Consumer Information for: APO-FLUTICASONE

What the medication is used for

APO-FLUTICASONE is used to treat:

seasonal allergic rhinitis (including hay fever)
perennial (year-round) rhinitis
Sinus pain and pressure associated with allergic rhinitis

What it does

When you spray APO-FLUTICASONE into your nose it helps reduce the following symptoms associated with rhinitis:

stuffy nose,
runny nose,
itchy nose,
sneezing,
eye redness,
itchy and watery eyes

When it should not be used

When it should not be used:

if you are allergic to fluticasone propionate or any of the other ingredients in APO- FLUTICASONE
if you have an untreated:
- fungal (yeast) infection
- bacterial infection
- tuberculosis infection of your respiratory tract

What the medicinal ingredient is

fluticasone propionate

What the non-medicinal ingredients are

Benzalkonium chloride (as a preservative), carboxymethylcellulose sodium, dextrose monohydrate, microcrystalline cellulose and phenylethyl alcohol, polysorbate 80 and purified water.

What dosage form it comes in

APO-FLUTICASONE Nasal Spray is a white to off- white, milky suspension for topical administration to the nasal mucosa by means of a metering atomizing spray pump.

Each metered dose of APO-FLUTICASONE Nasal Spray contains 50 mcg of fluticasone propionate.

APO-FLUTICASONE Nasal Spray is available in amber glass bottles of 16 g net weight (120 metered sprays).

Warnings and precautions

Serious Warnings and Precautions

Before you use APO-FLUTICASONE talk to your doctor or pharmacist if you:

Are pregnant or planning to become pregnant.
Are breastfeeding a baby.
Take a medicine for HIV infection (such as ritonavir).
Are allergic to any other corticosteroid.
Have severe liver disease.
Have been exposed to chickenpox or measles.
Have thyroid problems.
Have yellow or green discharge from your nose.
Have a fever or a nasal or sinus infection
Are recovering from recent surgery, trauma or ulcers in your nose.
Have a history of nose bleeds.
Are taking or have previously taken other steroids either as an injection or by mouth.
Have a blood clotting problem AND are taking Acetylsalicylic Acid (ASA).
Have a history of allergic reactions.
Are less than 4 years old.

You should avoid coming into contact with people who have measles or chickenpox while taking APO- FLUTICASONE. If you are exposed, tell your doctor right away.

Drugs like APO-FLUTICASONE can cause eye disorders:

Cataracts: clouding of the lens in the eye, blurry vision, eye pain;
Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
Detached retina: blurry vision, dark area in your vision or other changes in vision.

Contact your doctor if you experience blurry vision or other vision problems. You should have regular eye exams.

In children under 12 years of age, it is not recommended to use APO-FLUTICASONE for continuous, long-term treatment.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Drugs that may interact with APO-FLUTICASONE include:

Ritonavir used to treat HIV/ AIDS.
Ketoconazole used to treat fungal infections.
Acetylsalicylic acid used for pain and fever relief.

Proper use of this medication

APO-FLUTICASONE:

is for use in the nose only. Do NOT spray it in your eyes or mouth
takes 2-3 days to work. Take it each day without missing a dose to get the best results.

Take APO-FLUTICASONE exactly as recommended by your doctor. If you have any difficulties or you are unsure about how or when to take APO- FLUTICASONE, check with your doctor or pharmacist. Do not take more of your medicine or take it more often than your doctor tells you.

For seasonal allergic rhinitis, APO-FLUTICASONE works best if it is started before you are exposed to allergens. You should work with your doctor to determine the best time to start taking APO-FLUTICASONE.

If your symptoms have not improved after 3 weeks of taking APO-FLUTICASONE tell your doctor. Do not stop treatment even if you feel better unless told to do so by your doctor.

Usual Dose

For adolescents aged 12 – 17 years:
Recommended daily dose: 2 sprays into each nostril, once a day (200 mcg a day)
Maximum daily dose: 2 sprays into each nostril, twice a day (400 mcg a day)

For children aged 4-11 years:
Recommended daily dose: 1 spray into each nostril once a day (100 mcg a day)
Maximum daily dose: 2 sprays into each nostril, once a day (200 mcg a day)

Depending on how APO-FLUTICASONE is working for you, your doctor may increase your dose to the maximum daily dose.

