PENTASA SLOW RELEASE GRANULES 2 G

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MESALAZINE

متاح من:

FERRING PHARMACEUTICALS LTD

ATC رمز:

A07EC02

الشكل الصيدلاني:

GRANULES

تركيب:

MESALAZINE 2 G/SACHET

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

FERRING INTERNATIONAL CENTER SA, SWITZERLAND

المجموعة العلاجية:

MESALAZINE

المجال العلاجي:

MESALAZINE

الخصائص العلاجية:

Mild to moderate ulcerative colitis or Crohn's disease.

تاريخ الترخيص:

2023-07-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
PENTASA
PROLONGED RELEASE GRANULES, 1 GRAM, 2 GRAMS AND 4 GRAMS
COMPOSITION:
Each sachet of Pentasa PROLONGED RELEASE GRANULES 1 gr contains:
1000 mg of mesalazine
Each sachet of Pentasa PROLONGED RELEASE GRANULES 2 gr contains:
2000 mg of mesalazine
Each sachet of Pentasa PROLONGED RELEASE GRANULES 4 gr contains:
4000 mg 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?
Pentasa granules 1 gr, 2 gr and 4 gr: Anti-inflammatory medicine for
the treatment of mild to
moderate ulcerative colitis or Crohn’s disease.
THERAPEUTIC GROUP: Anti-inflammatory medicine belonging to the group
of medicines called
salicylates.
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 acetylsalicylic
acid.
•
have severe liver and/or kidney problems.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE TAKING THIS MEDICINE, CONSULT WITH YOUR DOCTOR IF YOU:
•
are allergic to sulphasalazine (risk of allergy to salicylates).
•
have or previously had liver or kidney disease.
•
have a medical condition that may make you prone to bleeding.
•
have an active peptic ulcer (gastric or duodenal ulcer).
•
are taking medicines that may affect kidney function, such as
non-steroidal anti-
inflammatory drugs (NSAIDs), such as aspirin.
•
have lung problems, particularly asthma.

خصائص المنتج

Page 1 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Pentasa® Suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pentasa suppository contains: 1g mesalazine
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppositories. Oblong, compressed white to light tan, speckled
suppositories
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Ulcerative Proctitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
1 suppository 1-2 times daily.
Method of administration
For rectal use.
A visit to the toilet is recommended before administration of
suppositories.
See separate instructions for use.
4.3
CONTRAINDICATIONS
PENTASA is contraindicated in:
- patients with known hypersensitivity to
mesalazine,
salicylates or any of the excipients
,
listed in section 6.1
- patients with severe liver and/or renal impairment
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is recommended when treating patients allergic to
sulphasalazine (risk of allergy to
salicylates). Severe cutaneous adverse reactions (SCARs), including
drug reaction with
eosinophilia and systemic symptoms (DRESS),
Stevens-Johnson syndrome (SJS) and
toxic epidermal necrolysis (TEN), have been reported in association
with mesalazine
treatment. In case of acute symptoms of intolerance i.e. abdominal
cramps, abdominal pain,
fever and severe headache and/or the first appearance of signs and
symptoms of severe skin
reactions, such as skin rash, mucosal lesions, or any other signs of
hypersensitivity, the
treatment should be discontinued immediately.
Caution is recommended in patients with impaired liver function. Liver
function parameters
like ALT or AST should be assessed prior to and during treatment, at
the discretion of the
treating physician
.
The drug is not recommended for use in patients with impaired renal
function and in patients
with haemorrhagic diathesis. Baseline renal function measurement is
required in all patients
initiating treatment with mesalazine. Urinary status (dip sticks)
should be determined prior to
and during t