OTRI-ALLERGIE

OTRI-ALLERGIE Nasal Spray Fluticasone

Important notes (mandatory information)

Otri-Allergie Nasal Spray Fluticasone. Active ingredient: Fluticasone propionate. Areas of application: for the symptomatic treatment of hay fever (seasonal allergic rhinitis).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Otri-Allergie Nasal Spray Fluticasone, suspension for adults
Active ingredient: 0.05 mg fluticasone propionate/spray actuation nasal spray

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS OTRI—ALLERGIE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING OTRI—ALLERGIE?
3. HOW TO USE OTRI—ALLERGIE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE OTRI—ALLERGIE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS OTRI-ALLERGIE AND WHAT IS IT USED FOR?

The active ingredient fluticasone propionate, a corticosteroid, has anti-inflammatory properties when used daily. The spray helps you control your body's reactions to allergens (triggers of an allergic reaction in the environment). It relieves symptoms such as sneezing, itchy and runny nose, itchy and watery eyes, and nasal congestion for up to 24 hours. Otri-Allergie is used for the symptomatic treatment of hay fever (seasonal allergic rhinitis). Note: Treatment may only be started after an initial diagnosis by a doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING OTRI-ALLERGIE?

Otri-Allergie must not be used if you are hypersensitive (allergic) to fluticasone propionate or any of the other ingredients (see list in section 6).

Warnings and precautions

Please talk to your doctor or pharmacist before using Otri-Allergie:

• if you are using other corticosteroid-containing medicines, such as ointments for eczema, asthma inhalers, tablets, injections, nasal sprays or eye or nose drops.
• if you have a nasal or sinus infection, a cold or fever, or have recently had nasal surgery, a nasal injury, or nasal tumors.

If your symptoms have not improved after 7 days or do not respond to treatment, inform your doctor. Do not use Otri-Allergie continuously for more than 3 months unless directed by your doctor. If corticosteroid nasal sprays are used in higher doses and for a longer period of time, side effects may occur due to the absorption of the active ingredient into the body. Such reactions occur much less frequently than when taking corticosteroid tablets and may vary in severity from patient to patient and with different corticosteroid-containing medicines. Possible side effects affecting the whole body include Cushing's syndrome, Cushingoid features, adrenal insufficiency, growth retardation in children and adolescents, eye conditions such as cataracts (clouding of the lens, cataracts) and glaucoma (glaucoma), and, more rarely, a reduction in bone mineral density, changes in blood sugar metabolism, changes in mood or behavior, including unusual hyperactivity, sleep disturbances, anxiety, depression or aggression. If the recommended dosage of corticosteroid nasal sprays is exceeded, clinically relevant adrenal insufficiency may occur. In such cases, temporary additional systemic corticosteroid administration should be considered in stressful situations (e.g. before surgery).

When taking other medicines

Inform your doctor or pharmacist before using this medicine if you are taking or have taken or are taking or using any other medicines (prescription or non-prescription), especially:

• Corticosteroid-containing medicines (including ointments for eczema, asthma inhalers, tablets, injections, nasal sprays, eye or nose drops),
• Ritonavir (for the treatment of HIV infection) or ketoconazole (for fungal infections).

Use of Otri-Allergie with food and drink

Otri-Allergie can be used at any time, regardless of food and drink.

Pregnancy, breastfeeding and fertility

Inform your doctor before using Otri-Allergie if you are planning to become pregnant, are pregnant or are breastfeeding. There is no information on the effect of Otri-Allergie on fertility.

Driving and operating machinery

Otri-Allergie has no influence on the ability to drive and use machines.

Otri-Allergie contains benzalkonium chloride

Benzalkonium chloride can cause bronchospasm (spasmodic narrowing of the airways), irritation of the nasal mucosa, and, especially with prolonged use, swelling of the nasal mucosa.

3. HOW TO USE OTRI-ALLERGIE?

Always use this medicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage for adults 18 years and older

Spray two sprays into each nostril once a day (200 micrograms fluticasone propionate), ideally in the morning. Once your symptoms have improved, you can reduce the dose to one spray per nostril once a day.

• Use the lowest possible dose to control your symptoms.
• If your symptoms have not improved after 7 days or you do not respond to treatment, inform your doctor or pharmacist.
• Do not use more than the recommended dose.

It may take 3 to 4 days to achieve maximum treatment success. It is therefore necessary that you use Otri-Allergie regularly. To prevent symptoms, start using Otri-Allergie before you come into contact with your typical "allergen". You should only use Otri-Allergie as long as you are exposed to the allergy-causing substances.

