Rivaroxaban Hi Tablets 2/160/5 mg (Pitavastatin Calcium Hydrate, Valsartan, Amlodipine Besilate)

Adult dose

Take 1 tablet once daily with water. It is recommended to take at the same time every day (e.g., before breakfast). Amlodipine/Valsartan combination should be administered in doses of 5/80 mg, 5/160 mg, or 10/160 mg according to blood pressure control. Pitavastatin Calcium is usually taken in an initial dosage of 1-2 mg once daily, with a maximum of 4 mg per day if necessary.

This medication can cause severe harm or death to the fetus and neonate if administered to pregnant women in the second and third trimesters, so use must be discontinued if pregnant or potentially pregnant. Do not use in patients with allergies to any component of this medication, those with specific liver or kidney diseases, pregnant or nursing women, and those genetically unable to digest lactose. Caution must be exercised when administering this medication to patients with low sodium or body fluid levels, hyperkalemia, renal artery stenosis, heart failure, or those recovering from myocardial infarction; careful pre-assessment and attentive monitoring during treatment are essential. Various side effects such as myalgia, liver dysfunction, blood abnormalities, and allergic reactions may occur, so immediate consultation with a physician is required if any unusual symptoms arise. Caution is needed during driving or operating machinery as dizziness or fatigue may occur. Interactions may occur when using with other drugs, so it is essential to inform healthcare providers of any other medications being taken. This medication is not recommended for use during pregnancy or breastfeeding, and women planning to become pregnant should consult prior to using this medication. Safety and efficacy have not been established for children under 18 years of age, so it should not be used in these patients. When administered to the elderly, dosage adjustments may be necessary, and careful observation for side effects is advised. In case of overdose, there is a risk of severe hypotension and shock, requiring immediate emergency treatment. This medication should be kept out of reach of children and stored in its original container to maintain quality.

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 mucosa, shortness of breath or difficulty breathing, 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,

Mild side effects

• Headache
• itching
• skin tingling
• dizziness
• insomnia
• mood changes
• tremors
• sensory impairment
• taste disturbances
• arrhythmia

Store this medication at room temperature between 1 to 30 degrees Celsius, and it is important to keep it in a sealed container to prevent air or moisture ingress.

Appearance

Pale yellow oval film-coated tablets

Package unit

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