Urorec 8 mg capsules

  • Name:

    Urorec 8 mg capsules

  • Company:
    info
  • Active Ingredients:

    Silodosin

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Summary of Product Characteristics last updated on medicines.ie: 10/6/2015
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Recordati Ireland Limited

Recordati Ireland Limited

Company Products

Medicine NameActive Ingredients
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Medicine Name Citrafleet Active Ingredients Citric Acid (Anhydrous), Magnesium Oxide Light, Sodium picosulfate
Medicine Name Cleenema Ready-to-Use 21.4g / 9.4g Enema Active Ingredients Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate
Medicine Name Kentera oxybutynin transdermal patch Active Ingredients Oxybutynin
Medicine Name Lercaril 10 mg/10 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Lercaril 20 mg/10 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Lercaril 20 mg/20 mg Film-coated Tablets Active Ingredients Enalapril Maleate, Lercanidipine Hydrochloride
Medicine Name Phospho-soda 24.4g / 10.8g oral solution Active Ingredients Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate
Medicine Name Reagila 1.5 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 3 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 4.5 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Reagila 6 mg hard capsules Active Ingredients Cariprazine hydrochloride
Medicine Name Urispas 200mg film-coated tablets Active Ingredients Flavoxate Hydrochloride, Lactose
Medicine Name Urorec 4 mg capsules Active Ingredients Silodosin
Medicine Name Urorec 8 mg capsules Active Ingredients Silodosin
Medicine Name Urorec capsules Active Ingredients Silodosin
Medicine Name Vitaros 3mg/g Cream Active Ingredients Alprostadil
Medicine Name Zanidip 10mg and 20mg Tablets Active Ingredients Lercanidipine Hydrochloride
Medicine Name Zanidip 10mg Tablets Active Ingredients Lercanidipine Hydrochloride
Medicine Name Zanidip 20mg Tablets Active Ingredients Lercanidipine Hydrochloride
1 - 0 of 20 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 June 2015 PIL

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

The section 5.1 of the SmPC has been updated in order to add efficacy and safety information from the European Phase IV open label clinical study undertaken in patients with benign prostate hyperplasia

Updated on 10 June 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 10 June 2015 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The section 5.1 of the SmPC has been updated in order to add efficacy and safety information from the European Phase IV open label clinical study undertaken in patients with benign prostate hyperplasia

Updated on 21 October 2014 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to dates as a result of renewal of product authorisation
Change of ADR reporting details from IMB to HPRA (Section 4.8)

Updated on 21 October 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to dates as a result of renewal of product authorisation
Change of ADR reporting details from IMB to HPRA (Section 4.8)

Updated on 6 January 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Addition of manufacturer
  • Change due to harmonisation of SPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Added the following to the Table in Section 4.8
Add Immune System Disorders to undesirable effects - Allergic-type reactions including facial swelling, swollen tongue and pharyngeal oedema1
Add Nervous System Disorders to undesirable effects - Loss of consciousness
Add Cardiac Disorders to undesirable effects - Tachycardia & Palpitations
Add to Vascular Disorders in undesirable effects - hypotension
Add Hepatobiliary disorders to undesirable effects - abnormal liver function tests
Add skin and subcutaneous tissue disorders to undesirable effects - skin rash, pruritis, urticarial & skin eruption

1 - adverse reactions from spontaneous reporting in the worldwide post-marketing experience (frequencies calculated from events reported in phase I-IV clinical trials and non-interventional studies).


Deleted the following text from Section 4.8:
Adverse reactions from spontaneous reporting:
There have been post-marketing reports of: tachycardia (uncommon), allergic-type reactions, such as skin rash, pruritus, urticaria and drug eruption (uncommon), palpitations (rare) and abnormal liver function tests (uncommon).

Updated on 6 January 2014 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Addition of manufacturer
  • Change due to harmonisation of SPC

Free text change information supplied by the pharmaceutical company

Added the following to the Table in Section 4.8
Add Immune System Disorders to undesirable effects - Allergic-type reactions including facial swelling, swollen tongue and pharyngeal oedema1
Add Nervous System Disorders to undesirable effects - Loss of consciousness
Add Cardiac Disorders to undesirable effects - Tachycardia & Palpitations
Add to Vascular Disorders in undesirable effects - hypotension
Add Hepatobiliary disorders to undesirable effects - abnormal liver function tests
Add skin and subcutaneous tissue disorders to undesirable effects - skin rash, pruritis, urticarial & skin eruption

1 - adverse reactions from spontaneous reporting in the worldwide post-marketing experience (frequencies calculated from events reported in phase I-IV clinical trials and non-interventional studies).


Deleted the following text from Section 4.8:
Adverse reactions from spontaneous reporting:
There have been post-marketing reports of: tachycardia (uncommon), allergic-type reactions, such as skin rash, pruritus, urticaria and drug eruption (uncommon), palpitations (rare) and abnormal liver function tests (uncommon).

Updated on 18 January 2013 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf Life changed from 2 years to 3 years

Updated on 18 January 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf Life changed from 2 years to 3 years

Updated on 3 May 2012 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation

Free text change information supplied by the pharmaceutical company

Section 2: Inserted the word "the"
Section 4.2: Inserted the heading "Posology"
Section 4.3: Inserted "listed in Section 6.1"
Section 4.6: Deleted "lactation" and inserted "breastfeeding"
Section 4.8: Adverse reactions from sponataneous reporting (post marketing reports) details added
Section 5.1: Inserted "Clinical Efficacy and Safety"
Section 9: Inserted "Date of First Authorisation"

Updated on 3 May 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2: Inserted the word "the"
Section 4.2: Inserted the heading "Posology"
Section 4.3: Inserted "listed in Section 6.1"
Section 4.6: Deleted "lactation" and inserted "breastfeeding"
Section 4.8: Adverse reactions from sponataneous reporting (post marketing reports) details added
Section 5.1: Inserted "Clinical Efficacy and Safety"
Section 9: Inserted "Date of First Authorisation"

Updated on 3 September 2010 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 3 September 2010 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided