CYMGEN Delayed release capsule Ref.[115346] Active ingredients: Duloxetine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

CYMGEN 30 mg capsules.

CYMGEN 60 mg capsules.

Pharmaceutical Form

Delayed release capsules.

CYMGEN 30: Hard gelatin capsule size ‘3’ opaque blue cap and opaque white body, imprinted with ‘F38’ on cap and body in green ink that contains white to light greyish white pellets.

CYMGEN 60: Hard gelatin capsule size ‘1’ opaque blue cap and opaque green body, imprinted with ‘F39’ on cap and body in white ink that contains white to light greyish white pellets.

Qualitative and quantitative composition

CYMGEN 30:

Each delayed-release capsule of CYMGEN 30 for oral administration contains enteric-coated pellets of duloxetine hydrochloride equivalent to 30 mg of duloxetine that are designed to prevent degradation of the medicine in the acidic environment of the stomach.

Contains sugar: Sucrose 55,5 mg.

For full list of excipients, see section 6.1.

CYMGEN 60:

Each delayed-release capsule of CYMGEN 60 for oral administration contains enteric-coated pellets of duloxetine hydrochloride equivalent to 60 mg of duloxetine that are designed to prevent degradation of the medicine in the acidic environment of the stomach.

Contains sugar: Sucrose 110,6 mg.

For full list of excipients, see section 6.1.

Active Ingredient

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

CYMGEN 30 mg:

Carmoisine (E122), FD&C blue no. 2 aluminium lake (E132), gelatin, hypromellose, hypromellose acetate succinate, iron oxide yellow (E172), patent blue V (E131), propylene glycol, shellac (E904), sodium lauryl sulfate, sucrose, sugar spheres, talc, triethyl citrate, titanium dioxide (E171).

CYMGEN 60 mg:

Carmoisine (E122), gelatin, hypromellose, hypromellose acetate succinate, iron oxide yellow (E172), patent blue V (E131), povidone, propylene glycol, shellac (E904), sodium lauryl sulfate, sucrose, sugar spheres, talc, triethyl citrate, titanium dioxide (E171).

Pack sizes and marketing

CYMGEN capsules are supplied in blister packs composed of cold-form aluminium laminate on one side and aluminium foil on the other side and packed in cartons of 28 capsules.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

CYMGEN 30: 41/1.2/1029
CYMGEN 60: 41/1.2/1030

17 April 2009

Drugs

Drug Countries
CYMGEN South Africa

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