Rivaroxaban Tablets 4/160/10 mg (Pitavastatin Calcium Hydrate, Valsartan, Amlodipine Besylate)

Adult dose

The dose is 1 tablet once daily with water. It is recommended to take it at the same time each day (e.g., before breakfast). Administer the amlodipine/valsartan combination as follows: ㆍ5/80 mg: For patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy. ㆍ5/160 mg: For patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg monotherapy.

This drug may cause serious harm to the fetus and newborn in the second and third trimesters of pregnancy; therefore, women who are pregnant or may become pregnant should not take it. Patients with allergies to any component in this medication, severe liver disease, kidney disease, or certain heart diseases should not take this drug. Patients with conditions like hypotension, hyperkalemia, or renal artery stenosis must consult their doctor before taking this medication, and periodically check blood pressure and potassium levels while on this medication. During treatment, symptoms such as myalgia, weakness, jaundice, and rash may occur, and patients should inform healthcare providers immediately if these symptoms appear. Caution is advised when driving or operating machinery, as dizziness or fatigue may occur, particularly in the elderly, starting with a low dose and gradually increasing is recommended for safety. Interactions may occur with other medications, so patients should inform healthcare providers of any other medications being taken. Pregnant or breastfeeding women should not use this medication; breastfeeding should be discontinued if taking this drug. Safety and efficacy for children have not been established; therefore, it should not be used in patients under 18 years of age. In cases of overdose, severe hypotension or cardiac problems may occur; patients should adhere strictly to dosing and seek immediate medical attention in case of overdose. This medication should be stored out of reach of children, and kept in its original container to prevent misuse or quality degradation.

Serious side effects

Rash, severe swelling, angioedema, severe allergic reactions, jaundice, liver dysfunction, hepatitis, acute renal failure, rhabdomyolysis, severe skin reactions, Stevens-Johnson syndrome, vesicular dermatitis, headache, seizures, paralysis, serious neurological symptoms, difficulty breathing, shortness of breath, asthma attack, thunderclap headache, thrombocytopenia, severe swelling or urinary disorders, generalized edema associated with elevated blood pressure

Mild side effects

• Headache
• itching
• sudden hearing loss
• vomiting
• dyspepsia
• alopecia
• purpura
• skin depigmentation
• photosensitivity
• myalgia

This medication should be stored at room temperature between 1°C and 30°C, ensuring it is kept in a tightly sealed container to prevent air exposure. Proper storage will maintain the effectiveness of the medication.

Appearance

Dark pink oval film-coated tablet

Package unit

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