LORIEN Capsule / Tablet Ref.[115290] Active ingredients: Fluoxetine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

LORIEN 20 mg capsules.

LORIEN TABLETS 20 mg.

Pharmaceutical Form

Capsules:

LORIEN is a white powder encapsulated within a size “3” hard gelatine capsule with an opaque green body and opaque green cap.

Tablets:

LORIEN TABLETS is a round, white tablet with bevelled edges, bisected on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each capsule of LORIEN contains 20 mg fluoxetine as fluoxetine hydrochloride.

Contains sugar: Lactose monohydrate 130,70 mg.

For full list of excipients, see section 6.1.

Each tablet of LORIEN TABLETS contains 20 mg fluoxetine as fluoxetine hydrochloride.

Sugar free.

For full list of excipients, see section 6.1.

Active Ingredient

Fluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism of action. Fluoxetine has practically no affinity to other receptors such as α1, α2, and β-adrenergic; serotonergic; dopaminergic; histaminergic1; muscarinic; and GABA receptors.

List of Excipients

LORIEN:

Colloidal anhydrous silica
Gelatine
Lactose monohydrate
Magnesium stearate
Maize starch
Patent blue
Povidone
Titanium
Dioxide yellow iron oxide

LORIEN TABLETS:

Colloidal silicon dioxide
Magnesium stearate
Maize starch
Microcrystalline cellulose

Pack sizes and marketing

LORIEN: 28 and 112 capsules are packed in a clear, polyvinylchloride/polyethylene/Aclar blister strip sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

The capsules are packed in a white polypropylene container with a white, round, flat-topped linear low density polyethylene cap, with ridges on the side and a tamper evident seal, together with a silica gel sachet and a leaflet.

The capsules are packed in a metallised polyester/laminant/opaque white linear low density polyethylene lay flat bag with a low density polyethylene zip.

LORIEN TABLETS: 28 or 30 tablets are packed in a clear polyvinylchloride/polyethylene/Aclar blister strip sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

28 or 30 tablets are packed in a white polypropylene container with a linear low density polyethylene tamper proof snap cap together with a white foam insert or silica gel sachet and a leaflet.

Not all packs and pack sizes are necessarily marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

LORIEN: 30/1.2/0024
LORIEN TABLETS: 34/1.2/0381

LORIEN: 27 March 1996
LORIEN TABLETS: 05 August 2002

Drugs

Drug Countries
LORIEN South Africa

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