Asamax 500

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Mesalazine 500mg

Предлага се от:

Seqirus (NZ) Ltd

INN (Международно Name):

Mesalazine 500 mg

дозиране:

500 mg

Лекарствена форма:

Suppository

Композиция:

Active: Mesalazine 500mg Excipient: Cetyl alcohol Docusate sodium Hard fat

Броя в опаковка:

Blister pack, Preformed suppository from (LDPE/PVC) x 30, 30 suppositories

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Chemi SpA

Терапевтични показания:

Treatment of ulcerative proctitis.

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, Preformed suppository from (LDPE/PVC) x 30 - 30 suppositories - 36 months from date of manufacture stored at or below 25°C

Дата Оторизация:

2005-08-29

Листовка

ASAMAX
®
500
1
ASAMAX
® 500
500 MG SUPPOSITORIES
MESALAZINE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ASAMAX
®
500 suppositories.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
ASAMAX 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 ARE ASAMAX
® 500 SUPPOSITORIES USED FOR
This medicine is used to treat ulcerative proctitis, a disease with
inflammation, ulcers and
sores in the rectum (back passage) 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 suppressing
inflammation in the 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.
This medicine is not addictive.
It is available only with a doctor's prescription.
BEFORE YOU USE ASAMAX
® 500 SUPPOSITORIES
_WHEN YOU MUST NOT USE THIS MEDICINE _
DO NOT USE ASAMAX
®
500 IF YOU HAVE:
•
an allergy* to any medicine containing mesalazine or aspirin-like
medicines, or any of the
ingredients listed at the end of this leaflet
•
a severe kidney or liver problem
•
problems with the clotting of your blood or you tend to bleed easily
•
a stomach or duodenal ulcer
*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 GIVE THIS MEDICINE TO A CHILD UNDER 2 YEARS OF AGE.
Safety and effectiveness in children younger than 2 years have not
been established.
ASAMAX
®
500
2
DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTE

Данни за продукта

NEW ZEALAND DATA SHEET
Page 1 of 7
1 ASAMAX® 500
Mesalazine (5-aminosalicylic acid) 500 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Asamax 500 suppository 500 mg: a yellow white to orange grey torpedo
shaped suppository with
smooth surface of fatty consistency, containing 500 mg mesalazine
(5-aminosalicylic acid). Length
approx. 3 cm, average weight: 2400 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of ulcerative proctitis.
4.2
Dose and method of administration
The dosage should be adapted to the severity of the disorder. For
adults and older children it is
generally recommended to take 1 g to 2 g daily in divided doses.
A visit to the toilet is recommended before administration of
suppositories.
The suppository is to be inserted into the rectum via the anus. This
is easiest when the patient is lying
down relaxed on one side with knees pulled up slightly.
4.3
Contraindications
Hypersensitivity to mesalazine, any other component of the product, or
salicylates.
Severe liver and/or renal impairment.
Increased tendency to bleeding.
Active ulcers of the stomach and/or duodenum.
4.4
Special warnings and precautions for use
Most patients who are intolerant or hypersensitive to sulfasalazine
are able to take Asamax without
risk of similar reactions. However, caution is recommended when
treating patients allergic to
sulfasalazine (risk of allergy to salicylates).
Caution is recommended in patients with impaired liver function. Liver
function parameters like
alanine aminotransferase (ALT) or aspartate transaminase (AST) should
be assessed prior to and
during treatment, at the discretion of the treating physician. The
medicine is not recommended for
use in patients with renal impairment. Mesalazine-induced
nephrotoxicity should be suspected in
patients developing renal dysfunction during treatment. The renal
function should be regularly
monitored (e.g. serum creatinine), especially during the initial phase