Xyzal 驅異樂全仿單 - 荷商葛蘭素史克

驅 異 樂
Xyzal ®
膜 衣 錠 5 毫 克
film-coated tablets 5mg
衛 署 藥 輸 字 第 023792 號
【 成 分 】
每 錠 含 主 成 分 levocetirizine dihydrochloride 5 毫 克 。
【 藥 理 作 用 】
抗 過 敏 製 劑 。
【 適 應 症 】
治 療 成 人 及 六 歲 以 上 孩 童 因 過 敏 性 鼻 炎 、 慢 性 蕁 麻 疹 等 所 引 起 的 各 種 過 敏 徵 狀 。
說 明 : 包 括 持 續 性 過 敏 性 鼻 炎 所 引 起 的 各 種 過 敏 徵 狀 。
【 用 法 用 量 】
本 藥 須 由 醫 師 處 方 使 用 。
服 用 時 以 水 伴 服 吞 入 , 飯 前 或 飯 後 均 可 。 建 議 每 日 單 次 服 用 。
◎ 成 人 及 十 二 歲 以 上 青 少 年 : 建 議 每 日 劑 量 為 5 毫 克 ( 一 錠 )。
◎ 老 年 患 者 : 患 有 中 度 到 嚴 重 腎 功 能 障 礙 的 老 年 患 者 , 需 調 整 其 劑 量 , 請 參 考 下 述 有 關 “ 腎 功 能 障 礙 患 者 " 之 用 量 。
◎ 六 歲 至 十 二 歲 的 孩 童 : 建 議 每 日 劑 量 為 5 毫 克 ( 一 錠 )。 六 歲 以 下 孩 童 尚 不 建 議 使 用 。
◎ 腎 功 能 障 礙 患 者 : 此 類 病 患 的 服 藥 間 隔 應 視 其 腎 功 能 的 狀 況 而 做 調 整 ( 如 下 表 )。 在 參 考 下 表 所 列 之 建 議 劑 量 前 , 必 須 先
測 得 患 者 的 肌 酸 酐 肅 清 率 (creatinine clearance, CLcr)。 而 CLcr 可 由 serum creatinine 以 下 列 公 式 估 得 :
CL cr =
[140 – age (years)] x weight (kg)
72 x serum creatinine (mg/dl)
( x 0.85 for women)
腎 功 能 狀 況 Creatinine clearance (ml/min) 劑 量 、 間 隔 時 間
正 常 ≧80 每 日 一 錠
輕 微 50–79 每 日 一 錠
中 度 30-49 隔 日 一 錠
嚴 重

除 了 上 述 經 由 臨 床 試 驗 發 現 的 副 作 用 外 , 由 藥 品 上 市 後 的 副 作 用 報 告 曾 發 現 下 列 非 常 罕 見 的 副 作 用 :
免 疫 系 統 : 過 敏 反 應
呼 吸 系 統 、 胸 廓 及 縱 隔 腔 : 呼 吸 困 難
胃 腸 道 : 噁 心
皮 膚 及 皮 下 組 織 : 血 管 神 經 性 水 腫 、 搔 癢 、 皮 疹 、 蕁 麻 疹
其 他 診 查 : 體 重 增 加
【 過 量 】
徵 狀 : 若 服 用 過 量 時 , 成 人 會 有 嗜 睡 的 現 象 , 孩 童 則 會 先 興 奮 不 安 , 而 後 伴 隨 睏 倦 。
處 置 : 對 於 levocetirizine 過 量 並 無 特 殊 的 解 毒 劑 。 在 處 理 服 用 過 量 的 案 例 時 , 建 議 以 徵 狀 治 療 。 亦 可 考 慮 洗 胃 ( 服 用
後 短 期 內 )。 血 液 透 析 (Hemodialysis) 對 levocetirizine 的 排 除 無 效 。
【 貯 存 】
請 保 存 於 25℃ 以 下 乾 燥 的 場 所 , 並 置 於 幼 兒 不 易 取 得 處 。
【 安 定 性 】
請 於 包 裝 上 所 標 示 的 有 效 期 限 內 使 用 。
【 包 裝 】
10,100 錠 鋁 箔 盒 裝 。
_____________________________________________________________________________________________________________________
製 造 廠 : UCB Farchim S.A.
廠 址 : Z.I. de Planchy, Chemin de Croix-Blanche 10, CH-1630 Bulle, Switzerland
包 裝 廠 : UCB Pharma S.p.A.
廠 址 : Via Praglia 15, 10044 Pianezza (TO), Italy
藥 商 : 荷 商 葛 蘭 素 史 克 藥 廠 股 份 有 限 公 司 台 灣 分 公 司
地 址 : 台 北 市 忠 孝 西 路 一 段 66 號 24 樓

