FLIXONASE Nasal Spray, Suspension 60 ml

Flixonase 50 micrograms / dose

nasal spray, suspension

fluticasone propionas

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

- Always use this medicine exactly in accordance with the package leaflet or as directed by your pharmacist.

- Keep the package leaflet in case you need to read it again.

- Ask your pharmacist if you need more information or advice.

- If any of the side effects gets serious, tell your doctor or pharmacist. Do the same for any side effects not listed in this leaflet. See point 4.

- If you do not feel better within 7 days or if you get sick, you should consult a doctor.

What you will find in the package leaflet

1. What Flixonase is and what it is used for

2. What to do before you start using Flixonase

3. How to use Flixonase

4. Possible side effects

5. How to store Flixonase

6. Package contents and other information

1. WHAT FLIXONASE IS AND WHAT IT IS USED FOR

The active substance is fluticasone propionate, a corticosteroid that has an anti-inflammatory effect in everyday use. This spray helps control your body's response to allergens ("trigger") in the environment.

Flixonase is used in adults aged 18 years and over to treat allergic symptoms of hay fever and allergic reactions to air such as pet allergies, mites and mold spores. It relieves symptoms of sneezing, itching of the eyes and tearing, nose itching and stuffy nose for up to 24 hours.

It may take 3 to 4 days before the protective function of the product develops completely. It is therefore important to continue to use it regularly in order to achieve the full therapeutic effect.

If you do not feel better within 7 days, or if you get sick, you should consult a doctor.

2. BEFORE YOU USE FLIXONASE

Do not use Flixonase:

- if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (referred to in section 6).

Warnings and precautions:

Tell your doctor or pharmacist before using Flixonase:

- if you are using corticosteroid medicines (including creams for eczema, asthma inhalers, tablets, injections, nasal sprays and eye or nasal drops);

- if you have an infection in the nose or sinus cavity or if you are cold;

- if you have high temperature;

- if you have recently had an operation, you have a nose or a nose in the nose.

If your symptoms do not improve after 7 days, talk to your doctor.

Do not use without interruption for more than 3 months unless your doctor tells you to do so.

If nasal sprays containing corticosteroids are used long-term in high doses, side effects may occur as a result of absorption of the drug into the body. These effects are much less likely to use corticosteroids in the form of a nasal spray than oral corticosteroids; in individual patients and between different corticosteroids, the effects may vary. Possible systemic effects may include Cushing's syndrome, cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma (increased eye pressure) and, more rarely, a reduction in bone mineral density, effect on glucose metabolism and a number of psychological effects and effects on behavior , including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (especially in children).

Treatment with higher than recommended doses of nasal corticosteroids may lead to clinically significant suppression of adrenal function. If a patient is being treated with higher than recommended doses, the addition of systemic corticosteroids should be considered during the stress or pre-planned operation.

Other medicines and Flixonase:

Tell your doctor or pharmacist about all the medicines you are taking, which you have recently taken or who you may be taking.

This is important if you are using any prescription medicines, especially:

- medicines containing corticosteroids (including creams for eczema, asthma inhalers, tablets, injections, nasal sprays and eye or nasal drops);

- medicines containing ritonavir (a medicine to treat HIV);

- medicines containing ketoconazole (for the treatment of fungal infections).

Flixonase with food and drink:

You can use Flixonase anytime of the day with or without food.

Pregnancy, Breastfeeding and Fertility:

If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor or pharmacist before taking this medicinal product. There are no data on the effects of this medicinal product on human fertility.

Driving and using machines:

Flixonase has no or negligible influence on the ability to drive or use machines.

Flixonase contains:

- benzalkonium chloride, which can cause irritation and, especially for long-term use, edema of the nasal mucosa.

3. HOW TO USE FLIXONASE

Always use this medicine exactly in accordance with the package leaflet or as directed by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist.

Dose in adults aged 18 years or over:

Two injections into each nostril once a day (200 micrograms of fluticasone propionate), preferably in the morning.

Once the symptoms improve, you can lower the dose per injection into each nostril once a day.

If the symptoms are particularly severe, it may be necessary to increase the dose to two injections into each nostril twice a day until the symptoms improve. This dose can only be used for a short time.

Do not use more than 8 injections (4 in each nostril per day).

Use the lowest dose needed to manage the symptoms.

If the symptoms do not improve or do not improve well after 7 days of use, talk to your doctor or pharmacist.

Do not exceed the recommended dose

Use in children and adolescents:

Do not use in children and adolescents under 18 years of age.

Method of administration:

Serve only in the nose (nasal administration).

