ZEDRAST Capsule, soft Ref.[115221] Active ingredients: Dutasteride

Source: Health Products Regulatory Authority (ZA)  Publisher: Zydus Healthcare SA (Pty) Ltd, Southdowns Office Park, Building B, Ground Floor, 22 Karee Street, Centurion, Pretoria 0157

Product name and form

ZEDRAST 0,5 mg soft capsules.

Pharmaceutical Form

Capsules, soft.

Opaque, yellow, oblong shaped soft gelatine capsules containing a clear, colourless to slightly yellowish oily liquid.

Qualitative and quantitative composition

Each capsule contains 0,5 mg dutasteride.

Preservatives: 0,2% m/m methyl hydroxybenzoate and 0,03% m/m propyl hydroxybenzoate.

Sugar free.

For the full list of excipients, see section 6.1.

Active Ingredient

Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by inhibiting both type 1 and type 2, 5α-reductase isoenzymes which are responsible for the conversion of testosterone to DHT.

List of Excipients

Capsule contents:

Butylated hydroxytoluene
Glycerol monocaprylocaprate (type I)

Capsule shell:

Ferric oxide yellow (colourant)
Gelatine
Glycerol
Methyl hydroxybenzoate
Propyl hydroxybenzoate
Titanium dioxide (colourant)

Pack sizes and marketing

Aluminium-aluminium blister strips containing 6 soft gelatine capsules, packed in an outer container.

Pack size: 6

OR

Opaque PVC/PVDC and aluminium blister strips containing 10 soft gelatine capsules, packed in an outer container.

Pack size: 10

Marketing authorization holder

Zydus Healthcare SA (Pty) Ltd, Southdowns Office Park, Building B, Ground Floor, 22 Karee Street, Centurion, Pretoria 0157

Marketing authorization dates and numbers

54/21.12/0491

Drugs

Drug Countries
ZEDRAST South Africa

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