What Metfocon is and what it is used for
What is Metfocon
Metfocon 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 helps absorb glucose (sugar) from the blood. Your body uses glucose to produce energy or store it as a reserve. If you have diabetes, your pancreas does not produce enough insulin or your body is unable to use the insulin it produces properly. This leads to elevated blood glucose levels. Metfocon helps reduce blood glucose to levels as close to normal as possible.
In adult overweight patients, long-term use of Metfocon also helps reduce the risk of complications associated with diabetes.
The use of Metfocon is associated with weight stabilization or moderate weight loss.
What is Metfocon used for?
Metfocon is used to treat type 2 diabetes (also known as 'non-insulin-dependent diabetes') when diet and exercise are not enough to control your blood sugar. It is especially used in overweight patients.
Adults can take Metfocon alone or with other antidiabetic medicines (medicines taken by mouth or insulin).
Children 10 years of age and older, as well as adolescents, can take Metfocon alone or in combination with insulin.
2. What you need to know before you take Metfocon
Do not take Metfocon:
If you are allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6).
If you have impaired kidney or liver function.
If you have uncontrolled diabetes, such as acute hyperglycaemia (high blood sugar), nausea, vomiting, dehydration, rapid weight loss or ketoacidosis. Ketoacedosis is a condition in which substances called 'ketone bodies' accumulate in the blood, which can lead to diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or unusual fruit breath.
If you have become dehydrated (dehydrated), for example with prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney complications, which can put you at risk for lactic acidosis (see “Warnings and Precautions” below).
If you have a severe infection, such as an infection of the lungs, respiratory system or kidneys. Severe infections can lead to kidney complications, which can put you at risk for lactic acidosis (see “Warnings and Precautions” below).
In case of heart failure, recent myocardial infarction, circulatory problems (eg shock) or difficulty breathing. This can lead to an insufficient supply of oxygen to the tissues, which can put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
If you drink a significant amount of alcohol.
If you are breast-feeding.
If any of the above apply to you, talk to your doctor before taking this medicine.
Be sure to consult your doctor if:
- You will have an examination, for example with an X-ray or a scanner, injection into the bloodstream of contrast agents containing iodine;
- You are about to have surgery.
Metfocon should be discontinued for a period of time before or after the test or surgery. Your doctor will decide if you need other treatment during this time. It is important to follow your doctor's instructions exactly.
Warnings and precautions
Please pay special attention to the risk of lactic acidosis.
Metfocon can cause a very rare but serious complication called lactic acidosis, especially if you have impaired kidney function. The risk of lactic acidosis is also increased in the case of uncontrolled diabetes, prolonged fasting or alcohol use. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle spasms, malaise, accompanied by severe fatigue and difficulty breathing. If you notice such signs, you may need urgent treatment. Stop taking Metfocon immediately and contact your doctor or the nearest hospital.
If taken alone, Metfocon does not cause hypoglycaemia (too low a blood sugar level). However, if you are taking Metfocon with other medicines to treat diabetes that may cause hypoglycaemia (for example, sulphonylureas, insulin or meglinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia, such as weakness, dizziness, sweating, palpitations, visual disturbances or difficulty concentrating, it is recommended that you take a liquid or food containing sugar.
Other medicines and Metfocon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are going to have intravenous iodine-containing contrast agents, such as an X-ray or a scan, you should stop taking Metfocon for a period of time before and after the test (see 'Be sure to talk to your doctor' above). .
Tell your doctor if you are taking any of these medicines in addition to Metfocon. You may need more frequent blood sugar tests or a change in the dose of Metfocon:
angiotensin-converting enzyme inhibitors (used to treat various diseases of the cardiovascular and circulatory systems, such as high blood pressure or heart failure);
diuretics (used to remove water from the body by increasing the amount of urine);
beta-2 antagonists, such as salbutamol or terbutaline (used to treat asthma);
corticosteroids and tetracosactide (used to treat various conditions, such as severe skin burns or asthma);
chlorpromazine (a neuroleptic that affects brain activity);
danazol (used to treat endometriosis, uterine disease);
other medicines to treat diabetes.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Metfocon with food, drinks and alcohol
Do not drink alcohol while taking this medicine. Alcohol may increase the risk of lactic acidosis, especially if you have liver problems or are malnourished. This also applies to medicinal products that contain alcohol.
Pregnancy, lactation and fertility
Insulin should be prescribed to treat diabetes during pregnancy.
Tell your doctor if you think you may be pregnant or are planning to have a baby to adjust your treatment.
Do not take this medicine if you are breast-feeding or planning to breast-feed.
Driving and using machines
Metfocon alone does not cause hypoglycaemia (too low a blood sugar level). This means that it does not affect the ability to drive and use machines.
However, caution should be exercised if you are taking Metfocon with other antidiabetic medicines that may cause hypoglycaemia (eg, sulphonylureas, insulin or meglinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, palpitations, disturbances, or difficulty concentrating. If you experience such symptoms, do not drive or use machines.
3. How to take Metfocon
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
Metfocon cannot replace the benefits of a healthy lifestyle. Continue to follow your recommended diet and exercise regularly.
Recommended dose
The usual starting dose for adults is 500 mg or 850 mg Metfocon 2 or 3 times a day. The maximum daily dose is 3000 mg, divided into 3 doses.
If you are also taking insulin, your doctor will tell you how to start treatment with Metfocon.
Control
Your doctor will check your blood sugar level regularly and adjust the dose of Metfocon to it. Consult your doctor regularly. This is especially important for children, adolescents and the elderly.
Your doctor will also check how your kidneys are working at least once a year. More frequent tests may be needed if you are elderly or have kidney problems.
Use in children and adolescents
The usual starting dose of Metfocon for children and over 10 years of age and adolescents is 500 mg or 850 mg once a day. The maximum daily dose is 2000 mg, divided into 2 or 3 doses. Treatment of children between 10 and 12 years of age is recommended only with a special prescription from your doctor, as experience in this age group is limited.
How to take Metfocon
Take Metfocon during or after a meal. This will avoid digestive 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 (for breakfast).
If your dose is divided into two doses, take them in the morning (for breakfast) and in the evening (for dinner).
If your dose is divided into three doses, take them in the morning (breakfast), lunch (lunch) and evening (dinner).
If you have the impression that the effect of Metfocon is too strong or too weak, talk to your doctor or pharmacist.
If you take more Metfocon than you should
If you take more Metfocon than you should, you may get lactic acidosis. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle spasms, malaise, accompanied by severe fatigue and difficulty breathing. In these cases, you may need urgent medical attention because lactate
5. How to store Metfocon
Keep out of reach of children.
If a child is being treated with Metfocon, parents and those in charge are advised to monitor how the medicine is taken.
This medicinal product does not require any special storage conditions.
Do not use after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and additional information
What Metfocon contains
The active substance is: metformin hydrochloride.
Metfocon 500 mg film-coated tablets:
Each film-coated tablet contains 500 mg metformin hydrochloride, corresponding to 390 mg metformin.
Metfocon 850 mg film-coated tablets:
Each film-coated tablet contains 850 mg metformin hydrochloride, corresponding to 663 mg metformin.
Metfocon 1000 mg film-coated tablets:
Each film-coated tablet contains 1000 mg metformin hydrochloride, corresponding to 780 mg metformin.
The other ingredients are: povidone (K-90), magnesium stearate, hypromellose, macrogol 400, macrogol 6000.
What Metfocon looks like and contents of the pack
Metfocon 500 mg film-coated tablets:
White, round, biconvex film-coated tablets 11.1 mm in diameter, engraved with "A" on one side and "60" on the other.
Metfocon 850 mg film-coated tablets:
White, round, biconvex film-coated tablets 12.8 mm in diameter, engraved with "A" on one side and "61" on the other.
Metfocon 1000 mg film-coated tablets:
White, oval, biconvex film-coated tablets measuring 19.3 mm x 9.3 mm, engraved with an "A" on one side and a score line between the engraved "6" and "2" on the other side.
The dividing line of Metfocon 1000 mg film-coated tablets is not intended to break the tablet.
Types of packaging:
Metfocon 500 mg / 850 mg: 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, 100, 120, 200, 300 or 400 film-coated tablets.
Metfocon 1000 mg: 20, 30, 40, 50, 60, 70, 80, 90, 100 or 180 film-coated tablets.
The tablets are packed in PVC / PVdC / Aluminum or PVC / Aluminum blisters containing 10 or 14 film-coated tablets.
Not all pack sizes may be marketed.