BECONASE 50 µg Susp nas en flacon pulvérisateur Fl/200doses

VIDAL
Medicines
Update of 02/01/2024

BECONASE 50 µg nasal spray suspension
beclometasone

Forms and presentations

Nasal spray suspension at 50 µg:  Pump spray bottle with metering pump delivering 200 sprays.

Composition

	per dose
Micronised beclometasone dipropionate monohydrate expressed as beclometasone dipropionate	50 µg

Excipients: microcrystalline cellulose, sodium carmellose, anhydrous glucose, benzalkonium chloride, phenylethyl alcohol, polysorbate 80, purified water.

Excipient with known effect: benzalkonium chloride.

Indications

• Perennial or seasonal allergic rhinitis.
  
• Inflammatory rhinitis, in particular eosinophilic rhinitis.
  

Dosage and administration

Dosage

1 spray = 50 µg.

Method of administration:

Nasal use.

• Shake the bottle gently before use.
  
• On first use or if the pump has not been used for several days, it is necessary to prime the pump and press the collar until a fine spray is obtained.
  

Contraindications

This medicine is contraindicated in cases of:

• Known hypersensitivity to one of the constituents.
  
• Haemostasis disorders, in particular epistaxis.
  
• Active or latent untreated pulmonary tuberculosis.
  
• Untreated active gastric ulcer.
  
• Child under 3 years of age.
  
• Oro-buccal-nasal and ophthalmic infection due to herpes simplex virus.
  

Warnings and precautions

Warnings:

• Systemic effects may occur with long-term treatment with high doses of nasal corticosteroids. The risk of systemic repercussions nevertheless remains lower than with oral corticosteroids and may vary depending on individual susceptibility and the composition of the corticosteroid product used. Possible systemic effects are: Cushing's syndrome or cushingoid symptoms, skin thinning, subcutaneous bruising, adrenal insufficiency, growth retardation in children and adolescents, decreased bone density, cataract and glaucoma and, more rarely, psychological and behavioural disorders including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggressiveness (particularly in children).
  
• Visual disturbances may occur during systemic or local corticosteroid therapy. In case of blurred vision or the appearance of any other visual symptom during corticosteroid therapy, an ophthalmological examination is required to look for, in particular, cataract, glaucoma, or a rarer lesion such as central serous chorioretinopathy, described with the administration of systemic or local corticosteroids.
  
• Concomitant administration of nasal corticosteroids in patients on long-term oral corticosteroid therapy does not exempt from the necessary precautions when reducing oral corticosteroid doses. These will be reduced very gradually and withdrawal must be carried out under careful medical supervision (watching for signs of acute or subacute adrenal insufficiency), continuing beyond the cessation of systemic corticosteroid therapy.
  
• The risk of systemic effects, corticosuprarenal suppression and impact on growth is increased in cases of concomitant administration of inhaled or a fortiori systemic corticosteroid therapy.
  
• In case of suspected adrenal insufficiency, particular precautions should be taken into account when nasal administration follows systemic corticosteroid therapy.
  
• The occurrence of a concomitant bacterial, viral or fungal bronchopulmonary infection requires discontinuation of local corticosteroid therapy and initiation of appropriate treatment.
  
• The occurrence of rhinosinusal and sinus infections requires appropriate treatment but does not constitute a specific contraindication to treatment with beclometasone dipropionate by nasal route.
  
• Local nasal administration of corticosteroids is not recommended in patients who have recently had ulceration of the nasal septum, or who have undergone surgery or trauma to the nose, until healing is complete.
  

Precautions for use

• Nasal patency should be ensured to allow optimal distribution of the product. Advise the patient to dry the nasal passages by blowing the nose before instillation.
  
• In case of major nasal obstruction, a detailed examination of the ENT area should be performed.
  
• Advise the patient that this is a regular and continuous treatment and that a delay of a few days may be necessary before effects on rhinitis symptoms are observed.
  
• During prolonged treatment, detailed examinations of the nasal mucosa are recommended. If atrophy of the nasal mucosa is observed, consideration should be given to reducing local corticosteroid doses or even discontinuing treatment.
  
• Although nasal beclometasone dipropionate usually controls seasonal allergic rhinitis, exposure to a particularly large quantity of summer allergens may in some cases require the initiation of additional treatment, in particular to better control ocular symptoms.
  
• Athletes' attention is drawn to the fact that this medicine contains an active substance that may induce a positive result in tests carried out during anti-doping controls.
  
• Beconase 50 micrograms, nasal spray suspension in a pump spray bottle contains 0,02 mg of benzalkonium chloride per dose.
  Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used over a long period.
  

