Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
Hyperprolactinaemia (idiopathic or originating from a prolactin-secreting pituitary microadenoma or macroadenoma).
Since dopaminergic stimulation may lead to symptoms of orthostatic hypotension, the dosage of NORPROLAC should be initiated gradually with the aid of the ‘starter pack’, and given only at bedtime.
The optimal dose must be titrated individually on the basis of the prolactin- lowering effect and tolerability.
With the ‘starter pack’ treatment begins with 25 micrograms/day for the first 3 days, followed by 50 micrograms/day for a further 3 days. From day 7 onwards, the recommended dose is 75 micrograms/day.
If necessary, the daily dose may then be increased stepwise until the optimal individual response is attained. The usual maintenance dosage is 75 to 150 micrograms/day.
Daily doses of 300 micrograms or higher doses are required in less than one- third of the patients.
In such cases, the daily dosage may be increased in steps of 75 to 150 micrograms at intervals not shorter than 4 weeks until satisfactory therapeutic effectiveness is achieved or reduced tolerability, requiring the discontinuation of treatment, occurs.
Experience with the use of NORPROLAC in elderly patients is not available.
Experience with the use of NORPROLAC in children is not available.
NORPROLAC should be taken once a day with some food at bedtime.
Acute overdosage with NORPROLAC tablets has not been reported. It would be expected to cause severe nausea, vomiting, headache, dizziness, drowsiness, hypotension and possibly collapse. Hallucinations could also occur.
Should be symptomatic.
The shelf life is 5 years. The expiry date is printed on the box. On the blister the expiry date is marked with the letters EXP.
The expiry date refers to original unopened boxes, which were stored below 25°C. No special warning with respect to light sensitivity or humidity is necessary because the tablets are protected by the packaging.
The ‘starter pack’ (NORPROLAC 25/50) consists of 3 tablets of 25 micrograms and 3 tablets of 50 micrograms. These tablets are packed in an aluminium PVC/PVDC blister which is sealed in a moisture proof aluminium bag.
None.
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