Acatar Allergi

Leaflet attached to the packaging: patient information

Acatar Allergy, 1 mg/ml, nasal spray, solution

Azelastine hydrochloride

Read the leaflet carefully 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 your doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

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

1. What is Acatar Allergy and what is it used for

Acatar Allergy contains azelastine, which belongs to a group of medicines that work by preventing the action of histamine (antihistamines) and other substances that the body produces during an allergic reaction, usually causing the patient to have a runny nose, sneezing, itching, or a stuffy nose.

The indications for use of Acatar Allergy are:

• treatment of symptoms of seasonal allergic rhinitis (hay fever);
• treatment of symptoms of perennial (non-seasonal) allergic rhinitis.

Acatar Allergy nasal spray is intended for use in adults, adolescents, and children over 6 years of age.

The onset of action of the medicine occurs within 15 minutes after administration and lasts for about 12 hours.

Allergic rhinitis may be chronic, with symptoms lasting more than 4 days a week and longer than 4 weeks.

If after 3 days there is no improvement or you feel worse, consult your doctor.

2. Important information before using Acatar Allergy

When not to use Acatar Allergy:

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Warnings and precautions

Before starting treatment with Acatar Allergy, discuss it with your doctor or pharmacist.

Patients with liver and/or kidney impairment

There is a lack of sufficient data on the use of Acatar Allergy in this group of patients.

Patients in advanced age

There is a lack of sufficient data on the use of Acatar Allergy in elderly patients.

Acatar Allergy and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

No interactions with other medicines have been reported.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Pregnancy

Despite the lack of data indicating harmful effects of azelastine on unborn children, it is not recommended to use this medicine during the first trimester of pregnancy.

Breastfeeding

Due to the lack of sufficient data on the safety of Acatar Allergy nasal spray, it should not be used during breastfeeding.

Driving and operating machinery

Very rarely, the following may occur: fatigue, tiredness, exhaustion, dizziness, or weakness, which may be caused by the disease itself or the use of Acatar Allergy.

In such cases, do not drive vehicles or operate machinery.

Keep in mind that drinking alcohol or taking other medicines may exacerbate these effects.

3. How to use Acatar Allergy

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

Adults, adolescents, and children over 6 years of age.

The recommended dose is one spray into each nostril twice a day (0.56 mg of azelastine hydrochloride per day).

How to use the spray

• 1. Blow your nose.
• 2. Before the first use, remove the plastic protective cap (Figure 1).
• 3. Remove the protective cap (Figure 2).
• 4. Before the first use, press the pump several times until a uniform spray is produced (3-4 times) (Figure 3).
• 5. Perform one spray into each nostril keeping your head upright, do not tilt your head back(Figure 4).
• 6. Wipe the tip of the pump and replace the protective cap.

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If azelastine has not been used for 6 or more days, the pump must be re-primed for use by pressing it several times until a fine mist appears.

Duration of use

Consult your doctor or pharmacist if symptoms worsen or persist for more than 3 days without significant improvement despite using Acatar Allergy nasal spray.

This medicine may be used until symptoms resolve.

The longest observation period in adults who used azelastine hydrochloride in a clinical trial was 12 months, and in children, it was 6 months.

The duration of treatment depends on the type, duration, and course of symptoms and is determined by the doctor.

Acatar Allergy nasal spray may only be used in patients with a doctor-diagnosed seasonal or perennial allergic rhinitis and according to the principles determined by the doctor.

Acatar Allergy should not be used without medical supervision for more than 4 weeks.

Use in children and adolescents

Acatar Allergy nasal spray should not be used 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 Acatar Allergy

In case of spraying too much of the medicine, contact your doctor or pharmacist.

No cases of azelastine hydrochloride overdose have been reported in humans.

After overdose or accidental ingestion, central nervous system disorders (drowsiness, disorientation, coma, tachycardia, hypotension) may be expected, similar to those found in animal studies.

In such cases, symptomatic treatment should be applied.

No specific antidote for azelastine is known.

Missing a dose of Acatar Allergy

Do not take a double dose to make up for a missed dose.

If you forget to take the medicine, take it as soon as you remember, and then take the next dose 12 hours later, if necessary.

Stopping use of Acatar Allergy

Do not stop treatment abruptly.

If you have any further doubts 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 everybody gets them.

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Frequent (may occur in less than 1 in 10 people): when the medicine is administered incorrectly (with the head tilted back, see section 3), a bitter taste in the mouth, which may sometimes cause nausea.

Uncommon (may occur in less than 1 in 100 people): irritation of the inflamed nasal mucosa (e.g., tingling, burning, itching), sneezing, and nasal bleeding.

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

Very rare (may occur in less than 1 in 10,000 people): hypersensitivity, fatigue (tiredness, exhaustion), dizziness, or weakness, which may also be caused by the disease, rash, itching, urticaria.

If you experience any of the above side effects, inform your doctor.

In case of the first symptoms of a hypersensitivity reaction, stop using Acatar Allergy immediately.

Your doctor will assess the severity of the symptoms and decide whether further action is necessary.

Countermeasures

Usually, the above side effects are transient.

Therefore, there is no need for special actions.

In case of a bitter taste in the mouth after using Acatar Allergy, drink a non-alcoholic beverage (such as juice, milk) to neutralize it.

If any of the side effects worsen or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw;

tel: +48 22 492 13 01; fax: + 48 22 492 13 09;

Website: https://smz.ezdrowie.gov.pl .

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acatar Allergy

Keep the medicine out of the 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.

Store in the original packaging.

Do not store in the refrigerator or freeze.

Do not store at temperatures above 25°C.

Do not use for more than 6 months after first opening.

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

Ask your pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

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6. Contents of the packaging and other information

What Acatar Allergy contains

• The active substance is azelastine hydrochloride 1 mg/ml.
• One application (0.14 ml) contains 0.14 mg of azelastine hydrochloride, which corresponds to 0.13 mg of azelastine.
• The other ingredients are: hypromellose 2910, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride, and purified water.

What Acatar Allergy looks like and what the pack contains

Acatar Allergy is a clear, colorless solution.

Acatar Allergy nasal spray is a multi-dose, plastic bottle (made of high-density polyethylene) with a pump spray.

One bottle contains 10 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o.,

ul. Ziębicka 40,

50-507 Wrocław

Manufacturer:

SAG Manufacturing, S.L.U

Ctra. N-I, Km 36, San Agustín de Guadalix

28750 Madrid, Spain

Galenicum Health, S.L.U

Sant Gabriel, 50, Esplugues de Llobregat

08950 Barcelona, Spain

For more information, please contact:

USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa

tel.+48 (22) 543 60 00

Date of last revision of the leaflet: July 2023

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