Medication info

Glycomet Tablet 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
White, biconvex oval film-coated tablets with a yellow tint
Packaging
60 tablets/bottle, 60 tablets/box [(10 tablets/PTP×6)], 10 tablets/box [(10 tablets/PTP×1)]
Approval status
Active

MFDS item code 202201744 · Approved 2022.04.29

Summary

Main use
Effectiveness in glycemic control and prevention of cardiovascular events in type 2 diabetes.
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, twice a day. The maximum recommended daily dose for each component should not exceed 25 mg of empagliflozin and 2000 mg of metformin, and is determined based on the patient's current treatment regimen, efficacy, and tolerability. For patients who do not achieve adequate glycemic control with metformin alone or in combination with insulin or other medications, the recommended dosage is 5 mg of empagliflozin twice daily (total daily dose of 10 mg) and the current dose of metformin.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Effectiveness in glycemic control and prevention of cardiovascular events in type 2 diabetes.

  • Difficulty in glycemic control
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication helps control blood sugar levels in adults with type 2 diabetes through the combined administration of empagliflozin and metformin. It should be used in conjunction with dietary and exercise therapy to enhance blood sugar management, especially suitable for adult patients whose blood sugar is not adequately controlled. Additionally, patients with confirmed cardiovascular disease require caution regarding the occurrence of cardiovascular events, necessitating reference to clinical trial information from specialists. Overall, this medication effectively improves blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. The maximum recommended daily dose for each component should not exceed 25 mg of empagliflozin and 2000 mg of metformin, and is determined based on the patient's current treatment regimen, efficacy, and tolerability. For patients who do not achieve adequate glycemic control with metformin alone or in combination with insulin or other medications, the recommended dosage is 5 mg of empagliflozin twice daily (total daily dose of 10 mg) and the current dose of metformin.

Precautions

This medication aids in controlling blood sugar. However, there is a risk of rare but serious side effects such as lactic acidosis, which can be dangerous and potentially life-threatening due to excessive lactate accumulation in the body. When taking this medication alongside insulin or other diabetes medications, it is important to closely monitor blood sugar levels, as hypoglycemia may occur. Patients with poor kidney function, severe infections, dehydration, or heart problems should not take this medication. Additionally, this medication should be temporarily discontinued before and after examinations using iodinated contrast agents, restarting only after kidney function has been confirmed as normal. It is also safest for pregnant or breastfeeding women not to take this medication. During treatment, increased urination or urinary and genital infections may occur; if symptoms appear, consult a healthcare provider. Regular checks may also be needed due to the risk of vitamin B12 deficiency. Alcohol consumption may increase the risk of side effects, so it is advisable to avoid it. Elderly patients and those with impaired kidney function should take this medication with particular caution, receiving regular kidney function checks. In cases of surgical procedures or severe acute illness, discontinuation of this medication may also be necessary. Throughout the treatment, attention should be paid to symptoms of hypoglycemia, especially in cases of irregular meals or excessive exercise. If unusual symptoms or side effects are suspected, it is important to consult a physician or pharmacist immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • severe rash accompanied by high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucous membranes
Show 12 more
  • difficulty or shortness of breath
  • asthma attacks
  • respiratory issues with cough and fever
  • jaundice (yellowing of skin or eyes)
  • profound lethargy
  • sudden and extremely severe headache
  • lightning-like headache
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • somnolence

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • erythema
  • peripheral edema
  • difficulty urinating
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • increased hematocrit
  • decreased vitamin B12
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • insomnia
  • weight loss
  • musculoskeletal pain
  • back pain

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

Storage

Store this medication in a tightly closed container to prevent exposure to air and moisture, and keep it at room temperature between 1°C and 30°C. This helps maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

White, biconvex oval film-coated tablets with a yellow tint

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.