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Product Information

The following adverse reactions have been reported during post-approval use of RHINOCORT AQUA Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. It may take up to 2 weeks before your symptoms improve. For best results, keep using the medication as directed, even if you feel fine. Call your doctor if your symptoms do not improve, or if they get worse while using Rhinocort Allergy. When intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur; if such changes happen, therapy should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

Read the Patient Information that comes with RHINOCORT AQUA (budesonide) Nasal Spray before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about RHINOCORT AQUA (budesonide) Nasal Spray, ask your healthcare provider or pharmacist.

5. Warnings and Precautions

Tell your doctor if you have rare but serious side effects of Rhinocort Aqua nasal spray including:

see WARNINGS AND PRECAUTIONS and Use In Specific Populations] DRUG INTERACTIONS Inhibitors of Cytochrome P450 3A4 The use of steroid nasal sprays like Rhinocort and Flonase can lead to an increased risk of a fungal infection ( Candida albicans ) in the throat or nasal passages. Signs of a fungal infection should be monitored if steroid nasal sprays are being used long-term.

discontinue treatment with RHINOCORT AQUA (budesonide) Nasal spray. In addition, nasal corticosteroids Uncommon (0.1% to 1%): Hypersensitivity reactions including urticaria, rash, dermatitis, angioedema, pruritus Maximum dose: 6 to less than 12 years is 128 mcg per day administered as 2 sprays per nostril once a day; 12 years and older is 256 mcg per day administered as 4 sprays per nostril once a day Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients; monitor growth routinely of pediatric patients receiving long-term treatment; to minimize systemic effects of intranasal corticosteroids, titrate each patient’s dosage to lowest one that effectively controls his/her symptoms

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.Budesonide, the active ingredient of RHINOCORT AQUA (budesonide) Nasal Spray, is an anti-inflammatory synthetic corticosteroid. The recommended starting dosage for adults and children 6 years of age and older is 64 mcg per day administered as one spray per nostril of RHINOCORT AQUA Nasal Spray 32 mcg once daily. Some patients who do not achieve symptom control at the recommended starting dosage may benefit from an increased dosage. The maximum recommended dosage for adults (12 years of age and older) is 256 mcg per day administered as four sprays per nostril once daily of RHINOCORT AQUA Nasal Spray 32 mcg and the maximum recommended dose for pediatric patients (6 to <12 years of age) is 128 mcg per day administered as two sprays per nostril once daily of RHINOCORT AQUA Nasal Spray 32 mcg. Allergic rhinitis is a common condition in the UK, affecting 20% of the population. While it is common and does not normally pose a serious health risk, it can be a very debilitating problem to have to live with.