Flixotide Nebules 2mg

  • Name:

    Flixotide Nebules 2mg

  • Company:
    info
  • Active Ingredients:

    Fluticasone Propionate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/10/19

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Summary of Product Characteristics last updated on medicines.ie: 15/11/2017
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Amoxil Paediatric Suspension Active Ingredients Amoxicillin trihydrate
Medicine Name Amoxil Vial for Injection 500mg Active Ingredients Amoxicillin sodium
Medicine Name ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed Active Ingredients Umeclidinium bromide, Vilanterol trifenatate
Medicine Name Augmentin 250 mg/125 mg film-coated tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 500mg/125mg Film-coated Tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 875/125mg Film Coated tablets Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin DUO Suspension 400/57mg Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin Intravenous 1.2g Active Ingredients Amoxicillin sodium, Potassium clavulanate
Medicine Name Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name AVAMYS 27.5 micrograms/spray nasal spray suspension Active Ingredients Fluticasone furoate
Medicine Name Avodart Soft Capsules 0.5mg Active Ingredients Dutasteride
Medicine Name Babyhaler Active Ingredients No Active Ingredients
Medicine Name Bactroban Nasal Ointment Active Ingredients Mupirocin calcium
Medicine Name Bactroban Ointment Active Ingredients Mupirocin
Medicine Name Becotide Evohaler 100 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 250 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 50 Active Ingredients Beclometasone Dipropionate
Medicine Name Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion Active Ingredients Belimumab
Medicine Name Betnovate C 0.1% / 3% w/w Cream Active Ingredients Betamethasone Valerate, Clioquinol
Medicine Name Betnovate Cream 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Ointment 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution Active Ingredients Betamethasone Valerate
1 - 0 of 136 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 23 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 14 January 2019 PIL

Reasons for updating

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

Updated on 15 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 November 2017 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 6 - date of revision

Updated on 15 November 2017 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
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company



Update to section 4.4 – addition of Visual Disturbance section (blurred vision)

Update to section 4.8 – addition of Eye Disorders section (blurred vision)

Updated on 3 May 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Update section 4.5 of SmPC to align to PRAC recommendation on drug interactions.

Updated on 3 May 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 18 February 2016 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Section 4.6 - Updated information on pregnancy and lactation

Section 5.1 - Updated information on pregnancy and lactation

Updated on 26 October 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 22 July 2015 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

Change to address of the Irish MA Holder

Updated on 21 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 27 March 2015 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

Section 4.8 updated to include

Epistaxis in frequency table as not known

 

Updated on 26 March 2015 PIL

Reasons for updating

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

Updated on 14 August 2014 SmPC

Reasons for updating

  • 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 - removal of trading as Allen and Hanburys

Updated on 14 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder
  • Addition of information on reporting a side effect.

Updated on 14 July 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Section 4.8 – Inclusion of adverse reaction



Section 4.8 - adverse event reporting - updated details from IMB to HPRA

Updated on 12 February 2014 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 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Changes to:

 

 

Section 4.4 - Special warnings and precautions for use,
Section 4.8 - Undesirable effects,
Section 7 - MARKETING AUTHORISATION HOLDER

 

Updated on 11 February 2014 PIL

Reasons for updating

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

Updated on 22 November 2012 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

4.2 Posology and Method of Administration

The following instruction/warning was added:

Fluticasone propionate for nebulisation should not be injected.

 

The instruction regarding the prophylactic nature of fluticasone propionate was updated to highlight that it should be taken regularly, even when the patient is asymptomatic.

 

4.4 Special Warnings and Special Precautions for Use

The following paragraph was added to specify the warning for asthma:

Fluticasone propionate is not for use in acute asthma attacks, but for routine long-term management.  Patients will require a fast- and short-acting inhaled bronchodilator to relieve acute asthmatic symptoms.

 

Added Possible systemic effects Cushing’s syndrome, Cushingoid features

 

Added the following wording as required following the PhVWP decision:

Possible systemic effects include… a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

 

Replaced the previous warnings regarding adrenal suppression, adrenal crisis and impaired adrenal reserve with the following:

Adrenal function and adrenal reserve usually remain within the normal range on recommended doses of fluticasone propionate therapy.  The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids.  However, the possibility of adverse effects in patients, resulting from prior or intermittent administration of oral steroids, may persist for some time.  The extent of the adrenal impairment may require specialist advice before elective procedures.  The possibility of impaired adrenal response should always be borne in mind in emergency situations, including surgery, which are likely to produce stress and appropriate corticosteroid treatment must be considered.

 

Added the warning:

Treatment with fluticasone propionate should not be stopped abruptly.

 

Added the following warning regarding diabetes mellitus:

There have been very rare reports of increases in blood glucose levels (see 4.8 Undesirable Effects) and this should be considered when prescribing to patients with a history of diabetes mellitus.

 

Replaced the warning on co-administration with Ritonavir to read:

During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression.  Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects (See 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction).

 

4.5 Interaction with Other Medicaments and Other Forms of Interaction

Replaced the interaction warning regarding ritonavir with the following:

A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can greatly increase fluticasone propionate plasma concentrations, resulting in markedly reduced serum cortisol concentrations.  During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving intranasal or inhaled fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression.  Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects.

 

Replaced the warning regarding co-administration with CYP3A inhibitors with a warning regarding other inhibitors of cytochrome P450 3A4, as follows

Studies have shown that other inhibitors of cytochrome P450 3A4 produce negligible (erythromycin) and minor (ketoconazole) increases in systemic exposure to fluticasone propionate without notable reductions in serum cortisol concentrations.  Nevertheless, care is advised when co-administering potent cytochrome P450 3A4 inhibitors (e.g. ketoconazole) as there is potential for increased systemic exposure to fluticasone propionate.

 

4.6 Pregnancy and Lactation

Added the subheadings ‘Pregnancy’ and ‘Lactation’

 

4.8 Undesirable Effects

Infections and Infestations

Updated the instructions on how to mitigate the effects of candidiasis of the mouth and throat (thrush) to read:

Such patients may find it helpful to rinse out their mouth with water after using their medication.

 

Endocrine Disorders

Added very rare undesirable effects Cushing’s syndrome and Cushingoid features

 

Added the following undesirable effects:

Metabolism and nutrition disorders

Very rare: Hyperglycaemia.

 

Psychiatric disorders

Very rare: Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children).

Frequency not known: Depression, aggression (predominantly in children)

 

Respiratory, Thoracic and Mediastinal Disorders

Updated the instructions on how to mitigate the effects of hoarseness to read:

In some patients inhaled fluticasone propionate may cause hoarseness.  It may be helpful to rinse out the mouth with water immediately after inhalation.

 

Updated the statement ‘As with other inhalation therapy, paradoxical bronchospasm may occur’ with the following additional statements:

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing.  This should be treated immediately with a fast-acting inhaled bronchodilator.  Fluticasone propionate should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.

 

4.9 Overdose

Updated to include two subsections ‘Signs and symptoms’ and ‘Treatment’

Symptoms and Signs

Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function.  This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.  However if higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression may result.  Monitoring of adrenal reserve may be necessary.  In cases of fluticasone propionate overdose, therapy may still be continued at a suitable dosage for symptom control.

 

Treatment

 Patients receiving higher than approved doses should be managed closely and the dose reduced gradually.

 

 

 

Updated on 20 November 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change due to harmonisation of PIL

Updated on 22 February 2011 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to warnings or special precautions for use

Updated on 20 August 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 22 May 2008 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 25 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie