ASACOL ENEMA

Χώρα: Νότια Αφρική

Γλώσσα: Αγγλικά

Πηγή: South African Health Products Regulatory Authority (SAHPRA)

Διαθέσιμο από:

Equity Pharmaceutical (Pty) Ltd

Δοσολογία:

See ingredients

Φαρμακοτεχνική μορφή:

ENEMA

Σύνθεση:

EACH 50,0 ml SUSPENSION CONTAINS MESALAZINE 2,0 g

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1998-03-06

Φύλλο οδηγιών χρήσης

Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
ASACOL ENEMA, 2 G/50 ML, RECTAL SUSPENSION
.
MESALAZINE (5-AMINOSALICYLIC ACID).
ANTIOXIDANT: SODIUM METABISULPHITE 0,05 G
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ASACOL ENEMA
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
ASACOL ENEMA has been prescribed for you personally and you should not
share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What ASACOL ENEMA is and what it is used for
2. What you need to know before you use ASACOL ENEMA
3. How to use ASACOL ENEMA
4. Possible side effects
5. How to store ASACOL ENEMA
6. Contents of the pack and other information
1. WHAT ASACOL ENEMA IS AND WHAT IT IS USED FOR
ASACOL ENEMA contains mesalazine, which is an anti-inflammatory
medicine used for: The treatment and
maintenance of remission in ulcerative colitis.
Ulcerative colitis is a disease of the large bowel (colon) and back
passage (rectum), in which the lining of the bowel
becomes inflamed (red and swollen). ASACOL ENEMA act locally in the
rectum to reduce this inflammation.
ASACOL ENEMA can also be used to prevent further episodes of
ulcerative colitis.
S3
Page 2 of 9
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ASACOL ENEMA
DO NOT USE ASACOL ENEMA:
•
If you are hypersensitive (allergic) to mesalazine or to the other
ingredients of ASACOL ENEMA (see section 6).
•
If you are hypersensitive (allergic) to aspirin or other salicylates.
•
If you have had serious kidney or liver problems.
•
If you are pregnant or breastfeeding your infant.
•
This medicine should not be used by children.
WARNINGS AND PRECAUTIONS
Take special care with ASACOL ENEMA:
When you start using ASACOL ENEMA and during treatment with ASACOL
ENEMA, your doctor may consider
regular examinations to check that your blood, liver, kidneys and
lungs are functioning normal. I

Αρχείο Π.Χ.Π.

Page 1 of 11
SCHEDULING STATUS
S3
1. NAME OF THE MEDICINE
ASACOL ENEMA (2 g, rectal suspension)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 50 ml enema:
Mesalazine (5-aminosalicylic acid) 2 g
Antioxidant:
Sodium metabisulphite 0,05 g
Preservative:
Sodium benzoate 0,1 % m/v
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Rectal suspension.
Brownish suspension with a characteristic odour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASACOL ENEMA is used for the treatment and maintenance of remission in
ulcerative colitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adult dose: Two gram administered at night per rectum.
METHOD OF ADMINISTRATION
Rectal use.
_Before using the enema_
: The bottle should be warmed to body temperature in a basin or bowl
of warm water for about
10 minutes. The bottle should be shaken well immediately before
inserting the enema.
_Inserting the enema:_
The screw cap must be twisted off from the bottle and the applicator
tip must be twisted on.
The applicator tip can be lubricated with vaseline. For the enema
administration the patient should lie on the left side
Page 2 of 11
with the left leg extended and the right leg bent. After inserting the
applicator tip into the rectum the liquid should be
pressed out gently and slowly. The tip should be withdrawn with the
container still compressed.
The patients should try to stay in the administration position for 5
to 10 minutes or until the urge to pass the enema has
disappeared. The enema should be retained in the bowel if possible
without evacuation of the bowels until the next morning.
4.3 CONTRAINDICATIONS
Hypersensitivity to mesalazine or to any of the excipients (see
section 6.1).
History of allergy to salicylates.
Severe liver impairment.
Severe renal impairment (GFR less than 30 ml per minute).
Safety in pregnancy and lactation has not been established.
Safety and efficacy have not been established in children.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood tests (differential blood count, liver f