Pentasa

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Mesalazine 10 mg/mL;  

Disponibil de la:

Pharmaco (NZ) Ltd

INN (nume internaţional):

Mesalazine 10 mg/mL

Dozare:

10 mg/mL

Forma farmaceutică:

Enema

Compoziție:

Active: Mesalazine 10 mg/mL   Excipient: Disodium edetate dihydrate Hydrochloric acid Purified water Sodium acetate trihydrate Sodium metabisulfite

Unități în pachet:

Bottle, plastic, Sample pack, 100 mL

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Syntese A/S

Indicații terapeutice:

Treatment of left-sided colitis.

Rezumat produs:

Package - Contents - Shelf Life: Bottle, plastic, 100mL - 7 dose units - 36 months from date of manufacture stored at or below 25°C

Data de autorizare:

1988-10-20

Prospect

PENTASA
®
_Mesalazine_
Enema
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PENTASA
®
.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
Please read this leaflet before
you start using PENTASA
®
.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
PENTASA
®
against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the
medicine. You may need to
read it again.
WHAT PENTASA
® IS
USED FOR
This medicine is used to treat
ulcerative proctosigmoiditis
and left-sided ulcerative colitis.
These are conditions with
inflammation, ulcers and sores
in the rectum (back passage)
and in the large bowel next to
the rectum causing bleeding,
stomach pain, and diarrhoea.
The active ingredient in this
medicine is mesalazine. It is
an anti-inflammatory agent,
chemically similar to aspirin,
and is thought to work by
helping to reduce inflammation
in the large bowel and rectum.
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.
There is no evidence that
PENTASA
®
is addictive.
It is available only with a
doctor’s prescription.
It is not expected to affect your
ability to drive a car or operate
machinery.
BEFORE YOU USE
PENTASA
®
_WHEN YOU MUST NOT USE IT_
_ _
_ _
DO NOT USE PENTASA
® IF YOU
HAVE AN ALLERGY TO:

any medicine containing
mesalazine or 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 PENTASA
® IF
YOU HAVE A SEVERE KIDNEY OR
LIVER PROBLEM.
DO NOT USE THIS MEDICINE
AFTER THE EXPIRY DATE PRINTE

Caracteristicilor produsului

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