PENTASA PROLONGED RELEASE GRANULES 4GSACHET

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

Mesalazine

متاح من:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC رمز:

A07EC02

الشكل الصيدلاني:

GRANULE, DELAYED RELEASE

تركيب:

Mesalazine 4000 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Ferring International Center SA

الوضع إذن:

ACTIVE

تاريخ الترخيص:

2019-01-18

خصائص المنتج

NAME OF THE MEDICINAL PRODUCT
PENTASA
®
SACHET 4 G
Prolonged release granules 4 g
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prolonged release granules 4 g: Each sachet contains 4 g mesalazine.
Excipients: Ethylcellulose and Povidone.
PHARMACEUTICAL FORM
Prolonged release granules 4 g
Appearance of PENTASA
®
Sachet prolonged release granules 4 g: White-grey to pale white-
brown granules.
THERAPEUTIC INDICATIONS
Treatment of mild to moderate ulcerative colitis.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ULCERATIVE COLITIS
Treatment of active disease:
Adults: Individual dosage, up to 4 g given once daily or in divided
doses.
Paediatric population:
There is only limited documentation for an effect in children (age
6-18 years).
METHOD OF ADMINISTRATION:
PENTASA
®
granules must not be chewed. The contents of the sachet should be
emptied onto the
tongue and washed down with some water or orange juice. Alternatively
the entire content of the
sachet can be taken with yogurt and consumed immediately.
CONTRAINDICATIONS
Hypersensitivity to mesalazine, any of the excipients, or salicylates.
Severe liver or renal impairment.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Most patients who are intolerant or hypersensitive to sulphasalazine
are able to take PENTASA
®
without risk of similar reactions. However, caution is recommended
when treating patients allergic
to sulphasalazine (risk of allergy to salicylates). Severe cutaneous
adverse reactions, including
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN),
have been reported in
association with mesalazine treatment. In case of acute intolerance
reactions such as abdominal
cramps, acute 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, therapy 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