Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Recordati Ireland Ltd., Raheens East, Ringaskiddy Co. Cork, Ireland
Urorec 4 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Yellow, opaque, hard gelatin capsule, size 3. |
Each hard capsule contains 4 mg silodosin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Silodosin |
Silodosin is highly selective for α1A-adrenoreceptors that are primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra. Blockade of these α1A-adrenoreceptors causes smooth muscle in these tissues to relax, thus decreasing bladder outlet resistance, without affecting detrusor smooth muscle contractility. |
| List of Excipients |
|---|
|
Capsule content: Starch, pregelatinised (maize) Capsule shell: Gelatin |
The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in cartons.
Packs of 5, 10, 20, 30, 50, 90, 100 capsules.
Not all pack sizes may be marketed.
Recordati Ireland Ltd., Raheens East, Ringaskiddy Co. Cork, Ireland
EU/1/09/608/001
EU/1/09/608/002
EU/1/09/608/003
EU/1/09/608/004
EU/1/09/608/005
EU/1/09/608/006
EU/1/09/608/007
Date of first authorisation: 29/01/2010
Date of latest renewal: 18/09/2014
| Drug | Countries | |
|---|---|---|
| UROREC | Austria, Australia, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, Tunisia, Turkey |
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