearate, macrogol 6000, titanium dioxide (E171). Appearance and contents of the package of Metfogamma 500mg: The package contains 30 (N1), 120 (N2), and 180 (N3) film-coated tablets. See also: Metfogamma - Metfogamma 850mg 180 tablets
