Medication info

Orobika Tablet 10/40 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Amlodipine Besylate›13.888mg / 1 tabletOlmesartan Medoxomil›40mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Reddish-brown round film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP X 3)]
Approval status
Expired

MFDS item code 202003042 · Approved 2020.04.24

This product's status changed to Expired on 2025.04.24. 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 administered once daily, with one tablet taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., morning). The recommended dosages are as follows: - 5/20 mg: For patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: For patients with 20 mg of olmesartan medoxomil.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively lower and control blood pressure in patients with essential hypertension whose blood pressure is not well managed with monotherapy of amlodipine or olmesartan medoxomil.

How to take

Adult dose

This medication is administered once daily, with one tablet taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., morning). The recommended dosages are as follows: - 5/20 mg: For patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: For patients with 20 mg of olmesartan medoxomil.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. It should not be administered to individuals with allergies to the main ingredients or similar medications, to pregnant or breastfeeding women, to patients with severe liver disease, heart valve issues, biliary obstruction, patients on renal dialysis, patients in shock, certain diabetic patients, or patients with severely impaired kidney function. Caution should be exercised in patients with low blood volume or sodium levels, as hypotension may occur, particularly during the initial administration. Patients with significant vascular dilation or heart disease may also need careful monitoring, as rapid vascular expansion can lead to hypotension. In patients with impaired kidney function or liver dysfunction, caution should be exercised as this medication can affect the kidneys or liver. Side effects such as dizziness, headache, hypotension, nausea, swelling, and others may occur during treatment; if unusual symptoms persist, consultation with healthcare professionals is advised. This medication should not be used during pregnancy, and breastfeeding women should either discontinue the medication or stop breastfeeding due to the potential transmission of the drug to the infant. Safety and efficacy have not been established for pediatric patients under 18 years of age. Elderly patients may have impaired liver or kidney function, so dosage adjustments and careful monitoring are necessary. In the case of overdose, hypotension and cardiac arrhythmias may occur, necessitating immediate medical treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), breathing difficulties, difficulty breathing, angioedema, acute renal failure, hair loss, toxic epidermal necrolysis, liver abnormalities (jaundice and elevated liver enzymes), worsening of cerebral infarction, severe allergic reactions, severe skin reactions, serious neurological symptoms, severe edema or urinary disturbances, severe rashes, blisters, skin peeling, oral/eye mucosal pain, severe allergic reactions, severe rash with high fever, seizures.

Mild side effects

  • Dizziness
  • headache
  • orthostatic hypotension
  • drowsiness
  • sensory disturbances
  • sensory loss
  • fainting
  • lightheadedness
  • palpitations
  • tachycardia
Show 25 more
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • rash
  • muscle tension
  • limb pain
  • back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • depression
  • fatigue
  • weakness
  • facial swelling
  • decreased blood potassium
  • increased blood creatinine levels
  • blood uric acid.

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air and moisture, at a temperature between 1 and 30 degrees Celsius. Proper storage preserves the medication's efficacy.

Appearance and packaging

Appearance

Reddish-brown round film-coated tablet

Package unit

30 tablets/box [(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.