MESASAL mesalazine 250 mg enteric coated tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

mesalazine, Quantity: 250 mg

Sẵn có từ:

Viatris Pty Ltd

INN (Tên quốc tế):

Mesalazine

Dạng dược phẩm:

Tablet, enteric coated

Thành phần:

Excipient Ingredients: microcrystalline cellulose; povidone; sodium carbonate; purified talc; titanium dioxide; iron oxide red; colloidal anhydrous silica; calcium stearate; glycine; iron oxide yellow; methacrylic acid copolymer; macrogol 6000; triethyl citrate

Tuyến hành chính:

Oral

Các đơn vị trong gói:

100 tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

INDICATIONS AS AT 12 SEPTEMBER 1990: Treatment of acute inflammatory large bowel disease. Maintenance therapy of Crohns colitis and ulcerative colitis in patients sensitive to sulfasalazine.

Tóm tắt sản phẩm:

Visual Identification: Round, biconvex tan coloured enteric coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2017-08-16

Tờ rơi thông tin

MESASAL
®
_mesalazine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about MESASAL. 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 MESASAL
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 MESASAL IS
USED FOR
MESASAL contains the active
ingredient mesalazine (5-
aminosalicylic acid) which is used to
treat:
•
acute inflammatory bowel disease
MESASAL is used for regular
treatment of:
•
Crohn's disease
•
ulcerative colitis
This medicine belongs to a group of
medicines called salicylates.
It works by suppressing
inflammation in the large intestine.
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.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
MESASAL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MESASAL IF YOU HAVE
AN ALLERGY TO:
•
mesalazine
•
any other aspirin-like medicines
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE MESASAL IF YOU:
•
have severe kidney problems
•
have a bleeding disorder or if you
are taking medicines to stop your
blood from clotting
•
have a stomach or duodenal ulcer
•
are in the last weeks of pregnancy
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE
TAKING THIS MEDICINE.
DO NOT TAKE T

Đặc tính sản phẩm

AUSTRALIAN PRODUCT INFORMATION
MESASAL
®
_mesalazine enteric-coated tablets _
1
NAME OF THE MEDICINE
Mesalazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric-coated tablet contains 250 mg of mesalazine as the active
ingredient.
Excipients of known effect: contains 23.9 mg elemental sodium per 250
mg tablet.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MESASAL 250 mg enteric-coated tablets are round, biconvex and tan
coloured.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of acute inflammatory large bowel disease
•
Maintenance therapy of Crohn's colitis and ulcerative colitis in
patients sensitive to sulfasalazine
4.2
DOSE AND METHOD OF ADMINISTRATION
In acute ulcerative colitis, remissions will usually occur within 8
weeks.
ADULTS
Treatment of Acute Ulcerative Colitis and Crohn’s Disease
500 mg (2 x 250 mg tablets) three times daily, (or as directed by a
physician). Total daily dose 1.5 g. The
tablets should be taken at least 30 minutes before meals with plenty
of fluid.
Prevention of Relapses in Ulcerative Colitis
250 mg three times daily.
Maintenance of Remission of Crohn’s Disease
250 mg three times daily.
4.3
CONTRAINDICATIONS
•
A history of hypersensitivity to mesalazine, other salicylates or any
of the excipients in MESASAL
•
Severe renal impairment (glomerular filtration rate < 20 mL/min)
•
Pathological tendency to bleeding, or concomitant anticoagulants
•
Active peptic ulceration
MESASAL is contraindicated in the last weeks of pregnancy (see Section
4.6 FERTILITY, PREGNANCY
AND LACTATION - USE IN PREGNANCY).
MESASAL
®
– PRODUCT INFORMATION
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be exercised when administering mesalazine to patients
with:
•
a history of hypersensitivity to sulfasalazine; although in general,
hypersensitivity reactions to
mesalazine appear to be less frequent than those observed for
sulfasalazine
Do not administer mesalazine with preparations which lower stool pH,
such as la