NASOBEC HAYFEVER, BECLOMETASONE DIPROPIONATE AQUEOUS NASAL

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

Adults:

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. e. 400 micrograms of beclometasone dipropionate.

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. If symptoms have not improved after 14 day’s treatment, medical advice must be sought. Beclometasone Dipropionate Aqueous Nasal Spray should not be used continuously for more than three months without consulting your doctor.

Elderly:

Dosage as for adults.

Individuals under the age of eighteen years:

Beclometasone Dipropionate Aqueous Nasal Spray is not indicated for individuals under the age of eighteen years, due to insufficient clinical data.

Adverse reactions listed below are based on clinical trials and classified according to MedDRA frequency and Ssystem Organ class.

Frequency categories are defined as according to the following convention:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

System Organ Class Adverse Event 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 Central serous retinopathy Not known Epistaxis, nasal dryness, nasal irritation, throat dryness, throat irritation CommonRespiratory, thoracic & tediastinal disorders 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. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Systemic effects of nasal corticosteroids may occur, particularly at high doses when used 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 corticosteroids, if possible, to the lowest dose at which effective control of symptoms is maintained.

In addition, consideration should also 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 corticosteroids 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. 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.

This product should not be used continuously for longer than 3 months without consulting a doctor. 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.

Medical advice should be sought before using Beclometasone Dipropionate Aqueous Nasal Spray in the case of recent injury or surgery to the nose, or problems with ulceration in the nose. Visual disturbances Visual disturbance may be reported with systemic and topical corticosteroid use.

If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Excipient(s):

Benzalkonium chloride Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. Long-term use may cause oedema of the nasal mucosa. Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you have asthma.

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