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Betacap Scalp Application 0.1% w/w Cutaneous Solution

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Pharmacy Only: Prescription

Updated on 23 January 2023

File name

BVSA-IPHA.SPC.pdf

Reasons for updating

  • Document format updated

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

Updated on 17 March 2022

File name

BVSA-IPHA.PIL.VP8-21-2a.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 22 November 2021

File name

BVSA-IPHA.PIL.VP5-21-1.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

In Section 2 What you need to know - warnings and precautions, the following text has been added:

"If there is a worsening of your condition during use consult your prescriber - you may be experiencing an allergic reaction, have an infection or your condition may require a different treatment.  If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using Betacap Scalp Application without consulting your prescriber unless your prescriber has previously advised you to do so.  If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment."

In Section 4 Possible side effects, the following text has been added:

"Steroid withdrawal reaction: If used continuously for prolonged periods a withdrawal reaction may occur on stopping treatment with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores."

In Section 6 Date of revision, the date has changed to:

"July 2021"

Updated on 22 November 2021

File name

BVSA-IPHA.SPC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use, has been updated with the following additional text:

"Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered."

Section 4.8 Undesirable effects, has been updated with the following additional text:

"Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4)"

Section 10 Date of revision of the text, the date has changed to:

"November 2021" 

 

Updated on 03 March 2021

File name

BVSA-IPHA.PIL.VP5-20-3.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 December 2020

File name

BVSA-IPHA.SPC.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 10 November 2020

File name

BVSA-IPHA.SPC.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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)

Updated on 31 August 2018

File name

BVSA-IPHA.SPC.06.05.15.11.05.15.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 20 May 2015

File name

PIL_8656_929.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 May 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 11 May 2015

Reasons for updating

  • New SPC for new product

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

Updated on 11 May 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail:medsafety@hpra.ie.



In section 10 Date of revision of the text, the date has changed to "April 2015"

Updated on 11 June 2014

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 12 August 2010

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 August 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 16 June 2009

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • 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

In section 1 (Name of the medicinal product) : the name has changed to Betacap Scalp Application 0.1% w/w Cutaneous Solution.
 
In section 4.2 (Posology and method of administration) : the following text has been added : For the treatment of seborrhoeic dermatitis in children, the product should not be used for longer than 7 days.
 
In section 6.1 (List of excipients) : the text (a water dispersible derivative of coconut oil) has been deleted and Carbomer has been changed to Carbopol.
 
In section 9 (Renewal of the authorisation) : the date has changed to 11 October 2008.
 
In section 10 (Date of revision of the text) : the date has changed to November 2008.

Updated on 13 August 2007

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 6.5 - Nature and contents of container: The text 'This is supplied as an original pack (OP)' has been removed.

Updated on 16 May 2005

Reasons for updating

  • 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)

Updated on 07 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 31 March 2004

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

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