Overdose

If you think you have taken too much APO- FLUTICASONE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you have taken larger doses than instructed for a long period of time, you should ask your doctor or pharmacist for advice.

Missed Dose

If you miss a dose, take your next dose at the usual time. Do NOT double the dose or take extra doses to make up for the missed one.

Instructions for use:

BEFORE USING

A. Shake the bottle gently, then remove the dust cover by gently squeezing the ribs between your finger and thumb and lifting off.

B. Hold the spray as shown with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle.

C. If using APO-FLUTICASONE Nasal Spray for the first time or if you have not used it for a week or more test the spray as follows: with the nozzle pointing away from you, press down several times as shown until a fine mist comes out of the nozzle.

USING THE SPRAY

D. Blow your nose gently.

E. Close one nostril as shown in the diagram and put the nozzle in the other nostril. Tilt your head forward slightly and keep the spray upright.

F. Start to breathe in through your nose and WHILE BREATHING IN press down with your fingers ONCE to release one spray.

G. Breathe out through your mouth. If a second spray in that nostril is required repeat steps F and G.

H. Repeat E, F, and G for the other nostril.

AFTER USE

I. Wipe the nozzle with a tissue or handkerchief and replace the cover.

CLEANING
J. Gently pull off the nozzle. Wash it in warm water.

K. Shake off excess water and allow to dry in a warm place but avoid excessive heat.

L. Gently push the nozzle back on top of the brown bottle. Replace the dust cover.

M. If the nozzle becomes blocked it can be removed as above and left to soak in warm water. Rinse under a cold tap, allow to dry and refit. Do not try to unblock the nozzle by inserting a pin or other sharp objects.

Side effects and what to do about them

Side effects may include:

A dry, irritated or burning sensation in your nose (you may also get streaks of blood when you blow your nose)
Nosebleeds
Sneezing, runny nose, congestion
Soreness, or sores in your nose or mouth
Headache
Dry or irritated eyes, blurred vision
Change in sense of taste and/or smell
Sore throat, throat irritation, dryness, hoarseness or cough
You get a constant whistling sound from your nose. This may be a sign of damage inside your nose.

Side effects that may occur with the use of corticosteroid nasal sprays are:

Slower healing of wounds. Do not use APO- FLUTICASONE until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.
Worsening of the symptoms of infections such as existing tuberculosis, fungal, bacterial or parasitic infections or herpes of the eye.
Slower growth in children has occurred with use of corticosteroid nasal spray. Slower growth in adolescents (12-17 years of age) may occur with use of corticosteroid nasal sprays. Your physician should monitor your growth regularly if you are in these age groups.

APO-FLUTICASONE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them
Symptom / effect	Talk to your healthcare professional In all cases	Stop taking drug and get immediate medical help
Rare
Psychological or Behavioural: Anxiety, depression or aggression, restlessness or trouble sleeping may occur, especially in children.		✔
Very Rare
Allergic Reactions: chest pain or tightness, wheezing, coughing or having difficulty breathing, suddenly feeling weak or lightheaded (which may lead to collapse or loss of consciousness), swelling around the face, mouth or tongue, eyes or lips with difficulty swallowing, skin rashes (hives) or redness.		✔
Unknown
Cushing’s Syndrome: Rapid weight gain especially around the body and face. Round “moon” face, excess sweating; thinning of the skin with easy bruising and dryness; muscle and bone weakness.	✔
Decreased Adrenal Function: tiredness, weakness, nausea and vomiting.	✔
Osteonecrosis (tiny breaks in a bone leading to eventual collapse): Progressive or persistent pain or limited range of motion in a joint or limb.	✔
Cataracts: Clouding of the lens in the eye, blurry vision, and/or eye pain.	✔
Glaucoma: increased pressure in your eyes, eye pain.		✔

This is not a complete list of side effects. For any unexpected effects while taking APO-FLUTICASONE, contact your doctor or pharmacist.

How to store

Store at room temperature 15°C-30°C. Shake gently before use. Do not use APO-FLUTICASONE after the expiry date shown on the pack.

Keep out of the reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
Call toll-free at 1-866-234-2345

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about APO- FLUTICASONE:

Talk to your doctor or pharmacist.
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada Website. Find the Consumer Information on the manufacturer’s website or by calling 1- 800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.

Last revised: May 19, 2020

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