Fluticason nasal

Package leaflet: Information for the patient

FLUTIXON NASAL
(137 micrograms + 50 micrograms)/nasal dose, nasal spray, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific patient only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What FLUTIXON NASAL is and what it is 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 pack and other information

1. What FLUTIXON NASAL is and what it is 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, thereby reducing symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

FLUTIXON NASAL is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with a single intranasal antihistamine or corticosteroid is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as: pollen (hay fever), house dust mites, mould spores, dust, or pet dander.
FLUTIXON NASAL relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, itching, and nasal congestion.

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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with FLUTIXON NASAL, discuss with your doctor or pharmacist:

• if the patient has recently undergone nasal surgery;
• if the patient has an infection in the nose. Nasal passage infections should be treated with antibacterial or antifungal medications. Patients who have been treated for nasal infection may continue allergy treatment with FLUTIXON NASAL;
• if the patient has tuberculosis or untreated infection;
• if the patient has noticed changes in vision or has previously been diagnosed with increased intraocular pressure, glaucoma, and/or cataracts. Such patients will be closely monitored during treatment with FLUTIXON NASAL;
• if the patient has adrenal gland function disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with FLUTIXON NASAL;
• if the patient has severe liver disease. In such cases, the risk of systemic adverse effects increases.

In these situations, the decision on whether FLUTIXON NASAL can be used should be made by the treating physician.
It is important that the patient uses the medicine at the dose indicated below in section 3 or as directed by the treating physician. Intranasal use of corticosteroids at doses higher than recommended may lead to adrenal suppression, a condition in which weight loss, fatigue, muscle weakness, low blood sugar, increased salt craving, joint pain, depression, and darker skin pigmentation may occur. In such cases, the doctor may recommend taking another medicine during periods of stress or before planned surgical procedures.
To avoid adrenal suppression, the doctor may recommend using the lowest effective dose that still controls nasal mucosal inflammation symptoms.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting treatment with FLUTIXON NASAL.

Children and adolescents
Use of this medicine is not recommended in children under 12 years of age.
Prolonged intranasal use of corticosteroids (such as FLUTIXON NASAL) may suppress growth rate in children and adolescents. The doctor will regularly monitor the child's growth and ensure that the lowest effective dose is used.

FLUTIXON NASAL with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without prescription.
Some medicines may increase the effect of FLUTIXON NASAL, and the doctor may recommend careful monitoring if the patient is taking such medicines (including certain HIV medications: ritonavir, cobicistat, and antifungal agents: ketoconazole). If the patient is taking sedatives or central nervous system depressants, FLUTIXON NASAL should not be used.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
FLUTIXON NASAL has minimal effect on the ability to drive and operate machinery. Very rarely, fatigue and dizziness may occur, which could be caused by the disease itself or by the use of FLUTIXON NASAL. In such cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

FLUTIXON NASAL contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium chloride may cause nasal irritation or swelling, especially with prolonged use.

3. How to use FLUTIXON NASAL

FLUTIXON NASAL should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
For optimal benefit, FLUTIXON NASAL must be used regularly.
Avoid contact with the eyes.

Adults and adolescents (aged 12 years and older)
It is recommended to administer one dose into each nostril in the morning and evening.

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

Use in patients with renal or hepatic impairment
There is no data available regarding use in patients with renal or hepatic impairment.

Method of administration
For nasal use only.
Please read the instructions below carefully and use the medicine exactly as directed.

INSTRUCTIONS FOR USE

Preparing the spray

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap.
2. If the nasal spray is being used for the first time, prime the pump by releasing a dose into the air.
3. Prime the pump by placing two fingers on either side of the pump and the thumb under the base of 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 up and down for 5 seconds, then remove the protective cap.
2. Blow your nose to clear the nostrils.
3. Tilt your head forward slightly, looking toward your toes. Do not tilt your head backward.
4. Hold the bottle upright and gently insert the nozzle into one nostril.
5. Block the other nostril with your finger, press the pump quickly once, and at the same time inhale gently through the nose (see Figure 2).

