PENTASA RECTAL SUSPENSION 1 G

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Mesalazine

Available from:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC code:

A07EC02

Pharmaceutical form:

SUSPENSION

Composition:

Mesalazine 0.01g/ml

Administration route:

RECTAL

Prescription type:

Prescription Only

Manufactured by:

Ferring-Léčiva, a.s.

Authorization status:

ACTIVE

Authorization date:

2016-12-14

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
PENTASA
®
Rectal Suspension 1 g
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle of rectal suspension contains 1 g (1g/100mL) mesalazine.
Excipients: Disodium edetate, sodium metabisulphite, sodium acetate,
purified water and
hydrochloric acid for pH adjustment.
PHARMACEUTICAL FORM
Rectal suspension 1 g.
Appearance of PENTASA
®
rectal suspension 1 g: White to slightly yellow suspension with a
pH value between 4.4 and 5.0.
THERAPEUTIC INDICATIONS
Treatment of ulcerative proctosigmoiditis.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Adults: 1 rectal suspension at bedtime.
Paediatric population:
There is little experience and only limited documentation for an
effect in children.
METHOD OF ADMINISTRATION:
1.
A visit to the toilet is recommended before administration of the
rectal suspension.
2.
Immediately before use take the rectal suspension bottle out of the
aluminium foil pack
and shake it well (Figure 1).
3.
To break the seal twist the nozzle clockwise one full turn (the nozzle
should then be in
the same direction as before turning) (Figure 2).
4.
Put your hand in one of the plastic disposal bags provided in the pack
(Figure 3).
5.
Hold the container as shown in the picture (Figure 4). Lubricate top
part of rectal
applicator.
6.
To administer the rectal suspension, lie on your left side with the
left leg straight and the
right leg bent forward for balance. Carefully insert the applicator
tip into the rectum.
Maintain sufficient steady hand pressure while dispersing the bottle
content. The bottle
content should be applied within max. 30-40 seconds (Figure 5).
7.
Once the bottle is empty, withdraw the tip with the bottle still
compressed.
8.
The
rectal
suspension
should
be
retained
in
the
bowel.
Remain
relaxed
in
the
administration position for 5-10 minutes or until the urge to pass the
rectal suspension
has disappeared (Figure 6). Try to retain the rectal suspension
overnight.
9.
Roll the plastic disposal bag over the empty bottle (Figure 7).
Discard it and wash your
hands.