Otriallergy control

OtriAllergy Control is used for symptomatic treatment of allergic rhinitis diagnosed by a physician.
Before using the medicine, read the package leaflet carefully and use the diagnostic tool located at the end of this leaflet.
This information is available in pharmacies and on the website: otriallergycontrol.com.
Package leaflet: information for the patient
OtriAllergy Control
50 micrograms/dose, nasal spray, suspension
Fluticasoni propionas
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 7 days, contact your doctor.

Leaflet contents

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

1. What OtriAllergy Control is and what it is used for
The active substance in OtriAllergy Control is fluticasone propionate, which belongs to a group of medicines called corticosteroids. When used daily, it reduces inflammation. This medicine helps control the body's reaction to allergens (substances that trigger allergic reactions) present in the environment.
OtriAllergy Control is used in adults aged 18 years and older to treat symptoms of allergic rhinitis caused by pollen (hay fever) or other airborne allergens such as house dust mites, mould spores, or animal dander.
For up to 24 hours after administration, the medicine relieves symptoms such as sneezing, itchy and watery eyes, runny nose, nasal itching, and blocked nose.
Maximum therapeutic effect may take 3–4 days of continuous use. Therefore, regular use of the medicine is recommended to achieve full therapeutic benefit.
Treatment should only be used during periods of allergen exposure.
If there is no improvement after 7 days or if you feel worse, consult your doctor.

2. Important information before using OtriAllergy Control

When not to use OtriAllergy Control:

• 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 OtriAllergy Control, consult your doctor or pharmacist if:

• You are using other corticosteroid-containing medicines (e.g. creams for eczema, inhaled medicines for asthma, tablets, injections, nasal sprays, or eye or nasal drops),
• You have nasal infections or sinusitis, a cold, high fever, recent nasal injury or surgery, or ulceration of the nasal mucosa.

If there is no improvement after 7 days, contact your doctor.
Do not use OtriAllergy Control for longer than 3 months without consulting your doctor.
If you experience blurred vision or other visual disturbances, which may be due to conditions such as cataracts or glaucoma, contact your doctor.
Systemic effects may occur when using intranasal corticosteroids, especially if high doses are used for prolonged periods. The likelihood of systemic effects is much lower than with oral corticosteroids and may vary between individual patients and different corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid facial features, adrenal suppression, growth retardation in children and adolescents, and less commonly, decreased bone mineral density, glucose metabolism disorders, and various psychiatric symptoms or behavioral changes such as psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children).
Using intranasal corticosteroids at higher than recommended doses may lead to clinically significant adrenal suppression. If a patient has used higher than recommended doses, the doctor may consider additional systemic corticosteroid therapy during periods of stress or before planned surgery.

OtriAllergy Control and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, and any medicines you plan to take.
This is particularly important if you are also using:

• Medicines containing corticosteroids (including topical creams and ointments for eczema, and medicines used to treat asthma: tablets, injections, nasal sprays, or eye or nasal drops),
• Ritonavir and cobicistat (medicines used in the treatment of HIV),
• Ketoconazole (a medicine used to treat fungal infections).

Some medicines may enhance the effect of OtriAllergy Control, and your doctor may recommend close monitoring of these medicines (including certain anti-HIV drugs: ritonavir, cobicistat).

Taking OtriAllergy Control with food and drink
This medicine can be used at any time of day, with or without food or drink.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There are no available data on the effect of OtriAllergy Control on fertility.

Driving and operating machinery
OtriAllergy Control has no known effect on the ability to drive or operate machinery.

This medicine contains benzalkonium chloride
This medicine contains 0.02 mg of benzalkonium chloride per spray dose, equivalent to 0.2 mg of benzalkonium chloride per 1 ml of solution.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially with long-term use.

3. How to use OtriAllergy Control

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Adults aged 18 years and above
The recommended dose is two sprays into each nostril once daily (200 micrograms of fluticasone propionate), preferably in the morning.
Once adequate control of symptoms has been achieved, the dose may be reduced to one spray into each nostril once daily.
If acute symptoms occur, the dose may be increased to two sprays into each nostril twice daily, but only for a short period.

• Do not use more than four sprays into each nostril per day.
• Use the lowest dose that provides effective control of symptoms.
• If there is no improvement or adequate symptom control after 7 days, consult your doctor or pharmacist.
• Treatment should only be used during the period of allergen exposure.
• Do not use more than the recommended dose.
• Do not use the medicine for longer than 3 months without consulting a doctor.

