Fanipos Plus

Leaflet attached to the packaging: patient information

Fanipos Plus

(137 micrograms + 50 micrograms)/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 as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fanipos Plus and what is it used for

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

Fanipos Plus is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis, if the use of other nasal medicines containing only an antihistamine or a corticosteroid is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as plant pollen (hay fever), house dust mites, mold spores, dust, or pet dander.
Fanipos Plus relieves allergy symptoms, such as: nasal discharge, postnasal drip, sneezing, and itching or a feeling of nasal congestion.

2. Important information before using Fanipos Plus

When not to use Fanipos Plus:

• If you are 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 treatment with Fanipos Plus, discuss with your doctor or pharmacist if:

• You have recently undergone nasal or oral surgery.
• You have a nasal infection. Nasal infections should be treated with antibacterial or antifungal medicines. People who have been treated with medicines for a nasal infection may continue to treat their allergy with Fanipos Plus.
• You have tuberculosis or an untreated infection.
• You have noticed a change in vision or have been diagnosed with increased intraocular pressure, glaucoma, and/or cataracts. People with these conditions will be closely monitored while using Fanipos Plus.
• You have adrenal gland problems. Caution is advised when switching from systemic steroid treatment to Fanipos Plus therapy.
• You have severe liver disease. The risk of systemic side effects increases.

In these cases, the doctor will decide whether to use Fanipos Plus.
It is essential to take the medicine in the dose prescribed below in section 3 or as recommended by your doctor.
Using nasal corticosteroids in higher doses than recommended may cause adrenal gland problems, a condition in which the body's production of cortisol may decrease, leading to weight loss, fatigue, muscle weakness, decreased blood sugar levels, increased salt requirements, joint pain, depression, and darker skin pigmentation. In such cases, your doctor may recommend taking another medicine during periods of stress or planned surgery.
To avoid adrenal gland problems, your doctor may recommend taking the medicine in the smallest dose that will continue to effectively control your symptoms.
In children and adolescents, long-term use of nasal corticosteroids (such as Fanipos Plus) may slow down growth rates. Your doctor will regularly check your child's growth and ensure that they are taking the medicine in the lowest effective dose.
If you experience blurred vision or other vision problems, consult your doctor.
If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before using Fanipos Plus.

Children

It is not recommended to use this medicine in children under 12 years of age.

Fanipos Plus and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those available without a prescription.
Some medicines may increase the effects of Fanipos Plus nasal spray, and your doctor may recommend close monitoring if you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole). Do not use Fanipos Plus if you are taking sedatives or central nervous system depressants.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Fanipos Plus has a minor influence on the ability to drive and use machines.
Rarely, drowsiness, weakness, or dizziness may occur, which may be caused by the disease itself or the use of Fanipos Plus. In such cases, do not drive or operate machinery. Be aware that drinking alcohol may increase these effects.

Fanipos Plus contains benzalkonium chloride.

This medicine contains 14 micrograms of benzalkonium chloride per actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
If you experience discomfort while using the spray, tell your doctor or pharmacist.

3. How to use Fanipos Plus

Always use this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
To get the most benefit from the treatment, Fanipos Plus must be used regularly.
Avoid contact with the eyes.

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 of age

• It is not recommended to use this medicine in children under 12 years of age.

Use in patients with renal or hepatic impairment

• There are no data on the use in patients with renal or hepatic impairment.

Method of administration

Nasal administration.
Read the instructions carefully and use the medicine only as directed.

INSTRUCTIONS FOR USE

Preparing the spray

• 1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap (see Figure 1).

Figure 1

• 2. If the nasal spray is 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 your thumb on the bottom of the bottle.
• 4. Press and release the pump 6 times, until a fine mist is produced (see Figure 2).
• 5. The pump is now primed and ready for use.

Figure 2

• 6. If the nasal spray has not been used for more than 7 days, re-prime the pump. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap (see Figure 1), and press and release the pump once.

Using the spray

• 1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap (see Figure 1).
• 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 applicator in the nostril.
• 5. Block the other nostril with your finger, press the pump quickly once, and at the same time, take a gentle breath in (see Figure 3).
• 6. Breathe out through your mouth.

Figure 3

• 7. Repeat the same steps for the other nostril.
• 8. After administration, take gentle breaths in and do not tilt your head back. This will prevent the medicine from going down your throat and causing an unpleasant taste (see Figure 4).

Figure 4

• 9. After each use, wipe the tip of the applicator with a clean tissue or cloth and replace the protective cap.
• 10. If the spray does not spray, do not puncture the tip of the applicator. Wash the tip of the applicator with water.

