Apo-Fluticasone: Uses, Side Effects and Dosage

What is APO-FLUTICASONE used for?

APO-FLUTICASONE is used in children and adolescents (4 to 17 years of age) to relieve:

• seasonal (i.e., hay fever) and year-round allergy symptoms caused by pollen, mold, dust and pets. Symptoms of allergy include: sneezing, itchy nose and throat, runny nose and itchy, watery eyes.
• nasal congestion and sinus pain and pressure.

How does APO-FLUTICASONE work?

APO-FLUTICASONE works directly within your nose and nasal passages to help reduce your allergic reaction at the source to relieve the symptoms that make you uncomfortable.

APO-FLUTICASONE controls several key inflammatory substances (i.e., histamine, chemokines, leukotrienes, cytokines, tryptases and prostaglandins) your body releases when you have an allergic reaction. In contrast, most non-prescription allergy medications will only act on one of these substances (i.e., histamine).

Because of the way it works, it may take several days for APO-FLUTICASONE to reach maximum effect. That’s why it’s best to use APO-FLUTICASONE regularly, as directed.

What are the ingredients in APO-FLUTICASONE?

Medicinal ingredients: Fluticasone propionate

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

APO-FLUTICASONE comes in the following dosage forms:

APO-FLUTICASONE comes in a nasal spray device that delivers 120 sprays. Each spray delivers a mist containing 50 mcg of fluticasone propionate.

Do not use APO-FLUTICASONE if:

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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-FLUTICASONE. Talk about any health conditions or problems you may have, including if you:

• Are pregnant (or planning to become pregnant).

• Are breastfeeding a baby.
• Take a medicine for HIV infection (such as ritonavir).
• Suffer from severe liver disease.
• Have been exposed to chickenpox or measles.
• Have a problem with your thyroid.
• 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.
• 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 asthma.
• Have or had a history of any eye disorder such as glaucoma (increased pressure in the eye) or cataracts (clouding of the lens in the eye).
• Have an eye infection caused by herpes.

Other warnings you should know about:

• You should avoid coming into contact with measles, chickenpox or tuberculosis while taking APO-FLUTICASONE. If you are exposed, tell your healthcare professional.

• Medicines 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 healthcare professional if you experience blurry vision or other vision problems. You should have regular eye exams.

• APO-FLUTICASONE is not recommended for continuous, long-term treatment in children under 12 years of age.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with APO-FLUTICASONE:

• Ritonavir (a medicine used to treat HIV infection or AIDS).
• Ketoconazole (a medicine used to treat fungal infections).
• Acetylsalicylic acid (a medicine for pain and fever relief).

How to take APO-FLUTICASONE:

• 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 prescribed by your healthcare professional.
• Do not take more of your medicine or take it more often than your healthcare professional tells you.

BEFORE USING

1. 1. Shake the bottle gently, then remove the dust cover by gently squeezing the ribs between your finger and thumb and lifting off.
2. 2. Hold the spray as shown with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle.
3. 3. 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

1. down several times as shown until a fine mist comes out of the nozzle.

USING THE SPRAY

1. 4. Blow your nose gently.
2. 5. 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.
3. 6. Start to breathe in through your nose and WHILE BREATHING IN press down with your fingers ONCE to release one spray.
4. 7. Breathe out through your mouth. If a second spray in that nostril is required repeat steps 6 and 7.
5. 8. Repeat 5, 6, and 7 for the other nostril.

AFTER USE

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

CLEANING

1. 10. Gently pull off the nozzle. Wash it in warm water.
2. 11. Shake off excess water and allow to dry in a warm place but avoid excessive heat.
3. 12. Gently push the nozzle back on top of the brown bottle. Replace the dust cover.
4. 13. 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.

Usual dose:

For adolescents (12 to 17 years of age):

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 (4 to 11 years of age):

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 healthcare professional may increase your dose to the maximum daily dose.

You may be tempted to stop using APO-FLUTICASONE when you start to feel better. It’s important you keep using APO-FLUTICASONE daily as long as you’re exposed to allergens that bother you, like pollen, mold, dust or pet dander. This way you’ll keep feeling relief. For seasonal allergies, APO-FLUTICASONE works best if it is started before the exposure to allergens occurs.

If your symptoms do not improve within 3 weeks of starting use or you get new symptoms such as severe facial pain or thick nasal discharge you may have something more than allergies, such as an infection. You should stop treatment and speak with your healthcare professional.

If you suffer allergy symptoms only during certain times, like when pollen levels are high, you may stop using APO-FLUTICASONE when that time ends.

If you have any difficulties or you are unsure about how or when to take APO-FLUTICASONE, check with your healthcare professional.

Overdose:

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.

What are possible side effects from using APO-FLUTICASONE?

These are not all the possible side effects you may have when taking APO-FLUTICASONE. If you experience any side effects not listed here, tell your healthcare professional.

Serious side effects are rare with APO-FLUTICASONE because it works in your nose and nasal passages. Very little of it travels through your body. However, like all medicines, APO-FLUTICASONE can cause side effects in some people.

Side effects with APO-FLUTICASONE may include:

• A dry, irritated or burning sensation in your nose
• Nosebleeds (you may also get streaks of blood when you blow your nose)
• Sneezing, runny nose, congestion
• Soreness, or sores in your nose or mouth
• Headache
• Dry or irritated eyes, blurred vision
• Unpleasant or 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, if you have surgery on your nose, or if your nose has been injured.
• Slower healing of wounds. Do not use APO-FLUTICASONE until your nose has healed if you have a sore in your nose.
• 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 sprays. Slower growth in adolescents (12 to 17 years of age) may occur with use of corticosteroid nasal sprays. Your healthcare professional should monitor your growth regularly if you are in these age groups.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store at room temperature (15°C - 30°C). Shake gently before use.
• Do not use APO-FLUTICASONE after the expiry date shown on the packaging.
• Keep out of the reach and sight of children.

If you want more information about APO-FLUTICASONE:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Website:

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: MAR 17, 2025