Fluticasone; Salmeterol Metered Dose Inhaler (MDI)

What is this medication?

FLUTICASONE; SALMETEROL (floo TIK a sone; sal ME te role) treats asthma and chronic obstructive pulmonary disease (COPD). It works by opening the airways of the lungs, making it easier to breathe. It is a combination of an inhaled steroid and a bronchodilator. It is often called a controller inhaler. Do not use it to treat a sudden asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Advair HFA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes (high blood sugar)
• Eye disease, such as glaucoma, cataracts, or blurred vision
• Heart disease
• High blood pressure
• Immune system problems
• Infections, such as tuberculosis (TB) or other bacterial, fungal, or viral infections
• Irregular heartbeat or rhythm
• Liver disease
• Osteoporosis, weak bones
• Seizures
• Taking other steroids like dexamethasone or prednisone
• Thyroid disease
• An unusual or allergic reaction to fluticasone, salmeterol, other corticosteroids, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is inhaled through the mouth. Rinse your mouth with water after use. Make sure not to swallow the water. Take it as directed on the prescription label at the same time every day. Do not use it more often than directed.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medication may also interact with the following:

• Aminophylline or theophylline
• Antiviral medications for HIV or AIDS
• Beta-blockers like metoprolol and propranolol
• Certain antibiotics like clarithromycin, erythromycin, levofloxacin, linezolid, and telithromycin
• Certain medications for fungal infections like ketoconazole, itraconazole, posaconazole, voriconazole
• Conivaptan
• Diuretics
• Medications for colds
• Medications for depression or emotional conditions
• Nefazodone
• Vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Talk to your care team about how to treat an acute asthma attack or bronchospasm (wheezing). Be sure to always have a short-acting inhaler with you. If you use your short-acting inhaler and your symptoms do not get better or if they get worse, call your care team right away.

You and your care team should develop an Asthma Action Plan that is just for you. Be sure to know what to do if you are in the yellow (asthma is getting worse) or red (medical alert) zones.

This medication can worsen breathing or cause wheezing right after you use it. Be sure you have a short-acting inhaler for acute attacks (wheezing) nearby. If this happens, stop using this medication right away and call your care team.

This medication may increase your risk of dying from asthma-related problems. Talk to your care team if you have questions.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. If you have not had the measles or chickenpox vaccines, tell your care team right away if you are around someone with these viruses.

This medication may slow your child's growth if it is taken for a long time at high doses. Your care team will monitor your child's growth.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

This medication may increase blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes.

Do not treat yourself for coughs, colds or allergies without asking your care team for advice. Some nonprescription medications can affect this one.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Flu-like symptoms—fever, chills, muscle pain, cough, headache, fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness, fatigue, dizziness
• Muscle pain or cramps
• Pain, tingling, or numbness in the hands or feet
• Sinus pain or pressure around the face or forehead
• Thrush—white patches in the mouth
• Wheezing or trouble breathing that is worse after use

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in taste
• Cough
• Dry mouth
• Headache
• Hoarseness
• Sore throat
• Tremors or shaking
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep inhaler away from extreme heat. Get rid of it when the dose counter reads "000" or after the expiration date, whichever is first.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.