GIBTULIO SM 10/1000MG Tablet

Name

• Brand Name: GIBTULIO-SM 10/1000 Tablet, GIBTULIO-SM 10/1000 Tablet ER
• Manufacturer: Lupin Ltd. (LUPIN LTD-ASPIRE DIV.)

Composition

Each tablet contains three active ingredients:

• Empagliflozin: 10 mg
• Metformin: 1000 mg
• Sitagliptin: 100 mg

Uses

GIBTULIO SM 10/1000MG Tablet is primarily used for the management of type 2 diabetes mellitus in adults. It is typically prescribed when diet and exercise alone are insufficient, or when blood sugar is not adequately controlled with Metformin monotherapy. This combination therapy helps improve blood sugar control by:

• Removing excess glucose through urine (Empagliflozin).
• Reducing sugar production in the liver and improving the body's response to insulin (Metformin).
• Increasing natural hormones (incretins) that stimulate insulin release after meals and reduce excess sugar release from the liver (Sitagliptin).

Effective management of blood sugar levels with this medication may also help lower the risk of diabetic complications such as retinopathy, nephropathy, neuropathy, diabetic foot ulcers, and delayed wound healing.

Dosage and Administration

GIBTULIO SM 10/1000MG Tablet should be taken orally with meals, usually once or twice daily, as advised by your doctor. It can be taken with or without food, but it is better to take it at a fixed time each day to maintain steady blood sugar control. Do not chew, crush, or break the tablet. The dosage depends on the medical condition and response to treatment. Do not skip doses or discontinue without medical advice. If a dose is missed, take it as soon as remembered, but do not double the dose.

Side Effects

Common side effects may include:

• Increased urination/frequent urge to urinate
• Nausea
• Diarrhea
• Stomach upset
• Skin rash
• Hypoglycemia (low blood glucose level), especially when taken with insulin or sulfonylureas
• Headache
• Increased thirst
• Constipation
• Urinary tract infection

Serious side effects, though rare, can include:

• Dehydration
• Ketoacidosis

Precautions

• Contraindications: Not recommended for patients with type 1 diabetes, severe kidney problems, end-stage renal disease, liver disease, metabolic acidosis, or diabetic ketoacidosis.
• Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding unless clearly needed and the benefits outweigh the risks. Consult a doctor if pregnant, planning pregnancy, or breastfeeding.
• Alcohol: Avoid alcohol consumption as it can increase the risk of lactic acidosis and low blood sugar.
• Driving and Machinery: Caution is advised when driving or operating machinery, as fluctuations in blood sugar may affect alertness.
• Kidney and Liver Function: Use with caution in patients with kidney or liver disease; dose adjustment may be needed. Regular monitoring of kidney function, blood sugar, and hydration status is advised.
• Other Warnings: Inform your doctor about all medical conditions, medications, and allergies before starting treatment. Not recommended for children under 18 years of age. Symptoms of low blood sugar (sweating, dizziness, fast heartbeat, intense thirst) should be addressed immediately with a sugary snack. Report symptoms like extreme thirst, nausea, vomiting, or rapid breathing (possible ketoacidosis) to your doctor immediately.

Storage

Store in a cool and dry place, away from sunlight. Keep out of sight and reach of children. Store below 30°C.

GIBTULIO SM 10/1000MG Tablet: Frequently Asked Questions

GIBTULIO SM 10/1000MG Tablet is a medication used to manage Type 2 Diabetes Mellitus. It combines three active ingredients: Empagliflozin, Metformin, and Sitagliptin, which work together to help control blood sugar levels.

What is GIBTULIO SM 10/1000MG Tablet used for?

GIBTULIO SM 10/1000MG Tablet is primarily used to manage Type 2 Diabetes Mellitus in adults, especially when diet and exercise alone are insufficient. It helps improve blood sugar control and can reduce the risk of diabetes-related complications such as heart disease, kidney problems, and nerve damage. It is not recommended for Type 1 diabetes.

How does GIBTULIO SM 10/1000MG Tablet work?

This medicine contains three active ingredients that work in complementary ways:

• Empagliflozin: This is an SGLT2 inhibitor that helps the kidneys remove excess sugar from the body through urine.
• Metformin: This reduces the production of sugar in the liver, decreases sugar absorption from food in the intestine, and improves the body's response to insulin.
• Sitagliptin: This increases natural hormones (incretins) that stimulate insulin release after meals and reduce excess sugar released by the liver.

Together, these actions lead to more effective and stable blood sugar control.

What is the usual dosage for GIBTULIO SM 10/1000MG Tablet?

GIBTULIO SM 10/1000MG Tablet is typically taken by mouth with meals, usually once or twice daily, as advised by your doctor. It is important to take it at the same time each day to maintain consistent blood sugar control. Do not chew, crush, or break the tablets; swallow them whole with water. The exact dose depends on your medical condition and how you respond to treatment.

What are the possible side effects of GIBTULIO SM 10/1000MG Tablet?

Common side effects can include increased urination, nausea, diarrhea, stomach upset, skin rash, headache, thirst, constipation, and urinary tract infections. More serious but less common side effects can include hypoglycemia (low blood sugar, especially when taken with insulin or sulfonylureas), dehydration, excessive thirst, and ketoacidosis. If side effects persist or worsen, consult your doctor.

Is GIBTULIO SM 10/1000MG Tablet safe during pregnancy or breastfeeding?

GIBTULIO SM 10/1000MG Tablet is generally not recommended during pregnancy or breastfeeding. Limited human data and animal studies suggest potential risks to the developing baby or that the medicine may pass into breast milk. You should discuss your full medical history with your doctor, including if you are pregnant, planning to get pregnant, or breastfeeding, before starting this treatment.

Can GIBTULIO SM 10/1000MG Tablet be taken with other medications?

It is important to inform your doctor about all the medications, supplements, or herbs you are currently taking or plan to take to avoid potential interactions. Combining GIBTULIO SM with insulin or sulfonylureas may increase the risk of low blood sugar. The medication can also interact with certain blood pressure medications (like diuretics), anti-infectives, and other drugs.

What precautions should be taken while using GIBTULIO SM 10/1000MG Tablet?

• Avoid alcohol consumption, as it can worsen side effects like lactic acidosis and increase the risk of low blood sugar.
• Caution is advised when driving or operating machinery, as fluctuations in blood sugar can affect alertness.
• This medicine is not recommended for children, or individuals with severe kidney problems, end-stage renal disease, or liver disease.
• Stay well-hydrated to prevent dehydration and kidney problems.
• Monitor blood sugar levels regularly and be aware of symptoms of low blood sugar (hypoglycemia) such as sweating, dizziness, or fast heartbeat.
• Discuss any history of frequent urinary or genital infections, heart failure, or low blood pressure with your doctor.

What happens if a dose of GIBTULIO SM 10/1000MG Tablet is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one. It is important not to skip doses frequently, as this can lead to uncontrolled blood sugar levels.

How should GIBTULIO SM 10/1000MG Tablet be stored?

GIBTULIO SM 10/1000MG Tablet should be stored in a cool and dry place, away from direct sunlight. Keep it out of sight and reach of children. The recommended storage temperature is below 30°C.