LOXENTIA Hard gastro-resistant capsule Ref.[50432] Active ingredients: Duloxetine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Loxentia 20mg hard gastro-resistant capsule.

Pharmaceutical Form

Hard gastro-resistant capsule.

White to almost white pellets in a hard gelatine capsule size 4 (average length: 14.4 mm). The capsule body and cap are light blue. The capsule body is imprinted with 20 in black.

Qualitative and quantitative composition

Each hard gastro-resistant capsule contains 20 mg duloxetine (as duloxetine hydrochloride).

Excipient with known effect: sucrose.

Each 20 mg hard gastro-resistant capsule contains up to 29 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Duloxetine

Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.

List of Excipients

Capsule contents:

Sugar spheres (sucrose, maize starch)
Hypromellose 6 cP
Sucrose
Hypromellose phthalate
Talc
Triethyl citrate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Indigotine (E132)
Ink (shellac, black iron oxide (E172))

Pack sizes and marketing

Blisters (OPA/Alu/[HDPE/PE + DES of CaO/HDPE] foil – Alu/PE foil): 7, 10, 14, 28, 30, 56, 60, 90 and 100 hard gastro-resistant capsules, in a box.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

PA1347/051/001

Date of first authorisation: 15th of May 2015
Date of last renewal: 17th February 2020

Drugs

Drug Countries
LOXENTIA Finland, Ireland

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