Balsafine Tablet 5/80 mg

Adult dose

Take 1 tablet once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). If blood pressure is not controlled, the dosage may be adjusted based on the doses of amlodipine or valsartan monotherapy: 5/80 mg, 5/160 mg, 10/160 mg. For patients with kidney impairment, mild to moderate (creatinine clearance over 10 mL/min) does not require dosage adjustment.

Child dose

The safety and efficacy in pediatric patients under 18 years have not been established, and administration is not recommended.

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, and should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to this medication, those with certain kidney and liver diseases, and women who are pregnant or breastfeeding should not use this drug. Patients who are sodium or fluid depleted may experience hypotension, so their condition should be assessed before taking the drug, and appropriate action should be taken immediately if symptoms of hypotension occur. Patients with high potassium levels or those taking potassium supplements should exercise caution and regularly monitor their blood potassium levels. Patients with kidney function issues or kidney transplant recipients must have their kidney function closely monitored when taking this drug. If symptoms of angioedema occur, this medication should be discontinued immediately and not re-administered. Patients with heart failure or myocardial infarction require careful observation including evaluation of kidney function. Dizziness or fatigue may occur when driving or operating machinery, so caution is advised. This medication may interact with certain other drugs; therefore, it is essential to consult a doctor or pharmacist if other medications are being taken. Pregnant women or those planning to become pregnant should not use this medication, and breastfeeding women are also advised to avoid it. Safety and efficacy have not been established in children under 18 years of age, and it is not recommended for this age group. Overdose may lead to hypotension or serious side effects; therefore, the dosage must be strictly followed and any unusual symptoms should be reported to healthcare professionals immediately.

Serious side effects

Urticaria, severe swelling (edema), 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 distress accompanying cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, consciousness disturbance, visual disturbances, paralysis, urination problems

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Dark yellow round film-coated tablet

Package unit

30 tablets/bottle