Medication info

Dubika Tablet 5/40mg

Prescription medicationTablet경구Expired
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
삼아제약(주)
Appearance
Pale yellow circular film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP x 2], 30 tablets/bottle
Approval status
Expired

MFDS item code 201500291 · Approved 2015.01.20

This product's status changed to Expired on 2025.01.20. 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 medicine is administered orally 1 tablet once a day with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosing is 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 whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg alone.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
삼아제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medicine is used for patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with amlodipine or olmesartan medoxomil. It effectively lowers blood pressure and helps in managing blood pressure by reducing the risk of cardiovascular complications.

How to take

Adult dose

This medicine is administered orally 1 tablet once a day with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosing is 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 whose blood pressure is not adequately controlled with olmesartan medoxomil 20 mg alone.

Child dose

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

Precautions

This medication can cause serious harm or death to the fetus and neonate if taken during pregnancy in the second and third trimesters. It should be stopped immediately if pregnancy is confirmed. Patients with allergies to this drug's active ingredients or similar substances, pregnant or breastfeeding women, those with severe liver impairment, patients with heart or biliary issues, kidney dialysis patients, those in severe shock, and certain diabetic patients and those with severely decreased kidney function should not be administered this drug. This drug should be used with caution in patients with dehydration or low sodium levels, very low blood pressure, severe heart disease, impaired kidney function, and those with decreased liver function, and blood pressure and conditions should be closely monitored at the initiation of treatment. This drug may cause side effects such as dizziness, headache, low blood pressure, edema, digestive disorders, skin rash, etc., so if any abnormal symptoms occur, consult with a healthcare professional immediately. Use of this drug during pregnancy should be avoided, especially after the second trimester, as it can pose serious risks to the fetus. Breastfeeding women should be cautious as this drug may be transmitted through breast milk and should consult a doctor about stopping breastfeeding while taking the medication. The safety and effectiveness in pediatric patients under 18 years old have not been established and its use is not recommended. In the elderly, kidney and liver functions may be reduced, so treatment should begin at a lower dose and be administered cautiously. In the event of overdose, symptoms such as hypotension and tachycardia may occur, and immediate medical treatment should be sought. This drug should be stored in a place protected from moisture, heat, and direct sunlight, out of reach of children. Interactions may occur with other drugs; if the patient is taking other medications, it is essential to inform the healthcare provider, and it is advisable to avoid taking this drug with grapefruit juice.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, difficulty breathing, severe rash accompanied by fever, blisters, peeling skin, pain of oral/ocular mucosa, jaundice (yellowing of the skin or eyes), extreme malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, severe swelling accompanied by increased blood pressure, vascular edema, acute kidney failure, oliguria, increased serum creatinine.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
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  • muscle stiffness
  • limb pain
  • low back pain
  • frequent urination
  • erectile dysfunction
  • fatigue
  • weakness
  • vascular edema
  • hair loss
  • itching
  • rash
  • palpitations
  • flushing
  • decreased blood pressure
  • orthostatic hypotension
  • cough
  • lightheadedness
  • decreased serum potassium
  • increased serum creatinine
  • increased serum uric acid
  • increased gamma-glutamyl transferase
  • hemoglobin

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C. Therefore, store it safely in a cool and dry place until use.

Appearance and packaging

Appearance

Pale yellow circular film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2], 30 tablets/bottle

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.