Asacol

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Mesalazine 400mg

Tilgjengelig fra:

Chiesi New Zealand Limited t/a Emerge Health

INN (International Name):

Mesalazine 400 mg

Dosering :

400 mg

Legemiddelform:

Enteric coated tablet

Sammensetning:

Active: Mesalazine 400mg Excipient: Iron oxide red Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Methacrylic acid copolymer Povidone Purified talc   Sodium starch glycolate Triethyl citrate

Enheter i pakken:

Blister pack, PVC/Al, 100 tablets

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Cambrex Karlskoga AB

Indikasjoner:

Induction of remission of mild to moderate episodes of ulcerative colitis. Maintenance of remission of ulcerative colitis.

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

1988-02-21

Informasjon til brukeren

ASACOL
®
NZ CMI v5.0
1
ASACOL
®
_Mesalazine _
_400 mg and 800 mg Enteric Coated Tablets _
_16.67% w/w (500 mg) Suppositories _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ASACOL. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using ASACOL
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT ASACOL IS USED
FOR
ASACOL contains the active
ingredient mesalazine. This is an
anti-inflammatory agent used to treat
types of inflammatory bowel disease.
ASACOL enteric coated tablets are
used to treat and prevent further
episodes of inflammatory intestinal
diseases, such as ulcerative or
idiopathic colitis and Crohn's disease.
ASACOL suppositories are used to
treat and prevent further episodes of
mild to moderate ulcerative colitis in
the rectum.
Ulcerative colitis and Crohn's disease
are diseases of the large bowel
(colon) or back passage (rectum), in
which the lining of the bowel
becomes inflamed (red and swollen).
ASACOL acts locally at the site of
inflammation (colon and rectum) to
reduce this inflammation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
ASACOL is not addictive.
It is available only with a doctor’s
prescription.
ASACOL is not expected to affect
your ability to drive a car or operate
machinery.
BEFORE YOU USE
ASACOL
_WHEN YOU MUST NOT TAKE IT _
Do not take ASACOL if you have an
allergy to:
•
any medicine containing
mesalazine
•
any of the other ingredients listed
at the end of this leaflet
•
aspirin or any other salicylates.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty b

Preparatomtale

ASACOL Data Sheet v5.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ASACOL 400 mg enteric coated tablet
ASACOL 800 mg enteric coated tablet
ASACOL 16.67% w/w suppository
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ENTERIC COATED TABLETS _
ASACOL enteric coated tablets contain 400 mg or 800 mg mesalazine as
the active ingredient.
Excipient with known effect: lactose monohydrate 76.4 mg or 152.8 mg.
_SUPPOSITORIES_
ASACOL suppositories contain 16.67% w/w (500 mg) mesalazine as the
active ingredient.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
ASACOL enteric coated tablets are reddish to brownish oblong tablets
with a glossy to matt
finish (ASACOL 400 mg dimensions: 15 x 6 x 7 mm; ASACOL 800 mg
dimensions:
17 x 8 x 8 mm).
ASACOL suppositories are light grey-brown, torpedo-shaped
suppositories.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ENTERIC COATED TABLETS
_Ulcerative Colitis: _
•
Induction of remission of mild to moderate episodes
•
Maintenance of remission.
_Crohn's ileo-colitis:_
•
Maintenance of remission.
SUPPOSITORIES
Treatment of mild to moderate distal (proctitis and proctosigmoiditis)
ulcerative colitis and
maintenance of remission of distal ulcerative colitis.
ASACOL Data Sheet v5.0
2
4.2 DOSE AND METHOD OF ADMINISTRATION
ENTERIC COATED TABLETS
_DOSAGE FOR ADULTS _
_Ulcerative colitis _
Induction of remission: 2.4 to 4.8 g (6 to 12 of the 400 mg tablets,
or 3 to 6 of the 800 mg
tablets) a day in divided doses. The dosage can be adjusted in
accordance with the response to
the treatment.
Maintenance of remission: 1.2 to 2.4 g (3 to 6 of the 400 mg tablets,
or up to 3 of the 800 mg
tablets) a day taken once daily or in divided doses.
_Crohn's ileo-colitis _
Maintenance of remission: 2.4 g (6 of the 400 mg tablets, or 3 of the
800 mg tablets) in divided
doses.
_Elderly patients _
Except in cases of severely impaired hepatic and renal function, the
dosage stated for adults can
be administered, see sections 4.3 and 4.4. No studies have been
performed with elderly patien