SILODYX Hard capsule Ref.[51092] Active ingredients: Silodosin

Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Recordati Ireland Ltd., Raheens East, Ringaskiddy Co. Cork, Ireland

Product name and form

Silodyx 4 mg hard capsules.

Silodyx 8 mg hard capsules.

Pharmaceutical Form
Hard capsule. Silodyx 4 mg hard capsules: Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 × 5.8 mm). Silodyx 8 mg hard capsules: White, opaque, hard gelatin capsule, size 0 (approximately 21.7 × 7.6 mm).

Qualitative and quantitative composition

Silodyx 4 mg hard capsules: Each hard capsule contains 4 mg silodosin.

Silodyx 8 mg hard capsules: Each hard capsule contains 8 mg silodosin.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Silodosin	Silodosin is highly selective for α_1A-adrenoreceptors that are primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra. Blockade of these α_1A-adrenoreceptors causes smooth muscle in these tissues to relax, thus decreasing bladder outlet resistance, without affecting detrusor smooth muscle contractility.

List of Excipients
Silodyx 4 mg and 8 mg hard capsules Capsule content: Starch, pregelatinised (maize) Mannitol (E421) Magnesium stearate Sodium laurilsulfate Capsule shell: Gelatin Titanium dioxide (E171) Yellow iron oxide (E172) (4 mg capsules only)

Pack sizes and marketing

The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in cartons.

Packs of 5, 10, 20, 30, 50, 90, 100 capsules.

Multipack containing 200 (2 packs of 100) capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Recordati Ireland Ltd., Raheens East, Ringaskiddy Co. Cork, Ireland

Marketing authorization dates and numbers

EU/1/09/607/001
EU/1/09/607/002
EU/1/09/607/003
EU/1/09/607/004
EU/1/09/607/005
EU/1/09/607/006
EU/1/09/607/007
EU/1/09/607/008
EU/1/09/607/009
EU/1/09/607/010
EU/1/09/607/011
EU/1/09/607/012
EU/1/09/607/013
EU/1/09/607/014
EU/1/09/607/015

Date of first authorisation: 29/01/2010
Date of latest renewal: 18/09/2014

Drugs

Drug	Countries
SILODYX	Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Turkey, South Africa

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