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Seroflo General Information

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Seroflo 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: fluticasone and salmeterol. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Salmeterol 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.

Seroflo must be used regularly to be effective. It does not work immediately and should not be used to relieve sudden shortness of breath or asthma attacks. If sudden breathing problems occur, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

How to Use Seroflo

Read the Medication Guide provided by your pharmacist before you start using Seroflo 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.

Use this device in a level, flat position. Inhale Seroflo by mouth as directed by your doctor, usually twice daily (in the morning and evening, 12 hours apart). You may or may not taste/feel the drug when you inhale. Either is normal. Do not exhale into the device.

Do not take the inhaler apart or wash the mouthpiece or any part of the device. Close the device after each use.

If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use Seroflo last.

Gargle and rinse your mouth with water after each use of Seroflo to help prevent irritation and yeast infections (thrush) in the mouth and throat. Do not swallow the rinse water.

The dosage is based on your medical condition, age, and response to treatment.

Use Seroflo regularly in order to get the most benefit from it. Seroflo 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 Seroflo more frequently, or stop using it without first consulting your doctor. Also, do not use other long-acting beta agonists while using Seroflo.

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.

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 Seroflo. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. See also Precautions section.

It may take 1 week or longer before you get the full benefit of Seroflo. Tell your doctor if your condition does not improve or if it worsens.

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.

Seroflo Possible Side Effects

Hoarseness, throat irritation, headache, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed Seroflo because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using Seroflo do not have serious side effects.

Seroflo may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Infrequently, Seroflo may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if any of these unlikely but serious side effects occur: white patches on tongue/in mouth, signs of infection (such as fever, persistent sore throat), mental/mood changes (such as nervousness), trouble sleeping, vision problems (such as blurred vision), increased thirst/urination, muscle cramps, shaking (tremors).

Get medical help right away if any of these rare but serious side effects occur: chest pain, fast/irregular heartbeat, severe dizziness, fainting, seizures.

A very serious allergic reaction to Seroflo is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Seroflo Precautions

Before using Seroflo, tell your doctor or pharmacist if you are allergic to fluticasone or salmeterol; or if you have any other allergies. Seroflo may contain inactive ingredients (such as lactose, milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using Seroflo, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), high blood pressure, bone loss (osteoporosis), heart disease (such as chest pain, heart attack, irregular heartbeat), overactive thyroid (hyperthyroidism), diabetes, eye problems (such as cataracts, glaucoma), seizures, liver disease.

Salmeterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Seroflo, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Seroflo safely.

Seroflo may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using Seroflo in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using Seroflo or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults with COPD may be at greater risk for pneumonia while using Seroflo. Older adults may also be more sensitive to the side effects of Seroflo, especially QT prolongation (see above).

Seroflo may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, Seroflo should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if Seroflo passes into breast milk. Consult your doctor before breast-feeding.

Seroflo Possible Intercations

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with Seroflo is: aldesleukin.

Other medications can affect the removal of fluticasone and salmeterol from your body, which may affect how Seroflo works. Examples include azole antifungals (such as ketoconazole), boceprevir, cobicistat, macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as lopinavir, ritonavir), nefazodone, telithromycin, among others.

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