Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: AOP Orphan Pharmaceuticals Gmbh, Leopold-Ungar-Platz 2, A-1190 Vienna, Austria
Ethylex 50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Capsule shaped, beige film-coated tablets with a break-score on each side. The tablet can be divided into equal doses. |
Each film-coated tablet contains 50 mg naltrexone hydrochloride.
Contains lactose monohydrate.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Naltrexone |
Naltrexone is an orally used, long acting specific opioid antagonist. Naltrexone binds competitively to receptors which are located in the central and peripheral nervous system and hence blocks the access for exogenously administered opioids. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coat: Opadry 31 F27245 Beige |
Pack sizes: 7, 14, 28, 30 and 56 tablets in PVC/PVDC/Aluminium blister.
Not all pack sizes may be marketed.
AOP Orphan Pharmaceuticals Gmbh, Leopold-Ungar-Platz 2, A-1190 Vienna, Austria
PA0934/002/001
Date of first authorisation: 20 April 2004
Date of last renewal: 19 April 2009
| Drug | Countries | |
|---|---|---|
| ETHYLEX | Austria, Ireland, Malta, Turkey |
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