MDBICA Tablet 5/20 mg (Amlodipine Besilate, Olmesartan Medoxomil)

Adult dose

This medication should be administered once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the 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 whose blood pressure is not adequately controlled with monotherapy of olmesartan medoxomil 20 mg.

Child dose

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

This medication can cause serious harm to the fetus and newborn during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Patients allergic to any component of this medication, pregnant or breastfeeding women, patients with severe liver impairment, or severe aortic stenosis should not take this medication. Patients with depletion of fluids or salts may experience hypotension when starting this medication, so they should carefully monitor their condition after starting treatment. If hypotension occurs, appropriate measures should be taken. Acute hypotension can rarely occur due to the vasodilatory effects, so close attention is needed in patients with severe aortic stenosis. Patients with severe coronary artery obstruction may have an increased risk of angina or myocardial infarction when taking this medication, thus caution is advised. Patients with heart failure should be monitored carefully, and patients with impaired renal function may experience changes in kidney function, necessitating regular tests. Patients with weakened liver function should take this medication with caution, and as it is metabolized in the liver, liver impairment patients should consult with their doctor before taking. Common side effects such as dizziness, headache, hypotension, dyspepsia, and edema may occur during treatment; persistent abnormal symptoms should be discussed with a healthcare professional. Administration during pregnancy poses significant risks to the fetus, so any pregnancy plans or existing pregnancies must be reported to a healthcare professional. Breastfeeding women are advised to stop nursing or discontinue the medication, as it may be passed into breast milk. Safety and efficacy in pediatric patients have not been established, so it is advisable not to administer to individuals under 18 years of age. Elderly patients should start at a lower dose considering potential renal and liver function decline, and should closely monitor for adverse reactions during treatment. In cases of overdose, symptoms related to hypotension and vasodilation may occur, requiring immediate medical treatment. This medication should be stored in a tightly sealed container, away from direct sunlight and moisture, and kept out of reach of children.

Serious side effects

• Hives
• severe swelling (edema)
• difficulty breathing
• jaundice
• sudden and severe headache
• fainting
• angioedema
• acute renal failure
• increased creatinine levels in the blood
• worsening of cerebral infarction

Mild side effects

Dizziness, headache, drowsiness, decreased libido, palpitations, hypotension, orthostatic hypotension, nausea, vomiting, dyspepsia, diarrhea, constipation, dry mouth, abdominal pain, rash, muscle rigidity, limb pain, back pain, frequent urination, erectile dysfunction, peripheral edema, fatigue, weakness, facial edema, decreased potassium levels in the blood, increased creatinine levels in the blood, increased uric acid levels in the blood, elevated gamma-glutamyl transpeptidase levels, decreased hemoglobin and hematocrit, flushing, abdominal pain,

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is safe to store it at a temperature between 1 to 30 degrees Celsius. Therefore, avoid direct sunlight, high or low temperatures, and keep it out of the reach of children.

Appearance

White, round film-coated tablets

Package unit

28 tablets (14 tablets/PTP packaging x 2)