Flutixon Nasal

Leaflet accompanying the packaging: patient information

FLUTIXON NASAL

(137 micrograms + 50 micrograms)/nasal dose, nasal spray, suspension
Azelastine hydrochloride + Fluticasone propionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is FLUTIXON NASAL and what is it used for
• 2. Important information before using FLUTIXON NASAL
• 3. How to use FLUTIXON NASAL
• 4. Possible side effects
• 5. How to store FLUTIXON NASAL
• 6. Contents of the packaging and other information

1. What is FLUTIXON NASAL and what is it used for

FLUTIXON NASAL contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the action of substances such as histamine, which the body produces as part of an allergic reaction, and thereby reduce the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

FLUTIXON NASAL is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis, if the use of a single nasal antihistamine or corticosteroid is considered insufficient.

2. Important information before using FLUTIXON NASAL

When not to use FLUTIXON NASAL:

• If the patient is allergic to azelastine hydrochloride or fluticasone propionate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use FLUTIXON NASAL, discuss it with your doctor or pharmacist:

• if the patient has recently undergone nasal surgery;
• if the patient has a nasal infection. Nasal infections should be treated with antibacterial or antifungal medicines. Patients who have been treated for a nasal infection may continue to treat their allergy with FLUTIXON NASAL;
• if the patient has tuberculosis or an untreated infection;
• if the patient notices a change in vision or has been diagnosed with increased intraocular pressure, glaucoma, and/or cataract. Patients with these conditions will be closely monitored during treatment with FLUTIXON NASAL;
• if the patient has adrenal function disorders. Caution is advised when switching from systemic steroid therapy to FLUTIXON NASAL therapy;
• if the patient has severe liver disease. This increases the risk of systemic side effects.

In these cases, the doctor will decide whether FLUTIXON NASAL can be used.

Children and adolescents

This medicine is not recommended for children under 12 years of age.

FLUTIXON NASAL and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

FLUTIXON NASAL has a minor influence on the ability to drive and use machines. Fatigue and dizziness may occur, which may be caused by the disease itself or the use of FLUTIXON NASAL. In such cases, do not drive or operate machinery. Be aware that drinking alcohol may enhance such effects.

FLUTIXON NASAL contains benzalkonium chloride

This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use FLUTIXON NASAL

FLUTIXON NASAL should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Adults and adolescents (12 years and older)

One dose should be administered into each nostril in the morning and evening.

Use in children under 12 years

This medicine is not recommended for children under 12 years of age.

Use in patients with renal and hepatic impairment

There are no data on the use of FLUTIXON NASAL in patients with renal and hepatic impairment.

Method of administration

Nasal administration.

INSTRUCTIONS FOR USE

Preparing the spray

• 1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap.
• 2. If the nasal spray is used for the first time, prime the pump by releasing a dose into the air.
• 3. To prime the pump, place two fingers on either side of the pump and your thumb under the bottle.
• 4. Press and release the pump 6 times, until a fine mist is produced (see Figure 1).

Figure 1

• 5. The pump is now primed and ready for use.
• 6. If the nasal spray has not been used for more than 7 days, re-prime the pump by pressing and releasing it once.

Using the spray

• 1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap.
• 2. Blow your nose to clear your nostrils.
• 3. Tilt your head forward towards your toes. Do not tilt your head back.
• 4. Hold the bottle upright and gently place the tip of the nozzle in one nostril.
• 5. Close the other nostril with your finger, press the pump quickly once, and at the same time, take a gentle breath in (see Figure 2).

Figure 2

• 6. Breathe out through your mouth.
• 7. Repeat the same steps for the other nostril.
• 8. After administration, breathe gently in and do not tilt your head back. This will prevent the medicine from going down your throat and tasting unpleasant.
• 9. After each use, wipe the nozzle tip with a clean tissue or cloth and replace the protective cap.
• 10. If the spray does not spray, do not try to unblock the nozzle. Wash the nozzle tip with water.

It is essential to use the dose prescribed by your doctor. Only use the dose recommended by your doctor.

Duration of treatment

FLUTIXON NASAL can be used for a long time. The duration of treatment should correspond to the period during which allergy symptoms occur.

Using a higher dose of FLUTIXON NASAL than recommended

In the event of using too much nasal spray, there is a small risk of complications. Consult your doctor if you are concerned or if you have been using a higher dose than recommended for a long time. If someone, especially a child, accidentally swallows FLUTIXON NASAL, seek medical attention immediately.

Missing a dose of FLUTIXON NASAL

Use the nasal spray as soon as you remember, and then use the next dose at the usual time. Do not use a double dose to make up for a missed dose.

Stopping treatment with FLUTIXON NASAL

Do not stop using FLUTIXON NASAL without consulting your doctor, due to the risk of reduced treatment effectiveness.

4. Possible side effects

Like all medicines, FLUTIXON NASAL can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people):

• Nosebleeds.

Common side effects (may affect up to 1 in 10 people):

• Headache,
• Bitter taste in the mouth, especially if you tilt your head back during nasal spray administration; this taste should disappear if you drink a non-alcoholic beverage a few minutes after using the medicine;
• Unpleasant odor.

Uncommon side effects (may affect up to 1 in 100 people):

• Mild irritation inside the nose; may cause a mild stinging sensation, itching, or sneezing;
• Dryness in the nose, cough, dryness in the throat, or throat irritation.

Rare side effects (may affect up to 1 in 1,000 people):

• Dryness in the mouth.

Very rare side effects (may affect less than 1 in 10,000 people):

• Dizziness or drowsiness,
• Cataract, glaucoma, or increased eye pressure, which may cause vision loss and/or redness and eye pain; these side effects have been reported after long-term use of nasal sprays containing fluticasone propionate;
• Skin and nasal mucosa damage,
• General malaise, feeling tired, weak, or exhausted,
• Rash, itching, or redness of the skin, itchy blisters on the skin,
• Bronchospasm (narrowing of the airways).

Seek medical attention immediately if you experience any of the following symptoms:

• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing

and/or breathing, as well as a sudden skin rash. These may be symptoms of a severe allergic reaction. Note: these symptoms are very rare.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Blurred vision,
• Ulcers on the nasal mucosa.

When using the medicine in high doses for a long time, systemic side effects (affecting the whole body) may occur. The likelihood of these side effects is much lower when using nasal corticosteroids than when treating with oral corticosteroids. These side effects may vary between patients and after using different corticosteroid medicines (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store FLUTIXON NASAL

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

Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.

Do not store in the refrigerator or freeze.

Shelf life after first opening: Do not use after 6 months from first opening the nasal spray.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What FLUTIXON NASAL contains

• The active substances are azelastine hydrochloride and fluticasone propionate. Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

After each actuation of the pump (0.14 g), 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate are delivered.

• The other ingredients are disodium edetate, glycerol, microcrystalline cellulose, sodium carmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What FLUTIXON NASAL looks like and contents of the pack

FLUTIXON NASAL is a white to off-white homogeneous suspension.

FLUTIXON NASAL is available in a brown glass bottle with a pump spray, nasal applicator, and protective cap, in a cardboard box.

The 25 ml bottle contains 23 g of nasal spray suspension (at least 120 doses).

FLUTIXON NASAL is available in:

packs containing 1 bottle of 23 g nasal spray suspension.

Marketing authorization holder:

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Poland

phone: 22 732 77 00

Manufacturer:

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: