Rivaroxaban High Tablet 2/80/5 mg (Pitavastatin Calcium Hydrate, Valsartan, Amlodipine Besilate)

Adult dose

Take 1 tablet once daily with water. It is recommended to take it at the same time each day (e.g., before breakfast). Amlodipine/Valsartan combination: - 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 80 mg valsartan monotherapy. - 5/160 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 160 mg valsartan monotherapy.

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, and use should be discontinued immediately if pregnancy is confirmed. Patients with allergies to this medication or similar drugs, pregnant or breastfeeding women, or those with severe liver or kidney dysfunction should not take this medication. Patients with sodium or fluid depletion, hyperkalemia, renal artery stenosis, or those who have recently undergone kidney transplantation should use this medication with caution under close observation by a physician. Patients with heart conditions such as heart failure, post-myocardial infarction, acute myocardial infarction, and severe aortic stenosis should also use it cautiously. This medication lowers blood pressure, so caution is needed for patients with hypotension, the elderly, and those before surgery. While taking this medication, side effects like headache, dizziness, edema, muscle pain, dyspepsia, and liver function abnormalities may occur, and patients should consult a physician immediately if they experience abnormal symptoms. Because dizziness or fatigue may occur while driving or operating machinery, caution is advised. This medication may interact with other drugs, so notify the physician or pharmacist if taking other medications. Women who are pregnant or planning to become pregnant, as well as those who are breastfeeding, should not take this medication, and use should be discontinued if pregnancy is confirmed during treatment. Safety for pediatric use has not been established, so it is advised not to use this medication in children under 18 years old. The elderly may respond more sensitively to this medication, so it is advisable to start with a lower dose and gradually increase it. Overdose may pose risks of severe hypotension and shock, so adhere to the prescribed dosage, and if an overdose occurs, visit a medical facility immediately. Store this medication out of reach of children and retain it in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), severe lethargy, sudden and very severe headache, lightning headache, seizures, confusion, visual disturbances.

Mild side effects

• Headache
• itching
• sudden hearing loss
• intestinal obstruction
• double vision
• hyperglycemia
• insomnia
• mood changes
• tremors
• sensory loss

This medication should be stored at room temperature between 1 to 30 degrees Celsius, and it is important to keep it in a tightly sealed container to prevent air and moisture from entering.

Appearance

Light purple round film-coated tablet

Package unit

30 tablets/PTP [6 tablets/PTP x 5]