BECLOMETHASONE HAYFEVER RELIEF NASAL

Category POM Beclometasone Dipropionate Aqueous Nasal Spray for intranasal administration only.

Adults and children:

There is insufficient clinical data at present to support the recommended use of this product in children under the age of six. A dose range of 200 to 400 μg per day is recommended. The recommended dosage for adults and children is two sprays into each nostril twice daily.

Once control of symptoms has been achieved a single spray into each nostril twice a day may be preferred. However, the minimum dose should be used at which effective control of symptoms is maintained. The total daily dose should not normally exceed eight sprays (400 micrograms/day).

For full therapeutic benefit regular use is essential. Furthermore, it should be explained to the patient that maximum relief may not be obtained with the first few doses and that patients co-operation to comply with the regular dosage schedule should be sought.

Category P Beclometasone Dipropionate Aqueous Nasal Spray is not recommended for children or adolescents under 18 years of age. A dose range of 200 to 400 μg per day is recommended. Usually a dosing regimen of two sprays into each nostril every morning and evening is recommended.

The maximum number of sprays that should be administered each day is 8. Once control of symptoms has been achieved a single spray into each nostril twice a day may be preferred. However, the minimum dose should be used at which effective control of symptoms is maintained.

If symptoms have not improved within 10 days the doctor should be consulted. This product should not be used continuously for longer than 3 months without consulting your doctor. 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 doses. If a dose is missed, then the next dose should be taken when it is due.

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. Systemic effects include hypothalmic-pituitary-adrenal (HPA) suppression and growth retardation in children and adolescents.

Rare cases of nasal septal perforation have been reported following the use of intranasal corticosteroids. Rare cases of raised intra-ocular pressure, cataract or glaucoma have been reported. 4). As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely.

Common hypersensitivity reactions including rashes, urticaria, pruritus and erythema, and very rare hypersensitivity reactions including oedema of the eyes, face, lips and throat, have been reported. Very rarely dyspnoea and/or bronchospasm have been reported.

Nasal and pharyngeal infection by Candida albicans has been reported. The frequency of occurrence is not known. 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.

Nasal passage infections and paranasal sinuses should be appropriately treated. Beclometasone Dipropionate Aqueous Nasal Spray may be used in conjunction with other medicaments if required. Caution should be exercised whilst transferring patients from systemic steroid treatment to Beclometasone Dipropionate Aqueous Nasal Spray if there is doubt that their adrenal function is impaired.

Beclometasone Dipropionate Aqueous Nasal Spray will control seasonal allergic rhinitis in most cases. However, an abnormally heavy challenge of summer allergies may, in certain situations, necessitate appropriate additional therapy, especially to control eye symptoms.

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).

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.

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.

3. Contra-Indications Beclometasone Dipropionate Aqueous Nasal Spray is contra-indicated in patients with a history of hypersensitivity to any of its components.