4.1. Therapeutic indications

Prevention and treatment of seasonal allergic rhinitis (hay fever).

4.2. Posology and method of administration

Posology

Dosage should be individualised.

Rhinitis (Adults including the elderly)

Recommended start dose

Once daily dosing

Twice daily dosing

256 micrograms per day

Two applications of 64 micrograms into each nostril each morning

One application of 64 micrograms into each nostril morning and evening

If good effect is achieved, one application of 64 micrograms into each nostril each morning.

The patient should be informed that the full effect of Benacort is not achieved until after a few days treatment. Treatment of seasonal rhinitis should, if possible, start before exposure to the allergens. If symptoms are not controlled, or persist for longer than 2 weeks of treatment, medical advice must be sought. This medicine should not be used continuously for longer than 3 months.

Patients should be reminded of the importance of taking this medicine regularly.

The dose should be titrated to the lowest dose at which effective control of symptoms is achieved.

Paediatric population: This spray should not be used in children and adolescents under 18 years of age.

Method of administration

For nasal inhalation.

For further details on how to administer the medicine, see Section 6.6.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Treatment should be stopped or the advice of a doctor or pharmacist should be sought if an improvement is not seen within 2 weeks or if symptoms have improved but are not adequately controlled.

This medicine should not be used for more than 3 months continuously.

Special care is required in the treatment of patients transferred from oral corticosteroids to this medicine where disturbances of the hypothalamic-pituitary-adrenal (HPA) axis could be expected.

Special care is needed in patients with fungal and viral infections of the airways.

Patients should consult a physician before use if:

• They are using a corticosteroid 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 severe or frequent nose bleeds, or have had 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 physician if they develop signs or symptoms of an infection, such as persistent fever, while taking this medicine.

Special care is needed where there is an infection in the nasal passages or sinuses.

Concomitant treatment may sometimes be necessary to counteract eye symptoms caused by the allergy.

Reduced liver function affects the elimination of corticosteroids, causing lower elimination rate and higher systemic exposure. Be aware of possible systemic side effects.

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).

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.

This product contains Potassium sorbate (E202) which may cause local skin reactions, (e.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.

Paediatric population

The long-term effects of nasal glucocorticosteroids in children are not fully known.

This medicine should not be used for children or adolescents under 18 years of age.

4.5. Interaction with other medicinal products and other forms of interaction

This medicine has not been observed to interact with any drug used for the treatment of rhinitis.

The metabolism of budesonide is primarily mediated by CYP3A enzymes. Co-treatment with CYP3A inhibitors, e.g. itraconazole, ketoconazole, clarithromycin, HIV protease inhibitors e.g. atazanavir, indinavir, nelfinavir, ritonavir and saquinavir, and cobicistat-containing products, is expected to increase the risk of systemic side effects (see section 4.4). The combination of this medicine with potent CYP3A inhibitors 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. This is of limited clinical importance for short-term (1-2 weeks) treatment with itraconazole or ketoconazole or other potent CYP3A inhibitors, but should be taken into consideration during long-term treatment. If this medicine is co-administered with anti-fungals (such as itraconazole and ketoconazole), the period between treatments should be as long as possible. A reduction of the budesonide dose should be considered.

Raised plasma concentrations of and enhanced effects of corticosteroids have been observed in women also treated with oestrogens and contraceptive steroids, but no effect has been observed with this medicine and concomitant intake of low dose combination oral contraceptives.

Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).

4.6. Fertility, pregnancy and lactation

Pregnancy

Results from prospective epidemiological studies and from worldwide post marketing experience indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budesonide during early pregnancy.

Breast-feeding

Budesonide is excreted in breast milk. At therapeutic doses of this medicine no effects on the breast-fed infant are anticipated since maternal systemic exposure after intranasal administration is low, so minimal exposure to intranasal budesonide in breast-fed infants is expected. This medicine may therefore be considered for use during breast feeding.

Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants.

In a pharmacokinetic study, the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma samples were all less than the limit of quantification.

Based on data from inhaled budesonide and the fact that budesonide exhibits linear PK properties within the therapeutic dosage intervals after nasal, inhaled, oral and rectal administrations, at therapeutic dose of budesonide, exposure to the breast-fed child is anticipated to be low.

As with other drugs the administration of this medicine during pregnancy or breast-feeding requires that the benefits for the mother are weighed against the risks for the foetus or nursing infant.

4.7. Effects on ability to drive and use machines

This medicine may have a moderate influence on the ability to drive and use machines. This medicine may cause blurred vision; patients should therefore be cautioned about engaging in activities such as driving a car or operating machinery, until they have established their own response to the drug.

4.8. Undesirable effects

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 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10 000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from 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.

System Organ Class (SOC)

Frequency

Adverse Drug Reaction (Preferred Term)

Immune system disorders

Uncommon

Hypersensitivity (Immediate and delayed hypersensitivity reactions including erythema, urticaria, rash, dermatitis, angioedema and pruritus)

Rare

Anaphylactic reaction

Endocrine disorders

Rare

Signs and symptoms of systemic corticosteroid effects, including adrenal suppression and growth retardation.

Eye disorders

Rare

Vision, blurred (see also section 4.4)

Not known

Cataract

Raised intraocular pressure or Glaucoma

Respiratory, thoracic and mediastinal disorders

Common

Epistaxis

Haemorrhagic secretion

Nasal discomfort (sneezing, stinging and dryness)

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.

In rare cases, signs or symptoms of systemic glucocorticosteroid-side effects such as Cushing's syndrome, Cushingoid features, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children), may occur with nasal glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous corticosteroid exposure, and individual sensitivity (see section 4.4).

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Acute overdose with this medicine even in excessive doses, is not expected to be a clinical problem.

Inhalation of high doses of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis function.