Do not swallow.

Do not spray into eyes.

Before using a new vial of Flixonase:

Flixonase has a cover that protects the nozzle and keeps it clean. Cover the cover before using the spray.

Before using a new bottle of Flixonase or if you have been using the spray for a few days, activate the spray to subsequently apply the correct dose.

Hold the vial with your thumb down and your forefinger and middle finger on each side of the nozzle. Do not move your thumb, press your fingers a few times until a fine mist appears. You should not aim the nozzle either on yourself or on anyone else.

If the spray still does not work, clean it as described under "Spray Cleaning". Do not try to clean or enlarge the small opening of the spray with a pin or any other sharp object to destroy the spray mechanism. 

How to use Flixonase:

- Carefully sneeze.

- Shake the vial well and remove the cover.

- Before using a new bottle of Flixonase or if you have not been using the spray for a few days, you will need to activate the spray. Push the pump several times until a fine mist appears.

- Hold the vial as indicated (Figure 3). Place the nozzle into one of the nostrils and close the other hole, head slightly forward and hold the vial up as shown (Figure 4). Move slightly from the center of your nose.

- Start slowly breathing through your nose. If you inhale, push your fingers down the collar and spray the dose into your nose.

- Exhale with your mouth. Repeat step 4 and apply the second dose to the same nostril.

- Remove the nozzle from this nostril and exhale with your mouth.

- Repeat steps 4 to 6 in the second nostril.

- After using the spray, wipe the nozzle with a clean napkin or handkerchief and replace the cover.

Spray cleaning:

- Remove cover and nozzle.

- Insert the nozzle and cover for a few minutes into warm water and then rinse under running water.

- Wait the rest of the water and let it dry in a warm place - not too hot!

- Place the nozzle.

- If necessary, push the pump several times until a fine mist appears. Install the cover.

- Do not try to clean or enlarge the small hole of the spray with a pin or any other sharp object to destroy the spray mechanism.

It may take 3 to 4 days before the protective function provided by Flixonase is fully developed. Start using Flixonase before you are exposed to your usual "trigger" allergy to prevent symptoms.

Flixonase should not be used for longer than the time you are exposed to your usual "trigger" allergy (eg pollen).

If you use more Flixonase than you should:

If you use more than it is recommended, tell your doctor.

If you forget Flixonase:

If you miss a dose, use the next dose at the time it is to be used. Do not double the next dose to replace the missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine may cause side effects, although not everybody gets them.

If nasal sprays containing corticosteroids are used long-term in high doses, side effects may occur as a result of absorption of the drug into the body.

Very rare but serious side effects: Get medical help immediately:

- signs of an allergic reaction such as rash, swelling of the mouth or face, difficulty in breathing;

- you will have new vision problems that have developed since you started using this medicine; in people who have used high doses of corticosteroids for several years, eye problems such as cataracts or glaucoma have been reported rarely;

- Small holes (perforations) appear in the nose barrier that separates the nostrils.

If you experience any of these symptoms, stop using this medicine and seek immediate medical attention.

Other very rare side effects:

They may affect up to 1 in 10,000 people:

- eye problems such as pain or blurred vision;

- Nasal problems such as pain and / or recurrent nose bleeds.

If you get any of these symptoms, stop using this medicine and tell your doctor immediately.

Possible Side Effects:

Can affect up to 1 in 10 people:

- Sneezing after the use of a sprays, but which soon disappears;

- an unpleasant taste or an unpleasant odor;

- feeling dry or irritated in the nose or throat;

- headache.

Very common side effects:

Can affect more than 1 in 10 people:

- occasional nose bleeds.

Undesirable effects reporting:

If any of the side effects gets serious, tell your doctor or pharmacist. Do the same for any side effects not listed in this leaflet. 7

5. HOW TO STORE FLIXONASE

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton after the expiry date and the bottle after EXP. Shelf life refers to the last day of that month.

Do not store above 30 ° C.

Do not dispose of any medicinal products in sewage or domestic waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Flixonase contains:

- the active substance is fluticasone propionate; one injection provides a 100 mg suspension containing 50 micrograms of fluticasone propionate as a given dose;

- the other ingredients are glucose, microcrystalline cellulose, carmellose sodium, phenethyl alcohol, benzalkonium chloride, polysorbate 80, and purified water.

What Flixonase looks like and contents of the pack:

Flixonase is a white opaque aqueous nasal spray, suspension.

Amber glass of amber-colored glass with pump, nasal applicator and cover. The vial contains 60 metered doses, the total content being not less than 7.0 g.