Fanipos plus

Patient Information Leaflet

Fanipos Plus
(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 for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine 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.

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 are types of allergic reactions to substances such as: plant pollens (hay fever), house dust mites, mould spores, dust, or pet dander.
Fanipos Plus helps relieve allergy symptoms such as nasal discharge, postnasal drip, sneezing, and nasal itching or 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 a nasal or oral injury.
• The patient has a nasal infection. Nasal infections should be treated with antibacterial or antifungal medications. Patients who have received treatment for nasal infections may continue to treat allergies using Fanipos Plus.
• The patient has tuberculosis or an untreated infection.
• 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 Fanipos Plus.
• The patient has adrenal gland function disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Fanipos Plus.
• The patient has severe liver disease. This increases the risk of systemic adverse reactions.

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 below in section 3 or as directed by the treating physician.
Using intranasal corticosteroids at doses higher than recommended may lead to adrenal suppression—a condition in which reduced body weight, fatigue, muscle weakness, low blood sugar levels, increased salt craving, joint pain, depression, and darkening of the skin may occur. In such cases, the doctor may recommend taking an alternative medicine during periods of stress or before planned surgical procedures.
To avoid adrenal suppression, the doctor may recommend using the lowest possible dose of the medicine that still effectively controls symptoms of nasal mucosal inflammation.
Long-term use of intranasal corticosteroids (such as Fanipos Plus) in children and adolescents may slow down growth rate. The doctor will regularly monitor the child's growth and ensure that the child is receiving the lowest effective dose.
If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.
If there is any uncertainty 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 the patient plans to take, including those available without a prescription.
Some medicines may increase the effect of Fanipos Plus nasal aerosol, 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 while 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 child, 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 either by the illness itself or by the use of Fanipos Plus. In such cases, patients should not drive or operate machinery. Be aware that alcohol consumption may worsen these effects.

Fanipos Plus 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 prolonged periods.
If the patient experiences discomfort during use of the aerosol, they should inform their doctor or pharmacist.

3. How to use Fanipos Plus

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
For 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

• Use of this medicine is not recommended 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 spray is being used for the first time, prime the pump by releasing a dose into the air.
3. Hold the bottle with two fingers on either side of the pump and the thumb at the bottom.
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 up and down for 5 seconds, remove the protective cap (see Figure 1), then 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 the nose to clear the nostrils.
3. Keep the head tilted forward, towards the toes. Do not tilt the head backward.
4. Hold the bottle upright and gently insert the nozzle into one nostril.
5. Block the other nostril with a finger, press the pump once quickly, and at the same time inhale gently (see Figure 3).
6. Breathe out through the mouth.

Figure 3

7. Repeat the same procedure for the other nostril.
8. After administering the medicine, take gentle breaths and do not tilt the 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 nozzle with a clean tissue or cloth and replace the protective cap.
10. If the spray does not work, do not pierce the nozzle. Clean the nozzle with water.

It is important to use the dose prescribed by the doctor. Always follow the dosage instructions given 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 spray is used, the risk of adverse effects is low. However, consult a doctor if you have 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 spray 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 Fanipos Plus
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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

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

• Nasal bleeding

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

• Headache
• Bitter taste in the mouth, particularly if the patient tilts the 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 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 sore throat

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

• Dry mouth

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

• Dizziness or drowsiness
• Cataract, glaucoma or increased eye pressure, which may lead to loss of vision and (or) redness and pain in the eyes. These adverse reactions have been reported after prolonged 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 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 the available data):

• Blurred vision
• Ulceration of the nasal mucosa

When the medicine is used in high doses over a long period of time, systemic adverse reactions (reactions affecting the whole body) may occur. The likelihood of such reactions is considerably lower with corticosteroids administered as a nasal spray than with oral corticosteroid therapy. These reactions 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 adverse reactions may lead to slowed growth velocity.

Decreased bone density (osteoporosis) has been observed in rare cases following prolonged use of intranasal 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 at 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

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the 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 stated on 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.
Length 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 required. Such practices help protect the environment.

6. Contents of the pack and other information

What Fanipos Plus contains
The active substances in this medicine 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.
Other ingredients are: edetate disodium, glycerol (E 422), microcrystalline cellulose, 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 amber glass bottle with a spray pump, nasal applicator, and cap.
Each 25 mL bottle contains 23 g of nasal aerosol suspension (providing at least 120 doses).
Each pack contains one bottle with 23 g of nasal aerosol suspension or a multipack containing three bottles, each with 23 g of nasal aerosol suspension.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

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

For further information, contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00

This medicine is authorised in the European Economic Area countries 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 137 microgrammes/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 verstuiving, neusspray, suspensie
Ireland: Nasusaf 137 micrograms/50 micrograms per actuation nasal spray, suspension
Iceland: Duonasa
Lithuania: Azelastine /Fluticasone Teva 137 mikrogramai/50 mikrogramų/ spūstelėjime 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