Properties
What is it?
Axelovert® Composition Active substance: Budesonide Excipients: Microcrystalline cellulose and sodium carmellose, anhydrous glucose, polysorbate 80, disodium edetate, potassium sorbate, hydrochloric acid for pH adjustment, purified water. Dosage form: Nasal spray, suspension, metered doses, 100mcg/dose. Active substance content: 1 ml of nasal spray suspension contains 2mg of budesonide. Description - Labeling: Axelovert® nasal spray is supplied in a 10 ml bottle containing 200 doses (100 mcg/dose) with a metered-dose spray pump. Pharmacotherapeutic category: Corticosteroid - anti-allergic. General information Axelovert® is an anti-inflammatory medication belonging to the class of corticosteroids. Budesonide reduces and prevents inflammation and swelling of the nasal mucosa. Indications - Treatment of symptoms of seasonal or chronic allergic rhinitis in adults and children (6 years and older) and treatment of symptoms of chronic non-allergic rhinitis in adults only; - Treatment of symptoms of nasal obstruction caused by nasal polyps in adults. Contraindications Hypersensitivity to budesonide and other ingredients of the medication. Special warnings and precautions General: The medication is intended for a specific condition and its use is recommended by a doctor. Overdose or prolonged treatment with corticosteroids may lead to symptoms or signs of hypercorticolemia, suppression of the hypothalamic-pituitary-adrenal axis, and/or growth retardation in children. The doctor should carefully monitor the growth rate of a child receiving glucocorticosteroids at any dose for a prolonged period and assess the benefits of treatment against the potential for growth retardation. Impaired liver function affects corticosteroid excretion. Inform your doctor if you have liver problems. Special precautions are necessary for patients with pulmonary tuberculosis and for patients with nasal, fungal, or viral infections and bacterial sinusitis, which should be treated accordingly. Children undergoing immunosuppressive therapy are more susceptible to infections than healthy children. For example, diseases such as chickenpox or measles may be more severe in children undergoing immunosuppressive therapy with glucocorticoids. Children and adults who are not immune to these diseases should exercise caution. If you contract such a virus, inform your doctor. Special attention should be paid to patients who have switched from systemic corticosteroid intake to Axelovert® nasal spray. If another steroid is used for oral inhalation, the total nasal and oral doses should be clarified to avoid unwanted steroid effects, especially in children. Characteristic of corticosteroids: As mentioned above, prolonged use of glucocorticoids leads to suppression of the hypothalamic-pituitary-adrenal axis, i.e., suppression of adrenal function. The level of suppression depends on the dose, the potency of the administered corticosteroids, the frequency and duration of administration within a 24-hour period, the half-life in tissues, and the total duration of treatment. The dose is adjusted based on the exacerbation or remission of the disease, the patient's individual response, and its impact on emotional and physical stress (infections, surgeries, injuries, etc.). Elderly: No special instructions. Doses are personalized. Pregnancy: During pregnancy, Axelovert® nasal spray can be used only if, in the doctor's opinion, the benefit to the mother outweighs the risk to the fetus. If you become pregnant while taking the medication, inform your doctor immediately. Lactation: During lactation, Axelovert® nasal spray can be used only if, in the doctor's opinion, the benefit to the mother outweighs the risk to the child. Children: Data on long-term nasal administration of steroids in children are not fully known. Read the section on dosage for children carefully. Ability to drive and operate machinery Axelovert® does not affect the ability to drive or operate machinery. Special warnings for excipients: Unknown. Interactions with other medicinal products and other forms of interaction Before using Axelovert®, inform your doctor if you are taking any other medications, especially those for fungal infections (ketoconazole), and also medications purchased without a prescription. Characteristic of corticosteroids: Precautions are necessary when taken together with phenytoin, phenobarbital, ephedrine, rifampicin, alcohol, non-steroidal anti-inflammatory drugs, potassium-sparing diuretics, bee venom, coumarin anticoagulants, insulin, or oral antidiabetic agents. Dosage Dosage is individual. Use as prescribed by a doctor. Read and follow the instructions for use carefully before using Axelovert® for the first time. Treatment of symptoms of seasonal or chronic allergic rhinitis Adults, elderly, and children from 6 years of age: The recommended initial dose is 200-400 mcg/day in total. The dose is taken once daily in the morning or divided into two doses - morning and evening, as follows: 200 mcg (4 sprays X 50 mcg or 2 sprays X 