PENTASA mesalazine 4 g prolonged release granules sachet
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
06-07-2021
Summary of Product characteristics
(SPC)
19-06-2021
Public Assessment Report
(PAR)
23-11-2017
Active ingredient:
mesalazine, Quantity: 4 g
Available from:
Ferring Pharmaceuticals Pty Ltd
INN (International Name):
Mesalazine
Pharmaceutical form:
Granules, modified release
Composition:
Excipient Ingredients: povidone; ethylcellulose
Administration route:
Oral
Units in package:
30 sachets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of mild to moderate ulcerative Colitis and Crohn's Disease and maintenance of remission.
Product summary:
Visual Identification: white-grey to pale white-brown cylindrical shaped granules; Container Type: Sachet; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-08-14
Patient Information leaflet
PENTASA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING PENTASA?
PENTASA contains the active ingredient mesalazine. PENTASA is taken to
treat Crohn's disease and ulcerative colitis: diseases
associated with inflammation, ulcers and sores in the bowel causing
bleeding, stomach pain, and diarrhoea.
For more information, see Section 1. Why am I taking PENTASA? in the
full CMI, starting from page 2.
2.
WHAT SHOULD I KNOW BEFORE I TAKE PENTASA?
Do not take if you have ever had an allergic reaction to PENTASA 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 take
PENTASA? in the full CMI, starting from page 2.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Care may be needed when taking PENTASA with some other medicines.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI, starting from page 2.
4.
HOW DO I TAKE PENTASA?
•
Tear or cut to open the sachet along the dotted line.
•
Empty the contents (granules) of the sachet onto the tongue and wash
down with water or juice
•
Swallow the PENTASA granules whole without chewing or crushing.
More instructions can be found in Section 4. How do I take PENTASA? in
the full CMI, starting from page 2.
5.
WHAT SHOULD I KNOW WHILE TAKING PENTASA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
PENTASA
•
Have all blood tests recommended by your doctor
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking this medicine
•
IF YOU BECOME PREGNANT WHILE TAKING THIS MEDICINE, TELL YOUR DOCTOR
IMMEDIATELY.
THINGS YOU
SHOULD NOT DO
•
Do not stop takin
Read the complete document
Summary of Product characteristics
PRODUCT INFORMATION
Page 1 of 15
#10223-V33A
AUSTRALIAN PRODUCT INFORMATION – PENTASA
®
(MESALAZINE) PROLONGED RELEASE TABLETS AND GRANULES
1
NAME OF THE MEDICINE
Mesalazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PENTASA prolonged release tablets contain either 0.5 g or 1 g
mesalazine as the active ingredient, and the
following inactive excipients: magnesium stearate, purified talc,
povidone, ethylcellulose, microcrystalline
cellulose.
PENTASA prolonged release granules in sachets contain either 1 g, 2 g
or 4 g mesalazine as the active
ingredient, and the following inactive excipients: ethylcellulose,
povidone.
3
PHARMACEUTICAL FORM
PENTASA 0.5 g prolonged release tablets are presented as white grey to
pale brown, speckled round
tablets with break mark and embossing: 500 mg on one side, PENTASA on
the other side.
PENTASA 1 g prolonged release tablets are presented as white-grey to
pale brown, speckled, oval
tablets. Embossing on both sides: PENTASA.
PENTASA 1 g, 2 g, and 4 g prolonged release granules are presented as
cylindrical shaped granules that
are white-grey to pale white brown in colour.
4
CLINICAL PARTICULARS
T
HERAPEUTIC INDICATIONS
Treatment of mild to moderate ulcerative colitis and Crohn’s disease
and maintenance of remission.
PRODUCT INFORMATION
Page 2 of 15
#10223-V33A
D
OSE AND METHOD OF ADMINISTRATION
ULCERATIVE COLITIS
_Treatment of active disease: _
Adults:_ _
Individual dosage, up to 4 g given once daily or in divided doses
_ _
_Maintenance treatment: _
Adults:_ _
2 g once daily OR individual dosage, starting with 1.5-2 g daily in
divided
doses
CROHN’S DISEASE
_Treatment of active disease: _
Adults:
Individual dosage, up to 4 g daily in divided doses
_Maintenance treatment: _
Adults:
Individual dosage, up to 4 g daily in divided doses
The contents of the sachet should be emptied onto the tongue and
washed down with some water or juice.
To facilitate swallowing, the tablets may be dispersed in 50 mL of
cold water. Stir and drink immediately. Do
not crush or chew the tablets or granul
Read the complete document
