Description
Product Overview / 商品概要
Kracie Hachimi-jio-gan Extract Tablets (クラシエ八味地黄丸料エキス錠)
Generic: Hachimi-jio-gan Extract / 八味地黄丸エキス
Therapeutic Category: Kampo (Traditional Japanese Herbal Medicine) Preparation / 漢方製剤
Manufactured by: Daihodo Pharmaceutical Co., Ltd. / 大峰堂薬品工業株式会社
Composition & Specification / 組成・規格
Active Ingredient: Per daily dose (18 tablets): Japanese Pharmacopoeia Hachimi-jio-gan Extract 5,200mg, extracted from the following crude drugs: Rehmannia Root (Jio) 5.0g, Cornus Fruit (Sanshuyu) 3.0g, Japanese Yam (Sanyaku) 3.0g, Water Plantain Tuber (Takusha) 3.0g, Poria Sclerotium (Bukuryo) 3.0g, Moutan Bark (Botanpi) 3.0g, Cinnamon Bark (Keihi) 1.0g, Processed Aconite Root Powder (Bushi-matsu) 1.0g / 本品1日量（18錠）中：日局ジオウ 5.0g、日局サンシュユ 3.0g、日局サンヤク 3.0g、日局タクシャ 3.0g、日局ブクリョウ 3.0g、日局ボタンピ 3.0g、日局ケイヒ 1.0g、日局ブシ末 1.0g の混合生薬より抽出した日局八味地黄丸エキス5,200mg
Additives: Honey (JP), Synthetic Aluminum Silicate (JP), Magnesium Stearate (JP), Sucrose (JP), Hypromellose Phthalate (JP), Hypromellose (JP), Macrogol 6000 (JP) / 日局ハチミツ、日局合成ケイ酸アルミニウム、日局ステアリン酸マグネシウム、日局白糖、日局ヒプロメロースフタル酸エステル、日局ヒプロメロース、日局マクロゴール6000
Appearance: Film-coated tablet; color: brown to dark brown; odor: almost none; taste: almost none; diameter: 10mm; thickness: 5.2mm; weight: 401mg; identification code: EKT-7
外観: 剤形：フィルムコーティング錠、色：褐色～暗褐色、におい：ほとんどない、味：ほとんどない、直径：10mm、厚さ：5.2mm、質量：401mg、識別コード：EKT-7
Indications / 効能効果
EN: The following conditions in patients who tire easily, have cold extremities, decreased or increased urine output, and occasional thirst: lower limb pain, lower back pain, numbness, blurred vision in the elderly, pruritus, dysuria, urinary frequency, edema
JA: 疲れやすくて、四肢が冷えやすく、尿量減少または多尿で、ときに口渇がある次の諸症：下肢痛、腰痛、しびれ、老人のかすみ目、かゆみ、排尿困難、頻尿、むくみ
Dosage and Administration / 用法用量
EN: Usually, adults take 18 tablets per day in 2 to 3 divided doses, administered orally before or between meals. Dosage may be adjusted according to age, body weight, and symptoms.
JA: 通常、成人1日18錠を2～3回に分割し、食前又は食間に経口投与する。なお、年齢、体重、症状により適宜増減する。
Contraindications / 禁忌
EN: No explicit contraindications listed in the package insert. Administration to pregnant women or women who may be pregnant is not recommended due to the risk of miscarriage/premature birth associated with Moutan Bark and potential adverse effects of processed aconite root powder.
JA: 禁忌に関する記載はPDFに明示なし。妊婦又は妊娠している可能性のある女性には投与しないことが望ましい（ボタンピによる流早産の危険性、ブシ末の副作用）。
Regulatory Information / 規制情報
Approval No.: 21900AMX00642000
Sales Started: December 1987 / 1987年12月
Classification Code: 875200
Storage: Store at room temperature / 室温保存
Shelf Life: 3 years / 3年
Packaging / 包装
Main Package (for sale): 252 tablets (3 tablets x 6 linked packs x 14 sheets) [individual packs] / 252錠（3錠×6連包×14シート）［分包］
Other Available Packages (by special order): 252 tablets (3 tablets x 6 linked packs x 14 sheets) [individual packs], 1,764 tablets (3 tablets x 6 linked packs x 98 sheets) [individual packs]
Full product insert (添付文書) is attached as a downloadable PDF. For detailed precautions, drug interactions, and safety information, please refer to the official package insert.
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