Zyclara 3.75% cream

  • Name:

    Zyclara 3.75% cream

  • Company:
    info
  • Active Ingredients:

    Imiquimod

  • Legal Category:

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

Summary of Product Characteristics last updated on medicines.ie: 21/2/2018
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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

Company Products

Medicine NameActive Ingredients
Medicine Name ALDARA 5% CREAM Active Ingredients Imiquimod
Medicine Name Ancotil 2.5g/250ml Solution for Infusion Active Ingredients Flucytosine
Medicine Name Brufen 400mg film-coated Tablets Active Ingredients Ibuprofen
Medicine Name Brufen 600mg film-coated tablets Active Ingredients Ibuprofen
Medicine Name Brufen Paediatric 100mg/5ml Oral Suspension Active Ingredients Ibuprofen
Medicine Name Brufen Retard 800mg prolonged release tablets Active Ingredients Ibuprofen
Medicine Name Calvidin 600mg/400IU Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Cibacen 10mg Film Coated Tablet Active Ingredients Benazepril Hydrochloride
Medicine Name Cibacen 5mg Film Coated Tablets Active Ingredients Benazepril Hydrochloride
Medicine Name Clozaril 100mg Tablets Active Ingredients Clozapine
Medicine Name Clozaril 25mg Tablets Active Ingredients Clozapine
Medicine Name Colifoam 10% w/w Rectal Foam Active Ingredients Hydrocortisone Acetate
Medicine Name Colofac 135mg Tablets Active Ingredients Mebeverine Hydochloride
Medicine Name Creon 10000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon 25000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon for Children 5000 Gastro-resistant Granules Active Ingredients Pancreatin
Medicine Name Cyklokapron 500mg Tablets Active Ingredients Tranexamic Acid
Medicine Name Dalmane 15mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Dalmane 30mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Desunin 4000IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Desunin 800IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name DIFFLAM 3% CREAM Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM ORAL RINSE Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM SPRAY Active Ingredients Benzydamine Hydrochloride
Medicine Name Dona 1500mg Powder for Oral Solution Active Ingredients Glucosamine Sulfate, Sodium Chloride
1 - 0 of 97 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 21 February 2018 PIL

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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

$0In section2: Benzyl alcohol 20.0mg/g cream added$0$0In section4.4: Warning added that benzyl alcohol may cause allergic reactions and mildlocal irritation$0$0In section4.8: Abdominal pain added as a uncommon undesirable effect undergastrointestinal disorders$0In section 10: Dateof revision changed

Updated on 21 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 February 2018 SmPC

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 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

$0In section2: Benzyl alcohol 20.0mg/g cream added$0$0In section4.4: Warning added that benzyl alcohol may cause allergic reactions and mildlocal irritation$0$0In section4.8: Abdominal pain added as a uncommon undesirable effect undergastrointestinal disorders$0In section 10: Dateof revision changed

Updated on 28 December 2017 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

$0In section4.3: Information added with regards recommendation of different therapy if thetreated lesion(s) show(s) insufficient response to Zyclara.$0$0In section4.4: Minor rewording of text.$0$0In section5.1: Information added regarding two open-label randomized, controlledstudies investigated the long-term effects of imiquimod 5% (and not with this3.75% product) in comparison to topical diclofenac (3% gel).$0$0In section10: Date of revision changed.$0

Updated on 28 December 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

$0In section4.3: Information added with regards recommendation of different therapy if thetreated lesion(s) show(s) insufficient response to Zyclara.$0$0In section4.4: Minor rewording of text.$0$0In section5.1: Information added regarding two open-label randomized, controlledstudies investigated the long-term effects of imiquimod 5% (and not with this3.75% product) in comparison to topical diclofenac (3% gel).$0$0In section10: Date of revision changed.$0

Updated on 18 April 2017 PIL

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 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 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2: Reference to treatment being initiated by a physician has been removed. Information regarding hepatic or renal impairment has been added.

In section 4.4: Information has been removed regarding no available data on use of Imiquimod for the treatment of AK in anatomical areas other than face and scalp. Information added to systemic reactions and special populations.

In section 4.5: slight text changes.

In section 4.6: Information added regarding breast-feeding

In section 4.8: Information added to adverse reactions – summary of safety profile

In section 4.9: Information added regarding management of overdose

In section 5.1: Information added regarding paediatric population

In section 9: Information added regards date of last renewal

In section 10: The date of revision has been changed.

Updated on 18 April 2017 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 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 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the 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 4.2: Reference to treatment being initiated by a physician has been removed. Information regarding hepatic or renal impairment has been added.

In section 4.4: Information has been removed regarding no available data on use of Imiquimod for the treatment of AK in anatomical areas other than face and scalp. Information added to systemic reactions and special populations.

In section 4.5: slight text changes.

In section 4.6: Information added regarding breast-feeding

In section 4.8: Information added to adverse reactions – summary of safety profile

In section 4.9: Information added regarding management of overdose

In section 5.1: Information added regarding paediatric population

In section 9: Information added regards date of last renewal

In section 10: The date of revision has been changed.

Updated on 9 February 2015 PIL

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.4: The sub-title has been corrected to the QRD template

In section 4.5: A minor text change has been made

In section 4.8: The adverse reaction reporting statement has been added

In section 5.1: The sub-title has been corrected

In section 5.2: Very minor layout changes have been made

In section 8: The marketing authorisation numbers are expanded

In section 9: The date of first authorisation has been corrected

In section 10: The date of revision has been changed

Updated on 9 February 2015 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number
  • 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 4.4: The sub-title has been corrected to the QRD template

In section 4.5: A minor text change has been made

In section 4.8: The adverse reaction reporting statement has been added

In section 5.1: The sub-title has been corrected

In section 5.2: Very minor layout changes have been made

In section 8: The marketing authorisation numbers are expanded

In section 9: The date of first authorisation has been corrected

In section 10: The date of revision has been changed

Updated on 6 November 2013 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 6 November 2013 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided