LAXADIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BISACODYL

Available from:

TEVA ISRAEL LTD

ATC code:

A06AB02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

BISACODYL 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

BISACODYL

Therapeutic area:

BISACODYL

Therapeutic indications:

All types of constipation in ambulatory and bedridden in patients over the age of 6 years . Preparation of patients for abdominal radiography and proctoscopy.

Authorization date:

2021-02-28

Patient Information leaflet

جلاعلا ةدم
زوجي لا ،ىرخأ ةل
ّ
هسم تارضحتسم يف رملأا وه امك
.ةيلاتتم مايأ 5 نم رثكلأ نيدعاسكلا
لوانت
كيلع ،موي لك ةل
ّ
هسم تارضحتسم لوانتل ةجاحب تنك اذإ
لامعتسلإا طرف .كاسملإا ببس داجيلإ
بيبطلل هجوتلا
.ررضلا ببسي دق
ءاودلا لامعتسإ ةقيرط
.ءام عم لماكلا هلكشب صرقلا علب بجي ●
ةيودأ وأ ،ةضومحلا تاداضم ،بيلحلا
لوانت زوجي لا ●
ضفخل ةيودأ( تانوتوربلا تاخضم تاطبثم
ةليصف نم
دعب وأ لبق ةعاس ىدم يف )ةدعملا يف
ةضومحلا
ميلسلا لمعلا عنمت اهنلأ اذه .نيدعاسكلا
صارقأ لوانت
.نيدعاسكلا صارقلأ
.مونلا لبق ءاسملا يف ءاودلا علب بجي ●
صرقلا رطش زوجي لاو قحسلا و
أ
غضملا زوجي لا ●
.صرقلا ءلاط ةيلاعف يف رضت لا يكل
ةدعاسملل مويلا ةليط لئاوس برش ىلع
صرحلا بجي ●
.فافجت ثودح عنمو زاربلا نييلت ىلع
6-12 للاخ
ً
ةداع ءاعملأا طاشن رضحتسملا ريثي
24 ىتح( لوطأ تقول كلذ جاتحي
ً
انايحأ هنكل ،ةعاس
.)ةعاس
ربكأ
ً
ايئاود
ً
ارادقم أطخلاب تلوانت اذإ
صارقأ نم يغبني امم رثكأ ةريبك ةيمك
تلوانت اذإ
ةينمز ةرتفل نيدعاسكلا صارقأ تلوانت وأ
نيدعاسكلا
:ةيلاتلا ضارعلأا رهظت دقو ررضل كلذ
يدؤي دق ،ة
ّ
لوطم
رثؤي دق يذلا مسجلا يف حلاملأاو لئاوسلل
نزاوت مدع ●
حلاملأا ىلعو )ءاعملأا تلاضع لثم(
تلاضعلا رتوت ىلع
.مدلا يف
ىمسي( مدلا
يف مويساتوپلا
بسن ضافخنإ
●
قاهرلإاب روعشلا ىلإ يدؤي دق ،)hypo

Summary of Product characteristics

Laxadin Tablets OKD 12/2020 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
LAXADIN
®
1
NAME OF THE MEDICINAL PRODUCT
LAXADIN
®
Film coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Bisacodyl 5mg.
Excipients with known effect:
Each Tablet contains 40 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets for oral administration.
White, round biconvex film coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
All types of constipation in ambulatory and bedridden in patients over
the age of 6
years.
Preparation of patients for abdominal radiography and proctoscopy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should not be chewed or crushed, but swallowed whole.
Adults
1-3 tablets at bedtime.
Children 6 Years of Age and Over
1 tablet or alternatively 0.3 mg/kg/body weight at bedtime.
4.3
CONTRAINDICATIONS
Laxadin
is
contraindicated
in
patients
with
ileus,
intestinal
obstruction,
acute
abdominal conditions including appendicitis, acute inflammatory bowel
diseases, and
severe abdominal pain associated with nausea and vomiting which may be
indicative
of the aforementioned severe conditions.
Laxadin is also contraindicated in severe dehydration and in patients
with known
hypersensitivity to bisacodyl or to any of the excipients listed in
section 6.1.
Laxadin Tablets OKD 12/2020 Notification
In case of rare hereditary conditions that may be incompatible with an
excipient of
the product (please refer to “Special warnings and special
precautions for use”) the
use of the product is contraindicated.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should not be used in children under the age of 6 years.
As with all laxatives, bisacodyl should not be taken on a continuous
daily basis for
more than five days without investigating the cause of constipation.
Frequent or prolonged use may cause dependence on laxatives.
Long term everyday use of stimulant laxatives may harm the intestinal
function and
should be avoided. If la