BUDESONIDE 64 Aqueous Nasal Spray

Active ingredients: Budesonide

Product name and form

Budesonide 64 micrograms/actuation, Aqueous Nasal Spray.

Pharmaceutical Form

Nasal spray, suspension.

White homogeneous suspension.

Qualitative and quantitative composition

The delivered (metered) dose of 0.05 ml nasal spray, suspension contains 64 micrograms of budesonide.

Excipient (s) with known effect: 0.06 mg of potassium sorbate/0.05 ml nasal spray, suspension

For the full list of excipients, see section 6.1.

Active Ingredient

Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers.

List of Excipients

Dispersible cellulose (Microcrystalline cellulose and carboxymethylcellulose sodium, (89:11, w/w))
Polysorbate 80
Potassium sorbate E202
Glucose, anhydrous
Disodium edetate
Hydrochloric acid, concentrated
Ascorbic acid E300
Purified water

Pack sizes and marketing

Amber type III glass bottle fitted with a plastic nasal spray pump and polypropylene nasal applicator: pack size of 1 x120 (1 × 10 ml) doses, 3 × 120 (3 × 10 ml) doses, 10 × 120 (10 × 10 ml) doses

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 04416/0784

30th July 2009