METFODIAB 500 mg. 100 tablets
Metfodiab refers to a group of medicines called anti-diabetes medicines (drug belongs to a group biguanides).
Metfodiab be used for the treatment of "type 2 diabetes" (non-insulin dependent diabetes).
In type 2 diabetes, your blood has too much sugar (glucose). The reason for this is that your body does not produce enough insulin or that produce insulin, which is not properly digested.
Insulin is a hormone that allows the body tissues to absorb glucose from the blood and use it for energy or store it for future use.
Metfodiab works by improving the sensitivity of your body to insulin. It helps your body use glucose properly again.
Metfodiab apply when diet and exercise have failed to control the levels of sugar in the blood.
Metfodiab can be used alone. However, sometimes administered together with other antidiabetic drugs or insulin.
Metfodiab can be used in children over 10 years, alone or with insulin.
In overweight patients, prolonged use of Metfodiab also helps reduce the risk of problems associated with diabetes.
2. What you should know before using Metfodiab
He Metfodiab take:
if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
if you have uncontrolled diabetes, for example. with severe hyperglycemia (elevated blood sugar), nausea, vomiting, dehydration, rapid weight loss or "diabetic ketoacidosis" diabetic coma. Ketoacidosis is a condition in which blood accumulates substances, so-called "ketone bodies" which leads to diabetic coma. The signs are abdominal pain, palpitations, drowsiness, or unusual breath fruit of his mouth (see also section 4: Possible side effects) if you have problems with your liver or kidneys;
if you have recently had a severe infection, injury or trauma (shock);
if you are dehydrated (dehydrated). Dehydration leads to kidney problems and increased risk of lactic acidosis;
If you have recently had a heart attack or have had other heart disorders;
if you have severe disorders of blood circulation or breathing difficulties;
if you abuse alcohol (everyday or only occasionally).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Metfodiab.
Pay special attention to the risk of lactic acidosis (excessive amount of lactic acid in the blood)
Metfodiab can cause rare but serious complication called lactic acidosis, particularly if your kidneys are not functioning properly. The risk of lactic acidosis increases with uncontrolled diabetes, prolonged fasting or alcohol consumption.
Symptoms of lactic acidosis are vomiting, stomach ache (or abdominal) with muscle cramps, malaise with severe fatigue and difficulty breathing.
If this occurs to you you may need immediate hospital treatment, as lactic acidosis may lead to coma. Immediately discontinue Metfodiab and contact your doctor or nearest hospital.
Metfodiab not cause hypoglycemia (very low blood sugar) when administered alone. However, if taking Metfodiab simultaneously with other medicines for the treatment of diabetes, which can cause hypoglycemia (such as insulin or other antidiabetic agents administered orally - eg. Sulphonylureas or meglitinides), this may lead to hypoglycemia. When symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, palpitations, visual disturbances and difficulty concentrating are advised to take food or drink containing sugar.
Your doctor will prescribe to do periodic laboratory tests to determine blood sugar and monitor your kidney function (creatinine or creatinine clearance) before treatment and then regularly as metformin (the active substance in Metfodiab) is excreted primarily through the kidneys.
Special care is required if renal function is impaired, such as the elderly or early antihypertensive treatment, diuretic therapy and when starting treatment with NSAIDs.
If you are X-ray with injection of iodinated (contrast) agents Your doctor will instruct you to temporarily stop taking this medicine. Tell your doctor that you are taking metformin, if you are such an X-ray. You should not start again taking this drug until you take 48 hours of X-ray and only if you made a study of renal function and the results are the norm.
If you have an operation, tell your doctor that you are taking Metfodiab. Your doctor will instruct you to temporarily stop taking this medicine. You should not start taking it again earlier than 48 hours after surgery or after it is possible to eat by mouth.
Follow the specific diet that you have been prescribed because it is important for controlling diabetes.
Do not miss the usual laboratory tests for diabetes control.
Children and adolescents
Children (especially in the age before puberty) doctor will regularly monitor the effect of metformin on growth and puberty.
Other medicines and Metfodiab
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is important that your doctor knows if you use corticosteroids (used to treat various conditions such as strong skin irritation or asthma), antihypertensive agents from the group of angiotensin converting enzyme inhibitors (used to treat high blood pressure), diuretics (water ), beta-2 agonists (e.g. salbutamol, terbutaline), other drugs for treating diabetes, iodinated contrast agents or medicines containing alcohol.
Metfodiab food, beverages and alcohol
Metfodiab should be taken during a meal or immediately after a meal.
Avoid alcohol and alcohol-containing substances because of increased risk of lactic acidosis especially if you have liver problems or suffer from malnutrition.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
During pregnancy the treatment of diabetes with insulin is carried out. If you find that you are pregnant while taking Metfodiab, your medicine will be replaced with insulin.
