Medication info

Gyromet Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
Orange to yellow, biconvex, oval film-coated tablets
Packaging
60 tablets/bottle, 60 tablets/box [(10 tablets/PTP×6)], 10 tablets/box [(10 tablets/PTP×1)]
Approval status
Active

MFDS item code 202201745 · Approved 2022.04.29

Summary

Main use
Effectiveness in blood sugar control of type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet once, twice a day. The maximum daily recommended dosage for each ingredient should not exceed empagliflozin 25 mg and metformin 2000 mg. Patients with insufficient blood sugar control may start with empagliflozin 5 mg twice a day (total of 10 mg per day) with their existing dose of metformin. If tolerance is good and additional blood sugar control is needed, empagliflozin may be increased to 25 mg.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Effectiveness in blood sugar control of type 2 diabetes and prevention of cardiovascular events

  • Abnormal blood sugar control in adult patients with type 2 diabetes
  • adult patients with type 2 diabetes who do not have sufficient blood sugar control
  • cardiovascular disease
View approved original text

This medication is used to improve blood sugar control in adults with type 2 diabetes when combined with a diet and exercise regimen. In particular, the combination of empagliflozin and metformin is suitable for patients with type 2 diabetes whose blood sugar is not adequately controlled. For patients with cardiovascular disease, special caution is needed regarding the occurrence of cardiovascular events, so it is important to follow the guidance of a healthcare professional. This medication helps improve blood sugar control and aids in diabetes management.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once, twice a day. The maximum daily recommended dosage for each ingredient should not exceed empagliflozin 25 mg and metformin 2000 mg. Patients with insufficient blood sugar control may start with empagliflozin 5 mg twice a day (total of 10 mg per day) with their existing dose of metformin. If tolerance is good and additional blood sugar control is needed, empagliflozin may be increased to 25 mg.

Precautions

This medication is used for the treatment of diabetes and helps in controlling blood sugar levels. However, this medication can cause a rare side effect known as severe lactic acidosis, so patients with poor kidney function or severe infections or dehydration should not use it. Additionally, caution is needed as hypoglycemic symptoms may occur when used with insulin or other blood sugar-lowering agents. It is also safer for patients with reduced kidney function, acute heart problems, or liver dysfunction to avoid this medication. Before and after tests using iodine contrast agents, this medication should be temporarily discontinued, and resumption should occur only after kidney function has returned to normal. Pregnant or breastfeeding women should not take this medication. Regular monitoring of kidney function and blood sugar levels is necessary while taking this medication, and monitoring of vitamin B12 levels is also important. Excessive alcohol consumption may increase the risk of side effects from this medication, so it is advisable to avoid it. Also, this medication may increase the risk of urinary tract infections and genital infections, so any signs of infection should be reported to a healthcare provider immediately. When there is inadequate fluid intake or dehydration, a loss of fluid volume may occur, requiring caution. If symptoms such as fever or pain/swelling in the genital area appear during the use of this medication, immediate treatment should be sought as these may indicate a severe infection. Elderly patients are at higher risk for decreased kidney function, so dosage adjustments and regular checks are necessary. In the event of an overdose, immediate medical attention should be sought. Finally, keep this medication out of the reach of children and store it in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), lactic acidosis, ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing, asthma attacks, respiratory distress with coughing and fever, jaundice (yellowing of skin or eyes), liver abnormalities, sudden and severe headache, lightning-like headache

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste alteration
  • itching
  • rash
  • urticaria
  • erythema
  • angioedema
  • dysuria
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of vitamin B12
  • reduced fluid volume
  • alteration in taste
  • dizziness
  • headache
  • insomnia
  • fatigue

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, avoid exposing it to extreme heat or cold, and it's advisable to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Orange to yellow, biconvex, oval film-coated tablets

Package unit

60 tablets/bottle, 60 tablets/box [(10 tablets/PTP×6)], 10 tablets/box [(10 tablets/PTP×1)]

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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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.