Properties
What is it?
Salbuair 2.5mg Inhalation Solution for Nebulizer Salbutamol Sulfate Read this leaflet carefully before using the medicine. - Keep the leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - The doctor has prescribed this medicine for you only. Do not pass it on to others. It may harm them, even if they have the same symptoms as you. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. In the leaflet you will find 1. What Salbuair 2.5mg is and what it is used for 2. What you need to know before using Salbuair 2.5mg 3. How to use Salbuair 2.5mg 4. Possible side effects 5. How to store Salbuair 2.5mg 6. Packaging and other information 1. What Salbuair 2.5mg is and what it is used for This medicine is presented in ampoules as an aqueous inhalation solution for use with a nebulizer. Salbuair 2.5mg contains 2.5mg of salbutamol (equivalent to 3mg of salbutamol sulfate) dissolved in 2.5ml of sterile isotonic sodium chloride solution. The active substance of this medicine, salbutamol, belongs to a group of medicines called bronchodilators, which relax the muscles of the airway walls in the lungs, helping to open the airway and make breathing easier. It is used to treat chronic bronchospasm (closure of the airways in the lungs) that is not responsive to standard therapy, and is also indicated in severe acute asthma. 2. What you need to know before using Salbuair 2.5mg Do not take Salbuair 2.5mg: - if you are allergic (hypersensitive) to salbutamol or any of the other ingredients of Salbuair 2.5mg. - during premature labor or when there is a risk of miscarriage. Take Salbuair 2.5mg with particular caution Talk to your doctor before starting treatment: - if you have any form of heart disease, heart rhythm disorder or angina. - if you have hyperthyroidism. - if you have high potassium levels in your blood. - if you have diabetes. - if you have high lactate levels in your blood (lactate acidosis), as an increase in lactate levels may complicate breathing problems. - if you are using salbutamol and ipratropium bromide at the same time, as this combination may cause eye-related disorders such as angle-closure glaucoma. Use of other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may interact with Salbuair 2.5mg. It is important to tell your doctor if you are taking any of the following medicines: - Non-selective beta-blockers, such as propranolol. - Certain medicines for depression (so-called monoamine oxidase inhibitors and tricyclic antidepressants). - Medicines containing anticholinergic agents (used to treat asthma, irritable bowel syndrome, Parkinson's disease, and incontinence). - Other medicines that improve breathing, e.g., terbutaline. Pregnancy and breastfeeding Consult your doctor or pharmacist before taking any medicine. If you need to take Salbuair 2.5mg during pregnancy or breastfeeding, your doctor will carefully assess the potential benefits and risks based on the severity of your clinical signs. Driving and using machinery The effect of Salbuair 2.5mg on the ability to drive or use machinery has not been described. Use of the medicine in athletes This medicine contains salbutamol, which may cause a positive result in a doping test (see recommendations in section 4.4 of the product characteristics). 3. How to use Salbuair 2.5mg Always use the medicine exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist. Use of the medicine in adults and children The recommended dose is 2.5mg approximately 4 times a day. Your doctor may increase the dose to 5mg up to 4 times a day. Your doctor may advise you to use the nebulizer regularly or only during severe breathing difficulties or respiratory failure. Salbuair 2.5mg is used with a suitable nebulizer. Inhalation of the mist is done through a mask or mouthpiece; your doctor will tell you which nebulizer to use and will explain how to use it. Instructions for correct use of the medicine The medicine should be inhaled using a nebulizer: it must not be injected or swallowed. 1. Prepare the nebulizer according to the manufacturer's and doctor's instructions. Ensure the nebulizer is clean. 2. Remove the plastic strip of ampoules from the box, open it, and take out one ampoule. Leave the remaining ampoules on the strip and store them in the box. 3. Open the ampoule by twisting the top part. 4. Unless your doctor advises otherwise, empty the liquid from the plastic ampoule completely into the nebulizer solution container. 5. Use the nebulizer as directed by your doctor. Dispose of the empty plastic ampoule. 6. After use, clean the nebulizer according to the manufacturer's instructions. Tell your doctor or pharmacist if you think the effect of Salbuair 2.5mg is too strong or too weak. If you take more Salbuair 2.5mg than you should If you take more than the recommended dose, you may experience heart rhythm disturbances, rapid heartbeat, tremor, blood pressure fluctuations, pulse-related disorders, angina, dry mouth, and visual accommodation disorders. If you overdose or accidentally ingest the medicine, contact your doctor or pharmacist immediately or call the poison control center at: 91 562 04 20, stating the name of the medicine and the amount of the dose taken. Seek medical attention from your treating physician or the emergency department of the nearest hospital. Bring this leaflet or the ampoule with you so that the treating physician knows which medicine you have taken. If you forget to take Salbuair 2.5mg If you forget to take Salbuair 2.5mg, continue treatment as prescribed or take the next dose earlier if you experience breathing problems. Do not take a double dose to make up for a missed dose. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. Although the frequency is not precisely determined, some patients may rarely experience chest pain (due to heart-related problems such as angina). Tell your doctor if you experience such symptoms during treatment with Salbuair 2.5mg, but do not stop taking the medicine without your doctor's advice. The following side effects have been reported: Common (affects 1 to 10 patients in 10) - Headache - Tremor - Tachycardia Uncommon (affects less than 1 patient in 100) - Rapid heartbeat - Irritation of the mouth and throat - Muscle spasms Rare (affects less than 1 patient in 1000) - Low potassium levels in the blood (hypokalemia) - Peripheral vasodilation Very rare (affects less than 1 patient in 10,000) - Allergic reactions (hypersensitivity), including angioedema and urticaria, bronchospasm, hypotension, and syncope. - Hyperactivity - Heart rhythm disturbances, including atrial fibrillation, supraventricular tachycardia, and extrasystole (heart rhythm disorders) - Paradoxical bronchospasm Frequency unknown - Myocardial ischemia (lack of blood circulation to part of the heart muscle) - Lactate acidosis 5. How to store Salbuair 2.5mg Keep the medicine out of reach of children. Store at a temperature not exceeding 25C. Store in the outer packaging to protect from light. The ampoule should be used immediately after opening; any remaining solution should not be used. Do not use the medicine after the expiry date indicated on the ampoule. The expiry date refers to the last day of the month indicated. Do not dispose of medicines down the drain or in household waste. Ask your pharmacist for information on how to dispose of unused medicines. These measures will help protect the environment. 6. Packaging and other information What Salbuair 2.5mg contains - The active substance is salbutamol sulfate. Each ampoule contains 2.5mg of salbutamol (equivalent to 3mg of salbutamol sulfate) dissolved in 2.5ml of sterile isotonic sodium chloride solution. - Other ingredients: sodium chloride, water for injection, and sulfuric acid. What Salbuair 2.5mg looks like and what the pack contains Salbuair 2.5mg is presented as a strip of 10 ampoules, it is a colorless or pale yellow solution in aluminum sachets. Each box contains 60 ampoules. Marketing authorization holder Laboratorio ALDO-UNION, S.L. Baronessa de Maldà, 73 08950 Esplugues de Llobregat Barcelona (Spain) Manufacturer Laboratoire Unither Espeis Industrial Nord 151 Rue André Duroche-ch 28028 80084 Amiens Cedex 2 France
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