Azelastin Pos

Patient leaflet attached to the packaging: information for the patient

Azelastin POS, 1 mg/ml, nasal spray, solution

Azelastine hydrochloride

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist.

• This leaflet should be kept, so that it can be re-read if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Azelastin POS and what is it used for
• 2. Important information before using Azelastin POS
• 3. How to use Azelastin POS
• 4. Possible side effects
• 5. How to store Azelastin POS
• 6. Package contents and other information

1. What is Azelastin POS and what is it used for

The active substance of Azelastin POS is azelastine, which belongs to a group of medicines called antihistamines. Antihistamines inhibit the action of histamine, a compound produced in the body during an allergic reaction.

Azelastin POS is used for the symptomatic treatment of hay fever (seasonal allergic rhinitis).

It is intended for use in adults and children over 6 years of age.

2. Important information before using Azelastin POS

When not to use Azelastin POS:

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

Azelastin POS should not be used in children under 6 years of age. The rules for use are the same for adolescents as for adults (see also section 3 "Use in children and adolescents").

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Warnings and precautions

Before starting to use Azelastin POS, the patient should discuss it with their doctor or pharmacist,

• if the patient is not sure whether their disorder is caused by an allergy.

Azelastin POS is not suitable for the treatment of a cold or flu.

Azelastin POS and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

There is no data on the effect of other medicines on the action of Azelastin POS.

Azelastin POS with food, drink, and alcohol

The interaction with food and drink is not known.

As a general rule, it is recommended to avoid consuming alcohol during treatment.

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 before using this medicine.

Pregnancy

Although it does not appear that azelastine has a harmful effect on the unborn child, the use of this medicine is not recommended during the first trimester of pregnancy.

Breastfeeding

Due to the lack of data, Azelastin POS should not be used during breastfeeding.

Driving and operating machinery

In very rare cases, the patient may experience fatigue, tiredness, exhaustion, dizziness, or weakness in connection with the disease symptoms or the use of Azelastin POS. In such cases, the patient should not drive or operate machinery. It should be remembered that consuming alcohol or taking other medicines may exacerbate these feelings.

3. How to use Azelastin POS

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dose:

The recommended dose is one spray of Azelastin POS into each nostril, twice a day (morning and evening). This corresponds to a daily dose of 0.56 mg of azelastine hydrochloride.

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Method of use:

Azelastin POS is intended for intranasal use.

• 1. Blow your nose before using Azelastin POS.
• 2. Remove the protective cap.
• 3. Press the pump until the spray is released (usually 1-2 times).
• 4. Keep your head straight and do not tilt it back.
• 5. Insert the tip into the nostril and press the pump once while gently inhaling.
• 6. Repeat the procedure for the other nostril.
• 7. Wipe the tip and replace the protective cap.

Azelastin POS should be used by one person only.

Duration of use:

Azelastin POS should be used until the symptoms decrease, but it should not be used continuously for more than 6 months.

If the symptoms worsen or, despite using Azelastin POS, no significant improvement is observed after 3 days, the patient should consult their doctor or pharmacist.

Use in children and adolescents

The use of Azelastin POS is not recommended in children under 6 years of age due to the lack of data on safety and efficacy.

Use of a higher than recommended dose of Azelastin POS

Azelastin POS is sprayed into the nose. Since one spray contains a small dose of azelastine, the occurrence of side effects is unlikely, even in the event of using a higher than recommended dose.

In the event of accidental ingestion of a larger amount of Azelastin POS (e.g., a child swallowing the contents of one bottle), the patient should immediately contact their doctor.

There is no data on overdose of the medicine in humans, but animal studies have shown that the following side effects may occur: restlessness, pronounced, persistent fatigue or drowsiness, excitement or tiredness, and exhaustion.

Missing a dose of Azelastin POS

No special action should be taken. The patient should continue treatment by taking the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping the use of Azelastin POS

Azelastin POS should be used regularly until the symptoms decrease. If the use of Azelastin POS is stopped, the typical symptoms of allergy may return.

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

4. Possible side effects

Like all medicines, Azelastin POS can cause side effects, although not everybody gets them.

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Assessment of side effects is usually based on the following frequency of occurrence:

Common side effects (may occur in less than 1 in 10 people): after use, an unpleasant taste in the mouth may appear (often due to incorrect spraying technique, i.e., tilting the head back while spraying), which may rarely lead to nausea.

Uncommon side effects (may occur in less than 1 in 100 people): discomfort in the nasal area due to inflammation of the nasal mucosa (burning, itching), sneezing, nasal bleeding.

Rare side effects (may occur in less than 1 in 1000 people): nausea.

Very rare side effects (may occur in less than 1 in 10,000 people): feeling of fatigue (tiredness, exhaustion), dizziness or weakness (may also occur in connection with the patient's condition), hypersensitivity reactions, rash, itching, urticaria.

If any side effects occur, the patient should stop using Azelastin POS and contact their doctor immediately. The listed side effects usually disappear quickly. If a bitter taste appears in the mouth after using Azelastin POS, it can be neutralized with a non-alcoholic drink (e.g., juice, milk).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Azelastin POS

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

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

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

Do not store in the refrigerator or freeze. Do not store above 25°C.

Shelf life after first opening: 6 months.

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.

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6. Package contents and other information

What Azelastin POS contains

The active substance of the medicine is azelastine hydrochloride. One pump actuation (one dose) delivers 0.14 ml of solution, which contains 0.14 mg of azelastine hydrochloride.

The other ingredients are: hypromellose, disodium edetate, anhydrous citric acid, disodium phosphate dodecahydrate, sodium chloride, purified water.

What Azelastin POS looks like and what the pack contains

Azelastin POS is a clear, colorless nasal spray solution supplied in a multidose container (high-density polyethylene) with a pump dispenser in a cardboard box.

1 set consists of 1 plastic container with a pump dispenser with a capacity of 10 ml.

Marketing authorization holder:

URSAPHARM Poland Sp. z o.o.,

ul. Wybrzeże Gdyńskie 27,

01-531 Warsaw

Tel.: 022 732 07 90

Fax: 022 732 07 99

www.ursapharm.pl

e-mail: [email protected]

Manufacturer:

URSAPHARM Arzneimittel GmbH

Industriestrasse 35

66 129 Saarbrücken

Germany

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

Austria

Azelastin POS Nasenspray 1 mg/ml

Belgium/Luxembourg

Pollival 1 mg/ml solution pour pulvérisation nasale

Germany

Pollival 1 mg/ml Nasenspray, Lösung

Netherlands

Pollispray 1 mg/ml neusspray, oplossing

Date of last revision of the leaflet:

Version 07/2024