Ajaduo M 25 Forte Tab

AJADUO M 25 FORTE TAB by LUPIN LTD

AJADUO M 25 FORTE TAB is a prescription medication manufactured by Lupin Ltd., indicated for the management of Type 2 Diabetes Mellitus. It is designed to help improve blood sugar control in adults and may also reduce the risk of heart-related death and hospitalization due to heart failure in patients with existing cardiovascular conditions.

Composition Each tablet of AJADUO M 25 FORTE TAB contains a triple fixed-dose combination of active ingredients:

• Empagliflozin: 25 mg
• Linagliptin: 5 mg
• Metformin (Extended Release/ER): 1000 mg

Uses

• To manage blood sugar levels in adults with Type 2 Diabetes Mellitus.
• To reduce the risk of cardiovascular death in adults with Type 2 Diabetes and pre-existing heart disease.
• To prevent hospitalization due to heart failure in patients with Type 2 Diabetes and existing heart conditions.
• Metformin, a component of this medicine, is also used off-label to support hormone balance in Polycystic Ovarian Syndrome (PCOS).

Dosage and Administration AJADUO M 25 FORTE TAB should be taken exactly as prescribed by your doctor, preferably at the same time each day. It is recommended to take the tablet with food. Swallow the tablet whole; do not chew, crush, or break it, especially since it contains an extended-release formulation of Metformin. Do not stop taking the medicine without your doctor's approval. If a dose is missed, take it as soon as you remember, unless it is close to the time for your next dose, in which case skip the missed dose.

Side Effects Common side effects may include:

• Upper respiratory tract infection, urinary tract infection
• Diarrhea, stomach discomfort, nausea, vomiting, constipation, not feeling hungry
• Headache, stuffy or runny nose, sore throat, cough
• Frequent urination, dizziness, light-headedness
• Low blood sugar (hypoglycemia)

Serious but rare side effects can include lactic acidosis, which may present as muscle pain, difficulty breathing, stomach pain, or weakness. Report any persistent or worsening side effects to your doctor.

Precautions

• Allergies: Do not take this medicine if you are allergic to empagliflozin, linagliptin, metformin, or any other ingredients.
• Kidney/Liver Conditions: Use with caution in patients with severe kidney disease; it is generally avoided in liver disease. Inform your doctor if you have kidney or liver problems, as metformin is cleared by the kidneys.
• Metabolic Acidosis: Not recommended for patients with metabolic acidosis.
• Age: Extra care is needed for older adults, and it may not be prescribed to patients 80 years of age or older.
• Pregnancy & Breastfeeding: AJADUO M 25 FORTE TAB is not recommended during pregnancy or breastfeeding due to potential risks.
• Alcohol Consumption: Avoid alcohol as it can increase the risk of lactic acidosis and cause fluctuations in blood sugar levels.
• Dehydration: Ensure adequate fluid intake daily unless otherwise advised by your doctor.
• Drug Interactions: Inform your doctor about all other medications, supplements, or herbal products you are taking. Interactions can occur with diuretics, certain heart medicines, cimetidine, birth control pills, insulin, or sulfonylureas, which may increase the risk of hypoglycemia.
• Surgery/Imaging: Inform your doctor before any planned surgeries or contrast imaging tests, as temporary discontinuation may be required to prevent kidney problems.
• Hypoglycemia: Carry a source of fast-acting sugar (e.g., glucose tablets, candy) to manage symptoms of low blood sugar.

Storage Store AJADUO M 25 FORTE TAB at room temperature, generally below 30°C. Keep the medicine away from direct sunlight, moisture, and out of the reach of children. Do not use the medicine past its expiry date.

AJADUO M 25 FORTE TAB is a combination medication used for the management of Type 2 Diabetes Mellitus. It combines three active ingredients: Empagliflozin, Linagliptin, and Metformin Extended Release (ER).

What is AJADUO M 25 FORTE TAB used for?

AJADUO M 25 FORTE TAB is primarily used to improve blood sugar control in adults with Type 2 Diabetes Mellitus, especially when diet and exercise alone are not sufficient. It can also help reduce the risk of heart-related death in adults with type 2 diabetes and pre-existing heart conditions. Additionally, metformin, one of its components, can support hormone balance in Polycystic Ovary Syndrome (PCOS).

How does AJADUO M 25 FORTE TAB work?

This medication works through multiple complementary mechanisms due to its three active ingredients:

• Empagliflozin (an SGLT2 inhibitor) blocks a protein in the kidneys (SGLT2), which normally reabsorbs sugar back into the blood. By blocking this, more sugar is removed from the body through urine.
• Linagliptin (a DPP-4 inhibitor) targets an enzyme (DPP-4) that breaks down hormones crucial for insulin release and for lowering sugar levels after meals. It enhances these hormones, improving insulin secretion and reducing glucagon release.
• Metformin reduces the amount of sugar the liver makes, lowers how much sugar the body absorbs from food, and makes the body more responsive to insulin.

What is the usual dosage?

AJADUO M 25 FORTE TAB should be taken exactly as prescribed by your doctor. It is typically taken once daily, with or without food, preferably at the same time each day. Do not chew, crush, or break the extended-release tablet.

What are the possible side effects?

Common side effects include upper respiratory tract infection, constipation, urinary tract infection, headache, stuffy or runny nose, sore throat, diarrhea, nausea, upset stomach, and genital fungal infections. Rare but serious side effects can include lactic acidosis (too much acid in the blood) and severe hypoglycemia (low blood sugar), especially when combined with other antidiabetic medications.

Is it safe during pregnancy or breastfeeding?

AJADUO M 25 FORTE TAB is generally not recommended during pregnancy or while breastfeeding due to potential risks to the baby. It is crucial to consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding to discuss alternative treatments.

Can it be taken with other medications?

Yes, but with caution. AJADUO M 25 FORTE TAB can interact with other medications, particularly those affecting kidney function or blood sugar, and other antidiabetic medications like insulin or sulfonylureas, which can increase the risk of low blood sugar. Always inform your doctor about all medicines, supplements, or herbal products you are currently taking to avoid potential interactions.

What precautions should be taken?

Inform your doctor if you have severe kidney disease, certain types of metabolic acidosis, or allergies to its ingredients. It should be used with caution in older adults, those with liver problems, or individuals who may become dehydrated. Avoid excessive alcohol consumption, as it can increase the risk of lactic acidosis and severe hypoglycemia. You may need to temporarily stop this medicine before any planned surgeries or contrast imaging tests. Staying well-hydrated is also important.

What happens if a dose is missed?

If you miss a dose, take it as soon as you remember. However, if it's nearly time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one.

How should it be stored?

Store the medicine at room temperature, away from direct sunlight and moisture. Keep it out of the reach of children.