Medication info

RM Sustained Release Tablet 500/5 mg

Prescription medicationTablet경구Approval revoked
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Approval revoked

MFDS item code 201903714 · 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 with the evening meal for adults.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Effect of Combination Replacement Therapy

View approved original text

This medication is used as 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 with the evening meal for adults.

Precautions

This medication can rarely cause a serious condition called lactic acidosis, which can be life-threatening, so caution is needed. Severe hypoglycemia may occur when taken with other diabetes medications. Patients allergic to any ingredient in this medication or similar medications should not use it. Patients with severely impaired liver function or liver disease may be at risk when taking this medication, so it should be avoided. It is also safer for patients with muscle disorders or those taking certain immunosuppressants, as well as for women who are pregnant or breastfeeding, to avoid using this medication. Patients with severely reduced kidney function or those experiencing dehydration, severe infections, or heart problems should also avoid taking this medication. This medication should be temporarily stopped before and after tests using iodine contrast agents, and it should not be restarted until kidney function returns to normal. This medication may interact with other drugs that affect blood sugar control; thus, be sure to inform your doctor or pharmacist about any other medications being taken. If during treatment symptoms such as muscle pain, muscle weakness, fatigue, or difficulty breathing occur, consult medical personnel immediately. Alcohol consumption can increase the risk of adverse effects from this medication, so excessive drinking should be avoided. Elderly patients or those with weak kidney function should regularly undergo kidney function tests, and dosage adjustments may be necessary. Women who are pregnant or may become pregnant should not take this medication and should use appropriate contraceptive methods. Nursing mothers should also avoid taking this medication. This medication has not been established for safety and effectiveness in children and adolescents under 19 years of age. In cases of overdose, there is no specific antidote, so one should seek appropriate treatment at a medical facility immediately. It is important to keep this medication out of the reach of children and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, severe allergic reactions; Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) with severe skin reactions; chest discomfort, difficulty breathing, shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever; jaundice, hepatitis, abnormal liver function, elevated transaminases; sudden and severe headache, confusion, visual disturbances, paralysis

Mild side effects

  • Diarrhea
  • upper abdominal pain
  • constipation
  • abdominal pain
  • belching
  • gastroesophageal reflux disease
  • upper abdominal discomfort
  • indigestion
  • cellulitis
  • paresthesia
Show 26 more
  • arthralgia
  • papular rash
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • myalgia
  • weakness
  • taste disturbance
  • nausea
  • vomiting
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • headache
  • dizziness
  • weakness
  • arthralgia
  • fatigue

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

Storage

This medication can be sensitive to air or moisture, so it must be stored in a sealed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow 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.