Beconase Hayfever

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Summary of Product Characteristics last updated on medicines.ie: 11/1/2019

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Chefaro Ireland Ltd

Chefaro Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Abidec Drops Active Ingredients Ascorbic acid, nicotinamide (B3), Pyridoxine Hydrochloride (Vitamin B6), Riboflavine (Vitamin B2), Thiamine Hydrochloride (Vitamin B1), Vitamin A (Palmitate), Vitamin D2 (ergocalciferol)
Medicine Name Beconase Hayfever Active Ingredients Beclometasone Dipropionate Monohydrate
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Medicine Name Nytol One-A-Night 50 mg Tablets Active Ingredients Diphenhydramine Hydrochloride
Medicine Name Paracetamol 500 mg Film-Coated Tablets (GSL) Active Ingredients Paracetamol
Medicine Name Paracetamol 500 mg Film-Coated Tablets (p) Active Ingredients Paracetamol
Medicine Name PrevAllergy Tablets Active Ingredients Cetirizine Dihydrochloride
Medicine Name Solpa-Extra Soluble Tablets Active Ingredients Caffeine, Paracetamol
Medicine Name Solpa-Plus tablets Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
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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 January 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 11 January 2019 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

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Updated on 21 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 21 March 2017 SmPC

Reasons for updating

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

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Free text change information supplied by the pharmaceutical company

In section 4.5 Interaction with other medicinal products and other forms of interaction, following wording has been updated. 

 

Beclomethasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely;  however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.

Updated on 16 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 March 2017 PIL

Reasons for updating

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

Updated on 30 November 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company



4.1 Therapeutic Indications

Beconase Hayfever prevents and relieves nasal congestion, sneezing and a runny, itchy nose due to hayfever and other seasonal allergic conditions. Once nasal congestion is cleared the pressure and pain around the eyes is also reduced.

Beconase
Hayfever is indicated for the prevention and treatment of allergic rhinitis, including hayfever, in adults aged 18 and over.


5.1 Pharmacodynamic properties

 

Pharmacotherapeutic group: Nasal preparations, corticosteroids. ATC code: R01AD01

 

Following topical administration beclomethasone 17,21-dipropionate (BDP) produces potent anti-inflammatory and vaso-constrictor effects.

 

BDP is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolysed via esterase enzymes to the active metabolite beclomethasone-17-monopropionate (B-17-MP), which has high topical anti-inflammatory activity.

 

Beclomethasone dipropionate offers a preventative background treatment for hayfever when taken prior to allergen challenge. After which with regular use, BDP can continue to prevent allergy symptoms from re-appearing by reducing the sensitivity of nasal membranes.

 

Clinical studies carried out on patients with allergic rhinitis showed efficacy in nose symptoms, more specifically sneezing, rhinorrhea, itchy nose, and nasal congestion.

 

Clinical data suggests that BDP improves ocular symptoms associated with allergic rhinitis. In a 6 week randomized, double-blind, parallel study involving 44 patients treated with BDP, there was a statistically significant improvement in mean ocular symptom scores (p<0.01) after the 15-day study period.

 

BDP seems to provide relief from sinus discomfort associated with allergic rhinitis by preventing nasal obstruction, which allows a better drainage of sinuses subsequently. The precise mechanism of action is not known.

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 13 November 2015 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

shelf life has changed from 24 months to 30 months.

Updated on 5 November 2015 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

Shelf life changed from 24 months to 30 months

Updated on 23 September 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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



2 Qualitative and quantitative composition

 

…Excipients with known effect:

Each 100 mg spray contains…

4.2 Posology and method of administration

 

Posology

 

Indication

Age group

Dose

Duration

Prevention and treatment of nasal congestion symptoms due to hayfever and other seasonal allergic conditions

Adults

Two intranasal applications into each nostril twice daily*

14 days**

 

*Total daily administration should not exceed 8 intranasal applications (400mcg/day).

Once symptoms are controlled, the dose can be reduced to 1 spray into each nostril 2 times a day (100 micrograms per day in each nostril). 

**If there is no response after 14 days of treatment, medical advice should be sought.

Do not use continuously for longer than 3 months without consulting your doctor.

