Fanipos

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Fanipos, 50 µg/dose nasal spray, suspension

Fluticasone propionate

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Fanipos and what is it used for

The medicine is called Fanipos (referred to as Fanipos in this leaflet). It contains 50 micrograms of the active substance, fluticasone propionate, in each dose. Fluticasone propionate belongs to a group of medicines called corticosteroids. Fanipos has anti-inflammatory properties. When administered into the nose, it reduces swelling and irritation. It is used to prevent and treat seasonal allergic rhinitis (e.g. hay fever) and perennial allergic rhinitis (e.g. stuffy nose or runny nose, sneezing, and itching caused by house dust mites or pet hair). It can be used in adults and children aged 4 and above.

2. Important information before using Fanipos

When not to use Fanipos

• if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Fanipos, you should discuss this with your doctor or pharmacist:

• if you have had nasal surgery;
• if you have had a recent nasal infection;
• if you have had a recent untreated infection, tuberculosis, or a herpes infection of the eye;
• if you have recently taken steroid injections or have taken oral steroids for a long time.

Fanipos may affect the production of hormones in your body, especially if it is used in higher doses than recommended for a long time. In such cases, your doctor may consider additional administration of corticosteroids during periods of stress, after serious injuries, or before planned surgery. The use of Fanipos usually leads to the control of seasonal allergic rhinitis (hay fever), but in cases of exposure to very high concentrations of pollen, additional treatment may be necessary to control other symptoms, such as itchy eyes. In such cases, you should consult your doctor. If you experience blurred vision or other vision disturbances, you should contact your doctor.

Children and adolescents

Fanipos nasal spray may have systemic effects, including growth retardation in children and adolescents, and less frequently, a range of psychological or behavioral effects, including hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children).

Fanipos and other medicines

You should tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Some medicines may affect the action of Fanipos, in particular, you should tell your doctor or pharmacist about the use of:

• any medicines used to treat fungal infections (e.g. ketoconazole);
• some medicines may enhance the effect of Fanipos, and your doctor may want to closely monitor your condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Fanipos contains benzalkonium chloride solution

This medicine contains 40 micrograms of benzalkonium chloride solution in each delivered dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Fanipos

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Recommended dose

Adults (including elderly patients) and children aged 12 and above

When starting to use Fanipos, you usually take two sprays into each nostril once a day, preferably in the morning. Your doctor may recommend using a maximum of two sprays into each nostril twice a day. After achieving control of symptoms, your doctor may recommend reducing the dose to one spray into each nostril once a day. If symptoms worsen while using this lower dose, the dose can be increased again to the initial dose.

Children aged 4 to 11

In children aged 4 to 11, you usually take one spray into each nostril once a day, preferably in the morning. Your doctor may recommend using a maximum of one spray into each nostril twice a day.

Fanipos is not indicated for children under 4 years of age.

Your doctor will recommend using the lowest dose of Fanipos that provides effective control of symptoms. The effect of the medicine may occur after a few days of treatment. Do not stop using the medicine unless your doctor tells you to. Do not use more doses of Fanipos than your doctor recommends. It is important not to use more doses of the medicine than your doctor recommends. If, despite using Fanipos, you still experience itching and tearing of the eyes associated with hay fever, you should tell your doctor. Your doctor may recommend using another medicine to relieve eye symptoms.

Before using the nasal spray

Fanipos has a protective cap that covers and keeps the pump clean. The protective cap should be removed before using the medicine and replaced after use. Before using the nasal spray for the first time, you should prepare the bottle:

• 1. Gently shake the bottle, then remove the protective cap.
• 2. Hold the bottle upright with your thumb on the bottom of the bottle and your index and middle fingers on either side of the pump. Make sure the pump is not pointing directly at you.
• 3. Press the pump with your fingers to release a spray (Fig.1).

(Fig.1)

• 4. Repeat steps 2 and 3 five more times – the spray is ready to use.

If you have not used Fanipos for the last 7 days, you should prepare it for use again, so that it produces a fine mist. If, after trying to prepare the bottle for use, the pump still does not work, it may be clogged. In this case, you should perform the following actions:

Cleaning the nasal spray bottle

• 1. Remove the protective cap (Fig.2) and pull the white ring up to remove the pump (Fig.3).

Protective cap

Fig. 2

Pump

Fig. 3

• 2. Soak the pump and protective cap in warm water for a few minutes, then rinse under running water (Fig. 4 and 5).

Protective cap

Fig. 4

Pump

Fig. 5

• 3. Shake off excess water and leave the pump and protective cap to dry in a warm (not hot) place.
• 4. Reinsert the pump onto the bottle (Fig.6).

Central hole Pump Pumping system

Fig. 6

• 5. Prepare the bottle for use, if necessary, by pressing the pump several times until a fine mist is produced.
• The pump should be cleaned at least once a week to prevent clogging. In case of clogging, additional cleaning is necessary.
• NEVER try to unclog or enlarge the hole in the pump with a needle or other sharp object, as this will damage the medicine spraying mechanism.

Using the nasal spray

• 1. Shake the bottle and remove the protective cap.
• 2. Gently blow your nose.
• 3. Block one nostril by pressing it with your finger and put the tip of the pump into the other nostril (Fig.7). Tilt your head forward slightly, so that the bottle is in a vertical position.

Fig.7

• 4. Take a slow breath in through your nose and at the same time press the pump ring firmly with your fingers to deliver the spray into the nostril (Fig.8).

Fig.8

• 5. Breathe out through your mouth. Repeat the actions described in point 4 to deliver a second spray into the same nostril.
• 6. Remove the pump tip from the nostril and breathe out through your mouth.
• 7. Repeat the actions described in points 3 to 6 to deliver the medicine into the other nostril (Fig.9).

Fig.9

After using the nasal spray

• You should carefully wipe the pump with a clean tissue and replace the protective cap.

Using a higher dose of Fanipos than recommended

It is important to use the medicine as recommended by your pharmacist or doctor. The medicine should be taken only in the doses recommended by your doctor; using a lower or higher dose than recommended may worsen symptoms. If you accidentally use a higher dose of Fanipos than recommended, you should contact your doctor. You should take this leaflet and the bottle with Fanipos to show them to your doctor.

Missing a dose of Fanipos

You should not take a double dose to make up for a missed dose. If you miss a dose of Fanipos at the scheduled time, you should take it as soon as you remember. If it is almost time for the next dose, you should wait and take the next dose at the scheduled time.

Stopping the use of Fanipos

Nasal symptoms may improve only after a few days of using Fanipos. Therefore, it is very important to use the medicine regularly, as your doctor has recommended, and to continue using it until your doctor recommends stopping, even if you feel better. If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fanipos can cause side effects, although not everybody gets them. If you are using high doses of Fanipos, you may need to take additional steroids during periods of high stress, during hospitalization after a serious injury, or before surgery. Treatment with nasal corticosteroids may affect the production of steroids in your body. The likelihood of this effect is higher when using high doses for a long time. Your doctor will help prevent this by prescribing the lowest dose of steroids that can adequately control your symptoms.

Some side effects are more serious than others, and if you experience any of the following symptoms, you should stop using Fanipos and contact your doctor as soon as possible:

• severe allergic reactions with sudden onset of rash, swelling (usually of the tongue, face, or lips), or difficulty breathing.
• bronchospasm (narrowing of the airways in the lungs, characterized by wheezing or severe shortness of breath and coughing).
• sudden drowsiness or dizziness (leading to fainting or loss of consciousness).

Other side effects

Very common: may affect more than 1 in 10 people

• nasal bleeding.

Common: may affect up to 1 in 10 people

• headache.
• unpleasant taste in the mouth, unpleasant smell in the nose.
• dryness and irritation of the throat and nasal mucosa, and sneezing.

Very rare: may affect up to 1 in 10,000 people

• glaucoma (increased intraocular pressure) and cataract (clouding of the lens of the eye), reported during long-term use.
• perforation of the nasal septum (the partition dividing the nasal cavity) and ulceration of the nasal mucosa. This usually affects patients who have undergone nasal surgery.

Frequency not known: frequency cannot be estimated from the available data

• blurred vision.
• ulcers of the nasal mucosa.

Additional side effects in children and adolescents

Children may have slowed growth compared to others, so in children receiving nasal corticosteroids for a long time, your doctor will need to regularly check their growth. Your doctor will help prevent growth retardation by prescribing the lowest dose of steroids that provides adequate control of symptoms.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform 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 181 C, 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

The medicine should be stored out of 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 month. Do not store above 25°C. Shelf-life after first opening: 3 months. The date of first opening can be written on the label of the multidose container. 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 package and other information

What Fanipos contains

• The active substance is fluticasone propionate. Each dose contains 50 micrograms of fluticasone propionate.
• The other ingredients are: glucose, dispersible cellulose, 2-phenylethanol, benzalkonium chloride solution (40 micrograms/dose), polysorbate 80, purified water.

What Fanipos looks like and contents of the package

Fanipos, nasal spray, is a white, non-transparent suspension in a brown glass bottle with a pump dispenser, in a carton box. Each bottle contains a suspension providing 60, 120, 150 doses, and 240 doses (2 bottles containing 120 doses each). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer

Teva Czech Industries s.r.o., Ostravska 29, 747 70 Opava – Komarov, Czech Republic, Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:

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