ASACOL mesalazine 1.6 g enteric coated tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

mesalazine, Quantity: 1.6 g

Tilgjengelig fra:

Chiesi Australia Pty Ltd

Legemiddelform:

Tablet, enteric coated

Sammensetning:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate type A; hypromellose; colloidal anhydrous silica; magnesium stearate; macrogol 6000; methacrylic acid copolymer; triethyl citrate; glyceryl monostearate; polysorbate 80; sodium hydroxide; maize starch; iron oxide red; iron oxide yellow; monobasic potassium phosphate

Administreringsrute:

Oral

Enheter i pakken:

60 tablets, 30 tablets, 90 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

ASACOL is indicated for the treatment of mild to moderate ulcerative colitis and maintenance of remission in adults.

Produkt oppsummering:

Visual Identification: Film-coated dark orange oblong tablets with a glossy to matte finish; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2020-10-06

Informasjon til brukeren

ASACOL CMI v7.0
ASACOL
®
_Mesalazine _
_400 mg, 800 mg and 1600 mg _
_Enteric Coated Tablets _
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
taking ASACOL against the
benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING 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
This medicine is used to treat
and prevent further episodes
of ulcerative colitis.
ASACOL contains the active
ingredient mesalazine. This is
an anti-inflammatory agent
used to treat ulcerative colitis.
Ulcerative colitis is a disease
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,
rectum and terminal ileum) 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 TAKE ASACOL
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ASACOL IF:
•
you are allergic to
mesalazine or any of the
other ingredients of this
medicine listed at the end
of this leaflet.
•
Patients who are
intolerant to lactose
should note that ASACOL
400 mg and 800 mg
tablets contain a small
amount of lactose. If your
doctor has told you that
you have intolerance to
some sugars, contact
your doctor before taking
this medicine
•
you are allergic to
salicylates (e.g. Aspirin)
•
you have severe liver
problems
•
you have severe kidney
problems.
DO NOT TAKE THIS MEDICINE
AFTER THE EXPIRY DATE PRINTED
O

Preparatomtale

ASACOL Product Information
ASACOL PI v7.0
1
AUSTRALIAN PRODUCT INFORMATION - ASACOL
® (MESALAZINE)
1
NAME OF THE MEDICINE
Mesalazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ASACOL enteric coated tablets contain 400 mg, 800 mg or 1600 mg
mesalazine as the active
ingredient.
Excipient with known effect: sugars as lactose (400 mg and 800 mg
tablets).
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
_ASACOL 400 MG AND 800 MG TABLETS _
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 consists of a tablet core which is coated with a copolymer
providing the tablet a pH-
dependent disintegration behaviour. Therefore ASACOL tablets resist
the acidic environment of
the stomach and small intestine, whereas disintegration and drug
release occurs from pH 7
onwards to ensure start of drug delivery at the target site, i.e.,
from the terminal ileum onwards.
_ASACOL 1600 MG TABLETS _
ASACOL enteric coated tablets are film coated dark orange oblong
tablets with a glossy to matte
finish (ASACOL 1600 mg dimensions: 23 x 11 x 9 mm).
The ASACOL tablet contains a core of 1600 mg mesalazine covered by a
multi-layer coating
system. This system consists of a layer of methacrylic acid - methyl
methacrylate copolymer
(Eudragit S) combined with starch particles on top of a middle
alkaline buffer layer (which
accelerates drug release). The coating is designed to delay release of
mesalazine until intestinal
fluids reach a pH of 7. The starch can be digested by colonic bacteria
which also provides a second
trigger for release of mesalazine from the coated tablet. Systemic
bioavailability/plasma
concentrations of mesalazine therefore are of no relevance for
therapeutic efficacy, but rather a
criterion for safety.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASACOL is indicated for the treatment of mild to moderate ulcerative
colitis and maintenance of
remiss