Flazena

Package leaflet: information for the patient

Flazena
(137 micrograms + 50 micrograms)/dose, nasal spray, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read the entire leaflet carefully before using this medicine, as 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 consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• This medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Flazena is and what it is used for

Flazena 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 during an allergic reaction, thereby reducing symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Flazena is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with other intranasal medicinal products containing either an antihistamine or a corticosteroid alone is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as: plant pollens (hay fever), house dust mites, mould spores, dust, or pet dander.
Flazena helps relieve allergy symptoms such as nasal discharge, postnasal drip, sneezing, nasal itching, and nasal congestion.

2. Important information before using Flazena

When not to use Flazena:

• 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 Flazena, discuss the following with your doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has an infection in the nasal area. Infections of the nasal passages should be treated with antibacterial or antifungal medications. Patients who have been treated for nasal infection may continue to treat allergies using Flazena.
• If the patient has tuberculosis or untreated infections.
• If the patient experiences 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 Flazena.
• If the patient has adrenal gland disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Flazena.
• If the patient has severe liver disease. In such cases, the risk of systemic adverse effects increases.

In these situations, the decision on whether Flazena can be used will be made by the treating physician.
It is important that the patient uses the medicine at the dose indicated in section 3 below or as directed by the treating physician. Using intranasal corticosteroids at doses higher than recommended may suppress adrenal function, a condition in which weight loss, fatigue, muscle weakness, low blood sugar levels, 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 of Flazena that still controls nasal mucosal inflammation symptoms adequately.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting Flazena.

Children and adolescents
Flazena is not recommended for use in children under 12 years of age.
Long-term intranasal corticosteroid use (such as Flazena) in children and adolescents may impair growth velocity. The doctor will regularly monitor the child's growth and ensure that the lowest effective dose is used.

Flazena with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines, as well as any medicines the patient plans to take.
Some medicines may increase the effect of Flazena nasal spray, and the doctor may recommend careful monitoring if the patient is taking such medicines (including certain HIV medications: ritonavir, cobicistat, and antifungal agents: ketoconazole). Do not use Flazena if the patient is taking sedatives or central nervous system depressants.

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

Driving and operating machinery
Flazena has a minor influence on the ability to drive and operate machinery. Very rarely, fatigue and dizziness may occur, which may be caused by the disease itself or by using Flazena. In such cases, the patient should not drive or operate machinery. Be aware that alcohol consumption may worsen these effects.

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

3. How to use Flazena

Flazena must always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
For optimal benefit, Flazena should 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 are no data available on the use of this medicine in patients with renal or hepatic impairment.

Method of administration
Nasal administration.
Please read the following instructions carefully and use the medicine exactly as directed.

INSTRUCTIONS FOR USE
Preparing the aerosol

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap.
2. If the nasal aerosol 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 at the bottom of the bottle.
4. Press and release the pump 6 times until a fine mist is produced (see Figure a).

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

Using the aerosol

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap.
2. Blow your nose to clear the nasal passages.
3. Tilt your head forward toward your toes. Do not tilt your head backward.
4. Hold the bottle upright and gently insert the spray nozzle into one nostril.
5. Close the other nostril with a finger, press the pump quickly once, and at the same time inhale gently (see Figure b).

6. Breathe out through your 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 spray nozzle with a clean tissue or cloth and replace the protective cap.
10. If the aerosol does not spray, do not pierce the nozzle. Clean the spray nozzle with water.

It is important to use the dose prescribed by your doctor. Use only the dosage regimen recommended by your doctor.

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

Use of more than the recommended dose of Flazena
If too high a dose of the nasal spray is used, the risk of complications is low. Consult your doctor if you experience any concerns or if an excessive dose has been used for a prolonged period. If anyone, especially a child, accidentally swallows Flazena, contact a doctor or the nearest hospital emergency department immediately.

Missed dose of Flazena
Use the nasal aerosol as soon as you remember, then take the next dose at the usual time. Do not use a double dose to make up for a missed dose.

Stopping Flazena treatment
Do not stop using Flazena without consulting your doctor, due to the risk of reduced treatment efficacy.

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

4. Possible adverse effects

Like all medicines, Flazena may cause adverse effects, although not everyone experiences them.

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

• Nosebleeds

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

• Headache
• Bitter taste in the mouth, especially if the patient tilts the head backwards during nasal aerosol administration. This taste should disappear if the patient drinks a non-alcoholic beverage a few minutes after using the medicine
• Unpleasant odour

Uncommon adverse effects (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 sore throat

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

• Dry mouth

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

• Dizziness or drowsiness
• Cataract, glaucoma or increased intraocular pressure, which may lead to loss of vision and (or) redness and eye pain. These adverse effects have been reported after long-term use of nasal aerosol containing fluticasone propionate.
• Skin and nasal mucosa damage
• Malaise, feeling of fatigue, exhaustion or weakness
• Rash, itching or redness of the skin, itchy skin blisters
• 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 appearance of a skin rash. These may be symptoms of a severe allergic reaction. Note: these symptoms are very rare.

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

• Blurred vision
• Nasal mucosal ulceration

When the medicine is used in high doses for a prolonged period, systemic adverse effects (affecting the whole body) may occur. The likelihood of such effects is significantly lower with corticosteroids administered as a nasal aerosol than with oral corticosteroid therapy. These effects may vary between individual patients and with different corticosteroid medicines (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 effects may cause growth suppression.
In rare cases, decreased bone density (osteoporosis) has been observed with long-term use of nasally administered corticosteroids.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Flazena medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and carton after:
EXP. The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Shelf-life after first opening of the bottle: Unused medicine should be discarded 6 months after
first opening of the nasal aerosol.
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 pack and other information

What Flazena 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 components are: edetate disodium, glycerol, microcrystalline cellulose, sodium croscarmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Flazena looks like and contents of the pack
Flazena is a white to almost white, homogeneous suspension.
Flazena is available in an amber glass bottle with a spray pump, nasal applicator, and protective cap, packed in a cardboard box.
Each 25 mL bottle contains 120 doses (23 g of nasal aerosol in the form of a suspension).
Flazena is available in bottles containing 120 doses.
Pack sizes available: 1 or 3 bottles.

Marketing Authorisation Holder:
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer:
FARMEA
10, rue Bouché Thomas
ZAC d’Orgemont
49007 Angers
France
Farmaclair
440 Avenue Du Général De Gaulle
14200 Hérouville-Saint-Clair
France
Depo-pack S.r.l
Via Giovanni Morandi 28
Saronno 21047, Italy

For further information, contact the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00

This medicinal product is authorised in the European Economic Area under the following names:
Denmark, Czech Republic, Norway, Slovakia, Sweden: Lutonaze
Germany: Azelastin/Fluticason Zentiva 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension
France: AZELASTINE CHLORHYDRATE / FLUTICASONE PROPIONATE ZENTIVA 137 microgrammes/50 microgrammes, suspension pour pulvérisation nasale
Lithuania: AZAVIN 137 mikrogramai/50 mikrogramų/dozėje nosies purškalas (suspensija)
Poland: Flazena
Romania: Lutonaze 137 micrograme/50 micrograme/doza spray nazal, suspensie
Hungary: Lutonaze 137 mikrogramm/50 mikrogramm szuszpenziós orrspray
Italy: Azelastina e Fluticasone Zentiva