BUDESONIDE

Posology For nasal use only. The dosage should be determined individually. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. The duration of the therapy with Budesonide nasal spray should be restricted to the period of allergen exposure and depends on the nature and the characteristics of the allergen.

For a full therapeutic benefit regular use is essential. Allergic rhinitis Initial dose Adults, adolescents and children from 6 years of age: The recommended initial dose of 256 micrograms may be administered once daily in the morning or divided into two administrations, in the morning and in the evening.

2 actuations into each nostril once daily in the morning or 1 actuation into each nostril in the morning and in the evening Children should be treated under guidance of an adult. The advice of a doctor is required for any treatment in children for more than 2 months over one year.

Concomitant therapy may sometimes be necessary to treat the symptoms affecting the eye caused by the allergy. Maintenance dose The desired clinical effect appears within about 1-2 weeks. Afterwards, the lowest dose should be chosen that keeps the patient just without symptoms.

No better efficacy is to be expected with a dose greater than 256 micrograms.

Nasal polyps Symptomatic treatment of nasal polyps in adults:

The recommended dose for the treatment of nasal polyps is 256 micrograms. The dose may be administered once daily in the morning or divided into two administrations, in the morning and in the evening. 2 actuations into each nostril once daily in the morning or 1 actuation into each nostril in the morning and in the evening After the desired clinical effect has appeared, the lowest dose should be chosen that keeps the patient without symptoms.

Method of administration 1. Gently blow your nose to clean the nostrils, if necessary. 2. Shake the bottle (figure 1). Remove the protective cap. Figure 1. 3. Hold the bottle as shown in figure 2. e. fill it with medicine). Pump the nozzle up and down several times (5-10 times), spraying into the air until an even mist is seen.

The priming effect remains for approximately 24 hours. If a longer period of time passes before the next dose is taken, the nozzle must be primed (filled with medicine) again. If Budesonide nasal spray suspension is used at shorter intervals it is sufficient to spray just once into the air.

g. allergic conjunctivitis or dermatitis, may become unmasked. They should be treated additionally if needed. In rare cases, signs or symptoms of systemic glucocorticosteroid-side effects may occur with nasal glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous corticosteroid exposure, and individual sensitivity Undesirable effects frequencies were defined as follows: - 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) Undesirable effects are presented by frequency category based on 1) Undesirable effects reported in clinical trials or epidemiological studies, if available, or 2) when the frequency cannot be estimated, the frequency category listed is "frequency not known".

4), increased eye pressure Not known glaucoma, cataract (with long-term treatment) Common local symptoms like nasal mucosa irritation, slight haemorrhagic secretion, epistaxis (immediately after application), dryness of the nasal mucosa, oropharyngeal pain Respiratory, thoracic and mediastinal disorders Rare nasal ulcer, nasal septum perforation, dysphonia Skin and subcutaneous tissue disorders Rare Bruising Uncommon muscle spasmMusculoskeletal and connective tissue disorders Rare osteoporosis (with long-term treatment) Infections and infestations Not known Nasal and oropharyngeal candidiasis Candida albicans infections Cases of nasal and pharyngeal Candida albicans infections have been described during treatment with local corticosteroids.

In such cases, it is preferable to discontinue nasal corticosteroid therapy and to consider starting an appropriate treatment. 4). 4). Paediatric population Growth retardation has been reported in children receiving intranasal steroids.

4. 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.

The risk of systemic effects, adrenal cortical slowing and impact on growth is increased in case of concomitant administration of inhaled or systemic corticosteroid therapy. Systemic effects of nasal corticosteroids may occur, particularly at high doses, when prescribed for prolonged periods, together with additional or previous therapy with corticoids and due to individual factors.

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, skin thinning, subcutaneous haematomas, adrenal suppression, growth retardation in children and adolescents, decreased bone density, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Treatment with higher than recommended doses of nasal corticosteroids 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 period of stress or elective surgery.

Glucocorticoids may increase blood glucose levels. This must be taken into account when prescribing to diabetic patients. In case of infections of the nose caused by bacteria or fungi, Budesonide nasal spray suspension should be used only if concomitant antibacterial or antifungal treatment is carried out.

g. every 6 months. If mucosal atrophy is observed, the doses of local corticosteroids should be reduced. Impaired liver function influences the pharmacokinetics of corticosteroids. Severe impairment of hepatic function influences the pharmacokinetics, including the elimination, of orally administered budesonide resulting in increased systemic availability and reduced elimination capacity.

1. • Disorders of haemostasis, or epistaxis. • Oro-nasal and ophthalmic herpes virus infection.