Allegro

Active Ingredients

Fluticasone propionate 0.05% w/w.

Each metered dose contains:

50 mcg fluticasone propionate.

Indications

Therapeutic group:

Corticosteroids

The active ingredient is fluticasone propionate, a corticosteroid with anti-inflammatory activity. Allegro nasal spray helps control your body’s reactions to allergens in the environment.

Allegro 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.

Instructions

Do not swallow.For intranasal use only.

Always shake well before use.

Before using a new Allegro nasal spray bottle:

Allegro 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 Allegro 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.

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.

Directions for using Allegro 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. Hold the bottle. 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. Breathe out through your mouth. Repeat the step to spray a second spray into the same nostril. Remove the nozzle from this nostril and breathe out through your mouth. Repeat the 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.

Allegro 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 Allegro nasal spray before being exposed to any of your common allergens.

Try to use the spray in the morning hours.

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

Two actuations into each nostril, once a day. When the symptoms improve, you can reduce the dosage to one actuation in each nostril, once a day. If the symptoms are particularly severe, you may need to spray two actuations in each nostril, twice a day,until the symptoms improve.

Do not use more than 8 actuations (4 times in each nostril) (400 mcg) per day.

Use the lowest possible dosage to control your symptoms.

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

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

The usual starting dosage is one actuation per day in each nostril, preferably in the morning.

The maximal dosage is 4 actuations (2 actuations in each nostril) per day.

Allegro nasal spray is not for use in children for a period longer than one month.

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 Allegro 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 if you are under 4 years of age.

Before using Allegro nasal spray, tell the physician if you have an infectionin your nose or sinuses, if you have high feveror if you recently underwent surgery,suffered an injuryor had ulcersin your nose.

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 monthsunless the physician has instructed you to do so.

The medicine is intended for adults and children over 4 years of age.

If you are taking or have recently taken other medicines, including non-prescription medicines and nutritional supplements, tell the physician or pharmacist,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 Allegro 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.

If you are pregnant, planning to become pregnant or breastfeeding,consult the physician or pharmacist before using this medicine.

Allegro Nasal Spray contains benzalkonium chloridewhich may cause breathing problems (bronchospasm).

Each pack contains a bottle with a pump containing 15 ml which are 120 metered doses.

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.