Urorec 8 mg capsules
- Name:
Urorec 8 mg capsules
- Company:
Recordati Ireland Limited
- Active Ingredients:
- 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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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Recordati Ireland Limited
Company Products
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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)
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)
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
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).
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
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).
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"
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"
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