Allerduo

LEAFLET INCLUDED IN THE PACKAGE

Leaflet included in the package: patient information

Allerduo

137 micrograms + 50 micrograms/dose, nasal spray, suspension

Azelastine hydrochloride + Fluticasone propionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Allerduo nasal spray and what is it used for

Allerduo nasal spray 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, and thus reduce the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Allerduo nasal spray is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis, if the use of a single nasal antihistamine or corticosteroid is not considered sufficient.

Seasonal and perennial allergic rhinitis is an allergic reaction to substances such as plant pollen (hay fever), house dust mites, molds, dust, or pet dander.

Allerduo nasal spray relieves allergy symptoms, such as: runny nose, postnasal drip, sneezing, itching, and stuffy nose.

2. Important information before using Allerduo nasal spray

When not to use Allerduo nasal spray:

• If the patient is allergic to azelastine hydrochloride or fluticasone propionate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Allerduo nasal spray, the patient should discuss it with their doctor or pharmacist:

• if the patient has recently undergone nasal surgery.
• if the patient has a nasal infection. Nasal infections should be treated with antibacterial or antifungal medicines. Patients who have been treated with medicines for a nasal infection may continue to treat their allergy with Allerduo nasal spray.
• if the patient has tuberculosis or an untreated infection.
• if the patient notices a change in vision or has previously been diagnosed with increased intraocular pressure, glaucoma, and/or cataract. Patients with these conditions will be closely monitored during treatment with Allerduo nasal spray.
• if the patient has adrenal gland problems. Caution is advised when switching from systemic steroid treatment to Allerduo nasal spray therapy.
• if the patient has severe liver disease. This increases the risk of systemic side effects.

In these cases, the doctor will decide whether Allerduo nasal spray can be used.

It is essential to take the medicine in the dose prescribed below in section 3 or as advised by the doctor.

Taking nasal corticosteroids in higher doses than recommended may lead to adrenal gland problems, which can cause weight loss, fatigue, muscle weakness, low blood sugar, increased salt requirements, joint pain, depression, and darker skin pigmentation.

In such cases, the doctor may prescribe another medicine during periods of stress or scheduled surgery.

To avoid adrenal gland problems, the doctor may prescribe the medicine in the smallest dose that will continue to effectively control the symptoms of allergic rhinitis.

Long-term use of nasal corticosteroids (such as Allerduo nasal spray) may slow down growth in children and adolescents.

The doctor will regularly check the child's growth and ensure that they are taking the smallest effective dose.

If the patient experiences blurred vision or other vision problems, they should contact their doctor.

In case of any doubts about whether any of the above situations apply to the patient, they should consult their doctor or pharmacist before starting treatment with Allerduo nasal spray.

Children

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

Allerduo nasal spray and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.

Some medicines may increase the effects of Allerduo nasal spray, and the doctor may recommend close monitoring if the patient is taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Allerduo nasal spray has a negligible influence on the ability to drive and use machines.

Rarely, fatigue and dizziness may occur, which may be caused by the disease itself or the use of Allerduo nasal spray.

In such cases, the patient should not drive or operate machinery.

They should be aware that drinking alcohol may increase these effects.

Allerduo nasal spray contains benzalkonium chloride

This medicine contains 14 micrograms of benzalkonium chloride per actuation, which corresponds to 0.014 mg/0.14 g.

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

If the patient experiences discomfort during use, they should tell their doctor or pharmacist.

Allerduo nasal spray contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per actuation, which means the medicine is considered "sodium-free".

3. How to use Allerduo nasal spray

This medicine should always be used as directed by the doctor.

In case of doubts, the patient should consult their doctor or pharmacist.

To get the most benefit from the treatment, Allerduo nasal spray must be used regularly.

The patient should avoid contact with the eyes.

Adults and adolescents (12 years and older)

• The recommended dose is one actuation into each nostril in the morning and evening.

Use in children under 12 years of age

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

Use in patients with renal and hepatic impairment

• There are no data on the use of this medicine in patients with renal and hepatic impairment.

Method of administration

Nasal administration.

The patient should carefully read the instructions below and use the medicine only as directed.

INSTRUCTIONS FOR USE

Preparing the nasal spray

• 1. Gently shake the bottle for about 5 seconds, moving it up and down, and then remove the cap (see Figure 1).

Figure 1

• 2. If the nasal spray is used for the first time, the pump must be primed by releasing a dose into the air.
• 3. To prime the pump, place two fingers on either side of the pump and the thumb under 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 spray has not been used for more than 7 days, the pump must be re-primed by pressing and releasing it once.

Using the nasal spray

• 1. Gently shake the bottle for about 5 seconds, moving it up and down, and then remove the cap (see Figure 1).
• 2. Blow the nose to clear the nostrils.
• 3. Tilt the head forward, towards the toes. Do not tilt the head back.
• 4. Hold the bottle upright and gently place the tip of the nozzle into the nostril.
• 5. Block the other nostril with a finger, press the pump quickly once, and at the same time, take a gentle breath in (see Figure 3).
• 6. Breathe out through the mouth.

Figure 3

• 7. Repeat the same steps for the other nostril.
• 8. After administration, breathe normally and do not tilt the head back. This will prevent the medicine from entering the throat and causing an unpleasant taste (see Figure 4).

