SPASMOLYT TABLET 20 MG

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

TROSPIUM CHLORIDE

から入手可能:

MYLAN HEALTHCARE SDN. BHD.

INN（国際名）:

TROSPIUM CHLORIDE

パッケージ内のユニット:

30Tablet Tablets; 100Tablet Tablets

製:

MADAUS GmBH

情報リーフレット

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製品の特徴

SPECIFICATION BOX: Beipackzettel
PRODUCT:
MADAUS-NO.:
LAETUS-CODE:
EAN-CODE:
704789
472
- - -
SIGHTMARKS:
- - -
PACK-SIZE:
165 x 296 mm (WZ 282)
FONT-SIZE:
Helvetica Neue LT Pro 8 pt
COUNTRY:
Malaysia
LANGUAGE:
english
CORRECTION:
1. Correction
DATE:
20.02.2017
Black
Spasmolyt 20 mg, Drg.
TW
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is trospium chloride. Each coated tablet
contains 20 mg trospium chloride.
Also contains: Wheat starch, Microcrystalline cellulose, Lactose
monohydrate, Povidone, Croscarmellose sodium, Stearic acid,
Silica colloidal anhydrous, Talc, Sucrose, Carmellose sodium,
Calcium carbonate E 170, Macrogol 8000, Titanium dioxide
E 171, Iron oxide hydrate yellow E 172, Beeswax white and Car-
nauba wax.
_Note for diabetics: 1 coated tablet corresponds to 0.06g carbohy-_
_drate (equivalent to 0.005 bread units)_
PHARMACEUTICAL FORM
Coated tablet.
Brownish-yellow, glossy coated, biconvex tablets.
CLINICAL PARTICULARS
Therapeutic indications
Symptomatic treatment of urge incontinence and/or increased
urinary frequency and urgency as may occur in patients with
overactive bladder (e.g. idiopathic or neurologic detrusor over-
activity).
Posology and method of administration
One coated tablet twice daily (equivalent to 40 mg of trospium
chloride per day).
The coated tablet should be swallowed whole with a glass of
water before the meals on empty stomach.
In patients with severe renal impairment (creatinine clearance
between 10 and 30 mL/min/1.73 m
2
) the recommended dosage
is: One coated tablet per day or every second day (equivalent to
20 mg of trospium chloride per day or every second day).
The coated tablet should be swallowed whole with a glass of
water before the meals on empty stomach.
The need for continued treatment should be reassessed at regu-
lar intervals of 3-6 months.
Since no data are available the use in children under 12 years of
age is contraindicated.
Contra-indications
Trospium chloride is contraindicated in patients with urinary re-
tention, severe gastro-intesti