ADEPEND Film-coated tablet Ref.[7824] Active ingredients: Naltrexone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002, Purkersdorf, Austria

Product name and form

Adepend 50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Capsule shaped, beige film-coated tablets with a break-score on each side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg naltrexone hydrochloride.

Excipients with known effect: contains 126,755 mg lactose monohydrate. For the 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
Powered cellulose
Crospovidone
Microcrystalline cellulose
Silica, colloidal anhydrous
Magnesium stearate

Film-coat:

Lactose monohydrate
Hypromellose
Titanium dioxide (E171)
Macrogol 4000
Black ferric oxide (E172)
Red ferric oxide (E172)
Yellow ferric oxide (E172)

Pack sizes and marketing

7, 10, 14, 28, 30 or 100 tablets in PVC/PVDC/Aluminium blister packed in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002, Purkersdorf, Austria

Marketing authorization dates and numbers

PL 30414/0013

22/12/2011 / 08/05/2015

Drugs

Drug Countries
ADEPEND Estonia, Croatia, Lithuania, Poland, United Kingdom

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