Medication info
RM Extended Release Tablet 500/10 mg

RM Extended Release Tablet 500/10 mg

Prescription medicationTablet경구Approval revoked
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Approval revoked

MFDS item code 201903716 · Approved 2019.06.04

This product's status changed to Approval revoked on 2026.02.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effect of combination replacement therapy
Who takes it
Adults
Adult dose
This medication is administered once daily in adults, together with the evening meal.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Effect of combination replacement therapy

View approved original text

This medication is used as a combination replacement therapy for patients who need to take metformin hydrochloride and rosuvastatin calcium together.

How to take

Adult dose

This medication is administered once daily in adults, together with the evening meal.

Precautions

This medication can rarely cause a serious metabolic complication known as lactic acidosis, which has been reported to result in fatalities. Additionally, caution is needed as severe hypoglycemia can occur when taken with other diabetes medications. It should not be administered if there is an allergy to any ingredients in this medication or to similar medications. This medication should not be used in patients with severe hepatic impairment or active liver disease. Patients with muscle disorders or muscle issues, as well as those taking certain immunosuppressants, should also avoid this medication. Women who are pregnant or breastfeeding, and those who may become pregnant should consult a doctor before using this medication. It should not be administered to patients with severely impaired renal function, dehydration, severe infections, or acute conditions such as heart failure. Patients scheduled for tests using certain contrast agents should stop taking this medication for a specific period before and after the examination and should resume after confirming the renal function status. This medication has not established safety and efficacy in children, thus should not be administered to those under 19 years of age. In older adults, renal function may be impaired, so renal function should be regularly tested and dosage adjusted accordingly. During treatment, if symptoms such as muscle pain, weakness, or fever occur, notify a physician immediately and undergo testing; if necessary, medication may be discontinued. It is advisable to avoid alcohol consumption while taking this medication, and the medication should be temporarily discontinued if dehydration or acute illness occurs. Regular monitoring of blood glucose, liver function, renal function, and blood tests should be conducted, and periodic checks of vitamin B12 levels are recommended. This medication may interact with other drugs, so if you are taking other medications, be sure to inform your healthcare provider. This medication should not be used during pregnancy, and it is advisable to avoid administration while breastfeeding.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, severe rash accompanied by fever, blistering, skin peeling, mouth/eye mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, breathing irregularities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures.

Mild side effects

Diarrhea, upper abdominal pain, constipation, abdominal pain, belching, gastroesophageal reflux disease, upper abdominal discomfort, indigestion, cellulitis, sensory disturbances, joint pain, papular rash, headache, dizziness, constipation, nausea, abdominal pain, itching, rash, muscle pain, weakness, impaired taste, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, abdominal bloating, hematological abnormalities (increased ALT, increased AST, elevated creatine phosphokinase, increased CK),

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture ingress. It is best to maintain storage temperature at room temperature between 1 to 30 degrees Celsius. Proper storage ensures the longevity of the medication's effectiveness.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

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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.