Rozalfos Tablets 10/50 mg (Amlodipine, Losartan Potassium)

Adult dose

The recommended dosage 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). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not controlled sufficiently after 2 weeks, the dose may be increased to 10/50 mg once daily.

Child dose

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

This medication can cause serious harm to the fetus, especially during the second and third trimesters of pregnancy, so it must be discontinued immediately if pregnancy is confirmed. When administered for the first time to patients with reduced blood volume, blood pressure may drop significantly, so those patients should stabilize their condition before administration. Patients with hypersensitivity to this medication, pregnant or potentially pregnant women, nursing mothers, patients with severe liver dysfunction, severe aortic stenosis, and shock should not use this medication. Caution should be exercised when administering to patients with volume depletion or impaired renal function, patients requiring strict sodium restriction, and patients with hyperkalemia. Dizziness, headache, and drowsiness may occur when taking this medication, so driving or operating hazardous machinery should be avoided. If liver or kidney disease is present, dosage adjustment of this medication may be necessary, and consultation with a physician is advised. Caution is necessary when this medication is taken with other antihypertensive drugs as the blood pressure-lowering effect may be enhanced. It is advisable to avoid taking this medication with grapefruit juice, as it may increase the plasma concentration of the medication and raise the risk of side effects. If blood pressure drops too low or if severe allergic reactions, symptoms of angioedema occur, medical attention should be sought immediately. An overdose may result in severe hypotension and tachycardia; hence, the dosage must be strictly adhered to, and emergency medical help should be obtained in case of an overdose. The safety and efficacy of this medication have not been established in children or adolescents under 18 years of age and, therefore, it is not recommended for use in this population. Store this medication out of reach of children and do not transfer it to another container.

Serious side effects

• Rash
• severe swelling (angioedema)
• chest discomfort
• difficulty breathing
• respiratory distress
• angioedema (possible airway obstruction)
• hepatitis
• impaired liver function
• jaundice
• extreme general malaise

Mild side effects

• Dizziness
• headache
• drowsiness
• weakness
• chest discomfort
• chest pain
• early satiety
• peripheral edema
• pitting edema
• abdominal discomfort

This medication should be stored in a tightly closed container, protected from air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius, at room temperature.

Appearance

Pink oblong film-coated tablet

Package unit

30 tablets/bottle