PENTASA mesalazine 1g suppository blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mesalazine, Quantity: 1000 mg

Available from:

Ferring Pharmaceuticals Pty Ltd

Pharmaceutical form:

Suppository, compressed

Composition:

Excipient Ingredients: purified talc; povidone; macrogol 6000; magnesium stearate

Administration route:

Rectal

Units in package:

28 suppositories, 5 suppositories, 30 suppositories

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of ulcerative procitis.

Product summary:

Visual Identification: white to tan spotted oblong suppositories; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-11-14

Patient Information leaflet

PENTASA
® (SUPPOSITORIES)
P
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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 PENTASA?
PENTASA contains the active ingredient mesalazine. PENTASA is used to
treat proctitis: a disease with inflammation, ulcers and
sores in the rectum (back passage) causing bleeding, stomach pain, and
diarrhoea.
For more information, see Section 1. Why am I using PENTASA? in the
full CMI, starting from page 2.
2.
WHAT SHOULD I KNOW BEFORE I USE PENTASA?
Do not use 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 use
PENTASA? in the full CMI, starting from page 2..
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Care may be needed when using 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 USE PENTASA?
•
Use as directed by your doctor.
•
Insert one suppository (1 g) into the rectum at bedtime.
•
More instructions can be found in Section 4. How do I use PENTASA? in
the full CMI, starting from page 2. and in the detailed
instructions in the pack.
5.
WHAT SHOULD I KNOW WHILE USING PENTASA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
PENTASA
•
Have all blood tests recommended by your doctor
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are using this medicine
•
IF YOU BECOME PREGNANT WHILE USING THIS MEDICINE, TELL YOUR DOCTOR
IMMEDIATELY.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or lower the dosage suddenly without
checking with your doctor
•
Do not use P

Summary of Product characteristics

PRODUCT INFORMATION
Page 1 of 11
#6572-V28A
AUSTRALIAN PRODUCT INFORMATION – PENTASA
®
(MESALAZINE) ENEMAS AND SUPPOSITORIES
1
NAME OF THE MEDICINE
Mesalazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PENTASA Enemas contain mesalazine 1g/100mL as the active ingredient as
well as the following inactive
excipients: disodium edetate, sodium metabisulphite, sodium acetate,
purified water, hydrochloric acid to pH
4.8.
PENTASA Suppositories contain 1 g mesalazine as the active ingredient
as well as the following inactive
excipients: magnesium stearate, purified talc, povidone and macrogol
6000.
3
PHARMACEUTICAL FORM
Enema 1 g
Suppositories 1 g
Appearance of PENTASA Enema 1 g: White to slightly yellow suspension
with a pH value between 4.4 and
5.0.
Appearance of PENTASA suppositories 1 g: White to tan, spotted, oblong
suppositories.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Enemas: Treatment of ulcerative proctosigmoiditis and/or treatment of
left-sided ulcerative colitis.
Suppositories: Treatment of ulcerative proctitis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
A visit to the toilet is recommended before administration of enemas
and suppositories.
Enemas: The contents of one (1 g) enema inserted into the rectum at
bedtime. Shake the enema container
well. The enema should be used not more than 5 minutes after being
shaken.
Suppositories: One (1 g) suppository once daily.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to mesalazine or any other component of the product
or salicylates.
Severe liver or renal impairment.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Most patients who are intolerant or hypersensitive to sulfasalazine
are able to take PENTASA without the risk
of similar reactions. However, caution is recommended when treating
patients allergic to sulfasalazine
because of the risk of allergy to salicylates (also see SECTION 4.3
CONTRAINDICATIONS).
PRODUCT INFORMATION
Page 2 of 11
#6572-V28A
Of 287 patients participating in a clinical study, 44 were known to be
allergic to sulfasalazine. Whilst only 3 of
t