Flixonase Allergy Relief Nasal Spray

  • Name:

    Flixonase Allergy Relief Nasal Spray

  • Company:
    info
  • Active Ingredients:

    Fluticasone Propionate

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/06/19

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Summary of Product Characteristics last updated on medicines.ie: 25/6/2020

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Address: 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Medical Information Direct Line: 1800 441 442

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Medicine Name Flixonase Allergy Relief Nasal Spray Active Ingredients Fluticasone Propionate
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1 - 0 of 45 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 25 June 2020 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Reduction in shelf life from 3 years to 2 years.

Updated on 6 June 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 5 June 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 11 January 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Supply through pharmacy only

Updated on 25 September 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 9 May 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 4 May 2018

Updated on 31 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 31 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 January 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

SPC updated to reflect PRAC recommendations

Updated on 31 January 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 28 April 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change in section 4.5 and 5.1.

Updated on 26 April 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 6 April 2016 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 September 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 10 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 22 May 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8 - Addition of HPRA reporting statement

Updated on 8 July 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Not for use in those under 18 years as opposed to those under 12 years.

Updated on 24 March 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 7 March 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 27 November 2013 SmPC

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 4.9 - Overdose

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4. Present:

2
            Posology and method of administration

 

Flixonase Allergy Relief is for administration by the intranasal route only.

 

Adults 18 years and over:  for the prophylaxis and treatment of allergic rhinitis:

Two sprays into each nostril once a day, preferably in the morning.  Once control is achieved the dose should be titrated down to the lowest effective dose of one spray in each nostril once a day (100 micrograms per day).

 

In some cases two sprays into each nostril twice daily may be required for short periods to achieve control of symptoms, after which the dose should be titrated down to the lowest effective dose (see above).

 

The maximum daily dose should not exceed four sprays into each nostril.

 

Elderly patients:

The normal adult dosage is applicable.

 

Children and adolescents under 18 years of age:

Do not use in those under 18 years of age.

 

Onset of action in the treatment of allergic rhinitis has been observed in some patients as early as 2-4 hours after use, with most users achieving symptomatic relief within 12 hours of treatment.

 

Prophylaxis of allergic rhinitis requires treatment before contact with allergen.

 

For full therapeutic benefit regular usage is recommended.

 

Maximum benefit may require 3-4 days of continuous treatment in some people (see section 5.1 Pharmacodynamic Properties).

 

When Flixonase Allergy Relief is discontinued, it may be several days before symptoms recur.

Proposed:

 

4.2            Posology and method of administration

 

Flixonase Allergy Relief is for administration by the intranasal route only.

 

Adults 18 years and over:  for the prophylaxis and treatment of allergic rhinitis:

Two sprays into each nostril once a day, preferably in the morning.  Once control is achieved the dose should be titrated down to the lowest effective dose of one spray in each nostril once a day (100 micrograms per day).

 

In some cases two sprays into each nostril twice daily may be required for short periods to achieve control of symptoms, after which the dose should be titrated down to the lowest effective dose (see above).

 

The maximum daily dose should not exceed four sprays into each nostril.

 

Elderly patients:

The normal adult dosage is applicable.

 

Children and adolescents under 18 years of age:

Do not use in those under 18 years of age.

 

Onset of action in the treatment of allergic rhinitis has been observed in some patients as early as 2-4 hours after use, with most users achieving symptomatic relief within 12 hours of treatment.

 

Prophylaxis of allergic rhinitis requires treatment before contact with allergen.

 

For full therapeutic benefit regular usage is recommended.

 

Maximum benefit may require 3-4 days of continuous treatment in some people (see section 5.1 Pharmacodynamic Properties).

 

When Flixonase Allergy Relief is discontinued, it may be several days before symptoms recur.



Present:

4.4            Special warnings and precautions for use

 

The full benefit of fluticasone propionate aqueous nasal spray may not be achieved until treatment has been administered for several days.

 

If improvement is not seen within 7 days of continuous use treatment should be stopped and the advice of a doctor sought.

 

If after 7 days of continuous use, symptoms have improved but are not adequately controlled then the advice of a pharmacist or doctor should be sought.

 

The nasal spray should not be used for more than 6 months continuously without consulting a doctor.

 

Local infection: Infections of the nasal airways should be appropriately treated but do not constitute a specific contraindication to treatment with intranasal fluticasone propionate.

 

Care must be taken when withdrawing patients from systemic steroid treatment, and commencing therapy with intranasal fluticasone propionate, particularly if there is any reason to suspect that their adrenal function is impaired.

 

Systemic effects of nasal corticosteroids (such as Cushing’s syndrome, hypertension, adrenal suppression) may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.

 

Reduced growth velocity has been observed in children treated with intranasal corticosteroids.