Interactions

The metabolism of beclometasone is less dependent on CYP3A than that of certain other corticosteroids, and interactions are generally unlikely; nevertheless, in case of concomitant use of potent CYP3A inhibitors (e.g. ritonavir, cobicistat), the possibility of systemic effects cannot be excluded and it is therefore advised to be cautious and to apply adequate monitoring when these agents are used.

Fertility, pregnancy and breastfeeding

Pregnancy:

Animal studies have shown, as with all corticosteroids, a teratogenic effect that varies according to species.

In clinical practice, epidemiological studies have not demonstrated a malformative effect associated with the use of beclometasone during the first trimester of pregnancy.

The neonatal problems described with systemic corticosteroid therapy (intrauterine growth retardation, neonatal adrenal insufficiency) have not, to date, been reported with administration of corticosteroids by this route.

Nevertheless, administration of the product during pregnancy should only be considered if the expected benefit to the mother is greater than the potential risk to the foetus.

Breastfeeding:

Excretion of beclometasone dipropionate into milk has not been studied in animals. It is estimated that beclometasone dipropionate is secreted into milk, but because of the low dose used and the nasal route of administration, it is unlikely that high levels will be found in milk.

Administration of beclometasone dipropionate to breastfeeding women should only be considered if the expected benefit to the mother justifies the risk to the child.

Adverse effects

Undesirable effects are listed below by organ class and by frequency.

Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), very rare (< 1/10 000) including isolated cases, and not known (cannot be estimated from the available data). Very common, common and uncommon effects were described in clinical trials. The corresponding incidence in the placebo arm was not taken into consideration since it was generally comparable to the incidence observed in the active substance arm.

"Very rare" undesirable effects are derived from spontaneous reports after marketing.

Organ class
Frequency	Adverse effects
Immune system disorders
Very rare	Hypersensitivity reactions, skin rashes, urticaria, pruritus, erythema, angioedema, anaphylaxis/anaphylactic reactions, bronchospasm.
Nervous system disorders
Common	Headache, unpleasant taste and odour.
Eye disorders
Very rare	Glaucoma, increased intraocular pressure, cataract.
Frequency not known	Blurred vision (see Warnings and Precautions for Use).
Respiratory, thoracic and mediastinal disorders
Common	Epistaxis, nasal dryness, nasal irritation, dryness and irritation of the throat
Very rare	Nasal septum perforation

Cases of nasal and pharyngeal Candida albicans infections have also been described during local corticosteroid treatment. In such cases, nasal corticosteroid therapy should be interrupted and appropriate treatment considered.

The risk of systemic effects related to beclometasone dipropionate administered nasally cannot be ruled out (see Warnings and Precautions for Use). This risk is increased in cases of concomitant administration of inhaled or, a fortiori, systemic corticosteroid therapy.

The risk of latent corticotropic insufficiency after prolonged administration should therefore be considered in cases of intercurrent infection, accident or surgical intervention.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

It may cause hypothalamic-pituitary-adrenal suppression and, if prolonged, clinical signs of hypercorticism. These symptoms will disappear after discontinuation of treatment, which should be gradual.

Management should be based on the clinical indication or on the recommendations of the national poison control centre, where applicable.

There is no specific treatment for an overdose of beclometasone propionate. In case of overdose, the patient should be managed and monitored appropriately.

Pharmacodynamics

Pharmacotherapeutic class: Corticosteroids, ATC code: R01AD01.

After nasal administration, beclometasone dipropionate has an anti-inflammatory activity on the nasal mucosa.

Beclometasone dipropionate exerts a local therapeutic effect at average daily doses of 400 µg in adults, whereas its suppressive effect on the hypothalamic-pituitary-adrenal axis via the nasal route only manifests at a dose equal to or greater than 8000 µg (8 mg). The difference between therapeutic doses and those likely to cause hormonal effects, as well as the metabolic inactivation of this product, explain the absence of undesirable systemic effects at the recommended dose.

Pharmacokinetics

After nasal administration, beclometasone dipropionate is partly absorbed through the nasal mucosa and partly swallowed. It is metabolised in the liver to beclometasone monopropionate and beclometasone-alcohol, then excreted as inactive metabolites in the bile and urine.

Storage conditions

Store at a temperature not exceeding + 25 °C.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Prescription, supply and reimbursement

LIST I

Marketing authorisation (AMM)

3400932929252 (1987, SmPC rev 01.04.2021).

Marketed in 1994.

Price:	5,26 euros (bottle of 200 sprays).
Social security reimbursement at 30 %.

GlaxoSmithKline Laboratories
23, rue François-Jacob. 92500 Rueil-Malmaison
Tel: 01 39 17 80 00
Medical information:
Tel: 01 39 17 84 44. Fax: 01 39 17 84 45
www.fr.gsk.com