Polmin Empagliflozin & Metformin Controlled Release Tablet 5/1000 mg

Adult dose

This medication should be taken once daily in the evening with food to reduce gastrointestinal side effects associated with metformin. For the 10/1000 mg controlled-release or 25/1000 mg controlled-release tablets, the recommended dosage is one tablet once a day. For the 5/1000 mg controlled-release or 12.5/1000 mg controlled-release tablets, patients should take two tablets at once once daily. To maintain the controlled-release properties, the tablets must be swallowed whole and not broken, crushed, or chewed. It is unknown whether the active ingredients may be found in stool due to incomplete dissolution. Healthcare professionals should evaluate glucose control in patients who repeatedly report the presence of the medication in feces (refer to usage precautions, section 5 general precautions). For patients unable to achieve adequate blood sugar control with metformin alone or in combination with other medications such as insulin, the initial recommended total dosage is 10 mg of empagliflozin and the current dosage of metformin. In cases where tolerance for 10 mg of empagliflozin is good and additional blood sugar control is needed, the dosage can be increased to 25 mg. For patients switching to this medication from a combination of empagliflozin and metformin, it is administered using their previous doses. When transitioning from immediate-release metformin to a controlled-release preparation, blood sugar control should be closely monitored and dosage adjusted appropriately. When used with sulfonylureas or insulin, consideration should be given to reducing the dosage of sulfonylureas or insulin to reduce the risk of hypoglycemia (refer to the precautions for use, sections 4 adverse reactions and 6 interactions).

This medication can rarely cause a serious condition known as lactic acidosis, and patients should be well aware of these symptoms. Lactic acidosis can occur when there is a high concentration of lactate in the blood, leading to acidification that can become life-threatening. Caution is necessary when using this drug with other diabetes medications, as there is a risk of hypoglycemia. Patients with moderate or severe renal impairment or renal failure should not take this medication. It should also not be administered in situations where renal function may rapidly decline. This medication is not used in patients with type 1 diabetes or diabetic ketoacidosis, nor in patients with acute or unstable heart failure. Particularly before and after tests using iodinated contrast agents, administration of this medication should be stopped and restarted only after renal function has returned to normal. It should also be discontinued for a certain period before and after surgery, and resumed only after physical stability is achieved. It is advisable not to administer this medication to patients with liver dysfunction, severe pulmonary dysfunction, excessive alcohol consumption, dehydration, diarrhea, or vomiting that could affect overall health. It is not recommended for women who are pregnant or may become pregnant, or for those who are breastfeeding; if breastfeeding, mothers should discontinue nursing. Elderly patients or those with reduced renal function should have their dosage adjusted and undergo regular renal function monitoring. During treatment, patients should be watchful for symptoms of hypoglycemia, especially if used in conjunction with insulin or sulfonylureas, as the risk of hypoglycemia can be increased. Urinary tract infections or genital infections may occur, so any symptoms of infection should be immediately discussed with healthcare providers. This medication may cause fluid loss, hence adequate hydration is necessary to avoid dehydration. Long-term use may lead to vitamin B12 deficiency, so it’s advisable to monitor blood vitamin B12 levels periodically. Alcohol consumption may increase the risk of side effects from this medication, so excessive drinking should be avoided while on treatment. This medication should not be broken or chewed, but swallowed whole; the tablet shell may pass in stool, which is a normal occurrence. While using this medication, regular monitoring of blood glucose and renal function is required, and any unusual symptoms should be promptly discussed with a physician.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), high fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain (severe skin reaction), breathlessness or difficulty in breathing, asthma attacks, cough with fever and respiratory issues, jaundice (yellowing of skin or eyes), extreme fatigue (liver dysfunction), sudden and extremely severe headache

Mild side effects

• Hypoglycemia
• urinary tract infections
• genital infections
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage will maintain the drug's effectiveness and ensure safe usage.

Appearance

Gray, oval-shaped, convex, controlled-release film-coated tablet

Package unit

30 tablets per bottle