Medication info

Orobika Tablets 5/40 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›40mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Pale yellow round film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP X 3)]
Approval status
Expired

MFDS item code 202003043 · 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 taken once daily, with or without food, along with water. It is recommended to take it at the same time each day, if possible (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: Administer to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Administer to patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg monotherapy.
Child dose
Safety and efficacy for pediatric patients under 18 years have not been established.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is prescribed for patients with essential hypertension who have difficulty controlling their blood pressure even with either amlodipine or olmesartan medoxomil alone. Essential hypertension refers to a persistent state of high blood pressure, and it is critical to effectively lower it. This medication helps to dilate blood vessels and regulate blood pressure to appropriate levels. Proper blood pressure management can significantly reduce the risk of complications such as heart disease or stroke. Therefore, this medication is used for the treatment of essential hypertension.

How to take

Adult dose

This medication is taken once daily, with or without food, along with water. It is recommended to take it at the same time each day, if possible (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: Administer to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Administer to patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg monotherapy.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. Individuals who are allergic to any components of this medication or similar drugs, pregnant or breastfeeding women, patients with severe liver or heart diseases, patients with biliary obstruction, patients undergoing dialysis, and patients with certain kidney diseases or diabetes should not take this medication. Patients who are deficient in fluid or salt may experience hypotension, so caution is needed, and patients with sudden vascular dilation or weakened cardiac function should also take it carefully. This medication may cause side effects such as dizziness, headache, hypotension, cough, digestive disturbances, skin rash, muscle pain, and swelling, so any unusual symptoms should be discussed with a doctor. Especially during pregnancy, this medication can have serious effects on the fetus, so those planning to become pregnant or who are pregnant should consult with a doctor. During breastfeeding, this medication may pass into breast milk and affect the baby, so breastfeeding should be discontinued or medication should be stopped. It is not recommended for children under 18, as the safety and efficacy of this medication have not been established. Elderly patients may experience decreased kidney and liver function, so they should start with a low dose and take it with caution. Overdosing on this medication can lead to severe hypotension and cardiac dysfunction, so strict adherence to the prescribed dose is essential, and immediate medical attention is required in case of overdose. Taking this medication with grapefruit juice may excessively enhance the blood pressure-lowering effect, so co-administration should be avoided. Taking it with other antihypertensive medications or potassium-sparing diuretics may increase serum potassium levels, so regular blood tests are necessary. Store this medication out of reach of children, and avoid exposure to moisture, heat, and direct sunlight.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), difficulty breathing, jaundice, sudden and very severe headache, seizures, confusion, vision disturbances, paralysis, significantly reduced urine output, serious systemic swelling with increased blood pressure, fainting, vascular edema, acute renal failure, toxic epidermal necrolysis, leukopenia, thrombocytopenia, worsened cerebral infarction

Mild side effects

  • Dizziness
  • headache
  • orthostatic hypotension
  • drowsiness
  • abnormal sensation
  • decreased sensation
  • palpitations
  • rapid heartbeat
  • hypotension
  • orthostatic hypotension
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  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • rash
  • muscle tension
  • limb pain
  • lower back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • dependent edema
  • fatigue
  • asthenia
  • facial swelling
  • decreased serum potassium
  • increased serum creatinine
  • increased serum uric acid
  • gamma-glutamyl transferase elevation

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the medication's efficacy for a long time.

Appearance and packaging

Appearance

Pale yellow round film-coated tablets

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.