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Alvesco 160 micrograms pressurised inhalation,solution

  • Name:

    Alvesco 160 micrograms pressurised inhalation,solution

  • Company:
    info
  • Active Ingredients:

    Ciclesonide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/01/19

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Summary of Product Characteristics last updated on medicines.ie: 8/1/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

Company Products

Medicine NameActive Ingredients
Medicine Name Alvesco 160 micrograms pressurised inhalation,solution Active Ingredients Ciclesonide
Medicine Name Alvesco 80 micrograms pressurised inhalation,solution Active Ingredients Ciclesonide
Medicine Name Arimidex Active Ingredients Anastrozole
Medicine Name Atacand 8mg 16mg Tablets Active Ingredients Candesartan Cilexetil
Medicine Name Atacand Plus 16/12.5mg Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Bricanyl Turbohaler Active Ingredients Terbutaline sulfate
Medicine Name Brilique 60 mg film-coated tablets Active Ingredients Ticagrelor
Medicine Name Brilique 90 mg film coated tablets Active Ingredients Ticagrelor
Medicine Name Brilique 90 mg Orodispersible Tablets Active Ingredients Ticagrelor
Medicine Name Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen Active Ingredients Exenatide
Medicine Name Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen Active Ingredients Exenatide
Medicine Name Casodex 50mg Tablets Active Ingredients Bicalutamide
Medicine Name Crestor 5 mg, 10 mg, 20 mg and 40 mg Tablets Active Ingredients Rosuvastatin Calcium
Medicine Name Daxas 250 mcg Film-Coated Tablets Active Ingredients roflumilast
Medicine Name Daxas 500 mcg Film-coated Tablets Active Ingredients roflumilast
Medicine Name Fasenra 30 mg solution for injection in pre filled syringe Active Ingredients Benralizumab
Medicine Name Fasenra 30 mg solution for injection in pre-filled pen Active Ingredients Benralizumab
Medicine Name Faslodex Active Ingredients Fulvestrant
Medicine Name Forxiga 10 mg Film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name Forxiga 5 mg film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate
Medicine Name IMFINZI 50 mg/mL concentrate for solution for infusion Active Ingredients durvalumab
Medicine Name IRESSA 250 mg film-coated tablets Active Ingredients gefitinib
Medicine Name Komboglyze 2.5mg-1000mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Komboglyze 2.5mg-850mg Tablets Active Ingredients Metformin Hydrochloride, Saxagliptin hydrochloride
Medicine Name Losec MUPS 10mg Gastro-resistant Tablets Active Ingredients omeprazole magnesium
1 - 0 of 53 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 9 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 8 January 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 7 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 June 2017 SmPC

Reasons for updating

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

Section 7 – Deletion of Takeda as MAH and addition of AstraZeneca as MAH
Section 8 – Change to licence number
Section 10 – Date of revision of text

Updated on 6 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 June 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 5 May 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

Summary of changes:

Change to section

Details of section

4.2 Posology and method of administration

Updated text:

 

The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. In patients with severe asthma and while reducing or discontinuing oral corticosteroids, a higher dose of up to 640mcg/day (given as 320mcg twice daily) may be used (see sec 5.1). Patients should be given a dose of inhaled ciclesonide which is appropriate to the severity of their disease. Symptoms start to improve with Alvesco within 24 hours of treatment. Once control is achieved, the dose of Alvesco should be individualised and titrated to the minimum dose needed to maintain good asthma control. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients.

 

Alvesco should preferably be administered in the evening although morning dosing of Alvesco has also been shown to be effective. The final decision on evening or morning dosing should be left to the discretion of the physician.

 

Symptoms start to improve with Alvesco within 24 hours of treatment. Once control is achieved, the dose of Alvesco should be individualised and titrated to the minimum dose needed to maintain good asthma control.

 

5.1 Pharmacodynamic properties

Deleted and updated text:

 

No study was performed to compare 160 micrograms, 320 micrograms and 640 micrograms daily dose in patients with severe asthma.

 

A further 52 week trial involving 367 patients with mild to moderate asthma, was unable to demonstrate a significant difference in the effect of higher doses of Ciclesonide (320 or 640 mcg per day) as compared to a lower dose (160 mcg per day) on asthma control.

 

10.          DATE OF REVISION OF THE TEXT

 

25 April 2017

 

Updated on 19 February 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 3 July 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 15 April 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name
  • Addition of information on reporting a side effect.

Updated on 15 April 2015 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Undesirable effects - How to report suspected adverse reactions:

Changed from:

IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.

To:
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 16 May 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.2 :
- addition of the subheading Posology
- addtion of the subheading Elderly and patients with renal or hepatic impairment
- removal of the subheading Specific patient groups
- addition of the subheading Paediatric population
- removal of the subheading Instructions for use/handling
 - addition of the subheading Method of administration and sub subheadingPrecautions to be taken before handling or administering the medicinal product

In section 4.3
- Addition of the wording listed in section 6.1 to the following sentence:
 Hypersensitivity to ciclesonide or any of the excipients listed in section 6.1

In section 4.6
-  addition of the heading Fertility, pregnancy and lactation
- removal of the subheading Pregnancy and Lactation
- addition of the subheading Fertility and Pregnancy
- addition of the subheading Breast-feeding

In section 4.8
- Addition of the following wording :
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 IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.

In section 5.2
- removal of subheading Renal or hepatic insufficiency, elderly
- addition of subheading Elderly
- addition of subheading Renal or hepatic impairment

In section 6.6
- Change of heading to Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
- Addition of the following wording:
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

In section 10
- Date of Revision amended to 2 May 2014 (previously 30th November 2012)

Updated on 16 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 18 December 2012 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7: Change to Marketing Authorisation Holder to Takeda GmbH
Section 10: Change to Date of Revision of the Text to 30/11/12

Updated on 18 December 2012 PIL

Reasons for updating

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

Updated on 22 September 2011 SmPC

Reasons for updating

  • 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

Change in revision date on SmPC from May to September 2011 following issue of IMB Schedule.  No other changes to SmPC wording.

Updated on 8 July 2011 SmPC

Reasons for updating

  • 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

Renewal approval.

Updated on 7 July 2011 PIL

Reasons for updating

  • Change to date of revision

Updated on 31 August 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 1 March 2010 SmPC

Reasons for updating

  • 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

Recent approval of a renewal application has led to a change to sections 9 and 10 as follows:

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
 
18 February 2005/24 February 2009

 

10.     DATE OF REVISION OF THE TEXT

5th February 2010

Updated on 23 February 2010 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 20 April 2009 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 20 April 2009 SmPC

Reasons for updating

  • 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

The frequencies of some side effects have been updated in Section 4.8, Undesirable Effects.

Updated on 18 February 2009 SmPC

Reasons for updating

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

Changes to Sections 4.2 and 5.1 of the SPC following a Commission Decision published in July 2008.  The amended sections now read as follows:

4.2 Posology and method of administration
The medicinal product is for inhalation use only.
Dosing recommendation for adults and adolescents:

The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. However in severe asthmatics, a 12 week study has shown that a dose of 640 micrograms/day (given 320 micrograms twice daily) has demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function (see section 5.1).

5.1 Pharmacodynamic properties
Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor. Once orally inhaled, ciclesonide is enzymatically converted in the lungs to the principal metabolite (C21-desmethylpropionyl-ciclesonide) which has a pronounced anti-inflammatory activity and is thus considered as the active metabolite.
In four clinical trials, ciclesonide has been shown to reduce airway hyperresponsivenes to adenosine monophosphate in hyperreactive patients with maximal effect observed at the dose of 640 micrograms. In another trial, pretreatment with ciclesonide for seven days significantly attenuated the early and late phase reactions following inhaled allergen challenge. Inhaled ciclesonide treatment was also shown to attenuate the increase in inflammatory cells (total eosinophils) and inflammatory mediators in induced sputum.

A controlled study compared 24-hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment. Compared to placebo, treatment with ciclesonide 320, 640, and 1280 micrograms/day did not statistically significantly lower the 24-hour time averages of plasma cortisol (AUC(0-24)/24 hours) nor was a dose-dependent effect seen.

In a clinical trial involving 164 adult male and female asthmatic patients, ciclesonide was given at doses of 320 micrograms or 640 micrograms/day over 12 weeks. After stimulation with 1 and 250 micrograms cosyntropin, no significant changes in plasma cortisol levels were observed versus placebo.

Double-blind placebo-controlled trials of 12-weeks duration in adults and adolescents have shown that treatment with ciclesonide resulted in improved lung function as measured by FEV1 and peak expiratory flow, improved asthma symptom control, and decreased need for inhaled beta-2 agonist. In a 12-week study of 680 severe asthmatics, previously treated with 500 - 1000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. At the end of the 12 week study period, the results showed a statistically significant difference between the doses of 160 micrograms and 640 micrograms/day ciclesonide with regard to the occurrence of an exacerbation after the first day of the study: 43 patients/339 (= 12.7%) in the 160 micrograms/day group and 23 patients/341 (6.7%) in the 640 micrograms/day group (Hazard ratio=0.526; p= 0.0134). Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively. No study was performed to compare 160 micrograms, 320 micrograms and 640 micrgrams daily dose in patients with severe asthma.

Updated on 18 February 2009 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 20 February 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7: Change of name of MAH
Section 8: Change of company number reflecting change of name of MAH
Section 10: Updated date of text revision

Updated on 20 February 2008 PIL

Reasons for updating

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

Updated on 10 August 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 May 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and method of administration

In this situation, patients should be reassessed and consideration given to the need for increased anti-inflammatory treatment therapy (e.g. a higher dose of Alvesco for a short period [see section 5.1] or a course of oral corticosteroids).

 

The above sentence constitutes the amendment, which is now in line with the extension of the Alvesco licence for use at a higher dose

 

Section 5.1 Pharmacodynamic properties  

A new paragraph has now been added see below

 

In a 12-week study of 680 severe asthmatics, previously treated with 500 – 1000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively.

Updated on 19 December 2006 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Very rare
(< 1/10,000, incl. isolated reports)
Immune System Disorders
Immediate or delayed hypersensitivity reactions such as angioedema with swelling of lips, tongue and pharynx

Updated on 31 August 2006 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3 Shelf life has been extended from 2 to 3 years
Section 10 Partial revision of text August 2006

Updated on 11 July 2006 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Change to side-effects

Updated on 24 April 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Updated on 11 May 2005 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 May 2005 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 28 April 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

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