Budoster® Nasal Spray 100 Microgram
BUDOSTER® 50 micrograms nasal spray, suspension 1 ml of nasal spray, suspension contains: active ingredient: 1 mg of Budesonide each actuation contains: 50 micrograms of Budesonide Excipients: glucose, microcrystalline cellulose and carboxymethylcellulose sodium (Avicel RC-591), potassium sorbate, polysorbate 80, disodium edetate, hydrochloric acid, purified water. BUDOSTER ® 100 micrograms nasal spray, suspension 1 ml of nasal spray, suspension contains: active ingredient: 2 mg Budesonide each actuation contains: 100 micrograms of Budesonide Excipients: glucose, microcrystalline cellulose and carboxymethylcellulose sodium (Avicel RC-591), potassium sorbate, polysorbate 80, disodium edetate, hydrochloric acid, purified water.
Pharmaceutical Form and Content:
Nasal sprays, suspension. — BUDOSTER ® 50 micrograms nasal spray, suspension from 10 ml bottle of nasal spray, suspension, which contains 10 mg of budesonide, with dosing valve by allowing 50 microliters 200 disbursements. — BUDOSTER ® 100 micrograms nasal spray, suspension from 10 ml bottle of nasal spray, suspension, which contains 20 mg of budesonide, fitted with a valve dosing by 50 microliters allowing 200 disbursements.
Riniti seasonal allergies, perennial allergic rhinitis and non-allergic. Treatment of nasal polyposis. Prophylaxis of recurrences of polyposis nasal after polypectomy.
Hypersensitivity to the active substance or any of the other ingredients.
Precautions for Use:
Particular attention is needed in patients with nasal infections in nature micotica or viral. The same goes for those with systemic bacterial infections, fungal or viral untreated and for those of Herpes simplex eye. In patients suffering from tuberculosis, the use of corticosteroids should follow after a careful assessment of the therapeutic benefits in comparison to the possible side effects. Because of inhibitory corticosteroids on the healing of skin lesions, patients with ulcers of recent nasal septum, surgery or trauma nasal should not be treated with nasal corticosteroids until the full recovery. Any appearance irritativi local phenomena as a result of the use of topical corticosteroids requires discontinuation of treatment. In patients treated with oral corticosteroids for the transition to the use of only nasal spray, suspension, budesonide should be done in a controlled manner to prevent imbalances of the ipotalamoipofisi-adrenal gland. Therefore must associate BUDOSTER ® nasal spray, suspension, gradually reducing the dose of oral corticosteroid. They are not recommended long-term treatment in children.
The cimetidine administered simultaneously with Budesonide it may be changed to an extent, however negligible, the pharmacokinetics.
In rare cases, after the use of budesonide by intranasally, you may experience hypersensitivity reactions immediate or dermatitis contact. Following treatment with inhaled corticosteroids or intranasal may occur the onset of increased intraocular pressure, glaucoma or cataracts. The administration of budesonide during pregnancy should be avoided unless there are special reasons. If it does not recommend the use mainly in the first three months of gestation. It is not known whether budesonide steps in breast milk. So precautionary purposes, and as is usually recommended for all corticosteroids, it is preferable not to administer the nasal spray, suspension, budesonide during the period of lactation. For those engaged in sport: the use of the drug without the need therapeutic constitutes doping and may however, to determine positive doping tests. Keep the medicine out of reach and sight of children.
Dose, Method and time of administration:
Doses and duration of treatment should be determined individually, according to the doctor. The medicine is not recommended for children younger than 6 years Treatment rhinitis dose recommended for adults and children over 6 years: two doses of 50 micrograms per nostril (100 micrograms / nostril) twice a day, morning and evening – or – two doses of 100 micrograms per each nostril (200 micrograms / nostril) once a day, in the morning. Treatment / prevention of nasal polyposis 200 micrograms (100 micrograms / nostril) twice a day.
Note: The full therapeutic effect of budesonide nasal spray, suspension, is reached only after several days of treatment (in rare cases no earlier than two weeks). The treatment of seasonal allergic rhinitis should be initiated prior to exposure to allergens. A concomitant therapy, for example with antihistamines, may sometimes be necessary to control the symptoms of ocular allergic nature. If the nasal passages are blocked, the first two or three days of therapy, the application of nasal spray, suspension of budesonide may be preceded by the administration of a nasal vasoconstrictor.
Instructions for Use:
Before each administration: Shake the bottle Remove the protective capsule dall’erogatore nasal with delicate rotate Keeping the bottle vertical as far from the figure and face, activate the valve dosing crushing the bottle between your fingers with the decision, until the formation of a fine spray.
Subsequently, the valve remains activated unless disassembly of the bottle or use very unusual Soffiarsi the nose gently before administration of BUDOSTER ® nasal spray, suspension, in order to free up the nostrils Hold his head slightly bowed, close a nostril with a finger, gently insert the nasal provider in the nostril and press upward the bottom of the bottle to produce a fine spray.
Remove the bottle from the nose and hold his head facing backwards to allow the dressing to spread to the bottom of the nose. Repeat the procedure in the nostril. Reapply the capsule of protection.
Use within 3 months from the bottle. In case of clogged, remove the nasal provider from the bottle and rinse in lukewarm water for several minutes. Do not use any object for groped to release the obstruction.
Symptoms local, as dry mucous membranes and nasal starnutazione can occasionally occur after the use of BUDOSTER ® nasal spray. They can also occur read secretions nasal bleeding and itching. Reactions skin (hives, rashes, angioedema, etc..) may in rare cases be associated with the therapy for nasal glucocorticosteroids. Were also reported extremely rare cases of ulceration of the mucous or drilling septal nasal following the use of nasal glucocorticosteroids. Compliance with the instructions contained in the leaflet reduces the risk of side effects. It ‘important to communicate your doctor or pharmacist the appearance of any side effects also not mentioned in the leaflet.
Expiry and Conservation:
Check the expiry date indicated on the package. The expiry date refers to the product packaging intact, properly preserved. Caution: Do not use the medicine after that date. Not store above 25 ° C. The period of validity after opening the bottle is 3 months. KEEP THE MEDICINAL AND REACH OUT OF THE SIGHT OF CHILDREN.