Children and adolescents
OtriAllergy Control nasal spray is not recommended for use in children and adolescents under 18 years of age.

Elderly patients
Dosage is the same as for adult patients.

Method of administration
For nasal use only.
Do not use in the eyes or mouth.
Do not swallow the medicine.

Before using OtriAllergy Control:
OtriAllergy Control is supplied with a protective cap that covers the spray nozzle and helps keep it clean. Remove the cap before use (Figure 1).
If OtriAllergy Control is being used for the first time or has not been used for a prolonged period, it must be prepared properly before use to ensure you receive a full dose of medicine.
Place your index and middle fingers on either side of the spray nozzle and your thumb underneath the bottle. Keeping your thumb steady, press down several times on the spray nozzle until a fine mist is produced (Figure 2). Do not point the spray nozzle towards yourself or others.

Figure 1

Figure 2

How to use OtriAllergy Control:

1. Gently blow your nose.
2. Shake the bottle gently and remove the cap.
3. If OtriAllergy Control is being used for the first time or has not been used for a prolonged period, prime the spray nozzle by pressing it several times until a fine mist appears.
4. Hold the bottle as shown in Figure 3. Close one nostril with a finger, and insert the spray nozzle into the other nostril. Tilt your head slightly forward and hold the spray nozzle vertically, as shown in Figure 4. Direct the nozzle slightly away from the nasal septum, towards the outer side of the nose.
5. Breathe in gently through your nose and, at the same time, press down firmly on the spray nozzle to release one dose of medicine into the nose.
6. Breathe out through your mouth, as shown in Figure 5.
7. Repeat steps 4 and 5 to administer a second spray into the same nostril.
8. Repeat steps 4, 5, and 6 to administer the required dose into the other nostril.
9. After administering the nasal spray, wipe the nozzle with a clean tissue or cloth and replace the protective cap.

Figure 3

Figure 4

Figure 5

Cleaning the nozzle and spray device:

1. Remove the cap and spray nozzle (Figure 6).
2. Soak the nozzle and cap in warm water for several minutes (Figure 7), then rinse thoroughly under running water (Figure 8).
3. Shake off excess water from the nozzle and cap, and allow them to dry in a warm place. Do not dry at high temperatures.
4. Reattach the spray nozzle to the medicine bottle (Figure 9).
5. If necessary, press the spray nozzle several times until a fine mist is produced. Replace the cap on the bottle.
6. Do not use a pin or any other sharp object to unblock the spray nozzle, as this may damage the spray mechanism.

Figures 6, 7, 8, 9

Maximum therapeutic effect of OtriAllergy Control may take 3–4 days of treatment. To prevent symptoms, start using OtriAllergy Control before the expected period of allergen exposure.
OtriAllergy Control should only be used during the period of allergen exposure (e.g. pollen season).

If you use more OtriAllergy Control than recommended
If you use more than the recommended dose of OtriAllergy Control, consult your doctor.

If you miss a dose of OtriAllergy Control
If you miss a dose, take the next dose as scheduled. Do not use a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
When corticosteroids are administered intranasally, particularly if used in high doses over a prolonged period, systemic effects may occur.
Some adverse reactions may be severe.
You should contact your doctor as soon as possible if any of the following serious adverse reactions occur (very rare):

• signs of an allergic reaction such as rash, swelling of the mouth or face, difficulty breathing
• new visual disturbances occurring after starting treatment with this medicine. Rare cases of vision disorders such as cataract or glaucoma have been reported in patients using corticosteroids in high doses over several years
• perforations (damage) of the nasal septum
• eye problems such as pain

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• blurred vision
• ulceration of the nasal mucosa

If any of the listed symptoms occur, you should stop using the medicine and seek medical advice immediately.
Other adverse reactions:
Very common adverse reactions (may affect more than 1 in 10 people)

• occasional nosebleeds

Common adverse reactions (may affect up to 1 in 10 people)

• sneezing, which resolves spontaneously
• unpleasant taste or smell sensation
• dryness or irritation of the nose or throat
• headache

Very rare adverse reactions (may affect up to 1 in 10,000 people)

• pain and/or bleeding from the nose
• increased intraocular pressure

If any of the listed symptoms occur, you should stop using the medicine and consult your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store OtriAllergy Control

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack following: Exp. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater 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 OtriAllergy Control contains

• The active substance is: fluticasone propionate. One dose of nasal aerosol delivers 100 mg of suspension containing 50 micrograms of fluticasone propionate.
• Other ingredients are: glucose (anhydrous), microcrystalline cellulose, sodium carboxymethylcellulose, phenylethyl alcohol, benzalkonium chloride, polysorbate 80, and purified water.

