NASOBEC AQUEOUS

Beclometasone Dipropionate Aqueous Nasal Spray is for administration by the intranasal route only.

Adults and children over six years old:

Two sprays twice daily into each nostril (400 micrograms beclometasone dipropionate per day) is the recommended initial dosage. It may be preferable for some patients to administer a single spray into each nostril three or four times daily.

Once control of symptoms has been achieved move the dosage down to one spray twice daily into each nostril (200 micrograms beclometasone dipropionate per day). A dosage regimen of one spray into each nostril morning and evening has been shown to be efficacious in some patients.

If symptoms reoccur, 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. Total daily administration should not normally exceed eight sprays.

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.

It should be made clear to patients that full therapeutic benefit will only be achieved after a few days treatment.

Elderly:

Dosage as for adults.

Children less than six years old:

Beclometasone Dipropionate Aqueous Nasal Spray is not indicated for children under six years old, due to insufficient clinical data.

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), very rare (<1/10,000) including isolated reports and not known (cannot be estimated from the available data).

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 Reaction Frequency Hypersensitivity reactions including: Rashes, urticaria, pruritis, erythema. Common Oedema of the eyes, face, lips and throat Very rare Dyspnoea and/or bronchospasm Very rare Immune system disorders Anaphylactoid/anaphylactic reactions Very rare Nervous system disorders Unpleasant taste, unpleasant smell.

4) Rare Glaucoma, raised intraocular pressure, cataract. Very rare Eye disorders Central serous retinopathy Not known Respiratory, Thoracic & Mediastinal disorders Epistaxis, nasal dryness, nasal irritation, throat dryness, throat irritation Common Nasal septum perforation.

Very rare Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. Blood stained crusts in the nose can occur when taking nasal sprays but these conditions are not progressive and are seldom troublesome.

Widespread use of beclometasone dipropionate for a decade has shown no serious local damage to mucous membranes. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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, blurred vision 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 for 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 contra-indication 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 appropriate additional therapy particularly to control eye symptoms.

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