PENTASA SLOW RELEASE TABLETS 500 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

MESALAZINE

Fáanlegur frá:

FERRING PHARMACEUTICALS LTD

ATC númer:

A07EC02

Lyfjaform:

TABLETS SLOW RELEASE

Samsetning:

MESALAZINE 500 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

FERRING INTERNATIONAL CENTER SA, SWITZERLAND

Meðferðarhópur:

MESALAZINE

Lækningarsvæði:

MESALAZINE

Ábendingar:

Mild to moderate ulcerative colitis.Crohn's disease

Leyfisdagur:

2014-06-30

Upplýsingar fylgiseðill

-يئوض س
ّ
سحت( يجسفنبلا
قوف ءوضلا
هاجتو سمشلا
هاجت ةطرفم ةيدلج ةيساسح
(Photosensitivity
نم دحاو لمعتسم نم لقأ ىدل رهظت ضارعأ -
ادج ةردان نايحأ يف رهظت ةيبناج ضارعأ
:
10,000 لصأ
افيزن ببست دق يتلاو ،مدلا ايلاخ عاونأ
ضعب يف ضافخنا( ىرخأ مد تابارطضاو مدلا
رقف
)قلحلا يف ملاآو ىمح ،تامدك ،ببسلا
لوهجم
زارب وأ/و )نينيعلا وأ/و دلجلا رارفصا(
ناقري ضارعلأا نمضتت( دبكلا يف تابارطضا
)نوللا حتاف
مكارت ببسب مروت( ةمذو وأ/و ،لوبلا يف مد
ضارعلأا نمضتت( ىلكلا يف تابارطضا
))لئاوسلا
زخو ضارعلأا نمضتت .نيقاسلاو نيديلا
باصعأ يف رثؤت ةلاح( يطيحم يبصع للاتعا
)ساسحلإا صقنو
نمضتت( ةئرلا بدنت وأ ةئرلاب طيحملا
ءاشغلا باهتلا ،ةئرلا يف ف
ّ
يلتو ةيسسحت لعف دودر
يف ملأ وأ ةحار مدع ،)
bronchospasm ( ةيسفنتلا كلاسملا جنشت ،لاعس
ضارعلأا
)ديازتم وأ/و يومد مغلب ،سفنتلا ءانثأ
ردصلا
ةقبطلا لكب اررض قحلي يذلا )
IBD ( يباهتللاا يعملا ضرم نم عون( نولوقلل
يلك باهتلا
)ةظيلغلا ءاعملأا نم ةيلخادلا
)ساكعنلال لباق( رعشلا طقاست
لصافملا يف وأ تلاضعلا يف ملأ
امو بلقلا ،ىلكلا ،دلجلا ،لصافملا لثم
مسجلا نم ةفلتخم قطانم بيصي نأ نكمي
باهتلا
لاثم( رربم ريغو يعيبط ريغ فيزن
،ىمح
،بعت ،لصافملا ملاآ ضارعلأا لمشت( كلذ
ىلإ
ةديدشلا
روثبلاو ةديدشلا تافلآا كلذ يف امب(
دلجلا ىلع ةيناوجرأ عقب ،تامدك ،)فنلأا
في�

Vara einkenni

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