ASACOL 400

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

MESALAZINE

Beschikbaar vanaf:

TRADIS GAT LTD

ATC-code:

A07EC02

farmaceutische vorm:

TABLETS ENTERIC COATED

Samenstelling:

MESALAZINE 400 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

TILLOTTS PHARMA AG, SWITZERLAND

Therapeutische categorie:

MESALAZINE

Therapeutisch gebied:

MESALAZINE

therapeutische indicaties:

Ulcerative colitis:-For the treatment of mild to moderate acute exacerbations. -For the maintenance of remission.Crohn's disease:-For the treatment of acute episodes.

Autorisatie datum:

2014-04-30

Bijsluiter

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Asacol
400 mg
Enteric-coated tablets
ACTIVE INGREDIENT:
mesalazine (5-aminosalicylic acid) 400 mg/tablet
Asacol
800 mg
Enteric-coated tablets
ACTIVE INGREDIENT:
mesalazine (5-aminosalicylic acid) 800 mg/tablet
Inactive ingredients and allergens: see section 2 ‘Important
information about some of this
medicine’s ingredients’ and 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?
This medicine is intended for treating ulcerative colitis (acute
exacerbation of colitis) and
Crohn’s disease (acute episodes) and for preventing recurrent
episodes of ulcerative colitis.
THERAPEUTIC GROUP:
aminosalicylates.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients
in this medicine (listed in section 6 ‘Additional information’)
•
You are sensitive (allergic) to salicylates such as aspirin
•
You have severe kidney problems
•
You have severe liver problems
•
Children under two years old
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE STARTING TREATMENT WITH ASACOL, TELL THE DOCTOR IF:
- you have ever had any problems with your liver or kidneys,
particularly if you are elderly
- you have any problems with the lungs, such as asthma
- you suffered an allergy to sulfasalazine in the past
- you have ever had allergic reactions of your heart such as
inflammation of the heart muscle
or heart sac. If you have had previous allergic reactions of your
heart that may have been
caused

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
ASACOL® 400 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains:
Mesalazine (5-aminosalicylic acid) 400 mg
Excipient with known effect: 76.4 mg lactose, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Enteric coated Tablet.
Reddish to brownish oblong tablets
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Ulcerative colitis: _
For the treatment of mild to moderate acute exacerbations. For the
maintenance of
remission.
_Crohn's disease: _
For the treatment of acute episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Ulcerative colitis: _
_Mild acute disease:_ 2.4 g (six tablets) once daily or in divided
doses, with concomitant
corticosteroid therapy to be taken when clinically indicated.
_Moderate acute disease: _2.4 g to 4.8 g (six to twelve tablets) a day
in divided doses, with
concomitant corticosteroid therapy where clinically indicated. 2.4 g
may be taken once
daily or in divided doses. Above 2.4 g daily should be taken in
divided doses.
The maximum adult dose should not exceed twelve tablets a day and not
exceed six tablets
taken together at any one time.
_Maintenance of remission_:_ _
1.2 to 2.4 g per day once daily or in divided doses.
_ _
Crohn’s disease:
2.4 g per day in divided doses.
Elderly population
Use in the elderly should be handled with caution and only for
patients having a normal
renal function.
Pediatric population
There is no specific dose recommendation for children.
Method of administration
The tablets should be taken before meals and must be swallowed whole
preferably with
some liquid. They must not be chewed, crushed or broken before
swallowing
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1
-
Known hypersensitivity to salicylates
- Severe liver impairment.
- Severe renal impairment (GFR less than 30 mL/min/1.73 m2).
- Children under the age of 2 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bl