Medication info

Rinaploem Controlled Release Tablets 12.5/2.5/1000 mg (Empagliflozin, Linagliptin, Metformin Hydrochloride)

Prescription medicationTablet
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletLinagliptin Micronized›2.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
White and light blue, oval, film-coated tablets with a double convex surface.
Packaging
Bottle packaging - 30 tablets/bottle
Approval status
Active

MFDS item code 202502781 · Approved 2025.10.28

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
The dosage of this medication should not exceed the maximum daily dose of empagliflozin 25 mg, linagliptin 5 mg, and extended-release metformin hydrochloride 2000 mg, based on the current treatment regimen, efficacy, and tolerance of each patient. This medication should be taken once daily in the evening with food, and dosage adjustments for metformin hydrochloride should be made gradually if needed. 10/5/1000

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used in conjunction with diet and exercise to improve blood sugar control in patients with type 2 diabetes. It contains a combination of three ingredients: empagliflozin, linagliptin, and metformin, which work together to assist in blood sugar management and effectively maintain stable blood sugar levels. Therefore, this medication is used to enhance blood sugar control in patients with type 2 diabetes.

Dosage and Administration

Adult dosage

The dosage of this medication should not exceed the maximum daily dose of empagliflozin 25 mg, linagliptin 5 mg, and extended-release metformin hydrochloride 2000 mg, based on the current treatment regimen, efficacy, and tolerance of each patient. This medication should be taken once daily in the evening with food, and dosage adjustments for metformin hydrochloride should be made gradually if needed. 10/5/1000

Precautions

This medication can cause a rare side effect known as severe lactic acidosis, which may threaten life; therefore, caution is required. The risk of lactic acidosis is particularly high in patients with significantly impaired kidney function or those with heart, liver, or lung dysfunction. Therefore, this medication should not be used in patients with severely impaired kidney function, those undergoing dialysis, patients with acute metabolic acidosis, or patients with severe heart failure. Additionally, patients who are about to undergo surgery, or those with severe infections, dehydration, or excessive alcohol intake should temporarily pause the use of this medication. There may be an increased risk of hypoglycemia if this drug is used in combination with other medications that lower blood sugar; if taking insulin or sulfonylureas alongside this medication, dose adjustments may be necessary. During treatment with this medication, regular blood tests should be conducted to monitor kidney function and vitamin B12 levels, and any abnormal symptoms should be promptly reported to the medical staff. Furthermore, this medication may increase the risk of urinary tract infections or genital fungal infections; if related symptoms occur, prompt treatment should be sought. Elderly patients or those at risk of reduced fluid volume should be cautious about dehydration and hypotension, and should consult a physician if any symptoms arise. This medication should be swallowed whole and not chewed or crushed; in some patients, the tablet coating may be excreted in stool, which is not a cause for concern. Caution is necessary when driving or operating machinery due to the risk of hypoglycemia, especially when combined with other blood sugar-lowering agents. It is advisable to avoid alcohol consumption during treatment, as acute or chronic excessive alcohol intake may increase the risk of lactic acidosis. Lastly, there may be interactions with other medications used in conjunction with this one, so it is essential to inform healthcare providers of all medications being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, lactic acidosis, ketoacidosis, severe allergic reactions, severe skin reactions, severe edema, liver abnormalities (jaundice), sudden and severe headaches, seizures, confusion, visual disturbances, paralysis, severe edema accompanied by high blood pressure, necrotizing fasciitis, pancreatitis, blistering pemphigoid, acute kidney injury, acute myocardial infarction, acute cholangitis, acute cholecystitis, cholangitis,

Mild side effects

Urinary tract infections, vulvovaginitis, balanitis and other genital infections, hypoglycemia (when used with sulfonylureas or insulin), cough, constipation, oral ulcers, itching, rash, musculoskeletal pain, increased urination, urinary difficulty, increased serum creatinine, increased serum lipids, taste sensitivity, nausea, vomiting, diarrhea, abdominal pain, decreased appetite, headache, dizziness, insomnia, depression, anxiety, vertigo, fever, fatigue,

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it should be stored in a sealed container. To maintain the efficacy of the medication, it is recommended to store it at room temperature, between 1 degree Celsius and 30 degrees Celsius.

Appearance and packaging

Appearance

White and light blue, oval, film-coated tablets with a double convex surface.

Package unit

Bottle packaging - 30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.