NASOFAN AQUEOUS

Posology Paediatric population The safety and efficacy of Nasofan Aqueous 50 micrograms Nasal Spray in children aged less than 4 years has not been established.

Adults and children of 12 years of age and over:

Two sprays into each nostril once a day (200 mcg), preferably in the morning is recommended. In some cases two sprays into each nostril twice a day (400 mcg) may be required. Once symptoms are under control a maintenance dose of one spray per nostril once a day (100 mcg) may be used.

If symptoms recur the dosage may be increased accordingly. The maximum daily dose should not exceed four sprays into each nostril (400 mcg). The minimum dose at which the effective control of symptoms is maintained should be used.

Elderly patients:

The normal adult dosage is applicable.

Children between ages of 4 and 11:

One spray into each nostril once a day (100 mcg), preferably in the morning, is recommended. In some cases one spray into each nostril twice a day (200 mcg) may be required. The maximum daily dose should not exceed two sprays into each nostril (200 mcg).

The minimum dose at which the effective control of symptoms is maintained should be used. For full therapeutic benefit regular usage is essential. The absence of an immediate effect should be explained to the patient since maximum relief may not be obtained for 3 to 4 days after commencement of treatment.

Method of administration Nasofan Aqueous 50 microgram Nasal Spray is for administration by the intranasal route only. Precautions to be taken before handling or administering the medicinal product Prior to first use Nasofan Aqueous 50 microgram Nasal Spray must be primed by pressing down and releasing the pump six times.

If Nasofan Aqueous 50 microgram Nasal Spray has not been used for 7 days it must be reprimed by pressing down and releasing the pump a sufficient number of times until a fine mist is produced.

The most frequently reported side effects were epistaxis (≥1/10) followed by headache, unpleasant taste and smell, dryness and irritation of the nose, dryness and irritation of the pharynx (≥1/100 to < 1/10). Adverse events are listed below by system organ class and frequency.

Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data). System Organ Class Adverse Event Frequency Hypersensitivity reactions with the following manifestations: Bronchospasm Rare Anaphylactic reactions Rare Anaphylactoid reactions Rare Cutaneous hypersensitivity reaction Very rare Immune system disorders Angioedema (mainly facial and oropharyngeal oedema) Very rare Nervous system disorders Headache, unpleasant taste, unpleasant smell.

Common Glaucoma, raised intraocular pressure, cataract These events have been identified from spontaneous reports following prolonged treatment. 4) Not known Epistaxis Very common Nasal dryness, nasal irritation, throat dryness, throat irritation.

Common Nasal septal perforation*, mucocutaneous ulceration Usually in patients who have had previous nasal surgery. Very rare Respiratory, Thoracic & Mediastinal disorders Nasal ulcers Not known *Cases of perforation of the nasal septal wall have been reported as a result of the use of corticosteroids.

Systemic effects of some nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. Paediatric population Some nasal corticosteroids have been reported to produce growth retardation in children when prescribed at licensed doses.

4). Reporting of suspected adverse reactions Reporting of 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.

Administration of treatment may be necessary for several days for the full benefit of Nasofan Aqueous 50 microgram Nasal Spray to be achieved. Upon transferring patients from systemic steroid treatment to Nasofan Aqueous 50 microgram Nasal Spray care must be taken if there is any reason to suppose that their adrenal function is impaired.

Systemic Effects of Corticosteroids 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).

2. Adrenal suppression may occur to clinically significant levels as a result of treatment with higher than recommended doses of nasal corticosteroids. 1 for data on intranasal fluticasone propionate). g. ketoconazole and protease inhibitors such as ritonavir) may occur.

g. Cushing’s syndrome and adrenal suppression have been observed). 5). Visual disturbance 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.

In most cases Nasofan Aqueous 50 microgram Nasal Spray will control seasonal allergic rhinitis, however in the event of an abnormally heavy challenge of summer allergens appropriate additional therapy may be necessitated in certain instances.

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