Xyzal ® film coated tablets 5mg
Registration No. 023792
COMPOSITION
Each film-coated tablet contains 5mg levocetirizine dihydrochloride.
PHARMACOTHERAPEUTIC GROUP
Antiallergic agent
THERAPEUTIC INDICATIONS
Levocetirizine is indicated for the treatment of symptoms associated with allergic
conditions in adults and children aged 6 years and above, such as: allergic rhinitis
and chronic urticaria.
Note: Including allergic symptoms of persistent allergic rhinitis.
POSOLOGY AND METHOD OF ADMINISTRATION
Xyzal ® is delivered on medical prescription only.
The film-coated tablet must be taken orally, swallowed whole with liquid and may
be taken with or without food. It is recommended to take the daily dose in one
single intake.
Adults and adolescents 12 years and above:
The daily recommended dose is 5 mg (1 film-coated tablet).
Elderly:
Adjustment of the dose is recommended in elderly patients with moderate to
severe renal impairment (see Patients with renal impairment below).
Children aged 6 to 12 years:
The daily recommended dose is 5 mg (1 film-coated tablet).
For children aged less than 6 years no adjusted dosage is yet possible.
Patients with renal impairment:
The dosing intervals must be individualized according to renal function. Refer to
the following table and adjust the dose as indicated. To use this dosing table, an
estimate of the patient’s creatinine clearance (CL cr ) in ml/min is needed. The CL cr
(ml/min) may be estimated from serum creatinine (mg/dl) determination using the
following formula:
CL cr =
[ 140 − age(
years)
]
x weight ( kg)
72 x serumcreatinine(
mg / dl)
( x 0. 85 for women)
Dosing Adjustments for Patients with Impaired Renal Function:
Group Creatinine clearance (ml/min) Dosage and frequency
Normal ≥80 1 tablet once daily
Mild 50 – 79 1 tablet once daily
Moderate 30 – 49 1 tablet once every 2 days
Severe

Patients with hepatic impairment:
No dose adjustments is needed in patients with solely hepatic impairment. In
patients with hepatic impairment and renal impairment, adjustment of the dose is
recommended (see Patients with renal impairment above).
Duration of use:
The duration of use depends on the type, duration and course of the complaints.
For hay fever 3-6 weeks, and in case of short-term pollen exposure as little as one
week, is generally sufficient. Clinical experience with 5 mg levocetirizine as a
film-coated tablets formulation is currently available for a 6-month treatment
period. For chronic urticaria and chronic allergic rhinitis, up to one year’s clinical
experience is available for the racemate, and up to 18 months in patients with
pruritus associated with atopic dermatitis.
CONTRA-INDICATIONS
History of hypersensitivity to levocetirizine or any of the other constituents of the
formulation or to any piperazine derivatives.
Patients with severe renal impairment at less than 10ml/min creatinine clearance.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
The use of Xyzal is not recommended in children aged less than 6 years since the
currently available film-coated tablets do not yet allow dose adaptation.
Precaution is recommended with intake of alcohol (see Interactions).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS
OF INTERACTION
No interaction studies have been performed with levocetirizine (including no
studies with CYP3A4 inducers); studies with the racemate compound cetirizine
demonstrated that there were no clinically relevant adverse interactions (with
pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide
and diazepam). A small decrease in the clearance of cetirizine (16%) was
observed in a multiple dose study with theophylline (400 mg once a day); while
the disposition of theophylline was not altered by concomitant cetirizine
administration.
The extent of absorption of levocetirizine is not reduced with food, although the
rate of absorption is decreased.
In sensitive patients the simultaneous administration of cetirizine or levocetirizine
and alcohol or other CNS depressants may have effects on the central nervous
system, although it has been shown that the racemate cetirizine does not
potentiate the effect of alcohol.
PREGNANCY AND LACTATION
For levocetirizine no clinical data on exposed pregnancies are available. Animal
studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryonal/fetal development, parturition or postnatal development. Caution
should be exercised when prescribing to pregnant or lactating woman.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Comparative clinical trials have revealed no evidence that levocetirizine at the

ecommended dose impairs mental alertness, reactivity or the ability to drive.
Nevertheless, some patients could experience somnolence, fatigue and asthenia
under therapy with Xyzal. Therefore, patients intending to drive, engage in
potentially hazardous activities or operate machinery should take their response
to the medicinal product into account.
UNDESIRABLE EFFECTS
In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the
patients in the levocetirizine 5mg group had at least one adverse drug reaction
compared to 11.3% in the placebo group. 91.6% of these adverse drug reactions
were mild to moderate.
In therapeutic trials, the drop out rate due to adverse events was 1.0% (9/935)
with levocetirizine 5mg and 1.8% (14/771) with placebo.
Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the
drug at the recommended dose of 5mg daily. From this poling, following incidence
of adverse drug reactions were reported at rates of 1% or greater (common:
>1/100, 1/1000,

Keep out of the reach and sight of children.
EXPIRY DATE
Do not use after the expiry date stated on the carton box and blister.
NATURE AND CONTENTS OF CONTAINER
Xyzal film-coated tablets are packed in aluminium blisters placed into cardboard
boxes containing 10 and 100 film-coated tablets.
Manufacturer : UCB Farchim S.A., Z.I. de Planchy, Chemin de Croix-Blanche 10,
CH-1630 Bulle, Switzerland
Packager : UCB Pharma S.p.A., Via Praglia 15, 10044 Pianezza (TO), Italy