Enstilar Cutaneous Foam

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/11/20

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Summary of Product Characteristics last updated on medicines.ie: 15/10/2020

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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 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
Medicine Name Locoid Cream 0.1% Active Ingredients Hydrocortisone 17-Butyrate
1 - 0 of 41 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 17 November 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 4 update to include application site pain.

Updated on 15 October 2020 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 15 October 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

New text added in red:

Duration of treatment

  • apply the foam once daily. It may be more convenient to use the foam in the evening
  • the normal treatment period is 4 weeks but your doctor may decide on a different treatment period.

 You may be told by your doctor to use Enstilar twice weekly once your psoriasis has cleared or almost cleared. Enstilar should be applied twice weekly on two non-consecutive days (e.g. Wednesday and Saturday) to areas previously affected by psoriasis. Between applications there should be 2-3 days without Enstilar treatment.

If symptoms reappear you should use Enstilar once daily as outlined above and contact your doctor to review your treatment.”

Updated on 15 October 2020

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

 New text shown in red:

“Posology

Flare treatment

Enstilar foam should be applied to the affected area once daily. The recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular supervision.

Long-term maintenance treatment

Patients who have responded at 4 weeks’ treatment using Enstilar once daily are suitable for long-term maintenance treatment. Enstilar should be applied twice weekly on two non-consecutive days to areas previously affected by psoriasis vulgaris. Between applications there should be 2-3 days without Enstilar treatment.

If signs of a relapse occur, flare treatment, as described above, should be re-initiated.

 Maximum dose

The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days of treatment. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand.

If using other topical products containing calcipotriol in addition to Enstilar, the total dose of all calcipotriol containing products should not exceed 15 g per day.

The total body surface area treated should not exceed 30%.

Special populations

Renal and hepatic impairment

The safety and efficacy of Enstilar foam in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.

Paediatric population

The safety and efficacy of Enstilar foam in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in sections 4.8 and 5.1, but no recommendation on a posology can be made.

Method of administration

For cutaneous use.

The can should be shaken for a few seconds before use. Enstilar should be applied by spraying holding the can at least 3 cm from the skin. The foam can be sprayed holding the can in any orientation except horizontally.

Enstilar should be sprayed directly onto each affected skin area and rubbed in gently.

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.

The hands should be washed after using Enstilar (unless Enstilar is used to treat the hands) to avoid accidentally spreading to other parts of the body as well as unintended drug absorption on the hands. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. It is recommended not to take a shower or bath immediately after application of Enstilar. Let the foam remain on the scalp and/or skin during the night or during the day.”

 

4.4       Special warnings and precautions for use

Minor clarifications are made to the local adverse reactions and concomitant skin infections sections.

 4.6       Fertility, pregnancy and lactation

Breast-feeding:
The statement regarding betamethasone passing into breast milk and risk of an adverse reaction in the infant has been changed from “seems unlikely” to “is very small” with therapeutic doses. 

 Fertility:
New text shown in red:

“Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility (see section 5.3). There are no data on human fertility.”

4.8       Undesirable effects

Application site pain is added as an uncommon undesirable effect.  A statement that application site burning is included in application site pain is added.

5.1       Pharmacodynamic properties

Study data regarding the PSO-Long trial added.

5.3       Preclinical safety data

The following statement is deleted

The estimated systemic exposure following topical application of Enstilar to psoriasis patients is negligible compared to the concentrations of calcipotriol evaluated in the oral in vivo studies, and there is no appreciable reproductive risk to humans receiving therapeutic exposure to Enstilar.”

Updated on 22 September 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Joint PIL superseded by individual PILs

Updated on 9 January 2020

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.2 Posology
New statement:

Currently available data in children aged 12 to 17 years are described in sections 4.8 and 5.1, but no recommendation on a posology can be made.”

This replaces the statement “No data are available.”

Section 4.8 Undesirable Effects

New statement:

“Paediatric population

No clinically relevant differences between the safety profiles in adult and adolescent populations have been observed. A total of 106 adolescent subjects were treated in one open-label clinical trial. See section 5.1 for further details regarding this trial.”

Section 5.1 Pharmacodynamic properties

New statement:

“Paediatric population

The effects on calcium metabolism were investigated in an uncontrolled, open-label, 4‑week trial in 106 adolescents aged 12 to 17 years with scalp and body psoriasis. The subjects used up to 105 g Enstilar per week. No cases of hypercalcaemia and no clinically relevant changes in urinary calcium were reported.

The adrenal response to ACTH challenge was measured in a subset of 33 subjects with extensive plaque psoriasis involving at least 20% of the scalp and 10% of the body surface area. After 4 weeks of treatment with Enstilar, 2 subjects had a cortisol level ≤18 mcg/dL at 30 minutes after ACTH challenge, but had normal response at 60 minutes. A third subject had minimal cortisol response to the ACTH challenge test at baseline resulting in inconclusive results after the treatment. None of these cases had any clinical manifestations.”

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

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

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

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

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

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

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

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