Oroten HCT Tablets 10/40/12.5 mg

Adult dosage

This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (for example, in the morning). The recommended dosages are as follows: - 5/20/12.5 mg: administered for patients whose blood pressure is not adequately controlled with amlodipine/olmesartan medoxomil 5/20 mg combination therapy. - 5/40/12.5 mg: administered for patients whose blood pressure is not adequately controlled with amlodipine/olmesartan medoxomil 5/40 mg combination therapy or this medication 5/20/12.5 mg.

Children's dosage

Safety and efficacy in pediatric patients under 18 years of age have not been established, so the use of this medication is not recommended.

This medication may cause serious harm or death to the fetus and newborn during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. It should not be used by individuals with hypersensitivity to this drug, its ingredients, or similar medications, nor by pregnant or breastfeeding women, patients with severe hypotension, and those with severe heart, kidney, or liver diseases. Patients with reduced blood volume or impaired kidney function may experience hypotensive symptoms during the initial use of this medication, so their condition should be closely monitored before and during treatment. This drug may affect kidney function, so patients with reduced kidney function should regularly check potassium, creatinine, and uric acid levels through blood tests. Patients with liver disease or impaired liver function should be cautious as hepatic coma may occur with this medication, and it is not recommended for patients with severe liver disease. As this medication lowers blood pressure, it may cause dizziness or lightheadedness; therefore, caution is advised when driving or operating hazardous machinery. This drug may cause skin sensitivity to sunlight, so exposure to sunlight should be avoided, or appropriate ultraviolet protection measures should be taken while using it. There may be interactions with other medications during use, particularly with lithium, nonsteroidal anti-inflammatory drugs, and other antihypertensives, so consultation with a specialist is necessary. In case of overdose, severe hypotension, palpitations, electrolyte imbalances, etc., may occur, and immediate medical attention should be sought if symptoms appear. This medication is not recommended for children as its safety and efficacy have not been established, and elderly patients should start at a low dose considering potential decreases in liver and kidney function. During breastfeeding, the components of this drug may be passed into breast milk affecting the baby, so cessation of breastfeeding or avoidance of this drug is recommended. When storing this medication, keep it out of reach of children and store it in a cool, dry place away from heat and direct sunlight.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mouth/eye mucosa, breathlessness or difficulty breathing, asthma attack, cough with fever accompanied respiratory abnormalities, jaundice, profound malaise, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision changes, paralysis, urine

Mild side effects

• Peripheral edema
• headache
• dizziness
• upper respiratory tract infection
• nasopharyngitis
• urinary tract infection
• sialadenitis
• leukopenia
• thrombocytopenia
• bone marrow suppression

This medication should be stored in an airtight container to protect it from air and moisture and kept at a cool room temperature between 1 to 30 degrees Celsius.

Appearance

Round film-coated tablet in grayish-red

Package unit

28 tablets (14 tablets/PTP×2) / carton