 

Paediatric population:

Not recommended in children and adolescents under the age of 18.

 

Regular usage is essential for full therapeutic benefit. Beconase Hayfever quickly starts to bring relief and reduce swelling in the nose although it may take a few days to build up to its maximum effect.

 

 

 

 

 

4.3 Contraindications

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.5 Interaction with other medicinal products and other forms of interaction

 

No known interactions with other drugs have been observed after intranasal use of beclomethasone.

 

4.6 Fertility, pregnancy and lactation

 

…It is reasonable to assume that beclometasone dipropionate is secreted in milk but at the dosages used for direct intranasal application, there is low potential for significant levels in breast milk. The use of beclometasone dipropionate in mothers breast feeding their babies requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and baby.

 

Fertility

 

There are no data available regarding the influence of Beconase Hayfever on fertility.

 

4.7 Effects on ability to drive and use machines

 

Beconase Hayfever has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable effects

 

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (21/10), common (21/100 and <1/10), uncommon (21/1000 and <1/100), rare (21/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data. In assigning adverse events frequencies, the background rates in placebo groups were taken into account, since these rates were

Body System Class

Undesirable Effect

Frequency

Comments

Immune system disorders

 

Hypersensitive reactions including rashes, urticaria, pruritis, erythema and oedema of the eyes, face, lips and throat, anaphylactoid/anaphylactic reactions, bronchospasm.

Very rare

 

Nervous system disorders

 

Unpleasant taste, unpleasant smell.

Common

As with other nasal sprays, unpleasant taste and smells have been reported.

Eye disorders

 

Glaucoma, raised intraocular pressure and cataract.

Very rare

 

Respiratory, thoracic and mediastinal disorders

 

Epistaxis, nasal dryness, nasal irritation, throat dryness, throat irritation.

 

Nasal septal perforation.

Common

 

 

 

Very rare

As with other nasal sprays, dryness and irritation of the nose and throat, and epistaxis have been reported. Nasal septal perforation has also been reported following the use of intranasal corticosteroids.

generally comparable to those in the active treatment group.

 

 

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: http://www.hpra.ie/;  e-mail: medsafety@hpra.ie

 

4.9 Overdose

 

Symptoms and signs

The only harmful effect that follows inhalation of larger amounts of the drug over a short period is suppression of hypothalamic-pituitary-adrenal (HPA) function.

 

Management

No special emergency action need be taken. Treatment with Beconase Hayfever should be continued at the recommended dose. HPA function recovers in a day or two.

 

5.1 Pharmacodynamic properties

 

Pharmacotherapeutic group: Nasal preparations, corticosteroids. ATC code: R01AD01

 

Following topical administration beclomethasone 17,21-dipropionate (BDP) produces potent anti-inflammatory and vaso-constrictor effects.

5.2 Pharmacokinetic properties

 

Biotransformation

BDP is cleared very rapidly from the circulation and plasma concentrations are undetectable (<50 pg/ml) following oral or intranasal dosing. Metabolism is meditated via esterase enzymes found in most tissues. The main product of metabolism is the active metabolite (B-17-MP). Minor inactive metabolites, beclometasone-21-monopropionate (B-21-MP) and beclometasone (BOH), are also formed but these contribute little to systemic exposure.

10 Date of revision of text

September 2015

Updated on 22 September 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 27 January 2014 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • 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

Updates to sections 4.4, 4.6, 4.8 and 5.2 of the SPC following alignment with the company's core safety data sheet.

Updated on 22 January 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 20 August 2013 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7 has been changed from GSK Ireland to

Chefaro Ireland Limited First Floor

Block A

The Crescent Building Northwood Office Park

Dublin 9 Ireland

Section 8 has changed to

PA 1186/008/001

Section 10 revision date has changed to January 2013

Updated on 6 February 2013 PIL

Reasons for updating

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

Updated on 28 October 2010 SmPC

Reasons for updating

  • Transfer of marketing authorisation holder
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • 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

In section 2 (qualitative and quantitative composition) the following was added:

Excipients: Each 100mg spray contains benzalkonium chloride solution equivalent to benzalkonium chloride 20 micrograms.

