SOFAMET table. 850 mg. 30 tablets
SOFAMET table. 850 mg. 30 tablets
SOFAMET WHAT IS AND WHAT IT IS USED
Sofamet belongs to a class of oral antidiabetic medicines called biguanides . Sofamet a medicament for the reduction of high blood sugar levels in adult patients with diabetes ( type 2 diabetes mellitus in adults) , especially in patients with overweight wherein only diet or with physical activity may not achieve satisfactory control of the blood glucose . Sofamet can be used alone and in combination with other drugs that lower blood glucose or insulin.
2 . BEFORE YOU TAKE SOFAMET
Do not take Sofamet at :
hypersensitivity to the active substance or any of the excipients ;
increased acidity of the blood in diabetes (diabetic ketoacidosis) state prior ketoacidosis ( diabetic coma ) ;
renal failure or impaired renal function (renal failure with elevated creatinine levels) ;
acute conditions that lead to impairment of renal function such as:
fluid loss during prolonged vomiting or severe diarrhea ( dehydration) ;
severe infections ;
disturbances in blood circulation ( shock) ;
before, during, and 48 hours after tests with intravenous administration of iodinated contrast media products;
acute or chronic disease which may cause a shortage of oxygen in the tissue ( tissue hypoxia ) as :
heart failure , or disorders in the function of the lung ( respiratory failure) ;
heart attack ( recent myocardial infarction) ;
disturbances in blood circulation ( shock) .
liver dysfunction , acute alcohol intoxication , alcoholism ;
period of breastfeeding.
Take special care with Sofamet
As metformin is excreted by the kidneys , tell your doctor if you have kidney disease was found . The study of the renal function by determining the levels of serum creatinine must be performed prior to initiation of therapy and periodically thereafter. If serum creatinine is the upper limit of normal , the evaluation should be performed at least 3-4 times a year ;
In the event of unacceptable accumulation , metformin may induce or facilitate increasing the acidity of the blood lactic acid ( lactic acidosis) - complication if not treated promptly can lead to life-threatening (e.g., coma ) . Cause of lactic acidosis can be not only an overdose , but failure to contraindications ;
Symptoms of lactic acidosis may beginning to resemble the side effects of metformin on the gastrointestinal tract : nausea , vomiting, diarrhea and abdominal pain . Within a few hours can manifest the full clinical picture with muscle pain and cramps, deep breathing noisy and blurred consciousness to coma. This requires immediate treatment in a hospital setting ;
Particular care is needed in cases where the expected impairment of renal function , such as at the beginning of therapy with certain medications for high blood pressure of rheumatic diseases or treatment with water tablets ;
It should be used with caution in liver function abnormalities ;
In studies with intravenous administration of iodinated radiopaque agents are at risk of renal impairment . Therefore, the administration of metformin should be discontinued prior to or during the study , and to be restarted no earlier than 48 hours afterwards, provided that renal function is normal ;
If you are scheduled for surgery with general anesthesia , treatment with metformin should be stopped two days before the operation. Treatment may be resumed two days after surgery , and only if it is found normal renal function;
During treatment with metformin Continue to follow the diet , paying particular attention to the daily intake of carbohydrates. If you are overweight , you should continue to follow your diet for weight reduction under medical supervision;
Ingestion of large amounts of alcohol is a risk of hypoglycaemia and lactic acidosis. During therapy with metformin should avoid alcohol ;
Metformin alone does not cause hypoglycemia, but it needs attention , when used in combination with insulin or sulphonylureas ;
When metformin hold regular conventional laboratory tests to monitor diabetes.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
During prolonged treatment with metformin both start and termination of additional drug therapy can affect the regulation of blood sugar.
Tell your doctor if you are being treated for diabetes with other oral antidiabetic agents (sulfonylureas and acarbose ) or insulin if you are taking or have recently taken any hormonal products (corticosteroids , estrogens , oral contraceptives , thyroid hormones , adrenaline ) , certain drugs for the treatment asthma ( beta- sympathomimetics) , drugs for the regulation of high blood pressure (ACE - inhibitors, beta - blockers, clonidine , reserpine , and the like . ) , water tablets ( diuretics) , non-steroidal anti-inflammatory agents , anti-coagulants (anticoagulants ) . If you are taking other medications such as MAO inhibitors, amiloride , digoxin , morphine, procainamide , quinidine , ranitidine , cimetidine trimethoprim , fibrates, vancomycin , cyclophosphamide or its derivatives , alcohol-containing products report this to your doctor. Tell your doctor if you are going with iodinated radiopaque agents.
