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Nizoral Cream

  • Name:

    Nizoral Cream

  • Company:
    info
  • Active Ingredients:

    Ketoconazole

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/03/21

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Summary of Product Characteristics last updated on medicines.ie: 4/3/2021

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (Bottle & Sachets) Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets Active Ingredients Paracetamol
Medicine Name Colpermin Gastro-Resistant Capsules Active Ingredients Peppermint Oil
Medicine Name Daktarin 2% w/w Cream Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Imodium Instants 2mg Orodispersible Tablets Active Ingredients Loperamide Hydrochloride
1 - 0 of 65 items.Total: Infinity pages

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 4 March 2021 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • 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 - date of revision

Updated on 4 March 2021 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 9 April 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 9 April 2020 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 18 September 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 17 September 2018 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 12 August 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 August 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 7 August 2015 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 7 August 2015 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Addition of the following text to Section 4.8

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.

Updated on 19 December 2014 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.2,  the sentence Nizoral Cream is for use in adults has been added.   Previously, there was no age restriction on the use of Nizoral Cream. 

Section 5.2, a clarification has been added, i.e. Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral Cream in adults on the skin

Updated on 17 December 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 30 April 2013 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Change to shelf-life of 36 months

Updated on 28 August 2012 SPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Minor changes to the text in sections 4.6, 4.8 and 5.1 of the SPC.

Updated on 25 July 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 15 May 2012 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Inclusion of excipient warning in section 4.4: Nizoral cream contains cetyl alcohol, stearyl alcohol and propylene glycol which may cause skin irritations (e.g: contact dermatitis).

Updated on 2 August 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 July 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 13 August 2010 SPC

Reasons for updating

  • 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

Update to section 4.8 Undesirable Effects - inclusion of MedRA table.

Updated on 12 August 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 29 October 2009 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

MA Holder changed to McNeil Healthcare Ireland Limited. MA Number changed to PA 823/52/2

Updated on 23 October 2009 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 16 October 2008 SPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 4.6 (pregnancy and lactation)  New Information
Section 4.8 (undesirable effects) New Information
Section 5.2 (pharmacokinetic properties) New Information
Section 5.3 (preclinical safety data) New Information
Section 10 (date of revision of text) changed to October 2008

Updated on 16 October 2008 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 23 September 2008 SPC

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

X

Change to section 7 – Marketing Authorisation Holder
New Address

X

Change to section 10 – Date of revision of text
Changed to September 2008

Updated on 22 September 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 20 June 2008 SPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.3 - Change to statement
Change to section 5.1 - Update new information
Change to section 10 - Changed to June 2008

Updated on 29 May 2008 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation

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 1 – trade name

NAME OF THE MEDICINAL PRODUCT

Changed to state 20mg/g

Change to section 2 – quantitative and qualitative composition

Includes all excipients

Change to section 6.2 - Incompatibilities

Changed to ‘Not Applicable’

Change to section 6.5 – Nature and Contents of Container

Not all pack sizes may be marketed

Change to section 9 – Date of Renewal of Authorisation

Change to May 2008

Updated on 29 May 2008 PIL

Reasons for updating

  • Change to storage instructions

Updated on 18 June 2007 PIL

Reasons for updating

  • Change of manufacturer

Updated on 29 September 2006 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 28 September 2006 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Improved electronic presentation
  • 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.
NAME OF THE MEDICINAL PRODUCT
Remove word trade  add TM after Nizoral

4.
CLINICAL PARTICULARS

Add number 4

4.1

Therapeutic Indications

Add tinea after vulvitis). Add Malassezia furfur (previously called Pityrosporum ovale)

4.2

Posology and method of administration

Replace Pityriasis with tinea

4.4

Special Warnings and Precautions for Use

Add to prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical…..etc.

4.5

Interaction with other medicinal products and other forms of interaction

Change to Interaction with other medicinal products. Remove paragraph and replace with None Known.

4.8

Undesirable effects

Add Topical treatment with Nizoral Cream is usually well tolerated.

Add burning sensation. Also in rare circumstances, allergic local skin phenomena etc

5.

PHARMACOLOGICAL PROPERTIES

Add the number 5

5.1

Pharmacodynamic properties

Remove Nizoral cream does not produce detectable blood levelsafter topical administration.

5.2

Pharmacokinetic properties

Nizoral cream does not produce detectable blood levels after topical administration.

10.

DATE OF REVISION OF THE TEXT

Remove Partial before Revision. I think the date here should be Aug 2006

 

 

Updated on 20 December 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 December 2005 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 9 August 2004 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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 not be renewed (A)

Updated on 5 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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