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

Duration of treatment

Fanipos Plus 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 Fanipos Plus 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 Fanipos Plus, seek medical attention immediately.

Missing a dose of Fanipos Plus

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 Fanipos Plus

Do not stop using Fanipos Plus without consulting your doctor, as this may lead to a lack of treatment effectiveness.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Nasal bleeding

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

• Headache
• Bitter taste in the mouth, especially if you tilt your head back while using the nasal spray. 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. This 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 up to 1 in 10,000 people):

• Dizziness or drowsiness
• Cataracts, glaucoma, or increased eye pressure, which may cause vision loss and/or eye redness and pain. These side effects have been reported after long-term use of nasal sprays containing fluticasone propionate.
• Skin and nasal mucosa damage
• Feeling unwell, tiredness, exhaustion, or weakness
• Rash, itching, or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the airways)

You should 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 or (and) breathing, and sudden appearance of 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 the available data):

• Blurred vision
• Ulceration of the nasal mucosa

In the event of using the medicine in high doses for a long time, systemic side effects may occur (side effects affecting the whole body). The likelihood of these side effects is much lower when using nasal corticosteroids than when using oral corticosteroids. These side effects may vary between patients and after using different corticosteroid medicines (see section 2).
Nasal corticosteroids may affect the normal production of hormones in the body, especially when used for a long time in high doses. In children and adolescents, these side effects may cause growth retardation.
In rare cases, decreased bone density (osteoporosis) has been observed when corticosteroids were used nasally for a long time.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fanipos Plus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the bottle and carton after EXP. The expiry date refers to the last day of that month.
Do not store in the refrigerator or freeze.
Shelf-life after first opening of the bottle: The unused medicine should be discarded 6 months after the first opening of 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 Fanipos Plus contains

The active substances are: azelastine hydrochloride and fluticasone propionate.
Each mL of suspension contains 1,000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.
After each actuation of the pump (0.14 g), 137 micrograms of azelastine hydrochloride (corresponding to 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate are released.
The other ingredients are: disodium edetate, glycerol (E 422), microcrystalline cellulose, sodium carmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and water for injections.

What Fanipos Plus looks like and contents of the pack

Fanipos Plus is a white nasal spray suspension, available in a brown glass bottle with a pump and applicator, and a protective cap.
Each bottle of 25 mL contains 23 g of nasal spray suspension (at least 120 doses).
Each pack contains one bottle with 23 g of nasal spray suspension or a multipack containing three bottles, each containing 23 g of nasal spray suspension.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Manufacturer

Teva Czech Industries s.r.o.
Ostravská 305/29
747 70 Opava - Komárov
Czech Republic

For further information, contact the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00

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

Austria:
Azelastin/Fluticason ratiopharm 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension
Bulgaria:
Дуоназе 137 микрограма/50 микрограма на впръскване спрей за нос, суспензия
Duonase 137 micrograms/50 micrograms per actuation nasal spray, suspension
Czech Republic:
Azelastin/Flutikason Teva
Croatia: Rhinaz 137 mikrograma/50 mikrograma po potisku, sprej za nos, suspenzija
Denmark:
Duonasa
Estonia:
Azelastine/Fluticasone Teva
Finland:
Duonasa 125 mikrogrammaa + 50 mikrogrammaa / annos nenäsumute, suspensio
France:
AZELASTINE CHLORHYDRATE /FLUTICASONE PROPIONATE TEVA
137microgrammes/50 microgrammes, suspension pour pulvérisation nasale
Spain: Azelastina/Fluticasona Teva 137 microgramos/50 microgramos/aplicación suspensión para pulverización nasal
Netherlands:
Azelastine/Fluticasonpropionaat Teva 137 microgram/50 microgram per verstuing, neusspray, suspensie
Ireland:
Nasusaf 137 micrograms/50 micrograms per actuation nasal spray, suspension
Iceland:
Duonasa
Lithuania:
Azelastine /Fluticasone Teva 137 mikrogramai/50 mikrogramų/ spūsnyje nosies purškalas (suspensija)
Latvia:
Azelastine/Fluticasone Teva 137 mikrogrami/50 mikrogrami izsmidzinājumā deguna aerosols, suspensija
Germany:
Azelastin/Fluticason-ratiopharm 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension
Norway: Azelastine hydrochloride/Fluticasone Teva
Poland:
Fanipos Plus
Portugal: Azelastina + Fluticasona Teva
Slovakia:
Azelastín/Flutikazón Teva 137 mikrogramov/50 mikrogramov
Sweden:
Azelastin/Flutikason Teva

Date of last revision of the leaflet: March 2025