Ducanova Tablet 60/5 mg (Fimasartan, Esamlodipine)

Adult dose

The recommended dosage for adults is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients whose blood pressure is not adequately controlled on Fimasartan 30 mg monotherapy, administer 30/2.5 mg. For patients whose blood pressure is not adequately controlled on Fimasartan 60 mg monotherapy, administer 60/2.5 mg.

Child dose

The 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 in the second and third trimesters of pregnancy; it should be discontinued immediately upon confirmation of pregnancy. It is contraindicated in patients with allergies to the active ingredients or similar components, in pregnant or breastfeeding women, in patients undergoing renal dialysis, in patients with severe liver impairment, and in patients with bile duct obstruction. Patients with low blood volume or low salt levels, impaired kidney function, renal artery hypertension, aortic stenosis or mitral stenosis, and the elderly should use this drug with caution and be closely monitored. Side effects such as dizziness, headache, facial or peripheral edema, urinary disturbances, insomnia, and flushing may occur; if symptoms are severe, consult a physician. Hypotension may occur, requiring the patient to lie down and administer fluids if blood pressure drops too low. This medication may increase serum potassium levels; therefore, patients with heart failure or renal disease should regularly check their potassium levels through blood tests. Interactions may occur when used with other antihypertensives, potassium-sparing diuretics, certain anti-inflammatory medications, and lithium. Always inform healthcare providers of other medications being taken. Use during pregnancy carries a risk of serious abnormalities to the fetus, so this medication should be avoided if planning to become pregnant or if currently pregnant. If breastfeeding, it is recommended to discontinue breastfeeding or this medication due to the possibility of excretion into breast milk. Safety in children and adolescents has not been established; it is advised not to use this medication in these populations. Overdose may result in hypotension, cardiac arrhythmias, and severe vasodilation. Care should be taken not to exceed the recommended dosage, and in case of overdose, consult healthcare providers immediately. This medication should be kept out of reach of children, and transferring to another container may compromise quality.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral or ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures,

Mild side effects

• Dizziness
• headache
• orthostatic dizziness
• insomnia
• flushing
• facial edema
• peripheral edema
• urinary disturbances
• dyspepsia
• vomiting

This medication is sensitive to light; it should be stored in a container that does not allow light. Additionally, it should be stored at room temperature between 1°C and 30°C for safe use.

Appearance

Orange-colored, rounded square film-coated tablet

Package unit

30 tablets / bottle, 300 tablets / bottle