Medication info

Hyubika Tablets 5/20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›20mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
White round film-coated tablet
Packaging
30 tablets/PTP [10 tablets/PTP x 3]
Approval status
Expired

MFDS item code 201907021 · Approved 2019.10.02

This product's status changed to Expired on 2024.10.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is taken once daily, 1 tablet, with or without food. It is recommended that it be taken at the same time every day (e.g., in the morning). The recommended dosing regimen is as follows: - 5/20 mg: For patients whose blood pressure is not adequately controlled with Amlodipine 5 mg or Olmesartan Medoxomil 20 mg monotherapy. - 10/20 mg: For patients whose blood pressure is not adequately controlled with Olmesartan Medoxomil 20 mg.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is suitable for patients with essential hypertension who find it difficult to control their blood pressure with monotherapy of either Amlodipine or Olmesartan Medoxomil. Hypertension places a burden on the heart and blood vessels, which can lead to various complications; therefore, effective blood pressure control is essential. This medication dilates blood vessels to safely lower blood pressure and protect cardiovascular health. As such, it is used for the treatment of essential hypertension.

How to take

Adult dose

This medication is taken once daily, 1 tablet, with or without food. It is recommended that it be taken at the same time every day (e.g., in the morning). The recommended dosing regimen is as follows: - 5/20 mg: For patients whose blood pressure is not adequately controlled with Amlodipine 5 mg or Olmesartan Medoxomil 20 mg monotherapy. - 10/20 mg: For patients whose blood pressure is not adequately controlled with Olmesartan Medoxomil 20 mg.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established.

Precautions

This medication may cause serious harm to the fetus and newborn when taken during the 2nd and 3rd trimesters of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. Patients with allergies to the active ingredients or similar classes of medications, those who are pregnant or breastfeeding, individuals with severe liver disease, certain heart conditions, patients on kidney dialysis, those in shock, and patients with particular diabetes conditions should not take this medication. Patients who are fluid or sodium depleted, those sensitive to vasodilator medications, patients with severe heart disease, and those with diminished kidney function should be particularly cautious and observe their condition carefully when taking this medication. Side effects such as dizziness, headache, blood pressure drops, indigestion, swelling, and rashes may occur, and immediate consultation with a physician is required if any unusual symptoms arise. Sudden discontinuation of beta-blockers can be risky, so patients currently taking beta-blockers should gradually reduce their dose under medical guidance. This medication may interact with other antihypertensive medications, diuretics, potassium-sparing medications, lithium, and non-steroidal anti-inflammatory drugs, so patients should inform their doctor or pharmacist of any other drugs they are taking. This medication should not be taken during pregnancy, and patients planning to become pregnant should switch to a safer alternative treatment. Breastfeeding mothers should consider discontinuing breastfeeding or this medication as it may be passed to the infant through breast milk. Safety and efficacy in patients under 18 years of age have not been established; hence, its use is not recommended in this age group. Elderly patients may experience decreased kidney and liver function, necessitating dose adjustments and close monitoring during treatment. In cases of overdose, symptoms such as hypotension, vasodilation, and arrhythmias may occur, requiring immediate medical attention. This medication should be stored out of direct sunlight and moisture in a place inaccessible to children, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), skin peeling, pain in oral/conjunctival mucosa, difficulty breathing, chest tightness, severe allergic reactions, severe skin reactions, respiratory distress, asthma attacks, cough accompanied by fever and respiratory anomalies, jaundice (yellowing of skin or eyes), extreme lethargy, liver damage (jaundice), sudden and severe headaches, seizures, confusion, visual disturbances, paralysis, severe neurological symptoms.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • sensory disturbances
  • sensory loss
  • syncope
  • vertigo
  • palpitations
  • rapid heartbeat
  • hypotension
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  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • indigestion
  • diarrhea
  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle tension
  • limb pain
  • back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • depressed edema
  • fatigue
  • weakness
  • facial swelling
  • decreased blood potassium
  • increased serum creatinine
  • increased serum uric acid
  • gamma-glutamyl

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is best stored at room temperature between 1°C and 30°C to maintain its potency for an extended period.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/PTP [10 tablets/PTP x 3]

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.