Roglicoem Tablet

Adult dose

This medication is administered 1 to 2 times daily, before meals or with meals. Dosage may be adjusted considering each patient's current treatment regimen, efficacy, and tolerability, with appropriate blood glucose monitoring. Typically, treatment begins with a low dose, and dosage can be adjusted based on the patient's current medications and blood glucose levels. In clinical trials, the initial daily dose was glimepiride/metformin hydrochloride 2 mg/500 mg.

This medication can cause severe lactic acidosis and hypoglycemia; therefore, caution should be exercised especially if kidney function deteriorates rapidly as the drug may accumulate and increase risk. If symptoms of dehydration, severe diarrhea, vomiting, or fever occur, the medication should be temporarily discontinued and a doctor consulted. Additionally, care is needed when taking this medication alongside antihypertensives, diuretics, or non-steroidal anti-inflammatory drugs, as they may affect kidney function. This medication should not be used in patients with insulin-dependent diabetes, acute metabolic acidosis, severe liver dysfunction, pregnant or breastfeeding women, and patients with severe renal impairment. Discontinue the medication before and after tests using iodinated contrast agents until kidney function stabilizes. During the initial dosage, the risk of hypoglycemia is high, so patients with irregular meals or frequent alcohol consumption, and the elderly, should be monitored carefully. Gastrointestinal symptoms (diarrhea, nausea, vomiting, etc.) may occur, typically transient but should be discussed with a doctor if severe. Rarely, skin rash, blood abnormalities, or nerve damage due to vitamin B12 deficiency may occur; any unusual symptoms should be reported immediately to healthcare professionals. This medication should be used alongside dietary therapy and exercise for blood glucose control, with regular blood glucose and kidney function tests. During treatment, if sudden fatigue, breathing difficulties, muscle pain, or abdominal pain occur, consult a doctor immediately, and consume sugar if hypoglycemic symptoms appear and seek medical assistance if needed. Furthermore, alcohol consumption may increase the risk of side effects, thus should be avoided. The elderly may have decreased kidney function requiring dosage adjustments and regular testing. Due to many drug interactions, always consult healthcare professionals before starting or stopping any new medication. It is safer not to take this medication for pregnant or breastfeeding women and to switch to insulin treatment if necessary. Safety in children has not been fully established, thus caution should be exercised when administering this medication to children. In the event of an overdose, hypoglycemia or lactic acidosis may occur, necessitating immediate emergency treatment, and blood dialysis may be beneficial. Caution should be exercised during driving or operating machinery due to potential hypoglycemia or impaired agility. Store this medication in a place out of reach of children and avoid transferring it to other containers for safety.

Serious side effects

• Hives, severe swelling, chest tightness, difficulty breathing, cold sweats, paleness, severe allergic reactions
• Severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin adverse reactions
• Shortness of breath or severe difficulty breathing, asthma attack, respiratory abnormalities accompanied by coughing and fever
• Yellowing of skin or eyes (jaundice), extreme fatigue, liver abnormalities
• Sudden and severe headache, lightning headache, seizures

Mild side effects

Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal distension, loss of appetite, indigestion, constipation, abdominal pain), unpleasant metallic taste, visual impairment, taste disorder, erythema, itching, rash, nausea, vomiting, discomfort in the upper abdomen, abdominal pain, diarrhea, thrombocytopenia, leukopenia, hemolytic anemia, erythrocytopenia, agranulocytosis, pancytopenia, decreased vitamin B12, increased liver enzymes, liver function impairment, hepatitis, allergies

This medication should be stored in a tightly sealed container away from air and moisture, and it is safe to keep at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness over time.

Appearance

White oblong film-coated tablet

Package unit

30 tablets / box [10 tablets / PTP × 3]