Pentasa

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Mesalazine 1 g;  

Tersedia dari:

Pharmaco (NZ) Ltd

INN (Nama Internasional):

Mesalazine 1 g

Dosis:

1 g

Bentuk farmasi:

Modified release tablet

Komposisi:

Active: Mesalazine 1 g   Excipient: Ethylcellulose Magnesium stearate Microcrystalline cellulose Povidone Purified talc

Unit dalam paket:

Blister pack, double aluminium foil, 60 tablets

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Syntese A/S

Indikasi Terapi:

Treatment of mild to moderate ulcerative colitis

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, double aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, double aluminium foil - 120 tablets - 36 months from date of manufacture stored at or below 25°C

Tanggal Otorisasi:

2009-07-27

Selebaran informasi

PENTASA® (sachets)
1
PENTASA® SACHETS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI (see from 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 (see from next page), starting from page 2.
2.
WHAT SHOULD I KNOW BEFORE I TAKE PENTASA?
Do not take PENTASA if you have ever had an allergic reaction to
mesalazine or any of the ingredients listed at the end of the CMI
(Section 7 Product details).
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 you are also taking 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 content of the sachet (granules) onto the tongue and wash
down with water or juice to swallow without chewing
or crushing the granules.
•
Alternatively, mix the entire content of the sachet (granules) with
yoghurt and consume immediately without chewing or
crushing the granules. 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
•
Tell any doctor, dentist or pharmacist you visit that you are taking
PENTASA
•
Have all blood tests recommended by your doctor
•
IF YOU BECOME PREGNANT WHILE TAKING THIS MEDICINE, TELL YOUR

Karakteristik produk

NEW ZEALAND DATA SHEET
PENTASA – PENTASA020
March 2023
Page 1 of 12
PENTASA
mesalazine
1 PENTASA
PENTASA 500mg Prolonged release tablet
PENTASA 1g Prolonged release tablet
PENTASA 10mg/mL Enema
PENTASA 1g Suppository
PENTASA 1g, 2g or 4g Granules, prolonged-release
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Prolonged release tablet 500mg: Contains 500mg mesalazine
Prolonged release tablet 1g: Contains 1g mesalazine
Enema: Contains 10mg/mL mesalazine
Suppository 1g: Contains 1g mesalazine
Granules, prolonged-release: Contains 1g, 2g or 4g mesalazine
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
_PROLONGED RELEASE TABLET 500MG_: white grey to pale brown speckled
round tablet with a break-mark.
Embossed 500mg on one side, PENTASA on the other side. The score line
is not intended for
breaking the tablet.
_PROLONGED RELEASE TABLET 1G:_ white-grey to pale brown, speckled,
oval tablet. Embossed on both
sides with PENTASA.
_ENEMA_: a white to slightly yellow suspension in purified water with
a pH value between 4.4 and 5.0.
Added buffering agents result is a slightly acidic suspension. Sodium
metabisulphite is added as an
antioxidant.
_SUPPOSITORY_: a white to light tan spotted oblong compressed
suppository, average weight 1580mg,
1cm diameter and 2.8cm long.
_GRANULES, PROLONGED-RELEASE:_ white-grey to pale white brown
cylindrical shaped granules, containing
1g, 2g or 4g mesalazine.
NEW ZEALAND DATA SHEET
PENTASA – PENTASA020
March 2023
Page 2 of 12
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_PROLONGED RELEASE TABLETS 500MG AND 1G, AND GRANULES 1G, 2G AND 4G: _
Treatment of mild to moderate ulcerative colitis or Crohn’s
disease._ _
_ENEMAS: _
Treatment of ulcerative proctosigmoiditis and left-sided colitis._ _
_SUPPOSITORIES: _
Treatment of ulcerative proctitis._ _
4.2
DOSE AND METHOD OF ADMINISTRATION
_ _
_PROLONGED RELEASE TABLETS 500MG AND 1G / PROLONGED RELEASE GRANULES
1G, 2G, 4G _
_ULCERATIVE COLITIS _
_TREATMENT OF ACTIVE DISEASE: _
_Adults: _Individual dosage, up to 4g o