SPASMO-LYT 20 MG

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

TROSPIUM CHLORIDE

MAH:

MEGAPHARM LTD

ATC_code:

G04BD09

pharmaceutical_form:

COATED TABLETS

composition:

TROSPIUM CHLORIDE 20 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

MADAUS GMBH, GERMANY

therapeutic_group:

TROSPIUM

therapeutic_area:

TROSPIUM

therapeutic_indication:

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 overactivity) .

authorization_date:

2022-03-31

PIL

.سفنتلا يف ةبوعص ىلإ
·
حفط ،سفنت قيضب بوحصملا
ّ
يئاجف ي
ّ
سسحت لعف در
.مدلا طغض يف ضافخناو ريفص ،
ّ
يدلج
·
،ةريطخ روثبب بوحصملا ،ريطخ ةيساسح طرف
لعف در
،مفلا ،نويعلا ،ناتفشلا) ةيطاخم ةيشغأ
وأ/و دلجلا ر
ّ
شقت
ا
ً
ضيأ رعشت نأ لمتحملا نم .(ة
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يلسانتلا ءاضعلأاو فنلأا
تلاضع ملأ
،ةريرعشق
،ةنوخس :ةيلاتلا
ضارعلأاب
.ديج ريغ ماع روعشو
نم رثكأ ىدل رهظت ضارعأ) ا
ً
دج ةعئاش ة
ّ
يبناج ضارعأ
:(١٠ نم دحاو لمعتسم
·
مفلا يف فافج
نيلمعتسم ١٠-١ ىدل رهظت ضارعأ) ةعئاش ة
ّ
يبناج ضارعأ
:(١٠٠ نيب نم
·
كاسمإ
·
نايثغ
·
نطب ملاآ
·
مضهلا يف تابوعص
١٠-١ ىدل رهظت ضارعأ) ةعئاش ريغ ة
ّ
يبناج ضارعأ
:( ١,٠٠٠ نيب نم نيلمعتسم
·
(Tachycardia) بلقلا عرست
·
عاد
ُ
ص
·
خافتنا
·
لاهسإ
·
ردصلا يف ملاآ
نيلمعتسم ١٠-١ ىدل رهظت ضارعأ) ةردان
ةيبناج ضارعأ
:(١٠,٠٠٠ نيب نم
·
راود
·
ةناثملا غيرفت يف لكاشم
·
لوبلا سابتحا
·
بيرق نع ماسجلأا ةيؤر يف لكاشم
·
ّ
يدلج حفط
·
لصافمو تلاضع ملاآ
:ة
ّ
يفاضإ ة
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يبناج ضارعأ
·
(tachyarrhythmia) مظتنم ريغو عيرس ضبن
·
سفنتلا يف تابوعص
·
ة
ّ
كح
·
ىرش
·
فعضلاب ماع موعش
·
دبكلا تاميزنإ ميق ضعب يف طسوتم ىتح
فيفخ عافترا
(ة
ّ
يلصم نيمأ تلاقان)
·
تظحول ةيبصعلاو كابترلاا ،ةسولهلا نم
ةقرفتم تلااح
امك ،نيجلاعتملا نم ةغلابلا ةيناكسلا
ةئفلا ىدل بلغلأا ىلع
لمع ةيلأ تاذ ىرخأ ةيودأو ة
ّ
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SPC

Spasmolyt – Summary of Product Characteristics
SPASPC 032011
MegaPharm Ltd.
1
1.
NAME OF THE MEDICINAL PRODUCT
SPASMO-LYT 20 MG, coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is trospium chloride. Each coated tablet
contains 20 mg trospium chloride.
Excipients: includes 7mg lactose monohydrate, 39mg sucrose and 19mg
wheat starch per coated tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet.
Brownish-yellow, glossy coated, biconvex tablets.
4.
CLINICAL PARTICULARS
4.1
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 overactivity).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One coated tablet twice daily (equivalent to 40 mg of trospium
chloride per day).
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 regular
intervals of 3-6 months.
Since no data are available the use in children under 12 years of age
is contraindicated.
4.3
CONTRAINDICATIONS
Trospium chloride is contraindicated in patients with urinary
retention, severe gastro-intestinal condition
(including toxic megacolon), myasthenia gravis, narrow-angle glaucoma,
and tachyarrhythmia.
Trospium chloride is also contraindicated in patients who have
demonstrated hypersensitivity to the active
substance or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Trospium chloride should be used with caution by patients:
-
With obstructive conditions of the gastrointestinal tract such as
pyloric stenosis
-
With obstruction of the urinary flow with the risk of formation of
urina