"The European Medicines Agency (EMA) has approved mepolizumab (Nucala, GlaxoSmithKline) as an add-on treatment for severe refractory eosinophilic asthma in adults in the 31 European countries covered by the EMA, according to a company state"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
BUDESONIDE/FORMOTEROL HFA INHALER - ORAL
COMMON BRAND NAME(S): Symbicort
WARNING: Rarely, serious (sometimes fatal) asthma-related breathing problems may occur in people with asthma who are treated with drugs similar to formoterol (long-acting beta agonists). In people with asthma, this product should only be used when one long-term medication (such as inhaled corticosteroids) does not control breathing problems. Before using this medication, it is important to learn how to use it properly. Discuss the risks and benefits of this medication with your doctor.
USES: This product is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It contains 2 medications: budesonide and formoterol. Budesonide belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Formoterol belongs to the class of drugs known as long-acting beta agonists. It works by opening airways in the lungs to make breathing easier. Controlling symptoms of breathing problems can decrease time lost from work or school.
This medication must be used regularly to be effective. It does not work immediately and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
Do not use this medication with other long-acting inhaled beta agonists (such as arformoterol) because doing so may increase your risk for side effects.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. Read the patient instructions for directions on how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist.
Follow the instructions for priming the inhaler if you are using it for the first time, if you have not used it for more than 7 days, or if the inhaler was dropped. When priming the inhaler, make sure to spray away from the face so that you do not get the medication into your eyes.
Shake the inhaler well for 5 seconds before each use. Inhale this medication by mouth as directed by your doctor, usually twice daily (in the morning and evening, 12 hours apart).
If your prescribed dose is 2 puffs, wait at least one minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug last.
Gargle and rinse your mouth with water after using this medication to help prevent irritation and yeast infections (thrush) in the mouth and throat. Do not swallow the rinse water.
Clean the inhaler once a week with a dry cloth. Do not take the inhaler apart.
The dosage is based on your medical condition and response to treatment.
Use this medication regularly in order to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more frequently, or stop using it without first consulting your doctor. Also, do not use other long-acting beta agonists while using this medication.
If you are regularly using a different corticosteroid taken by mouth (such as prednisone), you should not stop using it unless directed by your doctor. You may have withdrawal symptoms if the drug is suddenly stopped. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication after you begin using this product. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. See also Precautions section.
If you have been using a quick-relief inhaler (such as albuterol, also called salbutamol in some countries) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath/asthma attacks. Consult your doctor for details.
It may take 1 week or longer before you get the full benefit of this drug. Tell your doctor if your symptoms do not improve or if they worsen.
Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.
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