PENTASA SLOW RELEASE TABLETS 1 GRAM

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MESALAZINE

متاح من:

FERRING PHARMACEUTICALS LTD

ATC رمز:

A07EC02

الشكل الصيدلاني:

TABLETS SLOW RELEASE

تركيب:

MESALAZINE 1 G

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

FERRING INTERNATIONAL CENTER SA, SWITZERLAND

المجال العلاجي:

MESALAZINE

الخصائص العلاجية:

Mild to moderate ulcerative colitis. Crohn's disease.

تاريخ الترخيص:

2016-12-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
PENTASA SLOW RELEASE TABLETS 500 MG
PENTASA SLOW RELEASE TABLETS 1 GRAM
COMPOSITION:
Each Slow Release Tablet of 500 mg contains: 500 mg of mesalazine
Each Slow Release Tablet of 1 gram contains: 1 gram of mesalazine
INACTIVE INGREDIENTS: See section 6, 'Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult with your
doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For treatment of mild to moderate ulcerative colitis and Crohn’s
disease.
THERAPEUTIC GROUP: Anti-inflammatory medicine of the salicylates
class.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF YOU:

are sensitive (allergic) to mesalazine or to any of the other
ingredients of this
medicine (see section 6).

are sensitive (allergic) to other salicylates (such as aspirin).

have severe liver or kidney problems.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE TREATMENT WITH THIS MEDICINE, TELL YOUR DOCTOR IF YOU:
•
are allergic to sulphasalazine (risk of allergy to salicylates).
•
currently or previously had liver or kidney disease.
•
have a medical condition that can make you prone to bleeding.
•
have an active stomach ulcer or duodenal ulcer.
•
are taking medicines that may affect your kidney function, e.g.
nonsteroidal anti-
inflammatory drugs (NSAIDs) such as aspirin.
•
have a lung problem, particularly asthma.
•
have kidney problems; you will need periodic check-ups by your doctor.
Kidney stones may develop during treatment with mesalazine. Symptoms
may include pain
at the sides of your abdomen and blood in urine. Be sure to drink a
sufficient a

خصائص المنتج

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1.
NAME OF THE MEDICINAL PRODUCT
Pentasa® slow release tablets, 500 mg
Pentasa® slow release tablets, 1 g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Mesalazine
Each Pentasa slow release, 500mg tablet contains: 500 mg mesalazine.
Each Pentasa slow release, 1g tablet contains: 1000 mg mesalazine.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pentasa slow release tablets 500 mg. White-grey to pale-brown, specked
round tablets, scored
and marked 500mg on one
side and ‘PENTASA’ on the reverse side.
Pentasa slow release tablets 1 g. White-grey to pale-brown, specked
oval tablets, and marked
with ‘PENTASA’ on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderate ulcerative colitis and Crohn’s
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ULCERATIVE COLITIS
_Adults: _
Active treatment: Individual dosage, up to 4 g mesalazine once daily
or in two or three
divided doses.
Maintenance treatment: Recommended dosage, 2 g mesalazine once daily.
CROHN’S DISEASE
_Adults: _
Active treatment: Individual dosage, up to 4 g mesalazine daily in two
or three divided doses.
Maintenance treatment: Individual dosage, up to 4 g mesalazine daily
in two or three divided
doses.
PAEDIATRIC POPULATION
The safety and efficacy in children below 6 years have not been
established.
There is only limited documentation for an effect in children (age
6-18 years)
ULCERATIVE COLITIS
Children 6 years of age and older:
Active disease: To be determined individually, starting with 30-50
mg/kg/day in divided
doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose
should not exceed 4
g/day (maximum adult dose).
_ _
Maintenance treatment:
To be determined individually, starting with 15-30 mg/kg/day in
divided doses. The total dose
should not exceed 2 g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to
children up to a body
weight of 40 kg; and the normal adult dose to those above 40 kg.
_ _