ASACOL 1600

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MESALAZINE

متاح من:

TRADIS GAT LTD

ATC رمز:

A07EC02

الشكل الصيدلاني:

MODIFIED RELEASE TABLETS

تركيب:

MESALAZINE 1600 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TILLOTTS PHARMA GMBH, GEMANY

المجال العلاجي:

MESALAZINE

الخصائص العلاجية:

ASACOL 1600 is indicated for:Ulcerative colitis-For the treatment of mild to moderate acute disease-For the maintenance of remission

تاريخ الترخيص:

2023-07-27

نشرة المعلومات

1
1986
-
REGULATIONS (PREPARATIONS)
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
This medicine is dispensed with a doctor’s prescription only
ASACOL 1600
Modified release tablets
ACTIVE INGREDIENT
:
Each tablet contains 1600 mg mesalazine
Inactive ingredients and allergens: 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 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?
Asacol is indicated:
-
For treatment of mild to moderate acute ulcerative colitis.
-
For maintenance of disease remission.
THERAPEUTIC GROUP: Anti-inflammatory medicine against bowel
inflammation
Asacol is an anti-inflammatory medicine used for the treatment of
ulcerative colitis.
Ulcerative
colitis is a disease in which the wall of the colon or the back
passage (rectum) become inflamed
(red and swollen). This may lead to frequent and bloody stools, often
accompanied by abdominal
cramps.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to mesalazine or to any of the other
ingredients in
this medicine (see section 6).
•
You are sensitive (allergic) to salicylates (e.g. acetylsalicylic
acid).
•
You have severe liver problems.
•
You have severe kidney problems.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE STARTING TREATMENT WITH ASACOL, TELL YOUR DOCTOR IF YOU HAVE
ANY ILLNESSES, PARTICULARLY
IF:
-
You have any lung problems, e.g. asthma.
-
You have impaired function of kidneys, liver or lungs, especially if
you are elderly.
-
You suffered from allergy to sulphasalazine in the past.
2
-
You had an allergic reaction of the heart, such as inflammation of the
heart muscle or heart
sac. If you have had previous suspected mesalazine-induced al

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Asacol 1600 mg modified-release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains: 1600 mg mesalazine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Modified-release tablet.
Film-coated, red/brown oblong tablets dimension of 23 x 11 x 9 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Ulcerative colitis. _
For the treatment of mild to moderate acute disease. For the
maintenance of
remission.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, including the elderly (>65 years)
The dose should be adjusted according to the severity of the disease
and
tolerance.
_Acute disease_: In the event of exacerbation, the dose can be
increased to
4800 mg daily, once daily or in 2-3 divided doses.
Once clinical remission is achieved, the dose should gradually be
decreased to
maintenance dose.
Continued therapy should be carefully considered in subjects not
responding
by week 8.
_Maintenance treatment_: 1600 mg once daily.
Other oral mesalazine formulations are available if an alternative
dose for
maintenance treatment is considered more appropriate.
Elderly population
No studies have been carried out in older people.
Paediatric population
The safety and efficacy of Asacol in children and adolescents aged
younger
than 18 years of age has not been established.
Method of administration: oral.
The tablets must be swallowed whole with a glass of water. They must
not be
chewed, crushed or broken before swallowing. The tablets can be taken
with
or without food. If one or more doses have been missed, the next dose
is to be
taken as usual.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to salicylates (including mesalazine) or any of the
excipients listed in section 6.1.
•
Severe liver impairment.
•
Severe renal impairment (GFR < 30 ml/min/1.73 m
2
)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood tests (differential blood count; liver function parameters such
as ALT or
AST; serum creatinine