Important safety information including dosage, side effects, and precautions of Levocetirizine Evocetirizine tablets.
Dosage & Administration
・Take 1 tablet (5 mg) at a time, once a day before bedtime.
・The dosage may be adjusted according to the age or symptoms, but the maximum daily dose is 2 tablets (10 mg).
Side Effects
The following side effects have been reported:
・Drowsiness, fatigue
・Dry mouth, nausea, loss of appetite
・Eosinophilia
・Elevated liver enzymes (ALT, AST), increased total bilirubin
Serious side effects (Seek immediate medical attention):
In the event of an emergency or the appearance of any of the following serious side effects, stop taking this medication and consult the nearest medical institution.
・Shock or anaphylaxis: (Symptoms may include hives, facial or throat swelling, difficulty breathing, or low blood pressure.)
・Seizures
・Liver dysfunction (0.6%) or jaundice (frequency unknown)
・Thrombocytopenia (decrease in platelets)
Precautions
・If you have liver problems, are pregnant or nursing, always check with your physician before taking this medication to make sure it is safe for you to take.
・Store at room temperature.
・Under the above conditions, the shelf life is 5 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。