Drug Information for FLUTICASONE PROPIONATE Nasal Spray, 50 mcg (Roxane): Information for Patients

FLUTICASONE PROPIONATE

Nasal Spray, 50 mcg

Please read this leaflet carefully before you start to take your medicine. It provides a summary of information on your medicine. For further information ask your doctor or pharmacist.

WHAT YOU SHOULD KNOW ABOUT RHINITIS

Rhinitis is a word that means inflammation of the lining of the nose. If you suffer from rhinitis, your nose becomes stuffy and runny. Rhinitis can also make your nose itchy, and you may sneeze a lot. Rhinitis can be caused by allergies to pollen, animals, molds, or other materials - or it may have a nonallergic cause.

WHAT YOU SHOULD KNOW ABOUT FLUTICASONE PROPIONATE NASAL SPRAY

Your doctor has prescribed Fluticasone Propionate Nasal Spray, a medicine that can help treat your rhinitis. Fluticasone Propionate Nasal Spray contains fluticasone propionate, which is a synthetic corticosteroid. Corticosteroids are natural substances found in the body that help fight inflammation. When you spray fluticasone into your nose, it helps to reduce the symptoms of allergic reactions and the stuffiness, runniness, itching, and sneezing that can bother you.

THINGS TO REMEMBER ABOUT FLUTICASONE PROPIONATE NASAL SPRAY

• Shake gently before using.
• Use your nasal spray as directed by your doctor. The directions are on the pharmacy label.
• Keep your nasal spray out of the reach of children.

BEFORE USING YOUR NASAL SPRAY

• If you are pregnant (or intending to become pregnant),
• If you are breast-feeding a baby,
• If you are allergic to Fluticasone Propionate Nasal Spray or any other nasal corticosteroids,
• If you are taking a medicine containing ritonavir (commonly used to treat HIV infection or AIDS),

TELL YOUR DOCTOR BEFORE STARTING TO TAKE THIS MEDICINE. In some circumstances, this medicine may not be suitable and your doctor may wish to give you a different medicine. Make sure that your doctor knows what other medicines you are taking.

USING YOUR NASAL SPRAY

• Follow the instructions shown in the rest of this leaflet. If you have any problems, tell your doctor or pharmacist.
• It is important that you use it as directed by your doctor. The pharmacist’s label will usually tell you what dose to take and how often. If it doesn’t, or you are not sure, ask your doctor or pharmacist.

DOSAGE

• For ADULTS, the usual starting dosage is 2 sprays in each nostril once daily. Sometimes your doctor may recommend using 1 spray in each nostril twice a day (morning and evening). You should not use more than a total of 2 sprays in each nostril daily. After you have begun to feel better, 1 spray in each nostril daily may be adequate for you.
• For ADOLESCENTS and CHILDREN (4 years of age and older), the usual starting dosage is 1 spray in each nostril once daily. Sometimes your doctor may recommend using 2 sprays in each nostril daily. Then, after you have begun to feel better, 1 spray in each nostril daily may be adequate for you.
• DO NOT use more of your medicine or take it more often than your doctor advises.
• Fluticasone Propionate may begin to work within 12 hours of the first dose, but it takes several days of regular use to reach its greatest effect. It is important that you use Fluticasone Propionate Nasal Spray as prescribed by your doctor. Best results will be obtained by using the spray on a regular basis. If symptoms disappear, contact your doctor for further instructions.
• If you also have itchy, watery eyes, you should tell your doctor. You may be given an additional medication to treat your eyes. Be careful not to confuse them, particularly if the second medication is an eye drop.
• If you miss a dose, just take your regularly scheduled next dose when it is due. DO NOT DOUBLE the dose.

HOW TO USE YOUR NASAL SPRAY

Read the complete instructions carefully and use only as directed.

BEFORE USING

1. Shake the bottle gently and then remove the dust cap and the safety clip (Figure 1).

2. It is necessary to prime the pump into the air the first time it is used, or when you have not used it for a week or more. To prime the pump, hold the bottle as shown with the nasal applicator pointing away from you and with your forefinger and middle finger on either side of the nasal applicator and your thumb underneath the bottle. When you prime the pump for the first time, press down and release the pump six times (Figure 2).

The pump is now ready for use. If the pump is not used for 7 days, prime until a fine spray appears.

USING THE SPRAY

3. Blow your nose to clear your nostrils.

4. Close one nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril (Figure 3).

5. Start to breathe in through your nose, and WHILE BREATHING IN press firmly and quickly down once on the applicator to release the spray. To get a full actuation, use your forefinger and middle finger to spray while supporting the base of the bottle with your thumb. Avoid spraying in eyes. Breathe gently inwards through the nostril (Figure 4).

6. Breathe out through your mouth.

7. If a second spray is required in that nostril, repeat steps 4 though 6.

8. Repeat steps 4 through 7 in the other nostril.

9. Wipe the nasal applicator with a clean tissue and replace the dust cap and the safety clip (Figure 5).

10. Do not use this bottle for more than the labeled number of sprays even though the bottle is not completely empty. Before you throw the bottle away, you should consult your doctor to see if a refill is needed. Do not take extra doses or stop taking Fluticasone Propionate Nasal Spray without consulting your doctor.

CLEANING

Your nasal spray should be cleaned at least once a week. To do this:

1. Remove the dust cap and then gently pull upwards to free the nasal applicator.

2. Wash the applicator and dust cap under warm tap water. Allow to dry at room temperature, then place the applicator and dust cap back on the bottle.

3. If the nasal applicator becomes blocked, it can be removed as above and left to soak in warm water. Rinse with cold tap water, dry, and refit. Do not try to unblock the nasal applicator by inserting a pin or other sharp object.

Read the complete instructions carefully and use only as directed.

STORING YOUR NASAL SPRAY

• Keep you Fluticasone Propionate Nasal Spray out of the reach of children.
• Avoid spraying in eyes.
• Store between 4° and 30°C (39° and 86°F).
• Do not use your Fluticasone Propionate Nasal Spray after the date shown as “EXP” on the label or box.

REMEMBER: This medicine has been prescribed for you by your doctor. DO NOT give this medicine to anyone else.

FURTHER INFORMATION

This leaflet does not contain the complete information about your medicine. If you have any questions, or are not sure about something, then you should ask your doctor or pharmacist.

You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

10002064/01

Revised February 2005

© RLI, 2005