Enstilar Cutaneous Foam

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

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Summary of Product Characteristics last updated on medicines.ie: 11/11/2019

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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 11 November 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Addition of information on alternative format leaflets

Free text change information supplied by the pharmaceutical company

Section 3 How to use Enstilar®

New subtitle “When used on the body” at beginning of ‘Instruction for proper use’ section

Additional statements added to end of point 6 of this section.

“In order to achieve optimal effect, it is recommended that the body is not washed immediately after application of Enstilar.

Let the foam remain on the skin during the night or during the day.”

New 5 point instructions added “When used on the scalp

New 4 point instructions added “When you wash your hair, the following instructions might be useful”

 

Information on availability in Braille or alternative formats added.

Updated on 11 November 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Section 4.2 Posology
new statements:

If used on the scalp, Enstilar should be sprayed into the palm of the hand and then applied to affected scalp areas with the fingertips. Hair washing instructions are provided in the package leaflet.”

“Let the foam remain on the scalp and/or skin during the night or during the day.”

 Section 4.8 Undesirable Effects

Administrative corrections to the tabulation and footnotes

Updated on 4 March 2019 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

Change to date format to Month Year.

Updated on 11 October 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 17 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • 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 - date of revision

Updated on 13 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)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use


Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a
patient presents with symptoms such as blurred vision or other visual disturbances,
the patient should be considered for referral to an ophthalmologist for evaluation of
possible causes which may include cataract, glaucoma or rare diseases such as central
serous chorioretinopathy (CSCR) which have been reported after use of systemic and
topical corticosteroids.


4.8 Undesirable effects


The following adverse reaction has been added under the SOC Eye disorders with a frequency
not known: Vision, blurred (see also section 4.4)

 

10.     DATE OF REVISION OF THE TEXT

10 August 2018

Updated on 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 18 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 May 2017 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 11 May 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 May 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2016 PIL

Reasons for updating

  • New PIL for new product