Patient Medication Information: uses, side effects, how to take - Nu-Fluticasone
ABOUT THIS MEDICATION
What the medication is used for:
NU-FLUTICASONE Nasal Spray is used to treat seasonal allergic rhinitis (including hay fever) and perennial rhinitis. Symptoms of these conditions include pain and pressure around the nose and eyes (sinuses), itching, a blocked up feeling in the nose and excessive sneezing.
What it does:
NU-FLUTICASONE reduces the irritation and inflammation in the lining of the nose and nasal passages and so it relieves the pain and pressure around the nose and eyes, the blocked up feeling in the nose, the runny nose itching and sneezing.
When it should not be used:
Do not use NU-FLUTICASONE if any of the following applies to you:
- If you have a known allergy to fluticasone propionate or any of the ingredients used to make NU-FLUTICASONE Nasal Spray (see "What the important non-medicinal ingredients are").
- If you have untreated fungal bacterial or tuberculosis infections of the respiratory tract.
What the medicinal ingredient is:
Fluticasone Propionate
What the important nonmedicinal ingredients are: Benzalkonium chloride (as a preservative), dextrose mono-hydrate, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol, polysorbate 80 and purified water.
What dosage form it comes in:
NU-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 NU-FLUTICASONE Nasal Spray contains 50 mcg of fluticasone propionate.
NU-FLUTICASONE Nasal Spray is available in amber glass bottles of 16 g net weight (120 metered sprays).
WARNINGS AND PRECAUTIONS
Follow the 'Instructions for Use' found in the Proper Use Of This Medications Section, found below. If you have any problems tell your doctor or pharmacist.
Important Points to Remember
- Have you ever had to stop taking other medicines for this illness because you were allergic to it or it caused problems? If the answer is YES, tell your doctor as soon as possible if you have not already done so.
- Tell your doctor if you notice any discharge from your nose is yellow or green if you have not already done so.
- If your symptoms have not improved after three weeks of treatment with NU-FLUTICASONE Nasal Spray then tell your doctor.
- Please talk to your doctor for continuous treatment with NU-FLUTICASONE, especially for children under 12 years of age.
- NU-FLUTICASONE is not recommended for children below 4 years of age.
Please tell your doctor if you are pregnant or plan on becoming pregnant or if you are breast feeding a baby. Your doctor may decide not to prescribe this medicine in these circumstances.
INTERACTIONS WITH THIS MEDICATION
Make sure your doctor knows what other medication you are taking (such as those for allergies, nervousness, depression, migraine etc.), including those you can buy without a prescription as well as herbal and alternative medicines.
Due to the interaction between Ritonavir (a medicine used to treat HIV infection or AIDS) with either intranasal or inhaled fluticasone propionate, it is important that your doctor knows that you are taking Ritonavir.
PROPER USE OF THIS MEDICATION
It is important that you inhale each dose through the nose as instructed by your doctor or nurse. The label will usually tell you how many doses to take and how often. If it does not, or if you are not sure, ask your doctor or pharmacist.
- DO NOT inhale more doses or use your nasal spray more often than your doctor advises.
- It takes a few days for this medication to work. It is very important that you use it regularly. Do not stop treatment even if you feel better unless told to do so by your doctor.
Usual dose:
Adults and Children 12 years of age and older:
The usual dosage is 2 sprays (2 x 50 micrograms) in each nostril once a day in the morning. Your doctor may advise you to increase this to 2 sprays (2 x 50 micrograms) in each nostril twice a day.
Children 4-11 years of age:
The usual dosage is one spray (50 micrograms) in each nostril once a day in the morning. Your doctor may advise you to increase this to 2 sprays (2 x 50 micrograms) in each nostril, once a day.
Overdose: Tell your doctor if you have used more than you were told to use.
Missed Dose: If you miss a dose, do not worry; take a dose when you remember and take the next dose when it is due.
Instructions for use of NU-FLUTICASONE Nasal Spray
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 NU-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
Occasionally you may sneeze a little after using this spray but this soon stops. You may experience an unpleasant taste or smell.
If you feel unwell or have any other problems tell your doctor and follow the advice given.
| 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 call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Nose or throat pain | 3 | ||
| Nose bleed | 3 | |||
| Eye pain, blurred vision | 3 | |||
| Rare | Sudden wheeziness and chest pain or tightness | 3 | ||
| Swelling of the eyelids, face or lips | 3 | |||
| Lumpy skin rash or 'hives' anywhere on the body | 3 | |||
This is not a complete list of side effects. For any unexpected effects while taking NU-FLUTICASONE Nasal Spray, contact your doctor or pharmacist.
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HOW TO STORE IT
NU-FLUTICASONE Nasal Spray should be stored at room temperature 15-30˚C (59 – 86˚F). Shake gently before use. Keep out of reach of children. If your doctor decides to stop your treatment, do not keep any left over medicine unless your doctor tells you to.
MORE INFORMATION
REMEMBER that this medication is for YOU. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.
If you have any further questions or are not sure about anything, then you should ask your doctor or pharmacist.
You may want to read this leaflet again. PLEASE DO NOT THROW IT AWAY until you have finished your medication.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Nu-Pharm Inc. at:
1-800-267-1438
Last revised: October 15, 2009.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health product to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free to 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you should require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.