NASACORT Nasal Spray suspension Ref.[6451] Active ingredients: Triamcinolone

If there is any reason to suppose that adrenal function is impaired, care must be taken while transferring patients from systemic steroid treatment to Nasacort Allergy or Triamcinolone Nasal Spray. Patients taking steroids should consult their doctor before using this product.

In clinical studies with Nasacort Allergy or Triamcinolone Nasal Spray administered intranasally, the development of localised infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection develops it may require treatment with appropriate local therapy and discontinuation of treatment with Nasacort Allergy or Triamcinolone Nasal Spray.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have had recent nasal surgery or recent prolonged nose-bleeds or any other nasal problems should consult their doctor before using this product.

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).

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence of using higher than recommended doses then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

This product should not be used for longer than 3 months without consulting a doctor.

Glaucoma and/or cataracts have been reported in patients receiving nasal corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.

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.

Nasacort Allergy contains benzalkonium chloride, long term use may cause oedema of the nasal mucosa.

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.

Pregnancy

Nasacort Allergy or Triamcinolone Nasal Spray should only be used in pregnancy on medical advice. There are no adequate and well-controlled studies in pregnant women with Nasacort Allergy or Triamcinolone Nasal Spray. Because animal studies indicate a teratogenic effect, typical of corticosteroids, Nasacort Allergy or Triamcinolone Nasal Spray should not be administered during pregnancy unless the therapeutic benefit to the mother is considered to outweigh the risk to the foetus/baby (see section 5.3 Preclinical Safety Data).

Lactation

Nasacort Allergy or Triamcinolone Nasal Spray should only be used in lactation on medical advice. It is not known whether triamcinolone acetonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Nasacort Allergy or Triamcinolone Nasal Spray is administered to nursing women; therefore, the therapeutic benefit to the mother should outweigh any potential risk to the baby.

Nasacort Allergy or Triamcinolone Nasal Spray has no known effect on the ability to drive and operate machines.

The adverse events reported in clinical trials with Nasacort Allergy or Triamcinolone Nasal Spray most commonly involved the mucous membranes of the nose and throat.

The following frequency rating has been used, when applicable: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000 and not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The most frequent adverse reactions in adults were:

Infections and infestations

Common: flu syndrome, pharyngitis, rhinitis

Immune system disorders

Not known: hypersensitivity (including rash, urticaria, pruritus and facial oedema)

Psychiatric disorders

Not known: insomnia

Nervous system disorders

Common: headache

Not known: dizziness and alterations of taste and smell

Eye disorders

Not known: chorioretinopathy, cataract, glaucoma, increased ocular pressure, blurred vision (see also section 4.4)

Respiratory, thoracic and mediastinal disorders

Common: bronchitis, epistaxis, cough

Rare: nasal septum perforations

Not known: nasal irritation, dry mucous membrane, nasal congestion, sneezing, dyspnoea

Gastrointestinal disorders

Common: dyspepsia, tooth disorder

Not known: nausea

General disorders and administration site conditions

Not known: fatigue

Investigations

Not known: decreased blood cortisol

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.