BECLOMETASONE DIPROPIONATE AQUEOUS NASAL

Posology It is important to use this product regularly in order to achieve maximum relief from the symptoms. It should be explained to the patient that full therapeutic benefit may not be experienced until after the first few doses of Beclometasone Dipropionate Aqueous Nasal Spray.

Adults and Children (aged 6 years or over):

The recommended dosage is two sprays into each nostril twice a day (400 micrograms a day). Once control has been established, it may be possible to maintain control with fewer sprays. A dosage regimen of one spray into each nostril morning and evening has been shown to be efficacious in some patients.

However, should symptoms recur, patients should revert to the recommended dosage of two sprays into each nostril morning and evening. The minimum dose should be used at which effective control of symptoms is maintained. A total of eight sprays (400 micrograms) daily should generally not be exceeded.

For full therapeutic benefit regular usage is essential. The co-operation of the patient should be sought to comply with the regular dosage schedule and it should be explained that maximum relief may not be obtained within the first few applications.

Children under 6 years old:

Not recommended Method of administration For nasal administration only.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports.

Very common, common and uncommon reactions were generally determined from clinical trial data. Rare and very rare reactions were generally determined from spontaneous data. In assigning adverse reaction frequencies, the background rates in placebo groups were not taken into account, since these rates were generally comparable to those in the active treatment group.

System Organ Class Adverse Event Frequency Hypersensitivity reactions including:

Rash, urticaria, pruritus, erythema. Common Angioedema Very rare Immune system disorders Dyspnoea and/or bronchospasm Very rare Anaphylactoid/anaphylactic reactions Very rare Nervous system disorders Unpleasant taste, unpleasant smell.

Common Glaucoma, raised intraocular pressure, cataract. 4) Not known Epistaxis, nasal dryness, nasal irritation, throat dryness, throat irritation. CommonRespiratory, Thoracic & Mediastinal disorders Nasal septum perforation. Very rare Systemic effects of nasal corticosteroids may occur particularly when used at high doses for prolonged periods.

4 special warnings and precautions for use). 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.

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Systemic effects of nasal corticosteroids 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.

Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible to the lowest dose at which effective control of symptoms is maintained.

In addition, consideration should be given to referring the patient to a paediatric specialist. Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence of higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Care must be taken while transferring patients from systemic steroid treatment to Beclometasone Dipropionate Aqueous Nasal Spray if there is any reason to suppose that their adrenal function is impaired. Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Beclometasone Dipropionate Aqueous Nasal Spray.

Although Beclometasone Dipropionate Aqueous Nasal Spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate additional therapy particularly to control eye symptoms.

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