Children and adolescents

Otri-Allergie must not be used in children and adolescents under 18 years of age.

Method of administration

For nasal use only. Do not swallow. Do not spray into the eyes.

Before opening a new bottle of Otri-Allergie

Otri-Allergie has a protective cap that protects and keeps the spray nozzle clean. Remove the cap each time before using the spray. Before opening a new bottle of Otri-Allergie or if you have not used the spray for a few days, press the spray head down repeatedly until a fine mist forms. This ensures that the correct dose is delivered. Hold the bottle with your index and middle fingers on the spray head on either side of the spray nozzle and your thumb on the bottom of the bottle. Do not move your thumb and press the spray head down several times with both fingers until a fine mist comes out of the bottle. Make sure you do not point the nozzle opening at yourself or anyone else. If the spray still does not work, try cleaning it as described in the "Cleaning the Spray" section. However, do not try to pierce or enlarge the narrow spray opening with a needle or sharp object, as this will destroy the spray mechanism.

Using Otri-Allergie

1. Gently blow your nose.
2. Shake the bottle well and remove the protective cap.
3. If it is a new bottle of Otri—Allergie or if you have not used the spray for a few days, press the spray head down repeatedly until a fine mist has formed.
4. Hold the bottle with 3 fingers.
5. Close one nostril and insert the spray nozzle into the other nostril. Tilt your head slightly forward and hold the bottle upright. Keep the spray head away from the inside wall of the nose (nasal septum). Begin breathing slowly through the open nostril. Spray the fine mist into the nostril as you inhale by pressing the spray head firmly down with your fingers. Exhale slowly through your mouth. Repeat step 5 to spray a second spray into the same nostril if necessary.
6. Repeat steps 4 and 5 with the other nostril.
7. After use, gently clean the spray nozzle with a clean cloth and replace the protective cap.

Cleaning the nasal spray

Remove the protective cap and spray nozzle. Soak the spray nozzle and protective cap in warm water for several minutes. Rinse both parts under running water, shake off excess water, and let them dry in a warm but not hot place. Replace the spray nozzle on the bottle. If necessary, actuate the pump several times until a fine mist has formed. Replace the protective cap. Do not try to pierce or enlarge the narrow spray opening with a needle or sharp object, as this will destroy the spray mechanism.

If you have used too much Otri-Allergie

Inform your doctor.

If you forget to use Otri-Allergie

Take your next dose at the usual time. Never use two doses at once.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Otri-Allergie can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Stop taking the medicine and see a doctor immediately if you experience the following very rare but serious symptoms:

• Signs of an allergic reaction, such as rash, swelling of the mouth or face, or difficulty breathing.
• New onset of visual disturbances after using Otri—Allergie. Rare cases of visual disturbances (e.g. cataracts or glaucoma) have been reported in patients who have used corticosteroids in high doses and for a very long period of time.
• Signs of damage (e.g. perforation) to the nasal septum.

Other very rare side effects, which may affect 1 in 10,000 treated:

• Eye problems, such as pain or blurred vision.
• Nasal problems, such as pain and/or persistent bleeding.

Stop taking the medicine and tell your doctor.

Common side effects, which may affect 1 in 10 treated:

• Short-term sneezing after using the spray.
• Unpleasant odor or taste sensation.
• Dryness or irritation in the nose or throat.
• Headache.

Very common side effects, which may affect more than 1 in 10 treated:

• Nosebleeds.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE OTRI-ALLERGIE?

Keep out of reach of children. Do not use the medicine after the expiry date stated on the container. The expiry date refers to the last day of the month. Do not store above 30°C. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Otri-Allergie contains

The active ingredient is fluticasone propionate. 1 spray actuation (100 mg suspension) contains 0.05 mg fluticasone propionate. The other ingredients are: glucose (anhydrous), microcrystalline cellulose, carmellose sodium, phenylethyl alcohol, benzalkonium chloride, polysorbate 80, purified water.

What Otri-Allergie looks like and contents of the pack

Otri-Allergie is a white to opaque aqueous suspension in a brown glass spray bottle with a metering pump, an applicator and a protective cap. The bottle contains 60 sprays with a total volume of not less than 6 ml.

Pharmaceutical entrepreneur

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich

Barthstraße 4
80339 Munich

Telephone (089) 7877 - 209
Telefax (089) 7877 - 304
E-mail: medical.contactcenter@gsk.com

Manufacturer

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

This leaflet was last revised in October 2016.

Source: Information from the package leaflet
Status: 10/2019
Active ingredient: Fluticasone propionate. Areas of application: for the symptomatic treatment of hay fever (seasonal allergic rhinitis).