NASOBEC Nasal spray, suspension Ref.[49651] Active ingredients: Beclometasone

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, blurred vision, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroids, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should also be given to referring the patient to a paediatric specialist.

Care must be taken while transferring patients from systemic steroid treatment to Nasobec if there is any reason to suppose that their adrenal function is impaired.

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 corticosteroids cover should be considered during periods of stress or elective surgery.

Infections of the nasal passages and paranasal sinuses should be appropriately treated before treatment with Nasobec.

The use of the preparation should be avoided in the presence of untreated infections.

Particular care should be taken to minimise use of topical corticosteroids in patients with immunosuppression.

Particular caution is required in patients with a history of, or existent tuberculosis.

Cataracts have been associated with systemic steroid therapy. There have been rare reports of cataracts developing in patients who have been using intranasal or inhaled corticosteroids for prolonged periods, although together causes, including exposure to systemic steroids, cannot be excluded.

Although Nasobec will control seasonal allergic rhinitis in the majority of cases, concomitant therapy to control eye symptoms may be necessary during a heavy challenge to allergens.

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.

Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.

Pregnancy

There is inadequate evidence of safety in human pregnancy. Intra-uterine growth retardation cannot be ruled out during long-term therapy. Early studies in animals have demonstrated an increase in foetal cleft palate and growth retardation following maternal ingestion of high corticosteroid doses. However, direct intranasal application at the recommended doses ensures minimal systemic exposure.

The use of beclometasone dipropionate in pregnancy requires that the possible benefits of the drug be weighed against the possible hazards.

Breastfeeding

It is probable that beclometasone is excreted in milk. In mothers breast feeding their baby the therapeutic benefits of the drug should be weighed against the potential hazards to mother and baby.

Nasobec has no or negligible influence on the ability to drive and use machines.

Nasally administered glucocorticoids can cause undesirable systemic effects, especially if high doses are administered for extended periods.

The frequencies of adverse events are ranked according to the following: 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).

Paediatric population

Growth retardation has been reported in children receiving nasal corticosteroids (see section Special warnings and precautions for use).

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 HPRA Pharmacovigilance, Website: www.hpra.ie.

Not applicable.