BENACORT HAYFEVER RELIEF FOR ADULTS

Posology Adults aged 18 years and over, including the elderly Patients should commence treatment with two sprays into each nostril each morning. Once symptoms are under control, a maintenance dose of one spray into each nostril each morning may be used.

Total daily administration should not exceed four sprays (256 micrograms). If symptoms recur patients should revert to the starting dose. The lowest dose at which effective control of symptoms is achieved should be used. If symptoms persist or are not adequately controlled after 7 days of treatment patients should consult their doctor or pharmacist.

This medicine should not be used continuously for longer than 1 month without seeking medical advice. Patients should be reminded of the importance of taking this medicine regularly. The patient should be informed that the full effect of this medicine is not achieved until after a few day’s treatment.

Paediatric population:

This medicine should not be used in children and adolescents under 18 years of age. Method of administration For nasal inhalation. 6.

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with budesonide are listed below by System Organ Class (SOC). The frequencies are defined in accordance with current guidance, 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) and not known (cannot be estimated from the available data).

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known. 4) Eye disorders Not known Cataract Raised intraocular pressure or Glaucoma Common Epistaxis Haemorrhagic secretion Nasal discomfort (sneezing, stinging and dryness) Respiratory, thoracic and mediastinal disorders Rare Dysphonia Nasal septum perforation Nasal ulcer Musculoskeletal and connective tissue disorders Uncommon Muscle spasms General disorders and and administration site conditions Very rare Mucosal ulceration Injury, poisoning and procedural complications Rare Contusion* * based on mechanistic plausibility and extrapolation from other budesonide/corticosteroid formulations.

4). Paediatric population Growth retardation has been reported in children receiving intranasal steroids. 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.

Patients should consult a pharmacist or doctor before using this medicine if: • They are using a corticosteroid product for conditions such as asthma, allergies or skin rash • They currently have or have been exposed to someone who has tuberculosis, chicken pox or measles.

• They have fungal or viral infections of the airways. • They have severe or frequent nose bleeds, recent nose ulcers or nose surgery or a nose injury that has not healed. • They have ever been diagnosed with glaucoma or cataracts. • They have an eye infection or diabetes.

Patients should consult a pharmacist or doctor if they develop signs or symptoms of an infection, such as persistent fever, while taking this medicine. Concomitant treatment of seasonal allergic rhinitis may sometimes be necessary to counteract eye symptoms caused by the allergy.

Reduced liver function affects the elimination of corticosteroids, causing a lower elimination rate and higher systemic exposure. This may lead to possible systemic side effects. Systemic effects of intranasal 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 and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

In cases of clinically significant adrenal suppression, additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Co-treatment with CYP3A inhibitors including cobicistat-containing products is expected to increase the risk of systemic side effects.

The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side effects. g. contact dermatitis). 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.

The long-term effects of intranasal glucocorticosteroids in children are not fully known. This medicine should not be used for children or adolescents under 18 years of age.

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