PROSCAR 5 mg Tablets
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 31 January 2023
File name
IE-Proscar_5mg_EN_SPC_MAT_CRT Jul 2021.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 December 2022
File name
QRD-IE-Proscar-LFT-Heist-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 04 February 2022
File name
QRD_IE_Proscar_5mg_PIL_MAT_CRT_Jul 2021.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 26 August 2021
File name
IE-Proscar_5mg_EN_SPC_MAT_CRT Jul 2021.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 August 2021
File name
IE-Proscar_5mg_EN_SPC_MAT_CRT Jul 2021.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 06 May 2021
File name
Proscar_5mg_EN_SPC_QRD10.1_ Apr 2021.pdf
Reasons for updating
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Alignment with QRD Template 10.1.
Updated on 06 May 2021
File name
Proscar_5mg_EN_PIL_QRD10.1_Apr 2021_CRT.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 15 December 2020
File name
QRD_IE_PROSCAR_LFT_IA Heist_Oct 2020 (002).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 September 2020
File name
Proscar_5mg_IE_IB_SPC_EN_CRT (002).pdf.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 September 2020
File name
QRD_PIL_IE_Proscar_5mg_IB_CRT (002).pdf.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 14 May 2020
File name
QRD-IE-Proscar-5mg-EN-SPC-2x15-Packsize-harmonization-IAIN-CRT (002).pdf.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
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Removal of reference to calendar pack and revision date updated
Updated on 14 May 2020
File name
QRD_PIL_IE_Proscar_5mg (002).pdf.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Introduction of new pack/pack size
Updated on 18 December 2019
File name
PIL_IE_Proscar_5mg_2x15pack+SLU_CRT (002).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 December 2019
File name
IE-PROSCAR-EN-SPC-WS252+SLU-CRT (002).pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 October 2019
File name
QRD-IE-Proscar-5mg-tablets-2x15-PIL-Packsize-harmonization-CRT.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 6: A new pack size has been added & the revision date has been updated
Updated on 31 October 2019
File name
IE-Proscar-5mg-EN-SPC-2x15-Packsize-harmonization-CRT.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
A new pack size has been added (Section 6.5) and the revision date has been updated (Section 10)
Updated on 30 October 2019
File name
IE-Proscar-5mg-EN-SPC-2x15-Packsize-harmonization-CRT.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
A new pack size has been added
Updated on 21 August 2019
File name
IE-PROSCAR-EN-PL-WS252-CRT.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 August 2019
File name
IE-PROSCAR-EN-SPC-WS252-CRT.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.8: the addition of “Haematospermia” to the side effects, post-marketing experience section, under “Reproductive system and breast disorders” with the frequency “not known”.
- Section 10: Date of revision of the Text: new revision date is August 2019
Updated on 19 December 2018
File name
NK IE-Proscar-PIL-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 August 2018
File name
IE-Proscar-EN-PL-20180727-CRT (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 August 2018
File name
IE-Proscar-EN-SPC-20180727-CRT (2).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section 4.8 (addition of the adverse drug reaction “anxiety” with a frequency not known)
Updated on 27 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 September 2017
File name
PIL_11919_758.pdf
Reasons for updating
- New PIL for new product
Updated on 27 September 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section 4.4 (addition of statement regarding depression and depression-related disorders); 10 - Update of revision of the text;
Updated on 27 September 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 13 May 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 19 March 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 4.8, 10 - Addition of information on reporting a side effect
Updated on 19 March 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 08 April 2014
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 4.8, 10 - Updated adverse reactions: addition of angioedema related text for "Immune System disorders" (frequency unknown).
Updated on 07 April 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 25 July 2013
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 16 July 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 4.8, 10 - Updated adverse reactions for "Reproductive system and breast disorders" (frequency uncommon)
Updated on 12 February 2013
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 31 January 2013
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes to Sections: 4.5, 4.8, 10
Updated on 08 January 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Irish MA holder address change
Updated on 20 January 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update section 4.4, 4.5 & 4.7 of SPC following the outcome of the Final Assessment
Report for the PSUR work sharing procedure concerning Finasteride covering period 19th August 2008 – 18th August 2009
4.4 Special warnings and precautions for use
Hepatic insufficiency
The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically important drug interactions have been identified. Finasteride is metabolized primarily via, but does not appear to affect significantly, the cytochrome P450 3A4 system. Although the risk for finasteride to affect the pharmacokinetics of other drugs is estimated to be small, it is probable that inhibitors and inducers of cytochrome P450 3A4 will affect the plasma concentration of finasteride. However, based on established safety margins, any increase due to concomitant use of such inhibitors is unlikely to be of clinical significance‘Proscar’ does not appear to significantly affect the cytochrome P450-linked drug metabolising enzyme system. Compounds which have been tested in man include propranolol, digoxin, glibenclamide, warfarin, theophylline, and antipyrine and no clinically meaningful interactions were found.
