Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: AOP Orphan Pharmaceuticals Gmbh, Leopold-Ungar-Platz 2, A-1190 Vienna, Austria
For use as an additional therapy within a comprehensive treatment program including psychological guidance for alcohol dependence to support abstinence.
Ethylex treatment should be initiated and supervised by suitably qualified persons.
Administration of Ethylex should not be started before a naloxone challenge test is performed and a negative result obtained (see section 4.4).
Treatment with Ethylex should be considered only in patients who have remained opioid-free for a minimum of 7-10 days.
The recommended dose of naltrexone hydrochloride in adults is 50 mg per day (1 tablet).
As Ethylex is an adjunctive therapy and the full recovery process from alcohol dependence is individually variable, no standard duration of treatment can be stated; an initial period of three months should be considered. However, prolonged administration may be necessary.
Ethylex is not recommended for use in patients below 18 years of age. Safe use in children has not been established.
There is insufficient data on the safety and efficacy of naltrexone for this indication in elderly patients.
There is limited clinical experience with Ethylex overdose in patients. There was no evidence of toxicity in volunteers receiving 800 mg/day for seven days, however, in case of overdose, patients should be monitored and treated symptomatically in a closely supervised environment.
3 years.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Pack sizes: 7, 14, 28, 30 and 56 tablets in PVC/PVDC/Aluminium blister.
Not all pack sizes may be marketed.
No special requirements.
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