Figure 2

6. Breathe out through the mouth.
7. Repeat the same procedure for the other nostril.
8. After administering the medicine, take gentle breaths and do not tilt your head backward. This helps prevent the medicine from running down the throat and causing an unpleasant taste.
9. After each use, wipe the nozzle with a clean tissue or cloth and replace the protective cap.
10. If the spray does not release, do not pierce the nozzle. Clean the nozzle with water.

It is important to use the dose prescribed by your doctor. Always follow your doctor's instructions exactly.

Duration of treatment
FLUTIXON NASAL may be used long-term. The duration of treatment should correspond to the period during which allergy symptoms occur.

Overdose of FLUTIXON NASAL
If too much nasal spray is used, the risk of adverse effects is low. However, if you are concerned or if a higher than recommended dose has been used for a prolonged period, consult your doctor. If anyone, especially a child, accidentally swallows FLUTIXON NASAL, contact a doctor or the nearest hospital emergency department immediately.

Missed dose of FLUTIXON NASAL
Use the nasal spray as soon as you remember, then continue with the next dose at your regular time. Do not use a double dose to make up for a missed dose.

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, FLUTIXON NASAL may cause adverse reactions, although not
everyone will experience them.
Very common adverse reactions (may affect more than 1 in 10 people):

• nosebleeds.

Common adverse reactions (may affect less than 1 in 10 people):

• headache,
• bitter taste in the mouth, particularly if the patient tilts their head backward during nasal aerosol administration; this taste should disappear if the patient drinks a non-alcoholic beverage several minutes after using the medicine;
• unpleasant odour.

Uncommon adverse reactions (may affect less than 1 in 100 people):

• mild irritation inside the nose; this may cause mild stinging, itching or sneezing;
• dryness in the nose, cough, dry throat or throat irritation.

Rare adverse reactions (may affect less than 1 in 1,000 people):

• dryness in the mouth.

Very rare adverse reactions (may affect less than 1 in 10,000 people):

• dizziness or drowsiness,
• cataract, glaucoma or increased intraocular pressure, which may lead to vision loss and (or) eye redness and eye pain; these adverse reactions have been reported after long-term use of nasal aerosols containing fluticasone propionate;
• damage to the skin and nasal mucosa,
• malaise, feeling of fatigue, exhaustion or weakness,
• rash, itching or redness of the skin, itchy blisters on the skin,
• bronchospasm (narrowing of the lower airways).

Seek immediate medical help if any of the following symptoms occur:

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

and (or) breathing, and sudden onset of skin rash. These may be symptoms of a severe
allergic reaction. Note: these symptoms are very rare.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• blurred vision,
• ulceration of the nasal mucosa.

When the medicine is used at high doses for a prolonged period, systemic adverse reactions (affecting the whole body) may occur. The likelihood of such reactions is significantly lower with corticosteroids administered as a nasal aerosol than with orally administered corticosteroids. These adverse reactions may vary between individual patients and depending on the corticosteroid used (see section 2). Nasally administered corticosteroids may affect normal hormone production processes in the body, especially when used long-term at high doses. In children and adolescents, these adverse reactions may cause slowed growth rate.
Reduced bone density (osteoporosis) has been observed in rare cases with long-term use of nasally administered corticosteroids.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store FLUTIXON NASAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton following: EXP. The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Duration of use after first opening the bottle: Unused medicine should be discarded 6 months after first opening the nasal aerosol.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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.

Each spray actuation (0.14 g) delivers 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.

• Other ingredients are: disodium edetate, glycerol, microcrystalline cellulose, sodium carboxymethylcellulose, 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 supplied in an amber glass bottle with a spray pump, a nasal applicator, and a protective cap, packed in a cardboard box.
The 25 ml bottle contains 23 g of nasal aerosol in the form of a suspension (providing at least 120 doses).
FLUTIXON NASAL is available in:
packs containing 1 bottle with 23 g of nasal aerosol in the form of a suspension.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Tel. 22 732 77 00

Manufacturer:
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

This medicinal product is authorised for sale in the European Economic Area countries under the following names: