MESALZ mesalazine 1.2 g gastro-resistant prolonged release tablet bottle

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

mesalazine, Quantity: 1200 mg

זמין מ:

Sun Pharma ANZ Pty Ltd

טופס פרצבטיות:

Tablet, modified release

הרכב:

Excipient Ingredients: triethyl citrate; iron oxide red; magnesium stearate; sodium starch glycollate type A; titanium dioxide; methacrylic acid copolymer; purified talc; hypromellose; silicon dioxide; macrogol 6000; carmellose sodium; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

120 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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

leaflet_short:

Visual Identification: A reddish brown, oval shaped film coated tablet printed with RG70 in black colour on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

מצב אישור:

Registered

תאריך אישור:

2023-01-05

עלון מידע

MESALZ
1
MESALZ
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 MESALZ?
MESALZ contains the active ingredient mesalazine. MESALZ is used for
the treatment of ulcerative colitis.
For more information, see Section 1. Why am I using MESALZ? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MESALZ?
Do not use if you have ever had an allergic reaction to MESALZ 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
MESALZ? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MESALZ 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 MESALZ?
•
Your doctor will tell you what dose to take each day.
•
Take your tablets with our 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 MESALZ? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MESALZ?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using MESALZ.
•
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
•
MESALZ is unlikely to have any effect on your ability to drive or use
machines.
LOOKING AFTER
YOUR MEDICINE
•
Store MESALZ in a cool dry place where the temperature is below 25
°
C.
For more information, see Section 5. What should I know while using
MESA

מאפייני מוצר

MESALZ
1
AUSTRALIAN PRODUCT INFORMATION
MESALZ
(MESALAZINE) PROLONGED RELEASE TABLET
1
NAME OF THE MEDICINE
Mesalazine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MESALZ contains 1.2 g of the active ingredient mesalazine.
The MESALZ tablet contains a core of mesalazine (5-aminosalicylic
acid), 1.2 g, 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 reddish brown, oval shaped, film-coated
tablets, printed with
RG70 in black colour on one side and plain on the other side.
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
MESALZ 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.
MESALZ
2
CHILDREN AND ADOLESCENTS
MESALZ 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. MESALZ 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 MESALZ in
patients with hepatic or
renal impairment, dialysis or concomitant disease.
MONITORING ADVICE
The highest dose of 4.8 g/day is recommended for patients not
responding to lower doses of
mesalazine. When using the highest dose (4.8 g/day),