Balsafos Tablet 5/160 mg (Amlodipine Besylate, Valsartan)

Adult dose

The recommended dose of Balsafos tablets is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning) if possible.

Child dose

The safety and efficacy of this medication has not been established in pediatric patients under 18 years of age, and therefore its use is not recommended.

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Do not take this medication if you are allergic to any of its active ingredients or similar medications, if you are pregnant or breastfeeding, or if you have severe kidney or liver diseases, or a history of specific heart diseases or angioedema. Patients with low sodium or fluid levels may experience hypotension; therefore, it is essential to manage such conditions before taking this medication and to monitor blood pressure and condition carefully during treatment. This medication can increase blood potassium levels, so if taken with potassium supplements or potassium-sparing diuretics, potassium levels should be checked frequently. Patients with renal impairment or kidney transplant recipients should use caution as this medication may affect renal function. If symptoms of angioedema occur, discontinue use immediately and do not resume. Patients with heart failure or post-myocardial infarction should carefully monitor renal function and blood pressure while on this medication, and patients with acute myocardial infarction should also be cautious. Dose adjustments may be necessary for individuals with impaired liver function, and this medication should not be used in severe liver disease cases. Dizziness or fatigue may occur during treatment, so caution is advised when driving or operating machinery. When combining this medication with other antihypertensive medications or specific drugs, interactions may occur; therefore, consultation with a doctor or pharmacist is necessary, especially for frequent checks of potassium levels, renal function, and blood pressure. This medication is not recommended for children under 18 years of age. Overdose may lead to severe hypotension or cardiac issues, so care should be taken to not exceed the prescribed dosage. If pregnant or planning to become pregnant, consultation with a doctor is essential before taking this medicine, and breastfeeding women should also avoid this treatment.

Serious side effects

Hives, severe swelling (edema), angioedema, vasculitis, impaired liver function (hepatitis, jaundice), Stevens-Johnson syndrome, toxic epidermal necrolysis, severe allergic reactions, confusion, seizures, visual disturbances, paralysis, severe neurological symptoms, severe edema or urination issues, worsening heart failure, pulmonary edema, acute renal failure, myocardial infarction, severe hypotension, syncope, elevated serum potassium, renal failure, and kidney damage.

Mild side effects

• Headache
• dizziness
• drowsiness
• paresthesia
• lightheadedness
• tinnitus
• tachycardia
• palpitations
• syncope
• orthostatic hypotension

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, avoid storing it in excessively hot or cold places; storing it at room temperature between 1 degree and 30 degrees Celsius is safe.

Appearance

Dark yellow oblong film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging × 2)