PROSCAR 5 mg Tablets

  • Name:

    PROSCAR 5 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Finasteride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/10/19

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Summary of Product Characteristics last updated on medicines.ie: 31/10/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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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 31 October 2019 PIL

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 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 August 2019 SmPC

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

  1. 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”.
  2. Section 10: Date of revision of the Text: new revision date is August 2019

Updated on 19 December 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 9 August 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 9 August 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2017 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 September 2017 PIL

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 19 March 2015 SmPC

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 8 April 2014 SmPC

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 7 April 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 25 July 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 16 July 2013 SmPC

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 31 January 2013 SmPC

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 8 January 2013 SmPC

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 SmPC

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 1 April 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 March 2010 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change due to user-testing of patient information

Updated on 1 December 2009 SmPC

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

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

Finasteride is a competitive inhibitor of human Type II 5 -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.The recommended dosage is one 5 mg tablet daily, with or without food. '‘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.

Finasteride is a competitive inhibitor of human Type II 5 -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.

Updated on 20 August 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 9 April 2008 SmPC

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)

Free text change information supplied by the pharmaceutical company

Update section 4.6 & 5.3 in relation to  risk of Small amounts of finasteride been recovered from the semen in subjects receiving finasteride 5 mg/day. It is not known whether a male foetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride. When the patient’s sexual partner is or may potentially be pregnant, the patient is recommended to minimise exposure of his partner to semen.

Updated on 16 March 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 1 February 2007 SmPC

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 SmPC

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 1 March 2005 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)