IMODIUM CAPSULES
البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
نشرة المعلومات
(PIL)
14-08-2023
خصائص المنتج
(SPC)
16-03-2023
تقرير التقييم الجمهور
(PAR)
02-10-2018
العنصر النشط:
LOPERAMIDE HYDROCHLORIDE
متاح من:
J-C HEALTH CARE LTD
ATC رمز:
A07DA
الشكل الصيدلاني:
CAPSULES
تركيب:
LOPERAMIDE HYDROCHLORIDE 2 MG
طريقة التعاطي:
PER OS
نوع الوصفة الطبية :
Not required
المصنعة من قبل:
JANSSEN CILAG S.A., FRANCE
المجموعة العلاجية:
ANTIPROPULSIVES
الخصائص العلاجية:
Control and symptomatic relief of acute diarrhea in adults, adolescents and children aged 6 years and older.
تاريخ الترخيص:
2021-10-31
نشرة المعلومات
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed without a doctor’s prescription
This medicine requires a doctor’s prescription in children between
the ages of 6
-12
IMODIUM
®
CAPSULES
ACTIVE INGREDIENT
Each capsule contains: Loperamide hydrochloride 2 mg
For a list of inactive a
nd allergenic ingredients in the product: see section 6 “Further
Information”. See
also “Important information about some of the ingredients of the
medicine” in Section 2.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine is not intended for children and infants under the age
of 6. Use it properly. Consult a
pharmacist if you need further information. Refer to a doctor if the
signs of the disease (symptoms)
worsen or do not improve within 48 hours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Imodium is intended for the control and relief of acute diarrhea
symptoms in adults, adolescents and
children aged 6 years and older.
THERAPEUTIC GROUP: Antipropulsive.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional ingredients contained in the
medicine (that appear in section 6).
•
Do not use this product in children under 6 years of age.
•
You have a high fever or bloody stools (signs of acute dysentery).
•
You are suffering from an inflammation in the intestines such as
ulcerative colitis.
•
You are suffering from constipation or swelling in the abdominal
region (especially in children with severe
dehydration).
•
You have diarrhea caused by antibiotic treatment.
•
You have an intestinal infection caused by a bacterium, such as
Salmonella, Shigella or Campylobacter.
•
You are taking medicines that reduce bowel movements.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
•
BEFORE TREATMENT WITH THE MEDICI
اقرأ الوثيقة كاملة
خصائص المنتج
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
IMODIUM capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains:
Active substance: Loperamide hydrochloride 2 mg.
Excipients with known effect
Lactose monohydrate 127 mg.
For the full list of the excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules.
Opaque green cap and grey body, hard gelatin capsule imprinted with
‘Imodium’ on
cap and ‘Janssen’ on body containing white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IMODIUM is indicated for control and symptomatic relief of acute
diarrhea in adults, adolescents and
children aged 6 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHILDREN ABOVE 12 YEARS AND ADULTS
The starting dose is 2 capsules (4 mg).
Continue treatment with 1 capsule (2 mg), after each loose (soft)
stool.
The maximum daily dose is 8 capsules per day (16 mg).
_SPECIAL POPULATIONS _
CHILDREN AGED BETWEEN 6 AND 12 YEARS
(see section 4.3)
_ _
The following dosages should not be exceeded:
Six to eight years: 2 mg b.i.d. (4mg daily dose) (20 to 30 kg)
Eight to twelve years: 2 mg t.i.d. (6mg daily dose) (greater than 30
kg)
Following the first treatment day, it is recommended that subsequent
IMODIUM doses be administered
only after a loose stool. Total daily dosage should not exceed
recommended dosages for the first day
.
The data available regarding the use of loperamide HCl in children
under the age of 12 years are limited
(see section 4.8 "Undesirable effects").
_ _
ELDERLY
No dose adjustment is required in the elderly.
_ _
RENAL IMPAIRMENT
No dose adjustment is required in patients with impaired renal
function.
_ _
HEPATIC IMPAIRMENT
Although no pharmacokinetic data are available in patients with
hepatic impairment, loperamide HCl
should be used with caution in these patients due to reduced
first-pass metabolism (see section 4.4,
"Special warnings and precautions for use").
Method of administration
Oral use. The capsules should be taken with liquid.
ATTENTION
: Do
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