Biflown

Package leaflet: Information for the user

Biflown
(137 micrograms + 50 micrograms)/dose nasal spray, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. 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 individual. 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, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Biflown is and what it is used for

Biflown 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 the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Biflown 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 are types of allergic reactions to substances such as: plant pollens (hay fever), house dust mites, mould spores, dust, or pet dander.
Biflown helps relieve allergy symptoms such as nasal discharge, postnasal drip, sneezing, nasal itching, and nasal congestion.

2. Important information before using Biflown

When not to use Biflown

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

Warnings and precautions
Before starting treatment with Biflown, discuss this 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 medicines. Patients who have been treated for nasal infection may continue allergy treatment using Biflown.
• 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 Biflown.
• If the patient has adrenal gland function disorders. Caution is required when switching from systemic steroid therapy to treatment with Biflown.
• If the patient has severe liver disease. In this case, the risk of systemic adverse reactions increases.

In these cases, the decision on whether Biflown can be used will 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 corticosteroids used in doses higher than recommended may suppress adrenal function, 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 medicine at the lowest effective dose that still controls symptoms of nasal mucosal inflammation.
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 Biflown.

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

Biflown and 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 over-the-counter medicines.
Some medicines may increase the effect of Biflown, and the doctor may recommend careful monitoring if the patient is taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole). Do not use Biflown if the patient is taking sedatives or medicines acting on the central nervous system.

Pregnancy and breastfeeding
If the patient is pregnant, 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
Biflown has 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 Biflown. In such cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

Biflown 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 prolonged period.

3. How to use Biflown

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
For maximum benefit, Biflown must be used regularly.
Avoid contact with the eyes.

Use in 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 on the use of this medicine in patients with impaired renal or liver function.

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 underneath the bottle.
4. Press and release the pump 6 times until a fine mist is produced (see figure a).

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. Keep your head tilted forward, towards your toes. Do not tilt your head backward.
4. Hold the bottle upright and gently insert the spray nozzle into one nostril.
5. Block the other nostril with a finger, press the pump quickly once, and at the same time inhale gently (see figure b).

b

6. Breathe out through the mouth.
7. Repeat the same procedure for the other nostril.
8. After administering the medicine, breathe gently and do not tilt your head backward. This helps prevent the medicine from draining into 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 spray nozzle becomes blocked, do not pierce it or use a sharp object to unblock it. Clean the nozzle with water.

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

Duration of treatment
Biflown 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 Biflown
The risk of complications following an overdose of the nasal spray is low. However, if you become 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 Biflown, contact a doctor or the nearest hospital emergency department immediately.

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

Stopping Biflown treatment
Do not stop using Biflown without consulting your doctor, due to the risk of ineffective treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 their head backwards when administering the nasal spray. 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):

• Dryness in the 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 pain in the eyes. These adverse effects have been reported after long-term use of nasal spray containing fluticasone propionate.
• Skin and nasal mucosa damage
• 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 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
• Ulceration of the nasal mucosa

When the medicine is used in high doses over a long period, systemic adverse effects (affecting the whole body) may occur. The likelihood of such effects is considerably lower with corticosteroids administered as a nasal spray than with oral corticosteroid treatment. These effects may vary between individual patients and after using different corticosteroid medicines (see section 2). Nasal 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 slowed growth rate. In rare cases, decreased bone density (osteoporosis) has been observed with long-term use of intranasally administered corticosteroids.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Biflown

Keep the 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 outer carton
following: EXP. The expiry date refers to the last day of the stated month.
Do not store in a refrigerator or freeze.
Period of use after first opening: Any unused medicine should be discarded 6 months after
first opening of the nasal aerosol.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Biflown 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 croscarmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Biflown looks like and contents of the pack
Biflown is a white or almost white, homogeneous suspension.
Biflown is available in a brown glass bottle with a spray pump, applicator, and protective cap, packed in a cardboard box.
The 25 mL bottle contains 23 g of nasal suspension aerosol (providing at least 120 doses).
Biflown is available in:
pack containing 1 bottle with 23 g of nasal suspension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Solinea Sp. z o.o.
Elizówka, ul.Szafranowa 6
21-003 Ciecierzyn, Poland
(logo of the marketing authorisation holder)

Manufacturer
FARMEA
10, rue Bouché Thomas
ZAC d’Orgemont
49007 Angers
France
FARMACLAIR
440 Avenue Du Général De Gaulle
14200 Hérouville-Saint-Clair
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Biflown
Sweden: Biflown