Olotenshon Tablet 5/40 mg (Amlodipine Besilate, Olmesartan Medoxomil)

Adult dose

This medication is administered once a day, one tablet at any time of the day with water, preferably at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5 mg or Olmesartan Medoxomil 20 mg. - 10/20 mg: Administered to patients whose blood pressure is not adequately controlled with Olmesartan Medoxomil 20 mg alone.

Child dose

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

This medication may cause serious harm to the fetus and newborn if taken during the second or third trimester of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to the active ingredients of this medication, pregnant and breastfeeding women, patients with severe liver impairment, severe aortic stenosis, bile duct obstruction, renal dialysis, shock, and specific diabetic patients and renal impairment patients should not be given this medication. In patients with hypotension caused by fluid or salt depletion, hypotensive symptoms may occur, so their condition should be closely monitored during the initial administration, and appropriate measures should be taken if hypotension occurs. Acute hypotension may occur after taking this medication due to vasodilation, so particular caution is required for patients with severe aortic stenosis. Patients with severe obstructive coronary artery disease should exercise caution as the risk of angina or myocardial infarction may increase when taking this medication. Use this medication carefully in patients with congestive heart failure, and monitor carefully for changes in renal function in patients with renal impairment. Patients with liver dysfunction should be cautious as metabolism and excretion of this medication may be delayed. While taking this medication, side effects such as dizziness, headache, hypotension, orthostatic hypotension, edema, dyspepsia, etc., may arise, so if there are any unusual symptoms, immediate consultation with healthcare professionals is recommended. This medication may interact with other drugs, so if there are other medications being taken, it is essential to inform healthcare professionals, especially avoiding concurrent use with grapefruit juice. This medication should not be taken during pregnancy, and breastfeeding women are advised to discontinue breastfeeding or the medication since it may pass into breast milk. Safety and effectiveness have not been established for pediatric patients under 18 years of age, so it is not recommended for use in this population. For the elderly, starting at a lower dose is recommended considering renal and liver function decline. In case of overdose, hypotension and impaired heart function may occur, so immediate medical attention is required for appropriate treatment. This medication should be stored out of the reach of children and protected from moisture, heat, and direct sunlight.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucous membranes, difficulty breathing or shortness of breath, asthma attack, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

• Dizziness
• headache
• drowsiness
• paresthesia
• decreased libido
• palpitations
• hypotension
• orthostatic hypotension
• cough
• nausea

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to store the medication at a normal room temperature between 1 and 30 degrees Celsius, not in excessively hot or cold places.

Appearance

Pale yellow, round, film-coated tablets

Package unit

28 tablets (14 tablets/PTP × 2)