Olmesartan Medoxomil and Amlodipine Besilate Tablets 10/40 mg

Adult dose

This medication is administered as one tablet 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 dosing is as follows: - 5/20 mg: Administer to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Administer to 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 have not been established.

This medication can cause severe harm to the fetus and newborn during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to the active ingredients, those who are pregnant, nursing, have severe hepatic impairment, aortic stenosis, biliary obstruction, patients on renal dialysis, those in a state of shock, and certain diabetic patients should not take this medication. Patients with hypotension who are deficient in body fluids or salts may experience hypotension; thus, close monitoring is necessary during initial administration, and appropriate measures should be taken if hypotension occurs. Vasodilation may rarely lead to acute hypotension, so caution is advised in patients with aortic stenosis. Patients with severe obstructive coronary artery disease may have an increased risk of angina or myocardial infarction while taking this medication, so caution is required. Use in patients with heart failure should be done cautiously, and those with weakened renal function should be closely monitored for changes in kidney function. Patients with impaired liver function should also use this medication with caution; adverse reactions may include dizziness, headache, hypotension, orthostatic hypotension, nausea, vomiting, rash, edema, fatigue, etc. This medication may interact with other drugs; especially, it is advisable to avoid taking it with grapefruit juice, and dose adjustments or monitoring might be necessary depending on the concomitant medications. It may pose risks to the fetus during pregnancy, so those planning to become pregnant or currently pregnant should consult a physician, and nursing mothers should carefully consider the use of this medication. Safety in pediatric patients has not been established, and it is not recommended for those under 18 years of age. In elderly patients, it is preferable to start at a lower dose considering the possibility of impaired kidney and liver function. In case of overdose, symptoms such as hypotension and symptoms due to vasodilation may occur, and immediate medical attention should be sought for appropriate treatment. This medication should be stored in a tightly sealed container, away from direct sunlight and moisture, out of reach of children.

Serious side effects

• Hives
• angioedema
• hair loss
• elevated serum creatinine
• acute renal failure
• autoimmune hepatitis
• hyperkalemia
• angioedema
• toxic epidermal necrolysis
• severe swelling (edema)

Mild side effects

• Dizziness
• headache
• decreased libido
• drowsiness
• sensory abnormalities
• reduced perception
• palpitations
• hypotension
• orthostatic hypotension
• cough

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature at room temperature between 1 to 30 degrees Celsius. This helps to preserve the medication's effectiveness and safety for a long time.

Appearance

Brownish-red round film-coated tablets

Package unit

28 tablets (14 tablets/PTP x 2)