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.
2 years.
Use within 2 months of first opening the nasal spray.
None applicable.
Disodium edetate
Potassium sorbate (E202)
Glucose anhydrous
Microcrystalline cellulose (E460)
Carboxymethylcellulose sodium (E466)
Polysorbate 80 (E433)
Hydrochloric acid
Purified water
Nasal spray, suspension (nasal spray).
Tabulated list of adverse reactions
Adverse reactions, which have been associated with budesonide, are given below, listed by system organ class and frequency. Frequency is 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), very rare (<1/10,000) and not known (cannot be estimated from available data).
|
Immune system disorders |
Uncommon |
Immediate and delayed hypersensitivity reactions including 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 |
|
Not known |
Raised intraocular pressure or Glaucoma Cataract | |
|
Respiratory, thoracic and mediastinal disorders |
Common |
Haemorrhagic secretion and epistaxis Nasal Irritation (sneezing, stinging and dryness) |
|
Rare |
Nasal ulcer Nasal septum perforation Dysphonia | |
|
Very rare |
Ulceration of mucous membrane | |
|
Musculoskeletal and connective tissue disorders |
Uncommon |
Muscle spasm |
|
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.
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. Website: www.mhra.gov.uk/yellowcard.
The acute toxicity of budesonide is low and of the same order of magnitude and type as that of the reference glucocorticoids studied (beclomethasone dipropionate, flucinolone acetonide). Results from subacute and chronic toxicity studies show that the systemic effects of budesonide are less severe than or similar to those observed after administration of the other glucocorticosteroids e.g. decreased body weight gain and atrophy of lymphoid tissues and adrenal cortex. An increased incidence of brain gliomas in male rats in a carcinogenicity study could not be verified in a repeat study, in which the incidence of gliomas did not differ between any of the groups on active treatment (budesonide, prednisolone, triamcinolone acetonide) and the control groups. Liver changes (primary hepatocellular neoplasms) found in male rats in the original carcinogenicity study were noted again in the repeat study with budesonide, as well as with the reference glucocorticosteroids. These effects are most probably related to a receptor effect and thus represent a class effect.
Available clinical experience shows no indication that budesonide or other glucocorticosteroids induce brain gliomas or primary heptocellular neoplasms in man. Budesonide has been used successfully in the treatment of seasonal allergic rhinitis for several years.
In animal reproduction studies, corticosteroids such as budesonide have been shown to induce malformations (cleft palate, skeletal malformations). However these animal experimental results do not appear to be relevant in humans at the recommended doses.
Animal studies have also identified an involvement of excess prenatal glucocorticosteroids in increased risk for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behavioural exposures below the teratogenic dose range.
Prevention and treatment of seasonal allergic rhinitis (hay fever).
Pharmacotherapeutic group: Decongestants and other nasal preparations for topical use, corticosteroids. ATC code: R01A D05
Budesonide is a non-halogenated glucocorticosteroid with a high local anti-inflammatory action within the respiratory tract.
Bioavailablity of oral budesonide in man is low (11-13%) due to an extensive first-pass metabolism in the liver.
The systemic availability of budesonide from this medicine, with reference to the metered dose is 33%. In adults, the maximal plasma concentration after administration of 256 micrograms budesonide from this medicine is 0.64 nM and is reached within 0.7 hours. The AUC after administration of 256 micrograms budesonide from this medicine is 2.7 nmolxh/L in adults.
14th July 2017
Benacort 64 micrograms Nasal Spray
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom
Do not store above 30°C. Do not refrigerate or freeze.
This medicine is an aqueous solution of budesonide in a 10 ml amber/brown glass (type II) bottle. Each bottle is fitted with a spray pump and contains 120 actuations.
PL 15513/0404
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. As with other drugs the administration of this medicine during pregnancy requires that the benefits for the mother are weighed against the risks for the foetus.
Breast-feeding
Budesonide is excreted in breast milk. However, at therapeutic doses of Benacort no effects on the breast fed child are anticipated. This medicine can be used during breast feeding.
Maintenance treatment with inhaled Benacort (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.
Each actuation contains: Budesonide 64 micrograms (1.28 mg/ml).
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 without consulting a doctor or pharmacist.
Special care is demanded in treatment of patients transferred from oral steroids 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 and in patients with active or quiescent pulmonary tuberculosis.
Special care is needed where there is an infection in the nasal passages or sinuses, or in the case of recent surgery to the nose, or problems with ulceration in the nose.
Concomitant treatment of seasonal rhinitis 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).
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. Physicians should closely follow the growth of children taking glucocorticosteroids for longer term by any route, and weigh the benefits of the glucocorticosteroid therapy against the possibility of growth suppression.
This medicine should not be used for children or adolescents under 18 years of age.
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Co-treatment with CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products is expected to increase the risk of systemic corticosteroid side effects. Therefore, the combination should be avoided unless the benefit outweighs this increased risk, 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. A reduction in the dose of budesonide should also be considered.
This medicine has no or negligible influence on the ability to drive and use machines.
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 or If good effect is achieved, one application of 64 micrograms |
One application of 64 micrograms into each nostril morning and evening |
The minimum dose should be used at which effective control of symptoms is maintained. 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. Concomitant treatment may sometimes be necessary to counteract eye symptoms caused by the allergy. Benacort should not be used continuously for longer than 3 months without consulting your doctor or pharmacist.
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. There is insufficient data to recommend the use of Benacort in children.
Method of administration
For nasal inhalation.
Before using this medicine for the first time the nozzle must be primed (filled with the medicine). To do this the bottle is shaken and the protective cap removed. The bottle is then held upright and the nozzle pumped 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 loaded with medicine again. This time it is sufficient to spray just once into the air.
a. The patient is then instructed to blow their nose. Next, the bottle needs to be shaken and the protective cap removed.
b. The bottle is then held upright, with one finger held on either side of the nozzle.
c. The tip of the nozzle is inserted into the nostril and the nozzle pressed down once (or more as instructed by the doctor). The spray is then administered into the other nostril in the same way. Note: it is not necessary to inhale at the same time as spraying.
d. The nozzle needs to be wiped with a clean tissue after use and the protective cap replaced. The bottle should be stored in an upright position.
e. Keeping the Benacort nozzle clean
The plastic nozzle of Benacort should be cleaned regularly and at any time the spray of medicine is not coming out as it should. If this happens, first the nozzle should be checked to ensure that it is primed with medicine (see earlier). If, after the nozzle is primed again, the pump is still not working, the nozzle should be cleaned by using the following instructions:
The plastic nozzle is removed with a clean tissue and washed in warm, not hot, water. The nozzle is then rinsed thoroughly, dried and then replaced onto the top of the bottle. The nozzle should not be unblocked with a pin or other sharp object. After cleaning, the nozzle must be primed (filled with medicine) again before use.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation: 15th January 2009
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, HIV protease inhibitors and cobicistat-containing products, is expected to increase the risk of systemic side effects. 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. 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 could 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).