 

 

Medical advice should be sought before using Flixonase Allergy Relief in the case of:

·      concomitant use of other corticosteroid products, such as tablets, creams, ointments, asthma medications, similar nasal sprays or eye/nose drops.

·      fever or an infection in the nasal passages or sinuses.

·      recent injury or surgery to the nose, or problems with ulceration in the nose.

 

Although fluticasone propionate aqueous nasal spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy.


Proposed:

4.4            Special warnings and precautions for use

 

The full benefit of fluticasone propionate aqueous nasal spray may not be achieved until treatment has been administered for several days.

 

If improvement is not seen within 7 days of continuous use treatment should be stopped and the advice of a doctor sought.

 

If after 7 days of continuous use, symptoms have improved but are not adequately controlled then the advice of a pharmacist or doctor should be sought.

 

The nasal spray should not be used for more than 6 months continuously without consulting a doctor.

 

Local infection: Infections of the nasal airways should be appropriately treated but do not constitute a specific contraindication to treatment with intranasal fluticasone propionate.

 

Care must be taken when withdrawing patients from systemic steroid treatment, and commencing therapy with intranasal fluticasone propionate, particularly if there is any reason to suspect that their adrenal function is impaired.

 

Systemic effects of nasal corticosteroids (such as Cushing’s syndrome, hypertension, adrenal suppression) may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.

 

Reduced growth velocity has been observed in children treated with intranasal corticosteroids.

 

 

Medical advice should be sought before using Flixonase Allergy Relief in the case of:

·      concomitant use of other corticosteroid products, such as tablets, creams, ointments, asthma medications, similar nasal sprays or eye/nose drops.

·      fever or an infection in the nasal passages or sinuses.

·      recent injury or surgery to the nose, or problems with ulceration in the nose.

 

Although fluticasone propionate aqueous nasal spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy.

Present:


P
P

4.6            Pregnancy and lactation

 

Pregnancy:  There is inadequate evidence of safety in human pregnancy.  In animal reproduction studies adverse effects typical of potent corticosteroid are only seen at high systemic exposure levels; direct intranasal application ensures minimal systemic exposure.

 

The use of Fluticasone Propionate Allergy Relief during human pregnancy should be avoided unless thought essential by the doctor. Consumers should be advised to seek a medical opinion before using Flixonase Allergy Relief if they are pregnant or breast-feeding.

 

As with other drugs, the use of intranasal fluticasone propionate during pregnancy and lactation requires that the benefits be weighed against possible risks associated

with the product or with any alternative therapy.

Proposed:

6            Pregnancy and lactation

 

Pregnancy

There is inadequate evidence of the safety of fluticasone propionate in human pregnancy. In animal reproduction studies, adverse effects typical of potent corticosteroids are only seen at high systemic exposure levels; direct intranasal application ensures minimal systemic exposure. The use of Flixonase Allergy Relief should be avoided during pregnancy unless thought essential by the doctor. Medical advice should be sought before use if pregnant.

 

Lactation

Medical advice should be sought before use if breast-feeding.

 

The excretion of fluticasone propionate into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration, there was evidence of fluticasone

propionate in the breast milk. However, plasma levels in patients following intranasal application of fluticasone propionate at recommended doses are likely to be very low.

Present:

4.9            Overdose

There is no data available on the effects of acute or chronic overdosage with Flixonase Allergy Relief.  Intranasal administration of fluticasone propionate at 20 times the recommended dose in adults (2mg twice daily) for seven days to healthy human volunteers had no effect on hypothalamic-pituitary-adrenal axis function. 

Proposed:

 

4.9            Overdose

 

Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function.

There is no data available on the effects of acute or chronic overdosage with Flixonase Allergy Relief.  Intranasal administration of fluticasone propionate at 20 times the recommended dose in adults (2mg twice daily) for seven days to healthy human volunteers had no effect on hypothalamic-pituitary-adrenal axis function. 


 



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4.

Updated on 1 May 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 2 to 3 years.

Updated on 11 August 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 4 May 2010 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.1

The excipient name update - from Dispersible Cellulose (Avicel RC591) to Microcrystalline Cellulose and Carboxymethylcellulose (Carmellose) Sodium USNF (Avicel RC591)

Updated on 5 June 2009 PIL

Reasons for updating

  • Change to how the medicine works
  • Change to date of revision

Updated on 31 October 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1    Flixonase Allergy Relief 50 micrograms per dose Nasal Spray

 

Section 2    Each actuation delivers 100mg of suspension containing 50 micrograms of fluticaasone propionate

 

                    Excipients: also includes 20 micrograms of Benzalkonium Chloride per spray

 

                    For a full list of excipients, see section 6.1

 

 

(Changes are in bold)

 

Updated on 16 March 2006 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Updated on 15 June 2005 PIL

Reasons for updating

  • Change to side-effects

Updated on 28 October 2004 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 24 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 January 2004 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only