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Medicines
Spain
Silodosin

AEMPS 2013

Silodosin

Urorec 8 MG Capsulas Duras

8 mg cápsula duraSpainMarketedAuthorised 15 Apr 2013

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

UrorecEuropean Union · Recordati Ireland LtdSame brand
UrorecCroatiaSame brand
UrorecItaly · Capsula rigida · Recordati Ireland LTDSame brand
Urorec, 4 mg harde capsulesNetherlands · Capsule, hard · Recordati Ireland Ltd. (Co. Cork)Same brand
Urorec, 8 mg harde capsuleNetherlands · Capsule, hard · Recordati Ireland Ltd. (Co. Cork)Same brand
UROREC 4 mgRomania · 4 mg · caps. · Recordati Ireland LimitedSame brand
UROREC 8 mgRomania · 8 mg · caps. · Recordati Ireland LimitedSame brand

More with the same substance on this register

Silodosina Abamed 4 MG Capsulas Duras EfgSilodosin · 4 mg · cápsula duraSpain
Silodosina Abamed 8 MG Capsulas Duras EfgSilodosin · 8 mg · cápsula duraSpain

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Urorec®

Serbia · 4mg · kapsula, tvrda · Pharmaswiss D.O.O., Beograd

Same brand

🇷🇸Urorec®Serbia · 4mg · kapsula, tvrda · Pharmaswiss D.O.O., BeogradSame brand

🇷🇸Urorec®Serbia · 8mg · kapsula, tvrda · Pharmaswiss D.O.O., BeogradSame brand

🇨🇦Auro-SilodosinCanada · 8 MG · Capsule · Auro Pharma INCSame form

🇨🇦Auro-SilodosinCanada · 4 MG · Capsule · Auro Pharma INCSame form

🇨🇦Jamp SilodosinCanada · 4 MG · Capsule · Jamp Pharma CorporationSame form

🇭🇷Niksol 4 mg tvrde kapsuleCroatia · kapsula, tvrda · Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, HrvatskaSame form

🇭🇷Niksol 8 mg tvrde kapsuleCroatia · kapsula, tvrda · Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, HrvatskaSame form

🇮🇹Silodosina AristoItaly · Capsula rigida · Aristo Pharma GMBHSame form

🇮🇹Silodosina AurobindoItaly · Capsula rigida · Aurobindo Pharma (Italia) S.R.L.Same form

🇳🇱Silodosin Recordati 4 mg, capsules hardNetherlands · Capsule, hard · Recordati Ireland Ltd. (Co. Cork)Same form

🇺🇸SilodosinUnited States · 4MG, 8MG · capsule · Amneal Pharms CoSame form

🇺🇸RapafloUnited States · 4MG, 8MG · capsule · AbbvieSame form

🇧🇷Sil-HPBrazil · Apsen Farmaceutica S/ASame substance

🇧🇷RapafloBrazil · Allergan Produtos Farmacêuticos LtdaSame substance

🇧🇷RapafloBrazil · Biolab Farma Genericos LtdaSame substance

🇪🇺Silodosin RecordatiEuropean Union · Recordati Ireland LtdSame substance

🇪🇺SilodyxEuropean Union · Recordati Ireland LtdSame substance

🇸🇦FlopadexSaudi Arabia · Eva PharmaSame substance

Packs

Pack	Code	Status
UROREC 8 MG CAPSULAS DURAS 30	697626

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Silodosin
Strength: 8 mg
Dosage form: cápsula dura
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 15 Apr 2013
Registration: 09608011IP
Marketing authorisation holder: Recordati Ireland Limited
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica

AEMPSSilodosina Alter 4 MG Capsulas Duras EfgSilodosin · 4 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Alter 8 MG Capsulas Duras EfgSilodosin · 8 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Aurovitas 4 MG Capsulas Duras EfgSilodosin · 4 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Aurovitas 8 MG Capsulas Duras EfgSilodosin · 8 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Krka 4 MG Capsulas Duras EfgSilodosin · 4.00 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Krka 8 MG Capsulas Duras EfgSilodosin · 8.00 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Normon 4 MG Capsulas Duras EfgSilodosin · 4 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Normon 8 MG Capsulas Duras EfgSilodosin · 8 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Pensa 4 MG Capsulas Duras EfgSilodosin · 4 mg · cápsula dura🇪🇸Spain

AEMPSSilodosina Pensa 8 MG Capsulas Duras EfgSilodosin · 8 mg · cápsula dura🇪🇸Spain