Taking Sofamet with food and drink
During use of Sofamet should avoid consuming alcohol .
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine . It is not recommended to treat Sofamet pregnancies . In this case, usually prescribed insulin because it provides better control of blood glucose levels in the blood. Sofamet should not be used during breastfeeding.
Driving and using machines
Self- treatment with Sofamet induce hypoglycaemia and therefore has no effect on ability to drive and use machines. However, the risk of hypoglycaemia has when Sofamet is used in combination with other antidiabetics . If signs of hypoglycemia should avoid engaging in such activities.
Important information about some of the ingredients of Sofamet
Sofamet contains sorbitol as an excipient. If your doctor told you that you have an intolerance to some sugars, contact your doctor before taking the drug.
3 . HOW TO TAKE SOFAMET
Always take Sofamet exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
The dosage is determined by a doctor for each specific patient depending on the levels of blood glucose and regularly monitored by the physician.
Sofamet administered 2 to 3 times a day , during or after meals. Recommended that treatment begin with gradual dose escalation .
Usually it starts with 1 tablet per day. With an insufficient response, the dose is increased by 1 tablet once a week or every other week until a dose of 3 tablets a day. Later, the doctor can determine the maintenance dose of 1 tablet 2-3 times daily.
Since the elderly are often observed renal impairment dose Sofamet should be determined by her condition Therefore , renal function should be monitored regularly by your doctor.
Due to lack of sufficient data Sofamet not be used in children .
If you take more dose Sofamet
Please tell your doctor immediately if you take more than the usual dose Sofamet . Overdose with Sofamet not unduly low blood sugar ( hypoglycemia) , but may increase the risk of lactic acidosis. Symptoms of lactic acidosis may beginning to resemble the side effects of metformin on the gastrointestinal tract , vomiting, diarrhea and abdominal pain . Full clinical picture with muscle pain and cramps, deep breathing noisy and blurred consciousness and coma may develop within a few hours and requires immediate hospitalization.
If you forget to take Sofamet
If you forget to take Sofamet , take your normal dose on the next intake and try in the future to follow instructions given to you . Do not take a double dose to make up for a missed dose.
If you stop taking Sofamet
If you stop treatment alone without telling your doctor , you can expect an uncontrolled increase in blood glucose levels .
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, Sofamet can cause side effects, although not everybody gets them .
When treated with Sofamet may experience the following side effects: nausea , vomiting , loss of appetite , abdominal pain , diarrhea, metallic taste in the mouth.
Usually appear in the beginning of the treatment and in most cases resolve spontaneously . These events are rare , if they are taken with meals or immediately thereafter. The slow increase of the dose also will contribute to reduction of intestinal complaints.
Skin reactions such as rash or redness of the skin have been reported very rarely in some hypersensitive patients.
During continuous treatment attenuation level of vitamin B12 in the body.
In very rare cases may be severe metabolic disorders due to lactic acidosis.
Abnormal results of liver function tests or hepatitis occur rarely and resolved upon discontinuation of the drug.
If any of the side effects gets serious , or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5 . STORAGE SOFAMET
Store in the original package to protect from light and moisture.
Do not store above 25 ° C.
Keep out of reach of children.
Sofamet not use after the expiry date stated on the pack . The expiry date refers to the last day of that month.
Medicines should not be disposed of 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 . ADDITIONAL INFORMATION
What does Sofamet
The active ingredient metformin hydrochloride (metformin hydrochloride) 850 mg.
Other ingredients are: microcrystalline cellulose , Povidone K25 , sorbitol, magnesium stearate.
Film coating - opadry white .
Sofamet looks like and contents of pack
Oblong, biconvex film-coated tablets , scored on both sides, length 20 mm, width of 8 mm, height 6,5 mm, white in color , odorless .
10 film-coated tablets in blister PVC / aluminum foil 3 blisters in a carton with leaflet.