ALLERDUO

PACKAGE LEAFLET

Package leaflet: Information for the patient

Allerduo
137 micrograms + 50 micrograms/dose, nasal spray, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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 others, 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 Allerduo nasal spray is and what it is 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 pack and other information

1. What Allerduo nasal spray is and what it is 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, thereby reducing 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 when treatment with a single intranasal antihistamine or corticosteroid is not considered sufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as pollen (hay fever), house dust mites, moulds, dust, or pets.
Allerduo nasal spray helps relieve allergy symptoms such as nasal discharge, postnasal drip, sneezing, nasal itching, and nasal congestion.

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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Allerduo nasal spray, discuss the following with your doctor or
pharmacist:

• if the patient has recently undergone nasal surgery.
• if the patient has a nasal infection. Infections of the nasal passages should be treated with antibacterial or antifungal medications. Patients who have been treated for nasal infection may continue allergy treatment with Allerduo nasal spray.
• if the patient suffers from tuberculosis or has an untreated infection.
• if the patient has experienced 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 Allerduo nasal spray.
• if the patient has adrenal gland function disorders. Caution is required when switching from systemic steroid therapy to treatment with Allerduo nasal spray.
• if the patient has severe liver disease. In such cases, the risk of systemic adverse effects increases.

In these situations, the decision on whether Allerduo nasal spray can be used will be made by the
attending physician.
It is important that the patient uses the medicine at the dose indicated below in section 3 or as
recommended by the attending physician. Using intranasal corticosteroids at doses higher than
recommended may suppress adrenal function—a condition in which weight loss, 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 another medicine during periods
of stress or before planned surgical procedures.
To avoid adrenal suppression, the doctor may recommend using the medicine at the lowest dose
that still effectively controls symptoms of nasal mucosal inflammation.
Long-term use of intranasal corticosteroids (such as Allerduo nasal spray) may cause slowed growth
in children and adolescents. The doctor will regularly monitor the child's growth and ensure that the
lowest effective dose is used.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If in doubt whether any of the above conditions apply, consult a 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
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as
any medicines planned for use, including those available without prescription.
Some medicines may increase the effect of Allerduo nasal spray, and the doctor may recommend
careful monitoring if the patient is taking such medicines (including certain HIV medications: ritonavir,
cobicistat, and antifungal agents: ketoconazole).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Allerduo nasal spray has a minor influence on the ability to drive and operate machinery. Very
rarely, fatigue and dizziness may occur, which could be caused by the illness itself or by using Allerduo
nasal spray. In such cases, driving and operating machinery should be avoided. Be aware that alcohol
may worsen these effects.
Allerduo nasal spray contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray, equivalent to 0.014 mg/0.14 g.
Benzalkonium chloride may cause nasal irritation or swelling, especially with prolonged use.
If the patient experiences discomfort while using the spray, inform the doctor or pharmacist.
Allerduo nasal spray contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per spray, meaning the medicine is considered
"sodium-free".

3. How to use Allerduo nasal spray

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
For optimal therapeutic benefit, Allerduo nasal spray must be used regularly. Avoid contact with the eyes.
Adults and adolescents (12 years and older)

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

Use in children under 12 years of age

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

Use in patients with renal or hepatic impairment

• There is no data available regarding use 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 spray

1. Gently shake the bottle up and down for about 5 seconds, then remove the 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. Prime the pump by placing two fingers on either side of the pump and your thumb under the base of 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, re-prime the pump by pressing and releasing it once.

Using the spray

1. Gently shake the bottle up and down for about 5 seconds, then remove the cap (see Figure 1).
2. Blow your nose to clear the nasal passages.
3. Tilt your head forward, looking down toward your toes. Do not tilt your head backward.
4. Hold the bottle upright and gently insert the spray nozzle into one nostril.
5. Block the other nostril with a finger, press the pump quickly once, and at the same time inhale gently (see Figure 3).
6. Breathe out through your mouth.

Figure 3

7. Repeat the same procedure for the other nostril.
8. After administering the medicine, breathe normally and do not tilt your 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 spray nozzle with a clean tissue or cloth, then replace the cap.
10. If the spray does not release, do not pierce the nozzle. Clean the spray nozzle with water.

It is important to use the dose prescribed by your doctor. Only use the dosage as instructed by your doctor.
Duration of treatment
Allerduo nasal spray 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 Allerduo nasal spray
If too high a dose of nasal spray is used, the likelihood of adverse effects is low. However, consult your 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 Allerduo nasal spray, contact a doctor or the nearest hospital emergency department immediately.
Missing a dose of Allerduo nasal spray
Use the nasal spray as soon as you remember, then continue with your next dose at the usual time. Do not use a double dose to make up for a missed dose.
Stopping treatment with Allerduo nasal spray
Do not stop using Allerduo nasal spray without consulting your doctor, as this may result in reduced effectiveness of treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
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.

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

• nosebleeds.

Common side effects (may affect less than 1 in 10 people):

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

Uncommon side effects (may affect less than 1 in 100 people):

• slight irritation inside the nose; this may cause mild stinging, itching or sneezing,
• dryness in the nose, cough, dry throat or sore throat.

Rare side effects (may affect less than 1 in 1,000 people):

• dry mouth.

Very rare side effects (may affect less than 1 in 10,000 people):

• dizziness or drowsiness,
• cataract, glaucoma or increased intraocular pressure, which may lead to loss of vision and/or redness and pain in the eyes; these side effects have been reported after long-term use of nasal spray containing fluticasone propionate,
• damage to the skin and nasal mucosa,
• 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).

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

• blurred vision,
• nasal mucosal ulceration.

When the medicine is used in high doses over a long period of time, systemic side effects (side effects affecting the whole body) may occur. The likelihood of such effects is significantly lower with corticosteroids administered as a nasal spray than with oral corticosteroid therapy. These effects 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 side effects may cause growth suppression.
Rare cases of decreased bone density (osteoporosis) have been observed with long-term nasal administration of corticosteroids.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Allerduo nasal spray

Keep this medicine 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 stated month.
Do not store in a refrigerator or freeze.
Shelf-life after first opening of the bottle: Unused medicine should be discarded 6 months after first opening the nasal spray.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Allerduo nasal spray contains
The active substances are: azelastine hydrochloride and fluticasone propionate. Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.
With each actuation of the pump (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 carboxymethylcellulose, disodium edetate, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, purified water.

What Allerduo nasal spray looks like and contents of the pack
Allerduo nasal spray is a white, homogeneous suspension.
Allerduo nasal spray is available in an amber glass type I bottle with a spray pump, applicator made of polypropylene (PP) and a cap.
The 25 ml bottle contains 23 g of nasal spray as a suspension (providing at least 120 doses).
Allerduo nasal spray is available in:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel
Germany
For further information, contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +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 medicinal product is authorised in 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 microgrammes/50 microgrammes, suspension for 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