COMPOSITIONS :
Benofomin® Film coated tablet 500 mg, each film coated tablet contains : Metformin HCl 500 mg.
DESCRIPTIONS :
Benofomin® contains Metformin HCl as active ingredient is available in film coated tablet 500 mg and film coated caplet 850 mg.
INDICATIONS :
- For therapy in non-Insulin dependent diabetes patients and overweight whose blood sugar level cannot be controlled with diet alone. Could be used as monotherapy or given as combined drug with the sulphonylureas.
- For supplementary therapy in diabetes with Insulin dependence whose symptoms difficult to be controlled.
DOSAGE AND ADMINISTRATIONS :
Benofomin® given with meal or after meal.
Adults :
- Initiation :
Benofomin® film coated caplet 850 mg, 2 times daily or Benofomin® film coated tablet 500 mg, 3 times daily. This can be achieved in several days, but not infrequently the effect can be achieved after 2 weeks. If the desirable effects not achieved, the dose can be increased carefully until maximum 3 g daily. If the diabetes symptoms can be controlled already, the dose can be reduced.
- If Combined with Sulphonylurea Usage :
Initially given 1 film coated tablet Benofomin® 500 mg or ½ – 1 film coated caplet Benofomin® 850 mg, then increase the dose slowly until the optimal control achieved. Oftentimes the dose of sulphonylurea can be reduced in several patients even not necessary to be given anymore. The therapy can be continued with Benofomin® as monotherapy.
- If Given Concomitantly with Insulin :
- If The Insulin Dose is Less Than 60 Units Daily :
Initially given 1 Benofomin® film coated tablet 500 mg or ½ – 1 Benofomin® film coated caplet 850 mg, the Insulin dose reduced gradually (4 units every 2 – 4 days). The usage of Benofomin® film coated tablet or Benofomin® film coated caplet can be added every weekly interval.
2. If The Insulin Dose is More Than 60 Units Daily :
Sometimes Metformin HCl administration reduces the blood sugar level rapidly. Those kind of patients must be observed carefully in 24 hours after Metformin HCl administration. After that, follow the instruction in point (a).
Single Trial Dosage :
Determination of the blood sugar level after administration of a single trial dosage does not give any guidance if a diabetes patient will give any response to Metformin after weeks. Therefore, single dosage trial cannot be used as evaluation.
OVERDOSAGE :
Symptom of Overdosage :
Hypoglicemia could be happened if given concomitantly with sulphonylurea, Insulin, or Alcohol.
In excessive dose, acidosis may occurs.
Treatment of Overdosage :
Supportive therapy can be given intensively, particularly for fixing the loss of fluid from metabolic disorder.
CONTRAINDICATIONS :
- Hypersensitive to this drug.
- Diabetic coma and ketoacidosis.
- Renal impairment.
- Chronic liver disease, heart failure and myocardial infarction, alcoholism, history or conditions related to lactate acidosis, such as : Shock or pulmonary insufficiency and condition related to hypoxemia.
- Pregnancy and lactation.
WARNINGS AND PRECAUTIONS :
- Use carefully in patients with renal insufficiency.
- Not recommended for use in conditions causing dehydration or in patients whose has just recovered from serious infections or trauma.
- It is recommended to check the level of Vitamin B12 regularly in long term usage.
- Because of there is possibility of hypoglycaemia in combination therapy with sulphonylurea, the blood sugar level must be monitored.
- In the combination therapy of Metformin and Insulin, it is recommended to be conducted in the hospital so that the steady ratio of both drugs can be achieved.
- Use carefully in elderly patients with renal insufficiency.
- Not recommended for usage in children.
PRESENTATIONS :
Benofomin® Film coated tablet 500 mg Box, 10 strips @ 10 film coated tablets
Reg. No. DKL9402319417A1
STORAGE :
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
