Product Information

Fluticasone and Salmeterol inhalation

What is this medicine?

FLUTICASONE; SALMETEROL inhalation is for treating asthma that is not controlled with other asthma medicines or when more than one treatment is necessary. Fluticasone is a corticosteroid which decreases inflammation in the lungs. Salmeterol helps open the airways in the lungs. This medicine is intended for regular use. It will not cure your condition, but when used regularly it can open up your air passages and make breathing easier. It will not relieve an acute asthma attack. Fluticasone; salmeterol can be used along with other inhaled or oral asthma medications.

What should I tell my health care provider before I take this medicine?

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

• an asthmatic attack or bronchospasm
• chicken pox or measles (recent exposure or infection)
• diabetes
• heart disease including high blood pressure, irregular heart beat, blockage in heart vessels
• immune system problems
• infection, especially fungal infection or tuberculosis
• liver disease
• osteoporosis or other bone disease
• overactive thyroid
• pheochromocytoma
• seizures
• an unusual or allergic reaction to Fluticasone, Salmeterol, other corticosteroids, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

DO NOT use this medicine for an asthma attack. If you have severe onset or worsening of cough, wheezing, chest tightness, and/or shortness of breath seek immediate medical attention. Always keep a short-acting asthma medication such as albuterol on hand for asthma attacks.

This medicine is for inhalation through the mouth. Shake the inhaler well for 5 seconds before each spray. Prime the inhaler before the first use with 4 test sprays pointing away from your face. If you drop the inhaler or of it has not been used for 4 weeks, prime it with 2 test sprays pointing away from your face. Avoid contact with eyes. After using the inhaler, rinse your mouth with water to minimize build-up of medicine; do not swallow the water. Clean your inhaler at least once a week. Never place the inhaler in water to determine how much medicine is in it. Do not use more than the recommended dose.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

NOTE: This medicine is only for you. Don't share it with others.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, take only that dose and continue with your regular schedule, spacing doses evenly. Do not use double or extra doses.

What may interact with this medicine?

• arsenic trioxide
• astemizole
• bepridil
• beta-blockers, often used for high blood pressure or heart problems
• caffeine
• certain antibiotics (such as clarithromycin, erythromycin, gatifloxacin, gemifloxacin, grepafloxacin, levofloxacin, linezolid, moxifloxacin, sparfloxacin)
• chloroquine
• cisapride
• droperidol
• halofantrine
• levomethadyl
• medicines for colds and breathing difficulties
• medicines for heart disease or high blood pressure
• medicines known as MAO inhibitors, such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), and selegiline (Carbex®, Eldepryl®)
• medicines to control heart rhythm (examples: amiodarone, disopyramide, dofetilide, flecainide, procainamide, quinidine, sotalol)
• medicines for treating depression or mental illness (amoxapine, haloperidol, maprotiline, pimozide, phenothiazines, risperidone, sertindole, tricyclic antidepressants, ziprasidone)
• methadone
• pentamidine
• probucol
• some medicines for weight loss (including some herbal products, ephedra, ephedrine, dextroamphetamine)
• steroid hormones such as dexamethasone, cortisone, hydrocortisone
• terfenadine
• theophylline
• thyroid hormones
• water pills or diuretics

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking this medicine?

Visit your prescriber or health care professional for regular checks on your progress. Carry an identification card with your name, the type and dose of medicine you are taking, and your prescriber's name and address. It can take up to 2 weeks before you see the full effect of this medicine.

Check with your prescriber or health care professional if your symptoms do not improve. Seek emergency medical attention if your breathing problems get worse quickly while taking this medicine, or if your rescue inhaler (like albuterol) does not help your breathing. If you find that you are using your rescue inhaler more than normal or it is not as effective in treating your symptoms, you should contact your health care professional as soon as possible. You may need a change of therapy or may be having worsening of your lung condition. Do not stop using this medicine except on your prescriber's advice.

Using your inhalers regularly as prescribed will help control your symptoms; try not to run out of your medications. It is recommended that you keep an extra refill of your inhalers on hand in case you need them.

Tell your prescriber or health care professional if you are exposed to anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

People who are taking certain dosages of this medicine may need to avoid getting certain vaccines or may need to have changes in their vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your prescriber or health care professional that you are taking fluticasone; salmeterol before receiving any vaccine.

If you are going to have surgery tell your prescriber or health care professional that you are using this medicine.

What side effects may I notice from this medicine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• chest pain
• dizziness or lightheadedness
• fever or chills
• skin rash and itching (hives)
• sore mouth with white patches in the mouth or throat
• troubled breathing or wheezing
• unusual swelling
• unusual tiredness or weakness
• vision problems
• vomiting

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

• coughing, hoarseness, throat irritation
• diarrhea
• headache
• nausea
• nervousness
• sore throat
• stomach upset
• stuffy nose

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15—30 degrees C (59—86 degrees F) with mouthpiece facing down. Keep away from heat or open flames. Discard canister after 120 sprays.