Mesalazine 1.2 TAKEDA (mesalazine) 1.2 g prolonged release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mesalazine, Quantity: 1200 mg

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: methacrylic acid copolymer; purified talc; silicon dioxide; sodium starch glycollate; stearic acid; iron oxide red; carmellose sodium; Carnauba Wax; magnesium stearate; titanium dioxide; macrogol 6000; triethyl citrate

Administration route:

Oral

Units in package:

60 tablets, 12 tablets, 120 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the induction and maintenance of remission in patients with mild to moderate, active ulcerative colitis.

Product summary:

Visual Identification: Red-brown, ellipsoidal, film-coated tablet, S476 debossed on one side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-01-07

Patient Information leaflet

MESALAZINE 1.2 TAKEDA
M
E
S
A
L
A
Z
I
N
E
1
.
2
T
A
K
E
D
A
C
M
I
V
4
.
0
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MESALAZINE 1.2 TAKEDA?
MESALAZINE 1.2 TAKEDA contains the active ingredient mesalazine.
MESALAZINE 1.2 TAKEDA is used for the treatment of
ulcerative colitis.
For more information, see Section 1. Why am I using MESALAZINE 1.2
TAKEDA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MESALAZINE 1.2 TAKEDA?
Do not use if you have ever had an allergic reaction to MESALAZINE 1.2
TAKEDA or any of the ingredients listed at the end of the
CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I use
MESALAZINE 1.2 TAKEDA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MESALAZINE 1.2 TAKEDA and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MESALAZINE 1.2 TAKEDA?
•
Your doctor will tell you what dose to take each day.
•
Take your tablets with or without food at the same time each day. The
tablets must be swallowed whole and must not be
crushed or chewed. Follow all directions given to you by your
pharmacist or doctor carefully.
More instructions can be found in Section 4. How do I use MESALAZINE
1.2 TAKEDA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MESALAZINE 1.2 TAKEDA?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using MESALAZINE
1.2 TAKEDA. If you are pregnant
or intend to become pregnant while using this medicine, tell the
doctor immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or change the dosage without
checking with your doctor.
DRIVING
OR USING
MACHINES
•
MESALAZINE 1.2 TAKEDA is

Summary of Product characteristics

Mesalazine 1.2 TAKEDA PI V4.0 (CCDS V24)
1
AUSTRALIAN PRODUCT INFORMATION
MESALAZINE 1.2 TAKEDA (MESALAZINE) PROLONGED RELEASE TABLET
1
NAME
OF
THE
MEDICINE
Mesalazine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mesalazine 1.2 TAKEDA contains 1.2 g of the active ingredient
mesalazine.
The Mesalazine 1.2 TAKEDA tablet contains a core of mesalazine
(5-aminosalicylic acid),
1.2g, formulated in a multi-matrix system. This system is coated with
methacrylic acid
copolymers, Type A and Type B, which are designed to dissolve at
approximately pH 7. The
matrix of lipophilic and hydrophilic excipients facilitates the
extended delivery of effective
concentrations of mesalazine through the entire colon with limited
systemic absorption.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Gastro-resistant, prolonged release tablets.
APPEARANCE
The tablets are presented as red-brown, ellipsoidal, film-coated
tablets, debossed on one side
with S476.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the induction and maintenance of remission in patients with mild
to moderate, active
ulcerative colitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Mesalazine 1.2 TAKEDA is intended for once daily, oral administration.
ADULTS, INCLUDING THE ELDERLY (>65 YEARS)
For induction of remission: 2.4 to 4.8 g (two to four tablets) should
be taken once daily.
For maintenance of remission: 2.4 g (two tablets) should be taken once
daily.
Mesalazine 1.2 TAKEDA PI V4.0 (CCDS V24)
2
CHILDREN AND ADOLESCENTS
Mesalazine 1.2 TAKEDA is not recommended for use in children below the
age of 18 years
due to a lack of data on safety and efficacy.
METHOD OF ADMINISTRATION
For oral administration. Mesalazine 1.2 TAKEDA tablets must not be
crushed or chewed and
should be swallowed whole with or without food.
DOSAGE ADJUSTMENT
Specific studies have not been performed to investigate Mesalazine 1.2
TAKEDA in patients
with hepatic or renal impairment, dialysis or concomitant disease.
MONITORING ADVICE
The highest dose of