Fanipos plus

Patient Information Leaflet

Caution! Keep this leaflet! The packaging information in a foreign language.
Fanipos Plus (Azelastine + Fluticasone Teva)
(137 micrograms + 50 micrograms)/nasal dose, nasal spray, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Fanipos Plus and Azelastine + Fluticasone Teva are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, 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.

Table of contents

1. What Fanipos Plus is and what it is 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 pack and other information

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

Fanipos Plus is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with other intranasal medicines 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.
Fanipos Plus relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, nasal itching, or nasal congestion.

2. Important information before using Fanipos Plus

When not to use Fanipos Plus:

• 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 Fanipos Plus, consult a doctor or pharmacist if:

• The patient has recently undergone nasal or oral surgery or has suffered trauma to the nose or oral cavity.
• The patient has a nasal infection. Infections of the nasal passages should be treated with antibacterial or antifungal medications. Patients who have been treated for nasal infections may continue allergy treatment with Fanipos Plus.
• The patient suffers from tuberculosis or has an untreated infection.
• The patient has experienced 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 Fanipos Plus.
• The patient has adrenal gland dysfunction. Caution is required when switching from systemic steroid therapy to treatment with Fanipos Plus.
• The patient has severe liver disease. This increases the risk of systemic adverse effects.

In these cases, the decision on whether Fanipos Plus 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 physician may recommend taking another medicine during periods of stress or before planned surgical procedures.
To avoid adrenal suppression, the physician may recommend using the lowest effective dose that still controls symptoms of nasal mucosal inflammation.
Long-term use of intranasal corticosteroids (such as Fanipos Plus) in children and adolescents may slow growth velocity. The physician will regularly monitor the child's growth and ensure that the lowest effective dose is used.
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 Fanipos Plus.

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

Fanipos Plus and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use, including over-the-counter medicines.
Some medicines may increase the effect of Fanipos Plus 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 Fanipos Plus if taking sedatives or central nervous system depressants.

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

Driving and operating machinery
Fanipos Plus has a minor influence on the ability to drive and operate machinery. Very rarely, fatigue, weakness, or dizziness may occur, which could be caused by the underlying illness or by the use of Fanipos Plus. In such cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

Fanipos Plus contains benzalkonium chloride, solution
This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially with prolonged use.
If the patient experiences discomfort during use of the spray, inform the doctor or pharmacist.

3. How to use Fanipos Plus

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
For the treatment to be most effective, Fanipos Plus 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 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 (see Figure 1).

Figure 1

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

Using the aerosol

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap (see Figure 1).
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 your finger, press the pump quickly once, and at the same time inhale gently (see Figure 3).
6. Breathe out through your mouth.

Figure 3

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 running down the throat and causing an unpleasant taste (see Figure 4).

Figure 4

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. Wash the spray nozzle with water.

It is important to use the dose prescribed by your doctor. Always follow the dosage instructions provided by your doctor.
Duration of treatment
Fanipos Plus 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 Fanipos Plus
If too much nasal medicine is used, the risk of side effects is low. However, consult your doctor if you experience any concerns or if a higher-than-recommended dose has been used for a prolonged period. If anyone, especially a child, accidentally swallows Fanipos Plus, contact a doctor or the nearest hospital emergency department immediately.
Missed dose of Fanipos Plus
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 Fanipos Plus treatment
Do not stop using Fanipos Plus without consulting your doctor, as this may reduce the effectiveness of treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Nosebleeds

Common side effects (may occur in less than 1 in 10 people):

• Headache
• Bitter taste in the mouth, especially if the patient tilts their 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 side effects (may occur in less than 1 in 100 people):

• Mild irritation inside the nose. This may cause a slight stinging sensation, itching, or sneezing
• Dryness in the nose, cough, dry or sore throat

Rare side effects (may occur in less than 1 in 1,000 people):

• Dry mouth

Very rare side effects (may occur in 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 side 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 blisters on the skin
• Bronchospasm (narrowing of the lower airways)

Seek immediate medical attention 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.

Side 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 of time, systemic side effects (affecting the whole body) may occur. The likelihood of such effects is considerably lower with corticosteroids administered as a nasal aerosol than with oral corticosteroid therapy. These side effects may vary between individual patients and depending on the corticosteroid medicine 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 side effects may cause a reduction in growth rate. Rarely, decreased bone density (osteoporosis) has been observed with long-term use of intranasal corticosteroids.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of 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

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Fanipos Plus medicine

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store in the refrigerator. Do not freeze.
Shelf-life after first opening the bottle:
Any 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 required. Such measures help protect the environment.

6. Contents of the package 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.
Each spray actuation (0.14 g) delivers 137 micrograms of azelastine hydrochloride (equivalent to 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.
The other ingredients are: disodium edetate, glycerol (E 422), microcrystalline cellulose and sodium carboxymethylcellulose, 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 aerosol suspension, supplied in an orange glass bottle (type I) with a spray pump, polypropylene (PP) applicator, and cap, packed in a cardboard box.
Each 25 ml bottle contains 23 g of nasal aerosol suspension (providing at least 120 doses).
Each package contains either one bottle with 23 g of nasal aerosol suspension or a pack containing three bottles, each containing 23 g of nasal aerosol suspension.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Portugal, country of export:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorization Number in Portugal, country of export: 5866801
Parallel Import Authorization Number: 52/26

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Azelastin/Fluticason ratiopharm 137 Mikrogramm/50 Mikrogramm pro Spr Spram 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 137 microgrammes/50 microgrammes, suspension pour pulvérisation nasale
Germany: Azelastin/Fluticason-ratiopharm 137 Mikrogramm/50 Mikrogramm pro Sproß, Nasenspray, Suspension
Iceland: Duonasa
Ireland: Nasusaf 137 micrograms/50 micrograms per actuation nasal spray, suspension
Latvia: Azelastine/Fluticasone Teva 137 mikrogrami/50 mikrogrami izsmidzinājumā deguna aerosols, suspensija
Lithuania: Azelastine /Fluticasone Teva 137 mikrogramai/50 mikrogramų/spūstinė nosies purškalas (suspensija)
Netherlands: Azelastine/Fluticasonpropionaat Teva 137 microgram/50 microgram per verstuiving, neusspray, suspensie
Norway: Azelastine hydrochloride/Fluticasone Teva
Poland: Fanipos Plus
Portugal: Azelastina + Fluticasona Teva
Slovakia: Azelastín/Flutikazón Teva 137 mikrogramov/50 mikrogramov
Spain: Azelastina/Fluticasona Teva 137 microgramos/50 microgramos/aplicación, suspensión para pulverización nasal
Sweden: Azelastin/Flutikason Teva