4.7 Effects on ability to drive and use machines
There are no data to suggest that PROSCAR affects the ability to drive or use machines.
No clinically important drug interactions have been identified. ‘Proscar’ does not appear to significantly affect the cytochrome P450-linked drug metabolising enzyme system. Compounds which have been tested in man include propranolol, digoxin, glibenclamide, warfarin, theophylline, and antipyrine and no clinically meaningful interactions were found. No clinically important drug interactions have been identified. ‘Proscar’ does not appear to significantly affect the cytochrome P450-linked drug metabolising enzyme system. Compounds which have been tested in man include propranolol, digoxin, glibenclamide, warfarin, theophylline, and antipyrine and no clinically meaningful interactions were found.
Updated on 01 April 2010
Reasons for updating
- Change to side-effects
Updated on 05 March 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
PSUR review
Updated on 29 January 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change due to user-testing of patient information
Updated on 01 December 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes to sections: 4.2, 4.8 & 5.1
4.2 Posology and method of administration
The recommended dosage is one 5 mg tablet daily, with or without food. 'Proscar' can be administered alone or in combination with the alpha-blocker doxazosin (see section 5.1 'Pharmacodynamic properties').
4.8 Undesirable effects
‘Proscar’ is well tolerated. In controlled clinical studies where patients received 5 mg of finasteride over periods of up to four years, the following adverse reactions were considered possibly, probably or definitely drug-related and occurred with a frequency greater than placebo and greater than or equal to 1%: impotence, decreased libido, ejaculation disorders, decreased volume of ejaculate; breast tenderness, breast enlargement and rash. There was no evidence of increased adverse experiences with increased duration of treatment with ‘Proscar’ and the incidence of new drug-related sexual adverse experiences decreased with duration of treatment.
Medical therapy of prostatic symptoms (MTOPS)
The MTOPS study compared finasteride 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), combination therapy of finasteride 5 mg/day and doxazosin 4 or 8 mg/day (n=786), and placebo (n=737). In this study, the safety and tolerability profile of the combination therapy was generally consistent with the profiles of the individual components. The incidence of ejaculation disorder events without regard to drug relationship were: finasteride 8.3%, doxazosin 5.3%, combination 15.0%, placebo 3.9%.
5.1 Pharmacodynamic properties
Finasteride is a competitive inhibitor of human Type II 5 a-reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen, dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. ‘Proscar’ is highly effective in reducing circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor.
In clinical studies of patients with moderate to severe symptoms of BPH, an enlarged prostate on digital rectal examination and low residual urinary volumes, 'Proscar' reduced the incidence of acute retention of urine from 7/100 to 3/100 over four years and the need for surgery (TURP or prostatectomy) from 10/100 to 5/100. These reductions were associated with a 2-point improvement in QUASI-AUA symptom score (range 0-34), a sustained regression in prostate volume of approximately 20% and a sustained increase in urinary flow rate.
Medical therapy of prostatic symptoms
The Medical Therapy of Prostatic Symptoms (MTOPS) Trial was a 4- to 6-year study in 3047 men with symptomatic BPH who were randomised to receive finasteride 5 mg/day, doxazosin 4 or 8 mg/day*, the combination of finasteride 5 mg/day and doxazosin 4 or 8 mg/day*, or placebo. The primary endpoint was time to clinical progression of BPH, defined as a 
4 point confirmed increase from baseline in symptom score, acute urinary retention, BPH-related renal insufficiency, recurrent urinary tract infections or urosepsis, or incontinence. Compared to placebo, treatment with finasteride, doxazosin, or combination therapy resulted in a significant reduction in the risk of clinical progression of BPH by 34(p=0.002), 39 (p<0.001), and 67% (p<0.001), respectively. The majority of the events (274 out of 351) that constituted BPH progression were confirmed 4 point increases in symptom score; the risk of symptom score progression was reduced by 30 (95% CI 6 to 48%), 46 (95% CI 25 to 60%), and 64% (95% CI 48 to 75%) in the finasteride, doxazosin, and combination groups, respectively, compared to placebo. Acute urinary retention accounted for 41 of the 351 events of BPH progression; the risk of developing acute urinary retention was reduced by 67(p=0.011), 31 (p=0.296), and 79% (p=0.001) in the finasteride, doxazosin, and combination groups, respectively, compared to placebo. Only the finasteride and combination therapy groups were significantly different from placebo.
* Titrated from 1 mg to 4 or 8 mg as tolerated over a 3-week period
Updated on 20 August 2008
Reasons for updating
- Change to warnings or special precautions for use
Updated on 09 April 2008
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 16 March 2007
Reasons for updating
- New PIL for medicines.ie
Updated on 01 February 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Spc updated with the new PA holder deatils further to transfer of the Proscar licence to Merck Sharp & Dohme Ireland (Human Health).
Updated on 31 October 2005
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 March 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 February 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 August 2003
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)