Xyzal 驅異樂全仿單 - 荷商葛蘭素史克
Xyzal 驅異樂全仿單 - 荷商葛蘭素史克
Xyzal 驅異樂全仿單 - 荷商葛蘭素史克
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驅 異 樂<br />
<strong>Xyzal</strong> ®<br />
膜 衣 錠 5 毫 克<br />
film-coated tablets 5mg<br />
衛 署 藥 輸 字 第 023792 號<br />
【 成 分 】<br />
每 錠 含 主 成 分 levocetirizine dihydrochloride 5 毫 克 。<br />
【 藥 理 作 用 】<br />
抗 過 敏 製 劑 。<br />
【 適 應 症 】<br />
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 。<br />
說 明 : 包 括 持 續 性 過 敏 性 鼻 炎 所 引 起 的 各 種 過 敏 徵 狀 。<br />
【 用 法 用 量 】<br />
本 藥 須 由 醫 師 處 方 使 用 。<br />
服 用 時 以 水 伴 服 吞 入 , 飯 前 或 飯 後 均 可 。 建 議 每 日 單 次 服 用 。<br />
◎ 成 人 及 十 二 歲 以 上 青 少 年 : 建 議 每 日 劑 量 為 5 毫 克 ( 一 錠 )。<br />
◎ 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 。<br />
◎ 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 。<br />
◎ 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<br />
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 :<br />
CL cr =<br />
[140 – age (years)] x weight (kg)<br />
72 x serum creatinine (mg/dl)<br />
( x 0.85 for women)<br />
腎 功 能 狀 況 Creatinine clearance (ml/min) 劑 量 、 間 隔 時 間<br />
正 常 ≧80 每 日 一 錠<br />
輕 微 50–79 每 日 一 錠<br />
中 度 30-49 隔 日 一 錠<br />
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 :<br />
免 疫 系 統 : 過 敏 反 應<br />
呼 吸 系 統 、 胸 廓 及 縱 隔 腔 : 呼 吸 困 難<br />
胃 腸 道 : 噁 心<br />
皮 膚 及 皮 下 組 織 : 血 管 神 經 性 水 腫 、 搔 癢 、 皮 疹 、 蕁 麻 疹<br />
其 他 診 查 : 體 重 增 加<br />
【 過 量 】<br />
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 。<br />
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<br />
後 短 期 內 )。 血 液 透 析 (Hemodialysis) 對 levocetirizine 的 排 除 無 效 。<br />
【 貯 存 】<br />
請 保 存 於 25℃ 以 下 乾 燥 的 場 所 , 並 置 於 幼 兒 不 易 取 得 處 。<br />
【 安 定 性 】<br />
請 於 包 裝 上 所 標 示 的 有 效 期 限 內 使 用 。<br />
【 包 裝 】<br />
10,100 錠 鋁 箔 盒 裝 。<br />
_____________________________________________________________________________________________________________________<br />
製 造 廠 : UCB Farchim S.A.<br />
廠 址 : Z.I. de Planchy, Chemin de Croix-Blanche 10, CH-1630 Bulle, Switzerland<br />
包 裝 廠 : UCB Pharma S.p.A.<br />
廠 址 : Via Praglia 15, 10044 Pianezza (TO), Italy<br />
藥 商 : 荷 商 葛 蘭 素 史 克 藥 廠 股 份 有 限 公 司 台 灣 分 公 司<br />
地 址 : 台 北 市 忠 孝 西 路 一 段 66 號 24 樓
<strong>Xyzal</strong> ® film coated tablets 5mg<br />
Registration No. 023792<br />
COMPOSITION<br />
Each film-coated tablet contains 5mg levocetirizine dihydrochloride.<br />
PHARMACOTHERAPEUTIC GROUP<br />
Antiallergic agent<br />
THERAPEUTIC INDICATIONS<br />
Levocetirizine is indicated for the treatment of symptoms associated with allergic<br />
conditions in adults and children aged 6 years and above, such as: allergic rhinitis<br />
and chronic urticaria.<br />
Note: Including allergic symptoms of persistent allergic rhinitis.<br />
POSOLOGY AND METHOD OF ADMINISTRATION<br />
<strong>Xyzal</strong> ® is delivered on medical prescription only.<br />
The film-coated tablet must be taken orally, swallowed whole with liquid and may<br />
be taken with or without food. It is recommended to take the daily dose in one<br />
single intake.<br />
Adults and adolescents 12 years and above:<br />
The daily recommended dose is 5 mg (1 film-coated tablet).<br />
Elderly:<br />
Adjustment of the dose is recommended in elderly patients with moderate to<br />
severe renal impairment (see Patients with renal impairment below).<br />
Children aged 6 to 12 years:<br />
The daily recommended dose is 5 mg (1 film-coated tablet).<br />
For children aged less than 6 years no adjusted dosage is yet possible.<br />
Patients with renal impairment:<br />
The dosing intervals must be individualized according to renal function. Refer to<br />
the following table and adjust the dose as indicated. To use this dosing table, an<br />
estimate of the patient’s creatinine clearance (CL cr ) in ml/min is needed. The CL cr<br />
(ml/min) may be estimated from serum creatinine (mg/dl) determination using the<br />
following formula:<br />
CL cr =<br />
[ 140 − age(<br />
years)<br />
]<br />
x weight ( kg)<br />
72 x serumcreatinine(<br />
mg / dl)<br />
( x 0. 85 for women)<br />
Dosing Adjustments for Patients with Impaired Renal Function:<br />
Group Creatinine clearance (ml/min) Dosage and frequency<br />
Normal ≥80 1 tablet once daily<br />
Mild 50 – 79 1 tablet once daily<br />
Moderate 30 – 49 1 tablet once every 2 days<br />
Severe
Patients with hepatic impairment:<br />
No dose adjustments is needed in patients with solely hepatic impairment. In<br />
patients with hepatic impairment and renal impairment, adjustment of the dose is<br />
recommended (see Patients with renal impairment above).<br />
