Gibtulio-10mg (Empagliflozin 10mg) Tablets

Gibtulio general information

What is Gibtulio used for?

Gibtulio tablets10mg are used to treat Type 2 Diabetes Mellitus (T2DM), also known as non-insulin-dependent diabetes to improve control of blood sugar levels (glycaemic control) when diet and exercise alone does not provide adequate glycaemic control.  T2DM is a disease characterised by high blood sugar levels (hyperglycaemia ) that are difficult to control (poor glycaemic control) due to chronic damage to the beta cells of the pancreas and loss of their normal function, which is the production of insulin in response to increase in blood glucose, particularly following a meal.  Insulin resistance is another reason for poor glycaemic control in T2DM.  Gibtulio tablets10mg are used in combination with improved diet and increased exercise and can be used as monotherapy, when metformin is considered inappropriate due to intolerance, or as add-on therapy with other oral antihyperglycaemic medications such as, a thiazolidinedione, a sulphonylurea or insulin.  Gibtulio tablets10mg help restore glycaemic control and helps prevent or delay the development of serious complications of T2DM.  These include cardiovascular disease leading to heart attack and stroke; also microvascular damage (damage to capillaries) in the eye, kidney or nerves that can lead to diabetic retinopathy, nephropathy or neuropathy and contribute to blindness, kidney disease, foot ulcers.  In extreme cases microvascular damage can result in amputation. 

How does Gibtulio work?

Gibtulio tablets10mg contain empagliflozin, an oral antihyperglycaemic belonging to the gliflozin group of drugs that work by inhibiting glucose reabsorption by the kidney.  Under normal conditions the kidneys filter glucose out of the blood into the proximal renal tubules where it is reabsorbed back into the blood to be used as an energy source by the body.  Renal glucose reabsorption is carried out by the transporter protein sodium-glucose co-transporter 2 (SGLT2), which is responsible for the majority of filtered glucose reabsorption in proximal tubule of the kidneys.  Sodium-glucose co-transporter 2 SGLT1, located further down the proximal tubule reabsorbs the remaining glucose.  Under normal conditions there should be no filtered glucose remaining in the urine.  However, when there is too much glucose in the blood, as is the case in T2DM, it cannot all be reabsorbed and the excess is excreted in the urine.  Also the capacity to reabsorb glucose is increased in T2DM, which contributes to hyperglycaemia.  Empagliflozin in Gibtulio tablets10mg inhibit the action of SGLT2, which prevents glucose reabsorption and allows excess glucose to be excreted in the urine.  This results in reduced blood glucose levels and increased urinary glucose excretion; other health benefits include a reduction in blood pressure, due to increased diuretic effect (water loss) and reduced body weight due to a reduction in glucose availability.  Gibtulio tablets10mg reduce blood glucose levels and help maintain glycaemic control. 

What does Gibtulio contain?

Gibtulio tablets10mg contain the active ingredient empagliflozin, an oral antihyperglycaemic used to improve glycaemic control in T2DM. 

Treating Type 2 Diabetes Mellitus with Gibtulio

Gibtulio tablets10mg contain empagliflozin an oral antihyperglycaemic used to improve glycaemic control in T2DM, when diet and exercise alone is not sufficient to provide adequate glycaemic control.  T2DM is a disease characterised by high blood sugar levels (hyperglycaemia ) that are difficult to control (poor glycaemic control) due to chronic damage to the beta cells of the pancreas and loss of their normal function, which is the production of insulin in response to increase in blood glucose, particularly following a meal.  Insulin resistance is another reason for poor glycaemic control in T2DM.  Gibtulio tablets10mg are used in combination with improved diet and increased exercise and can be used as monotherapy or as add-on therapy with other oral antihyperglycaemic medications, when diet and exercise alone, does not provide adequate glycaemic control.  Empagliflozin in Gibtulio tablets10mg inhibits glucose reabsorption by the kidney and works by blocking the action of the sodium-glucose co-transporter 2 (SGLT2,) which is responsible for the majority of filtered glucose reabsorption in proximal tubule of the kidneys.  Under normal conditions the kidneys filter glucose out of the blood into the proximal renal tubules where it is reabsorbed back into the blood to be used as an energy source by the body.  In T2DM there is excess glucose in the blood and it cannot all be reabsorbed therefore, the excess is excreted in the urine.  Empagliflozin in Gibtulio tablets10mg prevents glucose reabsorption and allows excess glucose to be excreted in the urine.  This results in reduced blood glucose levels and increased urinary glucose excretion, which helps maintain glycaemic control.  Improving glycaemic control reduces risk of cardiovascular complications including microvascular damage (damage to capillaries) in the eye, kidney or nerves, which can lead to diabetic retinopathy, nephropathy or neuropathy, causing to blindness, kidney disease, foot ulcers and in extreme cases amputation. 

What are the side effects of Gibtulio?

The most commonly reported side effects when taking Gibtulio tablets10mg include: hypoglycaemia in combination with insulin or sulphonylurea, yeast infection of the vagina (vulvovaginal candidiasis) or penis (balanitis, balanoposthitis), urinary tract infection, increased urination frequency and urinary amount, dehydration, thirst, constipation, nausea.

When should Gibtulio not be used?

You should not use Gibtulio tablets10mg if you:

• are allergic to empagliflozin or any ingredients in Gibtulio
• are pregnant or are breastfeeding
• have type 1 (insulin dependent) diabetes
• have diabetic ketoacidosis
• have severe kidney or liver disease
• are taking other antidiabetics like insulin or a sulphonylurea without discussion with your doctor
• are taking medicines that interact with Gibtulio, including the antiinfective rifampin for treatment of tuberculosis, digoxin for heart failure, the anticonvulsants phenytoin, carbamazepine or phenobarbital, ritonavir for HIV infection, diuretics (water pills), cholestyramine for high cholesterol

What medications interact with Gibtulio?

Several medications interact with Gibtulio and should either not be taken while you are taking Gibtulio or only after discussion and instruction from your doctor:

• Drugs that cause a serious reaction with Gibtulio: other antidiabetics like insulin or a sulphonylurea can cause hypoglycaemia (low blood sugar), diuretics can increase risk of dehydration and hypotension (low blood pressure)
• Drugs that affect Gibtulio: rifampin for treatment of tuberculosis, the anticonvulsants phenytoin, carbamazepine or phenobarbital, ritonavir for HIV infection, cholestyramine for high cholesterol
• Drugs that are affected by Gibtulio: digoxin for heart failure

How should Gibtulio be taken?

You should take your Gibtulio tablets10mg swallowed whole with a glass of water, once daily with or without food at the same time each day but preferably before the first meal of the day.  The dose you take depends on your doctor’s recommendation and you should continue with your prescribed diet and exercise programme.  You should continue to take your Gibtulio tablets10mg for as long as recommended by your doctor. 

How long should you take Gibtulio?

You should continue to take your Gibtulio tablets10mg for as long as recommended by your doctor.  

Missed dose of Gibtulio

If you miss a dose of Gibtulio tablets10mg take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Gibtulio be stored?

You should store your Gibtulio tablets10mg below 25°C in a cool dry place.