Seretide Disk (fluticasone + salmeterol)

Seretide Disk is used for:

Long-term treatment of asthma and chronic obstructive pulmonary disease (COPD) in certain patients. It may also be used to treat other breathing conditions as determined by your doctor.

Seretide Disk is a long-acting corticosteroid and bronchodilator combination. It works by reducing inflammation and widening the airways in the lungs, which helps you breath more easily.

Do NOT use Seretide Disk if:

• you are allergic to any ingredient in Seretide Disk or to milk proteins
• you are having an asthma attack (eg, sudden, severe onset or worsening of asthma symptoms such as chest tightness, cough, shortness of breath, wheezing)
• you are using another type of long-acting inhaled bronchodilator (eg, formoterol inhalation powder, salmeterol inhalation powder)
• you are taking an azole antifungal (eg, ketoconazole), certain HIV protease inhibitors (eg, ritonavir), a macrolide antibiotic (eg, clarithromycin), nefazodone, or telithromycin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Seretide Disk:

Some medical conditions may interact with Seretide Disk. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days
• if you have high blood acid levels (eg, ketoacidosis) or a history of diabetes, glaucoma, or increased pressure in the eye, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, nervous system problems, liver problems, low blood potassium levels, seizures, thyroid problems, or an adrenal gland tumor
• if you are having a COPD flare-up, have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack
• if you have a fungal, bacterial, or parasitic infection; a viral infection (eg, measles, chickenpox, shingles); herpes virus infection of the eye; tuberculosis (TB); a history of a positive TB skin test; or immune system problems; or if you have had a recent vaccination
• if you have weak bones (osteoporosis) or have risk factors for osteoporosis (eg, a family history of osteoporosis, tobacco use, long-term use of corticosteroids or certain seizure medicines, limited physical exercise, poor nutrition)

Some MEDICINES MAY INTERACT with Seretide Disk. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, hydrochlorothiazide, furosemide) or long-acting inhaled bronchodilators (eg, salmeterol inhalation powder, formoterol inhalation powder) because the risk of low blood potassium or irregular heartbeat may be increased
• Beta-blockers (eg, propranolol) because they may decrease Seretide Disk's effectiveness
• Azole antifungals (eg, ketoconazole), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), delavirdine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin), MAOIs (eg, phenelzine), nefazodone, short-acting beta-agonist bronchodilators (eg, albuterol), telithromycin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Seretide Disk's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Seretide Disk may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Seretide Disk:

Use Seretide Disk as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not use a spacer with Seretide Disk.
• Always ready and use this device in a level, flat position.
• Hold the device in one hand and put the thumb of your other hand on the thumb grip. Push your thumb away from you as far as it will go until the mouthpiece appears and snaps into position.
• Hold the device in a level, flat position with the mouthpiece toward you. Slide the lever away from you as far as it will go until it clicks.
• Do NOT close or tilt the device, play with the lever, or move the lever more than 1 time. This may release or waste extra doses.
• Hold the device away from your mouth and breathe out fully. Do NOT breathe into the inhaler. Put the mouthpiece to your lips. Breathe in quickly and deeply through the device.
• Remove the device from your mouth. Hold your breath for about 10 seconds, or as long as is comfortable. Then breathe out slowly.
• Close the device. Put your thumb on the thumb grip and slide it back toward you as far as it will go. The device will click shut and the lever will return to its original position.
• Your dose of medicine is a very fine powder. Most, but not all, patients can taste or feel the dose. Do NOT use another dose if you do not taste or feel the medicine. If you are not sure if you are receiving your dose, contact your doctor or pharmacist.
• Rinse your mouth with water after using Seretide Disk. DO NOT swallow the rinse solution. Spit the rinse water out.
• If you are using other inhaled medicines, wait a few minutes between using Seretide Disk and other inhalers, unless directed otherwise by your doctor.
• Take your doses of Seretide Disk about 12 hours apart, unless your doctor tells you otherwise.
• Never wash the mouthpiece or any other part of the inhaler. Keep it dry. Store Seretide Disk in a dry place.
• Throw Seretide Disk away 1 month after you remove it from the foil pouch, or after the dose indicator reads 0, whichever comes first.
• You may breathe more easily after the first dose of Seretide Disk. However, it may take 1 week or longer to achieve the most benefit.
• Use Seretide Disk on a regular schedule to get the most benefit from it. Using Seretide Disk at the same times each day will help you remember to use it. Do not stop using Seretide Disk even if you feel better unless your doctor tells you to.
• If you miss a dose of Seretide Disk, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Seretide Disk.

Important safety information:

• Seretide Disk may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Seretide Disk with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Seretide Disk will not stop an asthma attack once one has started. Be sure to carry a short-acting bronchodilator with you at all times to treat any breathing problems that may occur between doses of Seretide Disk (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
• If you have been regularly using a short-acting bronchodilator inhaler (eg, albuterol), talk with your doctor about how to use it with Seretide Disk. Short-acting bronchodilators are normally only used with Seretide Disk to treat breathing problems that may occur between doses.
• Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
• If your symptoms do not get better within 1 week or if they get worse after you start using Seretide Disk, check with your doctor.
• Tell your doctor or dentist that you take Seretide Disk before you receive any medical or dental care, emergency care, or surgery.
• Tell your doctor at once if you notice your short-acting bronchodilator inhaler does not work as well, if you need to use it more often (eg, more than 4 times a day for more than 2 days in a row, or 1 whole canister within 8 weeks' time), or if you have a decrease in your peak meter flow results.
• The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Seretide Disk in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Seretide Disk may sometimes causes severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator inhaler. Seek medical care at once if your breathing does not improve after you use the short-acting bronchodilator. Tell your doctor about this reaction.
• Use caution if you switch from an oral steroid (eg, prednisone) to Seretide Disk. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, a sudden asthma attack, or severe fluid or electrolyte loss. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor at once if you have contact with anyone who has these infection.
• Check with your doctor before you receive any vaccine while you are using Seretide Disk.
• Diabetes patients - Seretide Disk may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including lung function tests and eye exams, may be performed while you use Seretide Disk. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Seretide Disk with caution in the ELDERLY; they may be more sensitive to its effects, especially pneumonia, decreased bone density, and effects on the heart.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Seretide Disk.
• Seretide Disk should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Seretide Disk while you are pregnant. It is not known if Seretide Disk is found in breast milk. If you are or will be breast-feeding while you use Seretide Disk, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Seretide Disk:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; mild muscle or bone pain; nausea; nervousness; throat irritation; tremor; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes; blurred vision or other vision changes; chest pain; choking; fast or irregular heartbeat; hoarseness; numbness or tingling in hands or feet; seizures; severe muscle weakness, cramps, or spasms; severe or persistent bone pain; severe or persistent dizziness or headache; signs of infection (eg, fever, chills, persistent headache/sore throat, ear pain, increased mucus production or change in mucus color); swelling or tightness in the throat; trouble sleeping; unusual tiredness or weakness; vaginal odor or discharge; weight gain; white patches or sores on the tongue or mouth; worsening of asthma symptoms (eg, increased wheezing, coughing, chest tightness, shortness of breath).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

If OVERDOSE is suspected:

Contact your local poison control center or emergency room immediately. Symptoms may include chest pain; fainting; muscle cramping; seizures; severe muscle weakness; severe or persistent dizziness, headache, or trouble sleeping; unusually fast or irregular heartbeat.

Proper storage of Seretide Disk:

Store Seretide Disk between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Seretide Disk out of the reach of children and away from pets.

General information:

• If you have any questions about Seretide Disk, please talk with your doctor, pharmacist, or other health care provider.
• Seretide Disk is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Seretide Disk. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.