When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
In section 4.3 Prostatic enlargement, paralytic ileus, pyloric stenosis, myasthenia gravis and hepatic impairment have been added as contraindications
In section 4.4 warnings have been added about ulcerative colitis, Down’s Syndrome, diarrhoea, fever and hepatic impairment have been added.
In section 4.5 the following sentences have been added:
There may be an increased risk of side effects when given with MAOIs due to inhibition of drug-metabolising enzymes.
There is an antagonism of effect of domperidone and metoclopramide on gastro-intestinal activity.
There could be a reduced effect of sublingual nitrate tablets due to failure to dissolve properly under the tongue owing to dry mouth.
A warning about grapefruit juice was also moved here.
In section 4.8 the following was added:
The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS II categories of frequency is not pertinent.
General: hyperthermia at high temperatures due to decreased sweating.
There have been rare reports of an increase in seizure frequency in epileptic patients (the same caution for this patient population is included in section 4.4).
An error has been corrected in section 4.9. Abuse has been amended to say absolute.
In section 5.2 the grapefruit juice warning has been removed. (Has been added above)
Section 10 has been updated to February 2010.
The scoreline is to allow breaking of the tablet into 2 for dosage purposes and ease of swallowing only.