Medication info
Sebiruca Tablet 10/40mg (Amlodipine, Olmesartan)

Sebiruca Tablet 10/40mg (Amlodipine, Olmesartan)

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›13.888mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Reddish-brown round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 202003822 · Approved 2020.05.26 · Insurance code 694004480

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is to be taken once daily, one tablet with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended doses are as follows: - 5/20mg: Administered to patients whose blood pressure is not adequately controlled with Amlodipine 5mg or Olmesartan Medoxomil 20mg monotherapy. - 10/20mg: Administered for those with blood pressure not adequately controlled with Olmesartan Medoxomil 20mg monotherapy.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with Amlodipine or Olmesartan Medoxomil. Maintaining blood pressure within the normal range is crucial in essential hypertension, and this drug helps effectively lower blood pressure, aiding in the prevention of complications. Therefore, this medication is suitable for individuals who have difficulties managing their blood pressure and is used to improve blood pressure.

How to take

Adult dose

This medication is to be taken once daily, one tablet with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended doses are as follows: - 5/20mg: Administered to patients whose blood pressure is not adequately controlled with Amlodipine 5mg or Olmesartan Medoxomil 20mg monotherapy. - 10/20mg: Administered for those with blood pressure not adequately controlled with Olmesartan Medoxomil 20mg monotherapy.

Child dose

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

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to any of the components of this medication, those who are pregnant or breastfeeding, those with severely impaired liver or kidney function, and those with specific heart conditions should not take this medication. In patients with depleted body fluids or salts, hypotension symptoms may occur, so careful monitoring of their condition should be performed especially during the early stages of treatment. There is a possibility of a sharp drop in blood pressure due to rapid vascular dilation, and if such symptoms occur, healthcare professionals should be notified immediately. Patients with weak heart or kidney function require careful observation and management when taking this medication. Adverse effects such as dizziness, headaches, low blood pressure, digestive disturbances, and skin rashes may occur during the use of this medication. If symptoms are severe or persistent, consultation with a physician is advised. This medication can interact with other drugs, so it is essential to inform healthcare professionals of any currently taken medications. In particular, taking this medication with grapefruit juice may lead to an unexpectedly strong blood pressure lowering effect, so it is advisable to avoid it. Women who are pregnant or planning to become pregnant should choose other treatment methods that are safe for the fetus instead of this medication, and immediately discontinue its use upon confirmation of pregnancy. While breastfeeding, this medication may pass into breast milk and affect the baby, so it is recommended to either stop breastfeeding or discontinue this medication. Children under 18 years of age should not take this medication as its safety and efficacy have not been established. Elderly patients may experience different effects and side effects due to impaired kidney and liver function, so it is advisable to start with a lower dose and be cautious in monitoring.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing (dyspnea), severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, cough accompanied by fever and respiratory abnormalities, yellowing of the skin or eyes (jaundice), sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, markedly reduced urine output, systemic reactions

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • decreased libido
  • flushing due to vasodilation
  • fatigue
  • edema
  • palpitations
  • cough
  • nausea
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  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • rash
  • muscle tension
  • limb pain
  • back pain
  • frequent urination
  • erectile dysfunction
  • weakness
  • facial swelling
  • decreased blood potassium
  • increased blood creatinine
  • increased blood uric acid
  • increased gamma-glutamyl transferase
  • decreased hemoglobin and hematocrit
  • hyperkalemia

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Reddish-brown round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)

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.