Description
PENTASA® rectal suspensions are designed to provide the distal part of the intestinal
tract with high concentrations of mesalazine and a low systemic absorption. Rectal
suspensions have been shown to reach and cover the descending colon
Directions
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
Ingredients
mesalazine
Cautions
Most patients who are intolerant or hypersensitive to sulphasalazine are able to
take PENTASA® without risk of similar reactions. However, caution is recommended
when treating patients allergic to sulphasalazine (risk of allergy to salicylates). In
case of acute intolerance reactions such as abdominal cramps, acute abdominal
pain, fever, severe headache and rash, therapy should be discontinued immediately.
Caution is recommended in patients with impaired liver function. Liver function
parameters like ALT or AST should be assessed prior to and during treatment, at
the discretion of the treating physician.
The drug is not recommended for use in patients with renal impairment. The renal
function should be monitored regularly (e.g. serum creatinine), especially during the
initial phase of treatment. Urinary status (dip sticks) should be determined prior to
and during treatment at the discretion of the treating physician. Mesalazine induced
nephrotoxicity should be suspected in patients developing renal dysfunction during
treatment. The concurrent use of other known nephrotoxic agents should increase
monitoring frequency of renal function.
Patients with pulmonary disease, in particular asthma, should be very carefully
monitored during a course of treatment. Please refer to section on Undesirable
Effects
Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have
been reported rarely. Serious blood dyscrasias have been reported very rarely
with mesalazine. Blood test for differential blood count is recommended prior
to and during treatment, at the discretion of the treating physician. As stated in
section Interaction with Other Medicinal Products and Other Forms of Interaction,
concomitant treatment with mesalazine can increase the risk of blood dyscrasia
in patients receiving azathioprine, or 6-mercaptopurine or thioguanine. Treatment
should be discontinued on suspicion or evidence of these adverse reactions.
As a guideline, follow-up tests are recommended 14 days after commencement of
treatment, then a further two to three tests at intervals of 4 weeks. If the findings
are normal, follow-up tests should be carried out every three months. If additional
symptoms occur, these tests should be performed immediately.
Product Code : 13796
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