Patient Medication Information: uses, side effects, how to take - Teva-Fluticasone
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-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 TEVA-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:
- if you are allergic to fluticasone propionate or any of the other ingredients in TEVA-FLUTICASONE.
if you have an untreated:
- fungal (yeast)
- bacterial infection
- tuberculosis infection of your respiratory tract.
What the medicinal ingredient is:
fluticasone propionate
What the nonmedicinal ingredients are:
Benzalkonium chloride, carboxymethylcellulose sodium, dextrose, microcrystalline cellulose, phenylethyl alcohol, Polysorbate 80, and water for injection.
What dosage forms it comes in:
Nasal spray: 50 mcg per spray (120 metered doses per device)
WARNINGS AND PRECAUTIONS
Before you use TEVA-FLUTICASONE talk to your doctor or pharmacist if you:
Are pregnant or planning to become pregnant.
- Are breastfeeding.
- 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.
- 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 TEVA-FLUTICASONE. If you are exposed, tell your doctor right away.
Drugs like TEVA-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.
You should have regular eye exams.
In children under 12 years of age, it is not recommended to use TEVA-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 TEVA-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

TEVA-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 TEVA-FLUTICASONE exactly as recommended by your doctor. If you have any difficulties or you are unsure about how or when to take TEVA-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, TEVA-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 TEVA-FLUTICASONE.
If your symptoms have not improved after 3 weeks of taking TEVA-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 TEVA-FLUTICASONE is working for you, your doctor may increase your dose to the maximum daily dose.
Overdose:
| If you think you, or a person you are caring for, have taken too much TEVA-FLUTICASONE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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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:
Parts of your TEVA-FLUTICASONE nasal spray:
The Dust Cover:
- Protects the nozzle and keeps it clean.
- Remember to take this off before using the spray.
- Do not throw the cover away. Always keep the cover on when you are not using the device.
The Nozzle will fit comfortably inside your nose. The medicine comes out from the nozzle.
Before Using your TEVA-FLUTICASONE nasal spray:
Your TEVA-FLUTICASONE nasal spray must be primed if you:
- are using it for the first time.
- have not used it for a few days.
- have just cleaned it.
How to prime your TEVA-FLUTICASONE nasal spray:
- 1.
Shake the bottle gently, then remove the dust cover by gently squeezing the ribs between your finger and thumb and lifting off (Figure 1).
Figure 1
- 2.
Hold the bottle (as shown) with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle (Figure 2).
Figure 2


- 3. With the nozzle pointing away from you, press down and release several times until a fine mist comes out of the nozzle (Figure 2).
- 4. The nasal spray is now ready to use.
How to use TEVA-FLUTICASONE:
Shake gently before each use.
Step 1: Blow your nose gently to clear your nostrils.
Step 2: Close one nostril. Tilt your head forward slightly. Keeping the bottle upright, carefully insert the nozzle into the other nostril (Figure 3).

Step 3: Start to breathe in through your nose and WHILE BREATHING IN press firmly and quickly down with your fingers 1 time to release the spray.
Figure 3
Step 4: Breathe out through your mouth.
Step 5: If a second spray in that nostril is required, repeat steps 2, 3 and 4.
Step 6: Repeat 2, 3, and 4 for the other nostril (Figure 4).
Figure 4
Step 7: Wipe the nozzle with a clean tissue or handkerchief and replace the dust cover (Figure 5)
Figure 5
Cleaning your TEVA-FLUTICASONE nasal spray
Your nasal spray should be cleaned at least once a week.
- 1. Remove the dust cover and then gently pull off the nozzle by pulling upwards.
- 2.
Wash the nozzle under warm tap water.
Shake off excess water and allow it to dry at room temperature.
- 3. Gently push the nozzle back on top of the bottle. Replace the dust cover.
- 4. If the nozzle becomes blocked it can be removed and left to soak in warm water. Rinse it under a cold tap, allow to dry and place it back on the bottle. 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

Side effects that may occur with the use of corticosteroid nasal sprays are:
- Slower healing of wounds. Do not use TEVA-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.
TEVA-FLUTICASONE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||||||||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||||||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek emergency medical assistance | |||||||||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek emergency medical assistance | |||||||||||||
| Only if severe | In all cases | ||||||||||||||
| Only if severe | In all cases | ||||||||||||||
| 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 TEVA-FLUTICASONE, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 4°C and 30°C. Store in original carton. Do not use TEVA-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:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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MORE INFORMATION
This document plus the full Product Monograph prepared for health professionals can be found by contacting Teva Canada Limited at:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
