Rivaroxaban High Tablet 4/160/5 mg (Pitavastatin Calcium Hydrate, Valsartan, Amlodipine Besylate)

Adult dose

This medicine is to be taken once daily, 1 tablet with water. It is recommended to take it at the same time each day (for example, before breakfast). It is advisable to adjust the individual component dosage before administering Amlodipine/Valsartan combination therapy; if blood pressure is not controlled, the following dosages may be taken: - 5/80 milligrams: for patients whose blood pressure is not adequately controlled with Amlodipine 5 mg or Valsartan 80 mg monotherapy.

This medicine can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it must be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to the ingredients of this medicine or with severe liver or kidney disorders, as well as pregnant or breastfeeding women, should not take this medication. Patients with sodium or fluid depletion, those with hyperkalemia, and patients with renal artery stenosis should use this drug with caution and monitor blood pressure and kidney function closely. In patients with heart disease, such as heart failure or post-myocardial infarction, or aortic valve stenosis patients, this medication should also be administered with caution. During medication, adverse effects such as blood pressure drop, edema, headache, itching, gastrointestinal disturbances, myalgia, and others may occur, so if these symptoms are severe or persistent, consult a doctor. Caution is needed when driving or operating machinery as dizziness or fatigue may occur. This medicine may interact with other drugs, so particular caution is needed when used with cyclosporine, fibrate medications, niacin, certain antibiotics, and drugs that increase potassium levels. Pregnant or breastfeeding women should not take this medication, and if pregnancy is confirmed during the course of treatment, it must be discontinued immediately. The safety for pediatric patients or those under 18 years of age has not been established, so it is advisable not to use it in this age group. Elderly patients may react more sensitively to the medication, so starting at a lower dose and gradually increasing is recommended. In case of overdose, severe hypotension or shock may occur; therefore, immediate medical attention is required.

Serious side effects

Hives, severe swelling (edema), angioedema, severe allergic reactions, skin peeling, severe rash, blisters, pain in oral/ocular mucous membranes, severe skin reactions, difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever, breathing problems, yellowing of skin or eyes (jaundice), liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, severe neurological effects

Mild side effects

• Headache
• itching
• sudden hearing loss
• intestinal obstruction
• diplopia
• hyperglycemia
• insomnia
• emotional changes
• tremors
• sensory loss

This medicine should be stored at room temperature between 1 to 30 degrees Celsius, and it's important to keep it in a tightly sealed container to prevent air exposure. This helps preserve the drug's efficacy for a longer period.

Appearance

Oval film-coated tablet of deep yellow color

Package unit

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