For a full list of excipients, see section 6.1.


In section 3 (pharmaceutical form) after the sentence "An aqueous white opaque suspension" the following was added:

"in a plastic bottle fitted with a metering atomising pump and nasal applicator."


In section 4.6 (pregnancy and lactation) Beconase Allergy Relief was changed to Beconase Hayfever

In section 6.4 (Special precautions for storage) the phrase "in order to protect from light" was added.

In section 7 (Marketing Authorisation Holder) "Trading as: Allen & hanbury's Ltd" was removed.

In section 9 (Date of first authorisation/renewal of the authorisation) date of last renewal was changed to 17 September 2009

In section 10 (Date of revision of the text) October 2008 was changed to October 2010

Updated on 12 August 2010 PIL

Reasons for updating

  • Transfer of Marketing Authorisation Holder
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 29 October 2008 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

5.1                 Pharmacodynamic properties

 

Beclomethasone dipropionate (BDP) following topical administration produces potent anti-inflammatory and vasoconstrictor effects. It offers preventative background treatment of hayfever when taken a few days prior to allergen challenge.

 

Following topical administration beclomethasone 17,21- dipropionate (BDP) produces potent anti-inflammatory and vaso-constrictor effects.

 

BDP is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolysed via esterase enzymes to the active metabolite beclomethasone-17-monopropionate (B-17-MP), which has high topical anti-inflammatory activity.

 

Beclomethasone dipropionate offers a preventative background treatment for hayfever when taken prior to allergen challenge. After which with regular use, BDP can continue to prevent allergy symptoms from re-appearing by reducing the sensitivity of nasal membranes.

 

5.2           Pharmacokinetic properties

 

Beclomethasone 17, 21-dipropionate (BDP) administered intravenously is cleared rapidly with a half-life of approximately 30 minutes.

 

BDP is bound to plasma proteins to the extent of 87%. Up to 14% of an intravenous dose of BDP is excreted in the urine in 96 hours, mainly as polar metabolites a proportion of which are conjugated. Up to 64% of the dose is excreted in faeces in this time, again primarily as free conjugated metabolites.

 

Following nasal administration of BDP an indefinable fraction is absorbed by the nasal mucosa, which does not result in measurable plasma concentrations of BDP (limit of quantitation 100pg/ml). The swallowed portion of the drug is absorbed from the gastro-intestinal tract and is rapidly metabolised.

 

The nasal mucosa is not known to contain any enzymes capable of metabolising BDP.

 

Absorption

Following intranasal administration of BDP, the systemic absorption was assessed by measuring the plasma concentrations of its active metabolite B-17-MP, for which the absolute bioavailability following intranasal administration is 44%

 

Following oral administration of BDP the systemic absorption was also assessed by measuring the plasma concentration of its active metabolite B-17-MP, for which the absolute bioavailability following oral administration is 41%

 

Metabolism

BDP is cleared very rapidly from the circulation and plasma concentrations are undetectable (<50 pg/ml) following oral or intranasal dosing. Metabolism is mediated via esterase enzymes found in most tissues. The main product of metabolism is the active metabolite (B-17-MP). Minor inactive metabolites, beclomethasone-21-monopropionate (B-21-MP) and beclomethasone (BOH), are also formed but these contribute little to systemic exposure.

 

Distribution

The tissue distribution at steady-state for BDP is moderate (201) but more extensive for B-17-MP (4241). Plasma protein binding is moderately high (87%).

 

Elimination

The elimination of BDP and B-17-MP are characterised by high plasma clearance (150 and 120 l/h) with corresponding terminal elimination half-lives of 0.5h and 2.7h. Following oral administration of trititated BDP, approximately 60% of the dose was excreted in the faeces within 96 hours mainly as free and conjugated polar metabolites. Approximately 12% of the dose was excreted as free and conjugated polar metabolites in the urine. The renal clearance of BDP and its metabolites is negligible.

 

Updated on 26 August 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 7 February 2006 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 7 February 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 6 January 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 December 2005 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 1 - Name of medicinal product

Legal category: Supply through pharmacy only

Updated on 22 December 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 May 2005 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 18 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 30 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only