PENTASA SLOW RELEASE GRANULES 4 G.

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

MESALAZINE

Verfügbar ab:

FERRING PHARMACEUTICALS LTD

ATC-Code:

A07EC02

Darreichungsform:

GRANULES

Zusammensetzung:

MESALAZINE 4000 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

FERRING INTERNATIONAL CENTER SA, SWITZERLAND

Therapiebereich:

MESALAZINE

Anwendungsgebiete:

Mild to moderate ulcerative colitis or crohn's disease.

Berechtigungsdatum:

2021-11-30

Gebrauchsinformation

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.

Fachinformation

1.TRADE NAME
Pentasa® slow release granules, 1g
Pentasa® slow release granules, 2g
Pentasa® slow release granules, 4g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains: 1g, 2g and 4gr mesalazine respectively.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged release granules 1 g
Prolonged release granules 2 g
Prolonged release granules 4 g
White grey to pale white-brown granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderate ulcerative colitis or 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._
_
CROHN’S DISEASE
Treatment of active disease:
Children 6 years of age and older: 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 adu