Betacap Scalp Application 0.1% w/w Cutaneous Solution

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Betacap Scalp Application 0.1% w/w Cutaneous Solution

Name:
Betacap Scalp Application 0.1% w/w Cutaneous Solution
Company:
Dermal Laboratories Limited
Active Ingredients:
Betamethasone Valerate
Legal Category:
Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/05/15

Company Products

Medicine Name	Active Ingredients
Medicine Name Anhydrol Forte 20% w/v Cutaneous Solution	Active Ingredients Aluminium Chloride Hexahydrate
Medicine Name Betacap Scalp Application 0.1% w/w Cutaneous Solution	Active Ingredients Betamethasone Valerate
Medicine Name Capasal Therapeutic Shampoo	Active Ingredients Coconut Oil, Distilled Coal Tar, Salicylic Acid
Medicine Name Dioderm 0.1% w/w Cream	Active Ingredients Hydrocortisone
Medicine Name Dithrocream	Active Ingredients Dithranol
Medicine Name Emulsiderm Emollient Bath Additive/Cutaneous Emulsion	Active Ingredients Benzalkonium Chloride, Isopropyl Myristate, Liquid Paraffin
Medicine Name Exterol 5% w/w Ear Drops, Solution	Active Ingredients Urea Hydrogen Peroxide
Medicine Name Glutarol 10% w/v Cutaneous Solution	Active Ingredients Glutaraldehyde
Medicine Name Ibugel 5% w/w Gel	Active Ingredients Ibuprofen
Medicine Name Nicam 4% w/w Gel	Active Ingredients Nicotinamide
Medicine Name Perinal Cutaneous Spray	Active Ingredients Hydrocortisone, Lidocaine Hydrochloride
Medicine Name Psoriderm Cream	Active Ingredients Distilled Coal Tar
Medicine Name Psoriderm Emulsion 40% w/v Bath Additive	Active Ingredients Distilled Coal Tar
Medicine Name Psoriderm Scalp Lotion Shampoo	Active Ingredients Distilled Coal Tar
Medicine Name Salactol Collodion	Active Ingredients Lactic Acid, Salicylic Acid
Medicine Name Salatac Gel	Active Ingredients Lactic Acid, Salicylic Acid

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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 August 2018 SmPC

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 PIL

Reasons for updating

New PIL for new product

Updated on 20 May 2015 PIL

Reasons for updating

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

Updated on 11 May 2015 SmPC

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 May 2015 SmPC

Reasons for updating

New SmPC for new product

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

Updated on 11 June 2014 PIL

Reasons for updating

Change to date of revision
Removal/change of distributor

Updated on 12 August 2010 PIL

Reasons for updating

Correction of spelling/typing errors

Updated on 25 August 2009 PIL

Reasons for updating

Change due to user-testing of patient information

Updated on 16 June 2009 PIL

Reasons for updating

Improved electronic presentation

Updated on 18 December 2008 SmPC

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 SmPC

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 SmPC

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 7 September 2004 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 31 March 2004 SmPC

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 SmPC

Reasons for updating

New SPC for medicines.ie

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