Rinaploem Sustained Release Tablets 10/5/1000 mg (Empagliflozin, Linagliptin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is 10 mg of empagliflozin, 5 mg of linagliptin, and 1000 mg of metformin hydrochloride taken once daily with a meal. To reduce gastrointestinal adverse effects, it should be taken in the evening. As a sustained release formulation, the tablets should not be broken, crushed, ground, or chewed but swallowed whole. Dosage adjustments may be necessary based on kidney function, and patients with moderate renal impairment should adjust the metformin hydrochloride dosage to 1 daily.

This medication can cause a rare adverse effect called lactic acidosis; if this symptom occurs, immediate medical attention should be sought. This medication should not be administered to certain patients. For example, it can be dangerous for those allergic to any of its components, patients with type 1 diabetes, patients with severely impaired kidney function, patients undergoing dialysis, and patients in severe infection or shock states. Patients scheduled to undergo examinations using iodine contrast agents should discontinue this medication for a certain period before and after the examination and should only resume taking it after confirming normal kidney function. Patients undergoing surgery should stop taking this medication 48 hours prior to the surgery and resume only after confirming normal kidney function post-surgery. While taking this medication, kidney function tests should be periodically conducted, and if kidney function deteriorates, the medication should be discontinued. Patients with heart failure or a history of pancreatitis should use this medication cautiously, and if symptoms of acute pancreatitis occur, they should stop taking it immediately and consult a physician. This medication may cause hypoglycemia; therefore, caution is necessary regarding hypoglycemic symptoms, especially when taking antidiabetic agents like insulin or sulfonylureas, and medication dosages may need adjustment. This medication can increase the risk of urinary infections and genital fungal infections; hence, if any signs of infection appear, immediate treatment should be pursued. Additionally, caution is necessary during dehydration, severe diarrhea, or vomiting due to the risk of adverse effects from fluid loss, and in such cases, medication can be temporarily suspended. Elderly patients, particularly those over 75 years of age, require extra caution due to an increased risk of fluid loss and low blood pressure. This medication is not recommended for patients with impaired liver function or those who consume excessive alcohol. A skin condition called bullous pemphigoid may occur rarely; if any blisters or rashes develop, the physician should be informed immediately. While taking this medication, do not crush, chew, or break the tablets; take them whole, and it is normal for the coating of the tablet to appear in the stool. When driving or operating machinery, caution is required due to the risk of hypoglycemic symptoms. Finally, it is important to undergo regular blood tests and consistently monitor health status under a physician's guidance while taking this medication.

Serious side effects

Urticaria, angioedema, vascular stent thrombosis, ketoacidosis, lactic acidosis, pancreatitis, bullous pemphigoid, perineal necrosis, severe edema associated with increased blood pressure, vascular stent stenosis, acute renal failure, liver abnormalities (jaundice), severe allergic reactions, severe skin adverse reactions, difficulty breathing, asthma attacks, respiratory distress, severe neurological symptoms (sudden and severe headache, lightning headache, seizures, confusion, visual disturbances

Mild side effects

• Urinary tract infections
• vulvovaginal candidiasis
• vulvitis
• balanitis
• nasopharyngitis
• cough
• constipation
• oral ulcers
• itching
• rash

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius to preserve its effectiveness.

Appearance

White and light yellow biconvex oval sustained release film-coated tablets

Package unit

Bottle packaging - 30 tablets/bottle