100 mcg) in each nostril in the morning or 100 mcg (2 sprays X 50 mcg or 1 spray X 100 mcg) in each nostril twice daily, morning and evening. The frequency of administration should not exceed 2 times per day. There is no data on the use in children under 6 years of age with this indication, so do not use the preparation in this group of patients. Treatment of symptoms of chronic non-allergic rhinitis. According to the dosage indicated above. This medication is not intended for children with this indication, as the required number of children did not participate in clinical trials. Treatment of symptoms of nasal obstruction caused by nasal polyps Recommended dose is 200 mcg twice daily (2 sprays X 50 mcg or 1 spray X 100 mcg) for up to 3 months. There is no data on the use in children with this indication, so its use is recommended only in adults. Note When starting to use Axelovert® nasal spray, symptoms will not disappear immediately. It should be used for several days (sometimes up to 2 weeks) for symptoms to improve. As soon as the desired clinical picture is achieved, the dose used should be reduced to the minimum required to control symptoms. In case of seasonal allergic rhinitis, try taking Axelovert® a few days before the onset of allergies. Axelovert® nasal spray is not indicated for relieving symptoms caused by eye allergies. In case of discomfort in the eyes, it is recommended to treat with another medication prescribed by a doctor to relieve these symptoms. The use of nasal spray in children should always be supervised by an adult to ensure adequate dosage and to ensure that the dosage corresponds to that prescribed by the doctor. Instructions for use Before using Axelovert® nasal spray for the first time, shake the bottle and then spray into the air several times (5-10 times) until the aerosol is uniform. If the medication is not used daily, shake the bottle before use and spray into the air once until the device is recharged. Follow the instructions shown in the pictures. 1) Remove the cap 2) Press down as shown by the arrow and wait until it sprays 3) Hold the bottle upright, place the tip of the applicator in the nostril, press down on the bottle with your thumb, and then release. Repeat the same procedure in the other nostril. 4) To keep the device clean, wipe the applicator and put on the protective cap after each use. Patient information All plastic parts of the dosing valve should be washed regularly with warm water. Remove the protective cap and detach the plastic applicator. Dry thoroughly after washing and reassemble the device. Overdose If the medication is taken in excess once, it will not have dangerous side effects. If the medication is consumed in excess for a prolonged period (months), side effects are likely to occur. In such cases, it is recommended to inform your doctor. Undesirable effects Along with the desired effect, any medication may cause certain side effects. Inform your doctor if the following side effects occur and develop: Most frequent side effects: nasal irritation, nosebleeds. Rare side effects: rapidly occurring and delayed hypersensitivity reactions, such as skin rash, etc. In such cases, inform your doctor immediately. Very rare side effects: ulcers, mycosis, and atrophy of the nasal mucosa. Local symptoms such as ringing in the ears, dryness, and sneezing may occur immediately after using the product. Inform your doctor if you experience any unusual reactions while using Axelovert® nasal spray. Characteristic of corticosteroids: Prolonged use may cause significant side effects. What to know if you miss a dose If you forget to take a dose of nasal spray, do not try to make it up. Take the next dose as prescribed. Do not take a double dose. Product expiration date Do not use after the expiration date indicated on the outer and inner packaging. Special storage precautions: Cover the preparation with the protective cap after use. Store at a temperature not exceeding 25°C. Do not freeze. Information for rational use of medication - The medication prescribed by your doctor for your specific medical problem should not be given to others or used for other conditions without consulting a doctor. - If any problems related to the medication arise during treatment, consult your doctor or pharmacist immediately. - If you have questions about the medication or want more information about your medical condition, be sure to consult your doctor or pharmacist. - To ensure that the medication you are being treated with is effective and safe, take it according to the given instructions. - For safety and health, it is essential to carefully read the full information related to the prescribed medication. - Do not store the medication in the bathroom cabinet, as heat and humidity can damage the medication and make it dangerous to health. - Do not store the medication for longer than intended or after the expiration date. - For safety, store the medication in a safe place, away from children. Disposal method The medical product is subject to medical disposal.
