Glibomet™

[Glibenclamide + Metformin]

Product Name

Active Ingredients

Each film-coated tablet contains: Active ingredients: Glibenclamide 2.5 mg; Metformin hydrochloride 400 mg.

Description / Properties

Glibomet is an oral antidiabetic preparation which combines two substances, at adequate dosages, capable of lowering glycemia, a sulphonylurea (Glibenclamide) that stimulates insulin secretion by the pancreas and a Biguanide (Metformin) that improves insulin action.

Marketing Authorization

Laboratori Guidotti S.p. A., Via Livornese 897 - Pisa - La Vettola.

Indications

Diabetes Mellitus Type 2 (non-insulin dependent) that cannot be controlled by diet alone or diet and sulphonylurea or Biguanide.

Contraindication

Individual hypersensitivity to the single active ingredients (Glibenclamide, Metformin) or to any of the excepients; gestational diabetes, type 1 diabetes (insulin dependent) diabetic coma and precoma, serum creatinine above 12mg/l; diabetics with previous episodes of lactic acidosis; seriously impaired liver or renal function; ongoing treatment with diuretics or anti-hypertensive agents susceptible of provoking alterations in the kidney function or during intravenous urography; severe cardio circulatory disorders (cardiac decompensation, cardiogenic or toxinfective shock; peripheral arterial circulatory disorders); serious respiratory disorders; adrenal insufficiency, chronic alcoholism; very low-calorie diets and especially fasting; serious dystrophic diseases; severe acute haemorrhage; shock; gangrene; pregnancy and lactation. During the two days prior to or following surgery.

Drug Interactions

The hypoglycemic effect of Glibenclamide can be increased by dicumarol and its derivatives, by monoaminoxidase inhibitors, by sulfa drugs, phenylbutazone and its derivatives, by chloramphenicol, cyclophosphamide, probenecid, phenyramidol and salicylates, oral miconazole, sulfinpyrazone, perhexiline and ingestion of large amounts of alcohol; it can be decreased by adrenalin, corticosteroids, oral contraceptives, thiazide diuretics and barbiturates. Caution must be exercised when administered contemporaneously with ?-blockers. It should be taken into consideration that Metformin may increase the effects of anti-coagulants.

Side Effects

Signs of hypoglycemia may develop (although rarely) especially in debilitated, elderly patients or in case of unusual physical stress, irregular eating habits or use of alcoholic beverages and in case of compromised renal and/or hepatic function (see also Precautions for Use). Headache and gastrointestinal disorders (nausea, loss of appetite, abdominal pain, vomiting or diarrhea) that may require the interruption of treatment are possible. Allergic cutaneous manifestations can occur in rare cases, but these are generally transitory and disappear as the treatment continues. Patients with a predisposition due to existing renal insufficiency, severe cardiocirculatory disorders or respiratory insufficiency, may show symptoms of lactic acidosis, though rarely, (see Precautions for use ) that require adequate medical treatment by the physician. Lactic acidosis may be favoured by the contemporaneous ingestion of alcohol. Blood cell count alterations are very rare and generally reversible.

Warning and Precautions

Patients under treatment must be frequently monitored to detect possible factors or conditions which may favour the appearance of lactic acidosis, taking into consideration that the risk of this inconvenience is more frequent in cases of hepatic and/or renal insufficiency, cardiorespiratory failure, alcohol intoxication, prolonged fasting, in treatment with diuretics and in gastrointestinal disorders; in each case, patients must be instructed to recognise the symptoms of lactic acidosis (anorexia, nausea, fever, vomiting, muscle cramps, increased respiratory frequency and volume, malaise, abdominal pain, diarrhea and possible obnubilation or loss of consciousness) and of hypoglycemia (headache, irritability, sleep disturbance, nervous depression, tremor, excessive sweating) so that they can immediately contact the physician, who must also be informed of ongoing febrile illnesses or digestive disorders. In this case, the physician should promptly examine the case. Since a slight disorder of renal function may also increase considerably the risk of lactic acidosis, it is necessary to assess renal function before starting the treatment and then repeatedly at least every 8 weeks during the first six months of therapy and subsequently every six months.

Special Warnings

Each treatment and in particular the transfer from or to other hypoglycemic must be prescribed by the physician. It is necessary to strictly follow the medical prescription concerning dosage and type of administration as well as the concomitant diet and exercise regimes. Use must be limited to patients affected by Diabetes Mellitus Type 2 which cannot be controlled by diet alone. In case of hypoglycemic symptoms (see. Side Effects) administer carbohydrates (sugar); in more serious cases, which only rarely lead to loss of consciousness, perform an i.v. slow infusion of glucose solution. In case of trauma, surgery, infective and febrile diseases it may be necessary to institute insulin therapy temporarily in order to maintain adequate metabolic control. After the ingestion of alcoholic beverages, it is necessary to consider the possibility of reactions such as general malaise, respiratory difficulty, palpitation, headache, nausea, vomiting.
The treatment must be suspended 48 hours prior to an angiography or urography and resumed, if necessary, 48 hours after the test.

Effects On Ability to Drive and Operate Machinery

The product may cause hypoglycemia and a consequent reduction in concentration and reaction ability. This must be taken into consideration before driving and operating machinery.

Dosage

The daily doses, administration and duration of treatment must be established by the physician for each patient on the basis of metabolic tests. In general, the starting dose is 2 tablets per day with main meals. Doses should never exceed 6 tablets. Subsequently, the daily dose must be gradually decreased until the minimum amount needed to control the glycemia is reached.

Overdose

Ingestion of an excessive dose can determine the onset of symptoms of hypoglycemia (see Precautions for Use) that may require administration of sugar or, in serious cases, the intervention of a physician. There may also be gastrointestinal disorders and symptoms, of lactic acidosis (see Precautions for Use) that require intervention by the physician.

Presentations Available

(Glibenclamide 2.5 mg + Metformin 400 mg) film-coated tablets

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