Duration of use:<br />
The duration of use depends on the type, duration and course of the complaints.<br />
For hay fever 3-6 weeks, and in case of short-term pollen exposure as little as one<br />
week, is generally sufficient. Clinical experience with 5 mg levocetirizine as a<br />
film-coated tablets formulation is currently available for a 6-month treatment<br />
period. For chronic urticaria and chronic allergic rhinitis, up to one year’s clinical<br />
experience is available for the racemate, and up to 18 months in patients with<br />
pruritus associated with atopic dermatitis.<br />
CONTRA-INDICATIONS<br />
History of hypersensitivity to levocetirizine or any of the other constituents of the<br />
formulation or to any piperazine derivatives.<br />
Patients with severe renal impairment at less than 10ml/min creatinine clearance.<br />
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE<br />
The use of <strong>Xyzal</strong> is not recommended in children aged less than 6 years since the<br />
currently available film-coated tablets do not yet allow dose adaptation.<br />
Precaution is recommended with intake of alcohol (see Interactions).<br />
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase<br />
deficiency or glucose-galactose malabsorption should not take this medicine.<br />
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS<br />
OF INTERACTION<br />
No interaction studies have been performed with levocetirizine (including no<br />
studies with CYP3A4 inducers); studies with the racemate compound cetirizine<br />
demonstrated that there were no clinically relevant adverse interactions (with<br />
pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide<br />
and diazepam). A small decrease in the clearance of cetirizine (16%) was<br />
observed in a multiple dose study with theophylline (400 mg once a day); while<br />
the disposition of theophylline was not altered by concomitant cetirizine<br />
administration.<br />
The extent of absorption of levocetirizine is not reduced with food, although the<br />
rate of absorption is decreased.<br />
In sensitive patients the simultaneous administration of cetirizine or levocetirizine<br />
and alcohol or other CNS depressants may have effects on the central nervous<br />
system, although it has been shown that the racemate cetirizine does not<br />
potentiate the effect of alcohol.<br />
PREGNANCY AND LACTATION<br />
For levocetirizine no clinical data on exposed pregnancies are available. Animal<br />
studies do not indicate direct or indirect harmful effects with respect to pregnancy,<br />
embryonal/fetal development, parturition or postnatal development. Caution<br />
should be exercised when prescribing to pregnant or lactating woman.<br />
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES<br />
Comparative clinical trials have revealed no evidence that levocetirizine at the
ecommended dose impairs mental alertness, reactivity or the ability to drive.<br />
Nevertheless, some patients could experience somnolence, fatigue and asthenia<br />
under therapy with <strong>Xyzal</strong>. Therefore, patients intending to drive, engage in<br />
potentially hazardous activities or operate machinery should take their response<br />
to the medicinal product into account.<br />
UNDESIRABLE EFFECTS<br />
In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the<br />
patients in the levocetirizine 5mg group had at least one adverse drug reaction<br />
compared to 11.3% in the placebo group. 91.6% of these adverse drug reactions<br />
were mild to moderate.<br />
In therapeutic trials, the drop out rate due to adverse events was 1.0% (9/935)<br />
with levocetirizine 5mg and 1.8% (14/771) with placebo.<br />
Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the<br />
drug at the recommended dose of 5mg daily. From this poling, following incidence<br />
of adverse drug reactions were reported at rates of 1% or greater (common:<br />
>1/100, 1/1000,
Keep out of the reach and sight of children.<br />
EXPIRY DATE<br />
Do not use after the expiry date stated on the carton box and blister.<br />
NATURE AND CONTENTS OF CONTAINER<br />
<strong>Xyzal</strong> film-coated tablets are packed in aluminium blisters placed into cardboard<br />
boxes containing 10 and 100 film-coated tablets.<br />
Manufacturer : UCB Farchim S.A., Z.I. de Planchy, Chemin de Croix-Blanche 10,<br />
CH-1630 Bulle, Switzerland<br />
Packager : UCB Pharma S.p.A., Via Praglia 15, 10044 Pianezza (TO), Italy