Important safety information including dosage, side effects, and precautions of Bilanoa tablets.
Dosage & Administration
・Take 1 tablet (20 mg) at a time, once a day on an empty stomach (approximately 1 hour before a meal or at least 2 hours after meal)
Side Effects
The following side effects have been reported:
・Drowsiness, headache, dry mouth, diarrhea, abdominal pain, liver enzyme elevations (AST, γ-GTP), nasal dryness
・Dizziness, insomnia, anxiety
・Stomach discomfort, dry mouth, indigestion, gastritis, nausea
・Right bundle branch block, sinus arrhythmia, prolonged QT interval, abnormal ECG findings, tachycardia, palpitations
・Elevated ALT (liver enzyme)
・Increased blood creatinine levels
・Shortness of breath, nasal discomfort
・Rash, itching, angioedema, erythema multiforme
・Tinnitus, fever, weight gain, elevated triglycerides, weakness, oral herpes, increased appetite, fatigue
Serious Side Effects (Seek immediate medical attention):
Stop taking this medication and consult a medical institution immediately if you experience any of the following severe reactions:
・Shock or anaphylaxis (Symptoms may include hives, facial or throat swelling, difficulty breathing, or low blood pressure.)
Precautions
・If you have moderate (30≦GFR<50mL/min/1.73m2) or severe (GFR<30mL/min/1.73m2) renal dysfunction, or if you are pregnant or nursing, please check with your doctor before taking this medication.
・Store at room temperature.
・Under the above conditions, the shelf life is 3 years.
Approval status in Japan
・「アレルギー性鼻炎、蕁麻疹、皮膚疾患（湿疹・皮膚炎、皮膚そう痒症）に伴うそう痒」を効能として承認されています。
※本診療科目で処方する医薬品は、医薬品副作用被害救済制度の対象外となります。
Availability of approved medicines that have the same active ingredients in Japan
・同じ有効成分を有し「アレルギー性鼻炎、蕁麻疹、皮膚疾患（湿疹・皮膚炎、皮膚そう痒症）に伴うそう痒」を効能として承認されている内服薬はありません。
Means of acquisition
・提携クリニックの医師が、国内医薬品販売代理店経由で購入しています。
Information on safety and approval in other countries
・諸外国で重篤な安全性情報の報告はありません。