Perinal Cutaneous Spray
- Name:
Perinal Cutaneous Spray
- Company:
Dermal Laboratories Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/02/20
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 25/2/2020
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Dermal Laboratories Limited
Company Products
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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 25 February 2020 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- 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
Sections 1, 2, 4, 5, 6 updated for POM to P reclassification. HPRA approved on 20/02/2020.
Updated on 25 February 2020 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Change to legal category
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Please note, Psoriderm Cream SPC uploaded in error on 25/02/2020, so immediately replaced with Perinal Cutaneous Spray SPC.
Updated on 25 February 2020 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Change to legal category
Legal category: Supply through pharmacy only
Updated on 31 August 2018 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
File format updated to PDF
Updated on 10 August 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 10 August 2015 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 4.8 Undesirable effects, in the HPRA address "IRL - Dublin" has been updated to "IRL - Dublin 2"
Updated on 11 March 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
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 4.8 Undesirable effects, the following text has been added:
In section 10 Date of revision of the text, the date has changed to "March 2015"
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; 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 "March 2015"
Updated on 11 March 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 11 March 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
- Removal/change of distributor
Updated on 18 March 2014 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 4.1 (Therapeutic indications) the text has changed to:
"Perinal is indicated for the symptomatic relief of anal and perianal pruritus, pain and inflammation such as associated with haemorrhoids, anal fissures or loose stools. Perinal is indicated in adults, children and adolescents. Use in children under 14 years is recommended only under medical supervision (see section 4.2)."
In section 4.2 (Posology and method of administration) the text has changed to:
"Spray once over the affected area up to three times daily, depending on the severity of the condition, or as recommended by the doctor.
The same dosage schedule applies to all age groups.
Paediatric population
Perinal is indicated in the paediatric population however special care should be exercised before treating children and adolescents aged under 14 years, to exclude any other underlying medical conditions."
In section 4.3 (Contra-indications) the text has changed to:
"Hypersensitivity to the active substances or to any of the excipients in section 6.1.
Not to be used on broken or infected skin."
In section 10 (Date of revision of the text) the date has changed to:
"February 2014"
"Perinal is indicated for the symptomatic relief of anal and perianal pruritus, pain and inflammation such as associated with haemorrhoids, anal fissures or loose stools. Perinal is indicated in adults, children and adolescents. Use in children under 14 years is recommended only under medical supervision (see section 4.2)."
In section 4.2 (Posology and method of administration) the text has changed to:
"Spray once over the affected area up to three times daily, depending on the severity of the condition, or as recommended by the doctor.
The same dosage schedule applies to all age groups.
Paediatric population
Perinal is indicated in the paediatric population however special care should be exercised before treating children and adolescents aged under 14 years, to exclude any other underlying medical conditions."
In section 4.3 (Contra-indications) the text has changed to:
"Hypersensitivity to the active substances or to any of the excipients in section 6.1.
Not to be used on broken or infected skin."
In section 10 (Date of revision of the text) the date has changed to:
"February 2014"
Updated on 28 January 2013 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 14 February 2012 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 10 (Date of revision of the text) the date has changed to "January 2012".
Updated on 13 February 2012 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 13 May 2011 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 2 December 2010 SmPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 6.1 (List of excipients) there is a change of name from "cetomacrogol 1000" to "macrogol cetostearyl ether (cetomacrogol)"
In section 10 (date of revision of the text) the date has changed to "November 2010"
In section 10 (date of revision of the text) the date has changed to "November 2010"
Updated on 19 January 2009 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 1 (Name of the Medicinal Product) : the name has changed to "Perinal Cutaneous Spray"
In section 10 (Date of Revision of the Text) : the date has changed to "December 2008"
Updated on 1 December 2008 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 4.3 (Contraindications) the text has changed to:
Not to be used if sensitive to lidocaine or any other of the ingredients. Not to be used on broken or infected skin. Do not use on children under the age of 14 years without medical supervision.
In section 4.4 (Special warnings and precautions for use) the text has changed to:
Perinal Spray is intended for use for limited periods and so should not be used continuously for longer than 7 days without medical advice. Patients should be instructed to seek medical advice if they experience persistent pain or bleeding from the anus, especially where associated with a change in bowel habit, if the stomach is distended or if they are losing weight. Prompt medical treatment may be very important under such circumstances.
Not to be used internally (inside the anus), or anywhere other than the anal area.
Medical supervision is required if used in conjunction with other medicines containing steroids, owing to possible additive effects.
Perinal Spray should be kept away from the eyes, nose and mouth.
In section 10 (Date of revision of the text) the text has changed to:
October 2008.
Updated on 13 August 2007 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through pharmacy only
Updated on 1 August 2007 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 1 August 2007 SmPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Update to section 4.6, pregnancy and lactation, in line with UK SPC.
Update to section 5.1, pharmacodynamic properties, to include ATC code.
Amends to sections 6.2, incompatibilities, and 6.6, special precautions.
Section 9 - renewal date changed to 5 June 2007.
Updated on 18 August 2006 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2 - Posology and method of administration: Text "The spray will operate in any orientation" deleted.
Section 4.4 - Special warnings and precautions for use: Text "Keep all medicines out of the reach of children" deleted.
Section 5.1 - Pharmacodynamic properties: Text "On application, finger contact with the affected area can be avoided which makes for improved hygiene, and lessens the risk of infection" deleted.
Section 5.2 - Pharmacokinetic properties: Text "Because the preparation is a clear solution, it is entirely homogeneous, and the availability of the active ingredients is optimal" deleted.
Updated on 27 July 2005 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through pharmacy only
Updated on 8 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 13 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only