What OtriAllergy Control looks like and contents of the pack
OtriAllergy Control is a nasal aerosol in the form of a white, opaque, aqueous suspension.
The amber glass bottle is equipped with a metering pump consisting of a PP applicator and a PP nozzle, packed in a cardboard box.
One bottle contains 60 doses of aerosol; total content not less than 7.0 g, or 120 doses of aerosol; total content not less than 14.0 g.

Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer
Glaxo Wellcome SA
Avda. Extremadura, 3
Pol. Ind. Allendeduero, Aranda de Duero
09400 Burgos
Spain

Importer
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

This medicinal product is authorised in the European Economic Area member states under the following names:
Belgium Otrivine Anti-Allergie 50 microgrammes/dose, suspension pour pulvérisation nasale
Estonia Flixonase, 50 mikrogrammi/pihustuses ninasprei, suspensioon
Ireland Fluticasone propionate 50 micrograms/actuation, nasal spray, suspension
Latvia Flixonase 50 mikrogrami/ izsmidzinājumā deguna aerosols, suspensija
Luxembourg Otrivine Anti-Allergie 50 microgrammes/dose, suspension pour pulvérisation nasale
Netherlands Flixonase Haleon 50 microgram/dosis, neusspray, suspensie
Norway Otrason 50 mikrogram/dose nesespray, suspensjon
Portugal Vibrocil Anti-Alergias 50 µg/dose Suspensão para pulverização nasal
Romania Vibrocil Alergii 50 micrograme/doza spray nazal, suspensie
Spain Rhinovin Alergia 50 microgramos/pulverización suspensión para pulverización Nasal
Hungary Flixonase Allergia 50 mikrogramm/adag szuszpenziós orrspray
United Kingdom Fluticasone propionate 50 micrograms/actuation, nasal spray, suspension
(Northern Ireland)

Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

MEDICINAL PRODUCT DIAGNOSTIC TOOL
OTRIALLERGY CONTROL

WARNING!
OtriAllergy Control is used to treat symptoms of allergic rhinitis caused by pollen (hay fever) or other airborne allergens (such as house dust mites, mould spores, or animal dander).

IF THE PATIENT DOES NOT MEET AT LEAST ONE OF THE FOLLOWING CRITERIA, THIS MEDICINE SHOULD NOT BE USED!

1.a
Has the patient been diagnosed by a doctor with allergic rhinitis caused by pollen (hay fever) or other airborne allergens (such as dust mites, mould spores, or animal dander)?

1.b
Can the patient independently distinguish allergy symptoms from those of a common cold or flu?

2 x YES — Continue to next questions
2 x NO or 1 x NO — DO NOT USE OtriAllergy Control without consulting a doctor.

2. Is the patient currently using:

   • medicines containing corticosteroids (including creams and ointments used in eczema, and medicines used to treat asthma: tablets, injections, nasal sprays, or eye or nose drops)
   • ritonavir and cobicistat (medicines used in HIV treatment)
   • ketoconazole (a medicine used for fungal infections)

3. Does the patient currently have:

   • symptoms of nasal or sinus infections
   • symptoms of a cold
   • high fever

4. Does any of the following apply to the patient?

   • Recent nasal surgery
   • Recent nasal injury
   • Ulceration of the nasal mucosa

5. Is the patient pregnant, suspect she may be pregnant, planning pregnancy soon, or breastfeeding?

6. Has the patient used OtriAllergy Control or another corticosteroid nasal spray continuously for more than 3 months?

At least 1 x YES in responses to questions 2–6
YES — OtriAllergy Control may be used
NO — Do not use OtriAllergy Control without consulting a doctor.

Warning! The full therapeutic effect may take 3–4 days of continuous treatment with OtriAllergy Control. Therefore, regular use is recommended to achieve full therapeutic benefit. However, if there is no improvement after 7 days, or if symptoms worsen, consult a doctor!