Figure 4

• 9. After each use, wipe the nozzle tip with a clean tissue or cloth and replace the cap.
• 10. In case of blockage, do not pierce the nozzle tip. Wash the nozzle tip with water.

It is essential to use the dose prescribed by the doctor.

Duration of treatment

Allerduo nasal spray may be used for a long time.

The duration of treatment should correspond to the period during which allergy symptoms occur.

Using a higher dose of Allerduo nasal spray than recommended

In case of using too much nasal spray, there is a small risk of complications.

The patient should consult their doctor if they are concerned or have been taking a higher dose than recommended for a long time.

If someone, especially a child, accidentally swallows Allerduo nasal spray, they should immediately contact a doctor or the nearest hospital emergency department.

Missing a dose of Allerduo nasal spray

The patient should use the nasal spray as soon as they remember and then use the next dose at the usual time.

They should not use a double dose to make up for a missed dose.

Stopping treatment with Allerduo nasal spray

The patient should not stop using Allerduo nasal spray without consulting their doctor, due to the risk of reduced treatment effectiveness.

In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately seek medical attention if they experience any of the following symptoms:

• swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing, and sudden appearance of a skin rash. These may be symptoms of a severe allergic reaction.Note: these symptoms are very rare.

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

• nasal bleeding.

Common side effects (may affect up to 1 in 10 people):

• headache,
• bitter taste in the mouth, especially if the patient tilts their head back during administration of the nasal spray; this taste should disappear if the patient drinks a non-alcoholic beverage a few minutes after using the medicine,
• unpleasant odor.

Uncommon side effects (may affect up to 1 in 100 people):

• mild irritation inside the nose; this may cause a mild stinging sensation, itching, or sneezing,
• dryness in the nose, cough, dryness of the throat, or throat irritation.

Rare side effects (may affect up to 1 in 1,000 people):

• dryness in the mouth.

Very rare side effects (may affect up to 1 in 10,000 people):

• dizziness or drowsiness,
• cataract, glaucoma, or increased intraocular pressure, which may cause vision loss and/or eye redness and pain; these side effects have been reported after long-term use of nasal sprays containing fluticasone propionate,
• skin and nasal mucosa damage,
• malaise, feeling tired, exhausted, or weak,
• rash, itching, or skin redness, itchy blisters on the skin,
• bronchospasm (narrowing of the airways).

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

• blurred vision,
• ulceration of the nasal mucosa.

In case of using the medicine in high doses for a long time, systemic side effects (affecting the whole body) may occur.

The risk of these side effects is much lower when using nasal corticosteroids than when using oral corticosteroids.

These side effects may vary from patient to patient and may depend on the specific corticosteroid medicine used (see section 2).

Nasal corticosteroids may affect the normal production of hormones in the body, especially when used for a long time in high doses.

In children and adolescents, these side effects may cause growth retardation.

Rarely, cases of decreased bone density (osteoporosis) have been observed when corticosteroids were used nasally for a long time.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their 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 181C,

02-222 Warsaw,

phone: +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.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Allerduo nasal spray

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton after "EXP".

The expiry date refers to the last day of the month stated.

Do not store in the refrigerator or freeze.

Shelf life after first opening the bottle: the unused medicine should be discarded 6 months after first opening the nasal spray.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the package and other information

What Allerduo nasal spray contains

The active substances of the medicine are azelastine hydrochloride and fluticasone propionate.

Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

After each actuation (0.14 g), 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate are released.

The other ingredients are glycerol, microcrystalline cellulose, sodium carmellose, disodium edetate, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Allerduo nasal spray looks like and contents of the package

Allerduo nasal spray is a white, homogeneous suspension.

Allerduo nasal spray is available in a brown glass bottle with a pump spray, applicator, and cap.

The 25 ml bottle contains 23 g of nasal spray suspension (at least 120 doses).

Allerduo nasal spray is available in:

• packs containing 1 bottle with 23 g of nasal spray suspension,
• bulk packs containing 3 bottles, each with 23 g of nasal spray suspension.

Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:

Stada Pharm Sp. z o.o.

ul. Krakowiaków 44

02-255 Warsaw

Phone: +48 22 737 79 20

Manufacturer

ELPEN Pharmaceutical Co. Inc.

95 Marathonos Avenue

19009 Pikermi, Attiki

Greece

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Clonmel Healthcare Limited

3 Waterford Road

Clonmel

Co. Tipperary

E91 D768

Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Salvera/Tenera/Aiunera

Denmark:

Azelastine/Fluticasone STADA

Finland:

Azelastine/Fluticasone STADA

France:

Azelastine hydrochloride / Propionate de Fluticasone EG 137 micrograms/50 micrograms, suspension pour pulvérisation nasale

Ireland:

Nasorinit 137 micrograms/50 micrograms per actuation, nasal spray suspension

Netherlands:

Azelastine/Fluticasonpropionaat CF 137 microgram/50 microgram per verstuiving, neusspray, suspensie

Germany:

Azelastin/Fluticason AL Nasenspray 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension

Norway:

Azelastine/Fluticasone STADA

Poland:

Allerduo

Slovakia:

Azelastín/Flutikazón STADA

Sweden:

Azelastine/Fluticasone STADA

Hungary:

Azelastine/Fluticasone Stada 137 mikrogramm/50 mikrogramm szuszpenziós orrspray

Italy:

Azelastina e Fluticasone EG

Date of last revision of the leaflet: