Read the entire package insert carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administering the medicine contained in this leaflet or those given by your pharmacist.
-Keep this leaflet, as you may have to read it again.
-If you need advice or more information, ask your pharmacist.
-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4
-You should see a doctor if it gets worse or does not get better after 7 days.
Contents of the leaflet
1.What is Flonase and what is it used for
What you need to know before you start using Flonase
3.How to use Flonase
4.Possible adverse effects
5.Conservation of Flonase
6.Contents of the packaging and additional information
1. What is Flonase and what is it used for
The active principle is fluticasone propionate, a corticoid that, when used daily, has an anti-inflammatory action. This nasal spray suspension helps control your body's reaction to allergens ("triggers") in the environment. Flonase is used in adults aged 18 and over to relieve the symptoms associated with allergic rhinitis caused by pollen and other airborne allergens such as allergy to pets, dust mites and fungal spores. Relieves symptoms such as sneezing, runny nose, itchy or stuffy nose, itchy and watery eyes, up to 24 hours. It can take 3 or 4 days to reach the maximum level of protection. It is therefore important to continue regular use to achieve maximum therapeutic benefit.
You should see a doctor if it gets worse or does not get better after 7 days.
2. What you need to know before you start using Flonase.
Do not use Flonase:
-If you are allergic to fluticasone propionate or any of the other components of this medicine (listed in Section 6).
Warnings and Precautions
Check with your doctor or pharmacist before you start using Flonase:
-If you are using medications containing steroids (including eczema creams, asthma inhalers, pills, injections, nasal sprays, or eye or nose drops)
-If you have an infection in your nose or sinuses, if you have a cold, fever or have recently had surgery, injuries or sores in your nose.
If your symptoms do not improve after 7 days, talk to your doctor.
Do not use the medicine continuously for more than 3 months unless your doctor tells you to.
When steroid nasal sprays are used at high doses, for prolonged periods, adverse reactions can occur due to absorption of the drug by the body. These effects are much less likely than with oral steroids and may vary in individual patients and between different steroid preparations.
Potential systemic effects may include Cushing's syndrome, cushingoid symptoms, adrenal inhibition, growth retardation in children and adolescents, cataracts, glaucoma and, more rarely, reduced bone mineral density, effects on glucose metabolism, and a range of psychological and behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (especially in children).
Treatment with higher than recommended doses of nasal steroids may result in clinically significant adrenal suppression. If there is evidence of use of higher than recommended doses, additional coverage with systemic steroids during periods of stress or elective surgery should be considered.
Use of Flonase with other medications
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medications, especially:
-Medicines containing steroids (including eczema creams, asthma inhalers, tablets, injections, nasal sprays, or nose or eye drops)
-ritonavir,( an HIV drug)
-ketoconazole (for fungal infections).
Use of Flonase with food and drinks.
You can use Flonase at any time of day, with or without food.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you might be pregnant, or plan to become pregnant, talk to your doctor or pharmacist before using this medication. There are no data on the effects of this drug on fertility.
Driving and use of machines.
Flonase is not likely to affect your ability to drive or use tools or machines.
Flonase can cause bronchospasm (sudden choking sensation) as well as irritation and, especially for long-term use, oedema of the nasal mucosa, because it contains benzalkonium chloride.
3. How to use Flonase
Follow exactly the instructions for administering the medicine contained in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Adults from 18 years old:
The recommended dose is two sprays in each nostril once a day (200 micrograms of fluticasone propionate), ideally in the morning.
Once your symptoms have improved, you can reduce the dose to a spray in each nostril once a day.
If your symptoms are especially strong, you may need to apply two sprays to each nostril twice a day until your symptoms improve, but this is only for short-term use.
-Do not apply more than 8 sprays (4 sprays per nostril) per day
-Use the lowest possible dose to control your symptoms.
-If your symptoms do not improve, or are not well controlled after 7 days, consult your doctor or pharmacist.
-Don't use more than the recommended dose.
Use in children and adolescents:
This medicine should not be used in children or adolescents under 18 years of age.
Form of administration
Use only on the nose.
Do not ingest.
Do not spray in the eyes.
Before using a new bottle of Flonase:
The Flonase sprayer has a cap that protects the nozzle and keeps it clean. Remember to remove it before using the sprayer
Before starting a new bottle of Flonase, or if you haven't used it in a few days, prime the device (press the spraying device several times) to make sure you get the right dose.
Hold the bottle with your thumb underneath and your index and middle fingers on the neck on either side of the mouthpiece. Holding your thumb steady, press down with your fingers several times until a fine spray is obtained.
When doing this, be sure not to point the nozzle at yourself or others.
If the sprayer still does not work, try cleaning it as described in the "cleaning the sprayer" section. Do not try to unblock or enlarge the small spray hole with a needle or other sharp object as this will damage the sprayer mechanism.
Use of Flonase:
- Blow your nose gently.
- Shake the bottle well and remove the protective cap.
- If this is a new bottle of Flonase, or if you have not used the sprayer in a few days, you will need to prime the device.
Press down the spraying device several times until a fine spray is obtained.
- Hold the bottle as shown in Figure 3. Place the mouthpiece in one nostril and cover the other,
- Tilt your head forward slightly and keep the bottle straight.
Aim slightly away from the center of your nose.
- Start breathing in slowly through your nose.
While breathing in, press firmly on the neck of the spray with your fingers to project a spray into your nose
- Exhale through your mouth. Repeat step 4 to apply a second spray in the same nostril.
- Remove the mouthpiece from the nostril on which you have already applied the medication and breathe out through your mouth
- Repeat steps 4-6 on the other nostril.
- After using the sprayer, carefully wipe the nozzle with a clean tissue and replace the protective cap.
Cleaning the sprayer:
- Remove the protective cap and nozzle
- Immerse the nozzle and protective cap in warm water for a few minutes (Figure 7) and then rinse under running water
- Shake off excess water and let dry in a warm place - not too hot!
- Retighten the nozzle on the sprayer (Figure 9).
- If necessary, press down the spraying device several times until a fine spray is obtained.
Replace the protective cover.
- Do not try to unblock or enlarge the small spray hole with a needle or other sharp object as this will damage the sprayer mechanism.
It can take 3 or 4 days to reach the maximum level of protection provided by Flonase. To prevent symptoms, start using Flonase before exposure to your usual "triggers.
You should not use Flonase for longer than you are exposed to your usual "triggers" (e.g. pollen).
If you use more Flonase than you should
Talk to your doctor if you use more Flonase than recommended.
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to use Flonase
If you miss a dose, simply use the next one when due. Do not use a double dose to make up for a missed dose.
If you have any other questions about using this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medications, this drug can produce adverse effects, although not everyone suffers from them
When high-dose nasal corticosteroid sprays are used for long periods of time, adverse effects can occur due to absorption of the drug by the body.
Very rare but very serious adverse effects, seek medical help immediately.
- Signs of an allergic reaction, such as a skin rash, swelling of the mouth or face, or difficulty breathing
- Changes in vision that develop after starting to use this product.
Rare cases of eye problems such as cataracts or glaucoma have been reported in people who have used large amounts of steroids over a period of several years.
- Small holes (perforations) in the nasal septum
If you develop any of these symptoms, stop taking the medication and seek medical help immediately.
Other very rare adverse effects
They can affect up to 1 in 10,000 people
- Eye problems, such as pain or blurred vision
- Nasal problems such as pain and/or persistent bleeding
If you experience any of these symptoms, stop taking the medication and seek medical help.
Frequent adverse effects
Can affect up to 1 in 10 people
- Sneezes after using the spray. These cease soon.
- Perceive an unpleasant smell or taste.
- Dryness or irritation of the nose or throat
- Headache.
Very frequent adverse effects
They affect more than 1 in 10 people
-Occasional nosebleeds
Communication of adverse effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
You can also communicate them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es
. By reporting adverse effects you can help provide more information about the safety of this medicine.
5. Conservation of Flonase
Keep out of sight and reach of children.
Do not use this medicine after the expiration date shown on the bottle after "CAD".
The expiration date is the last day of the month indicated.
Do not store above 30°C ̊C.
Medications should not be thrown down the drain or in the trash.
Deposit unneeded containers and medication at the pharmacy's Sigre Point. If in doubt, ask your pharmacist how to dispose of packaging and medicines you do not need
. In this way, you will help protect the environment.
6. Package contents and additional information
Composition of Flonase
-The active ingredient is fluticasone propionate. Each spray releases 100 mg of suspension containing 50 micrograms of fluticasone propionate as the emitted dose.
-The other components (excipients) are glucose (anhydrous), microcrystalline cellulose, sodium carmellose, phenylethanol, benzalkonium chloride, polysorbate 80 and purified water.
Product appearance and package contents
Flonase is a white, opaque, watery nasal spray suspension
The amber glass bottle is equipped with a spraying device, nasal applicator and protective cap. The bottle contains 60 sprays, with a total content of not less than 7.0g .