Do not take this medicine if you are breastfeeding.
Driving and using machines
When administered alone, metformin does not cause hypoglycemia, and therefore does not affect the ability to drive and use machines.
However, you should know that there is a risk of hypoglycaemia when metformin is used in combination with other antidiabetic drugs (sulfonylureas, insulin, meglitinide, repaglinide). If it develops symptoms such as weakness, dizziness, increased sweating, palpitations, visual disturbances and difficulty concentrating not drive or operate machinery.
2. How to take Metfodiab
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Monotherapy and in combination with other antidiabetic drugs
The usual starting dose of Metfodiab 500 mg or 850 mg tablet 2 or 3 times during the day or immediately after a meal.
After 10-15 days your doctor will adjust your dose depending on your response to treatment. Metfodiab maximum dose is 3 g daily.
Combination with insulin:
Metfodiab can be administered with insulin. Your doctor will advise you on the correct dosage of insulin and Metfodiab.
Your doctor will check your kidney function and if your dose is determined in accordance with it.
Children and adolescents (10 to 18 years)
Monotherapy and in combination with other oral antidiabetic drugs:
The usual starting dose Metfodiab 500 mg or 850 mg tablets once daily with food or immediately after meals.
After 10-15 days your doctor will adjust your dose accordingly depending on your response to treatment. The maximum dose of Metfodiab is 2 g daily divided into 2 or 3 doses.
Method of administration
The tablets are taken orally.
Swallow the tablets whole, without chewing, during meals or after meals. This will avoid gastric discomfort. Take each tablet with a glass of water.
For a dose of 1 tablet a day, take your tablet at breakfast.
For a dose of 2 tablets per day, take 1 tablet at breakfast and 1 tablet at dinner.
For a dose of 3 tablets a day, take 1 tablet at breakfast, 1 tablet at lunch and 1 tablet at dinner.
If you take more than the amount Metfodiab
If you take more than the amount Metfodiab, it is possible to develop lactic acidosis. Symptoms include: vomiting, abdominal pain with cramps, malaise, weakness and difficulty breathing.
Contact your doctor immediately or pharmacist.
If you forget to take Metfodiab
Do not take a double dose to make up the missed dose. Take your next dose at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 patients):
Gastrointestinal disorders such as nausea, vomiting, diarrhea, pain in the abdomen and loss of appetite. These side effects occur most frequently at the beginning of treatment and disappear quickly in most cases. To prevent is recommended Metfodiab be taken 2 or 3 daily doses during or after meals. If symptoms persist, stop taking Metfodiab and contact your doctor.
Common (may affect up to 1 in 10 patients):
Very rare (may affect up to 1 in 1000 patients):
Lactic acidosis. This side effect is very rare, but serious complication particularly if your kidneys are not functioning properly. If you develop this side effect, you will need urgent medical attention. The symptoms are:
pain in the abdomen with spasms;
If you have these symptoms you need urgent treatment, which takes place in a hospital as lactic acidosis leads to coma. Stop immediately taking Metfodiab and contact your doctor or go to hospital.
Changes in liver function tests or hepatitis (inflammation of the liver; symptoms include fatigue, loss of appetite, decreased weight, with or without yellowing of the eyes. Stop taking Metfodiab and contact your doctor;
Skin reactions such as redness, itching, hives;
Low levels of vitamin B12 in the blood.
Children and adolescents
In children and adolescents the limited data showed that adverse reactions are of the same nature and severity as those seen in adults.
5. How to store Metfodiab
This medicinal product does not require any special storage conditions.
Keep out of reach of children. If a child is treated with Metfodiab, parents should monitor the use of the drug.
Do not use this medicine after the expiry date stated on the outer carton container tablets or blister. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
The active substance is metformin hydrochloride.
Each Metfodiab 500 mg film-coated tablet contains 500 mg metformin hydrochloride.
Each Metfodiab 850 mg tablets contain 850 mg of metformin hydrochloride.
Each Metfodiab 1000 mg film-coated tablet contains 1000 mg metformin hydrochloride.
Other ingredients are:
tablet core: povidone K25, 50 stearic acid, silica colloidal anhydrous;
Coating: Hypromellose 5sR, titanium dioxide, hypromellose 15sR, hypromellose 50sR, macrogol 400.
Metfodiab looks like and contents of the pack
Tablets 500 mg: white, round, biconvex film-coated tablet with "MF" on one side.
Tablets 850 mg: white, round, biconvex film-coated tablet with "MH" on one side.
Tablets of 1000 mg: white, oval-shaped capsule, biconvex tablets scored on one side and "M" and "T" on each side of the score. The tablet can be divided into two equal halves.