Fucibet Cream

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/11/19

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Summary of Product Characteristics last updated on medicines.ie: 21/8/2018

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LEO Pharma

LEO Pharma

Company Products

Medicine NameActive Ingredients
Medicine Name Dovobet Gel Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovobet Ointment Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovonex Cream Active Ingredients Calcipotriol hydrate
Medicine Name Dovonex Ointment Active Ingredients Calcipotriol
Medicine Name Dovonex Psoriasis 50 microgram/g ointment Active Ingredients Calcipotriol
Medicine Name Enstilar Cutaneous Foam Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Fucibet Cream Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucibet Lipid Cream Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucidin Cream Active Ingredients Fusidic Acid
Medicine Name Fucidin H Cream Active Ingredients Fusidic Acid Hemihydrate, Hydrocortisone Acetate
Medicine Name Fucidin Ointment Active Ingredients Sodium Fusidate
Medicine Name Fucidin Suspension Active Ingredients Fusidic Acid Hemihydrate
Medicine Name Fucidin Tablets Active Ingredients Sodium Fusidate
Medicine Name innohep 10,000 IU in 0.5 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 10,000 IU/ml Solution for Injection (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 12,000 IU in 0.6ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 14,000 IU in 0.7 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 16,000 IU in 0.8ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 18,000 IU in 0.9ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 2,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 3,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 4,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 8,000 IU in 0.4ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name Kyntheum 210 mg Solution for Injection Active Ingredients Brodalumab
1 - 0 of 40 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 15 November 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 21 August 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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: Product subject to medical prescription which may not be renewed (A)

Updated on 17 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 17 August 2018 SmPC

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 not be renewed (A)

Updated on 22 July 2014 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • 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)

Free text change information supplied by the pharmaceutical company

Section 2: Minor editorial update.

Section 4.3: General update.

Section 4.4: New warning and precautions added for Fucibet in regards to children. Information on HPA axis suppression has been added following systemic use of topical corticosteroids.

Section 4.5: Section 6.6: Update in line with the QRD.

Section 4.6: Updated information on Pregnancy, Breastfeeding and Fertility mostly in line with QRD. A statement is added regarding no reproductive toxicity is shown in animals following topical application of betamethasone valerate.

Section 4.7: Minor editorial update.

Section 4.8: Undesirable effects are not tabulated and adverse even reporting statement has been added.

Section 4.9: Updated information on overdose for topically applied corticosteroids.

Section 5.3: Corticosteroid studies in animals showing reproductive toxicity has been added.

Section 6.6: Update in line with the QRD.

Section 10: Date of Revision updated.

Updated on 18 July 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 7 September 2011 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 29 August 2011 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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 6.1 List of excipinets. The following excipient has been added:

all-rac-α-tocopherol

Section 10. Date of (Partial) revision of the text. UPdated to:

July 2011

Updated on 9 February 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company


Section 3. Pharmaceutical form

Cream

A white to off white homogenous cream

 

Section 6.3 Shelf life

3 years

After first opening of container: 3 months

 

Section 6.4 Special precautions for storage

Store below 30°cThis medicinal product does not require any special storage conditions

 

Section 10. Date of (Partial) Revision of the text

November 2009December 2010

Updated on 9 February 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 22 September 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 8 September 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

In section 2, the quantity of the excipients has been added.

Updated on 6 August 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 2 quantitative composition declaration
Section 6.1 'for pH adjustment' added after sodium hydroxide
Section 6.4 updated as per guideline
Section 6.5 sample pack and sentence 'Not all pack sizes may be marketed' added
Section 10 revised to 10th July 2009

Updated on 6 August 2009 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 10 December 2008 PIL

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to side-effects
  • Change to date of revision

Updated on 24 November 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 4.6 - Pregnancy and lactation
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Safety sections of SPC (4.3, 4.4, 4.6 & 4.8) updated in line with updated Company Core Safety Information.

Updated on 24 July 2008 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 9 January 2007 SmPC

Reasons for updating

  • 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 10. Date revised to December 2006

Updated on 20 July 2006 SmPC

Reasons for updating

  • 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 10 - date changed (Part 1 of PA revised)

Updated on 9 August 2005 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 19 July 2005 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Updated on 9 March 2005 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 23 February 2005 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Updated on 2 February 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Updated on 29 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 July 2004 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • Addition of legal category

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