Flixonase nasal spray for the treatment and prevention of seasonal and permanent allergic rhinitis

Active ingredients

Each metered spray contains:

50 mcg fluticasone propionate.

Indications

Therapeutic group: corticosteroids.

Flixonase nasal spray is intended for prevention and treatment of seasonal allergic rhinitis, including hay fever and perennial rhinitis in adults and children from 4 years of age and above.

The active ingredient is fluticasone propionate, a corticosteroid with anti-inflammatory activity.

This spray helps control your body’s reactions to allergens in the environment.

Instructions

For intranasal use only. Do not swallow.

Always shake well before use.

Before using a new Flixonase nasal spray bottle:

Flixonase nasal spray has a cap which protects the nozzle and keeps it clean. Remember to take the cap off before using the spray. Before starting to use a new bottle of Flixonase nasal spray or if you did not use the spray for a few days, press the pump down a few times until a fine mist is obtained. Hold the bottle with the forefinger and middle finger supporting from either side of the nozzle and the thumb under the bottle. Without moving the thumb, press down with your fingers to pump the spray. While pressing, make sure that the spray nozzle is not facing you or any other person. If the spray still does not work, try to clean it. Do not use a pin or sharp object to try to open a blockage or to enlarge the hole in the spray nozzle, since this will ruin the spraying mechanism.

Using Flixonase nasal spray:

Shake the bottle well and take off the cap. Blow your nose gently. Close one nostril and insert the nozzle in the other nostril. Tilt your head slightly forward and keep the bottle upright. Start to breathe in slowly through your nose. While you are breathing in, spray a gentle spray into the nostril by firmly pressing down with your fingers on the collar of the nozzle. Remove the nozzle from this nostril and breathe out through your mouth. Repeat these steps for your other nostril.

After using the spray, carefully wipe the nozzle with a clean tissue or handkerchief, and close the spray with the cap.

Cleaning the spray:

Take off the cap and the nozzle. Soak the nozzle and cap in warm water for a few minutes and then rinse under running tap water. Shake the excess water off and let it dry. Put the nozzle back on. If necessary, press the pump a few times until a fine mist is obtained.

The usual dosage for adults and children over the age of 12, is generally:

Two actuations into each nostril, once a day - preferably in the morning. If the symptoms are particularly severe, you may need to spray two actuations in each nostril, twice a day, until the symptoms improve. When the symptoms improve, you can reduce the dosage to one actuation in each nostril, once a day. Do not exceed the maximum daily dosage of 4 sprays into each nostril.

The usual dosage for children ages 4 to 11, is generally:

One spray into each nostril once daily - preferably in the morning. Do not exceed the maximum daily dosage of 2 sprays into each nostril. Flixonase nasal spray is not for use in children for a period longer than 1 month.

Flixonase nasal spray quickly begins to reduce inflammation and swelling in your nose, although it may require 3 to 4 days to achieve its maximal protective activity. To prevent onset of symptoms, start using Flixonase before being exposed to one of your common allergens.

Use the lowest possible dosage to control your symptoms.

Try to use the spray in the morning hours.

If your symptoms do not improve or are not well controlled , or disease worsen after 7 days, consult your physician or pharmacist.

Do not exceed the recommended dose.

If you forgot to take the medicine do not take a double dose; take the next dose at the regular time.

Warnings

Do not use Flixonase nasal spray if you are sensitive (allergic) to the active ingredient or any of the additional ingredients contained in the medicine.

Do not use this medicine for children under 4 years of age.

Do not use this medicine without consulting a physician before starting treatment:

• If you are pregnant, planning to become pregnant or breastfeeding.
• If you have an infection in the nasal cavity or sinuses, if you have high fever or if you recently underwent surgery, suffered an injury or had ulcers in your nose.
• If your adrenal gland is underactive.

If the symptoms do not improve, or are not under control, after 7 days, consult your physician or pharmacist.

Contact the physician if you experience blurred vision or other visual disturbances, which can be the result of conditions such as cataract or glaucoma.

Do not use the spray for more than 3 consecutive months unless the physician has instructed you to do so.

If you are taking, or have recently taken, other medicines, including non-prescription medicines or nutritional supplements, inform the attending doctor or pharmacist, in order to prevent hazards or lack of efficacy arising from drug interactions, particularly if you are taking:

• Corticosteroids (including creams for eczema, inhalers for asthma, tablets, injections, nasal sprays and eye drops or nose drops).
• Ritonavir or cobicistat (medicines to treat HIV).
• Ketoconazole (to treat fungal infections).

Some medicines might increase the effect of Flixonase nasal spray, and therefore, if you are taking these medicines (including several medicines used to treat HIV: ritonavir, cobicistat), your physician may want to monitor your condition.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.