METFODIAB 1000 mg. 30 tablets

What is Metfodiab and what it is used
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 produces insulin, which is not absorbed correctly.
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 your body's sensitivity 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. Yet sometimes used together with other anti-diabetes medicines or with insulin.
Metfodiab can be used in children over 10 years, alone or with insulin.

In obese patients, prolonged use of Metfodiab also helps reduce the risk of problems associated with diabetes.

2. What you should know before using Metfodiab
He take Metfodiab:
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. Signs are stomach pain, palpitations, drowsiness, or unusual breath fruit of the 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 abusing alcohol consumption (every day or only occasionally).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Metfodiab.

Pay special attention to the risk of lactic acidosis (excess 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 pain (or abdominal) with muscle cramps, malaise with severe fatigue and difficulty breathing.
If this occurs in you may need immediate hospital treatment, as lactic acidosis may lead to coma. Immediately discontinue Metfodiab and contact a doctor or nearest hospital.

Metfodiab induce hypoglycaemia (very low blood sugar) when used alone. However, if taking Metfodiab concomitantly with other drugs for the treatment of diabetes, which can cause hypoglycemia (such as insulin or other antidiabetics orally - eg. Sulphonylureas or meglitinides), this may lead to hypoglycemia. When symptoms of hypoglycaemia, such as weakness, dizziness, increased sweating, palpitations, visual impairment, difficulty in concentration, it is recommended 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 ingredient in Metfodiab) is excreted primarily through the kidneys.
Special care is required if renal function is impaired, for example in the elderly or in 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. Should not re-start taking this medicine until 48 hours have elapsed from the X-ray and then only if you made a study of renal function and the results are the norm.
If you have surgery, 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 before 48 hours have elapsed after surgery or after it is possible to eat by mouth.

Follow the specific diet, you are prescribed, because it is important for controlling diabetes.
Do not miss the usual laboratory tests for diabetes control.

Children and adolescents
In children (especially in the age before puberty) doctor will regularly monitor the impact 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 the doctor knows if you are taking corticosteroids (used to treat various conditions such as strong skin inflammation 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 meals or immediately after meals.
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, 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 metformin alone does not cause hypoglycaemia, which 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, a meglitinide, repaglinide). If you develop symptoms such as weakness, dizziness, increased sweating, palpitations, visual impairment, difficulty in concentration do not drive or operate machinery.

2. How to take Metfodiab
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Adults
Monotherapy and in combination with other antidiabetic agents
The usual starting dose is 500 mg Metfodiab 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. The maximum dose is Metfodiab 3 g daily.

Combination with insulin:
Metfodiab can be administered with insulin. Your doctor will advise you on the correct dose of insulin and Metfodiab.

Elderly:
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 is 500 mg Metfodiab 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 per day, take your tablet at breakfast.
For a dose of 2 tablets per day, take one tablet at breakfast and 1 tablet of dinner.
For a dose of 3 tablets a day, take 1 tablet at breakfast, 1 tablet at lunch and 1 tablet of dinner.
If you take more dose Metfodiab
If you take more dose Metfodiab, it is possible to develop lactic acidosis. Symptoms include vomiting, abdominal pain with cramps, malaise, weakness and difficulty breathing.
Immediately contact a doctor or pharmacist.

If you forget to take Metfodiab
Do not take a double dose to make up the missed dose. Take the 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. In order to avoid, recommended Metfodiab be administered in 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):
Dysgeusia.
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 emergency medical care. The symptoms are:
vomiting;
pain in the abdomen with spasms;
malaise;
weakness;
difficulty breathing.
If you have these symptoms you need urgent treatment, which takes place in a hospital, as lactic acidosis leads to coma. Stop taking Metfodiab immediately 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, weight reduction, 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 Limited data indicate that adverse effects 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 the reach and sight of children. If the 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 carton, container tablets or blister. The expiry date refers to the last day of that month.