Allergodil Sprint

Package Leaflet: Information for the Patient

Allergodil SPRINT, 1.5 mg/mL, Nasal Spray, Solution
Azelastine Hydrochloride

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 2 to 3 days, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

1. What is Allergodil SPRINT and what is it used for

Allergodil SPRINT, nasal spray contains azelastine hydrochloride, a substance belonging to the group of antihistamine medicines. Antihistamine medicines prevent the action of histamine produced by the body as a result of an allergic reaction.
Allergodil SPRINT, nasal spray is used to treat symptoms of allergic rhinitis in adults, adolescents, and children aged 6 and older. Allergic rhinitis is a type of allergic reaction to allergens such as plant pollen, dust mites, or animal dander.
Allergodil SPRINT, nasal spray reduces the severity of symptoms such as runny nose, sneezing, itching, or stuffy nose.
If there is no improvement or the patient feels worse after 2 to 3 days of using the medicine, a doctor should be consulted. The medicine should not be used for more than 4 weeks without consulting a doctor.

2. Important information before using Allergodil SPRINT

When not to use Allergodil SPRINT

• if the patient is allergic to azelastine hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• in children under 6 years of age.

Warnings and precautions

Before starting to use Allergodil SPRINT, the patient should discuss it with their doctor or pharmacist.

Children

Allergodil SPRINT should not be used in children under 6 years of age.

Allergodil SPRINT 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.
No studies have been conducted on the interaction of Allergodil SPRINT, nasal spray with other medicines.

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.
There are limited data on the effects of using Allergodil SPRINT during pregnancy and breastfeeding.

Driving and using machines

Allergodil SPRINT has a minor effect on the ability to drive and use machines.
Rarely, fatigue, tiredness, exhaustion, dizziness, or weakness may occur, which may be caused by the disease itself or the use of Allergodil SPRINT. In such cases, the patient should not drive or operate machines. The patient should be aware that drinking alcohol may enhance such effects.

3. How to use Allergodil SPRINT

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Allergodil SPRINT is intended for use in the nose only.

Important:

In case of doubts about using the medicine, the patient should consult their doctor or pharmacist. If the patient is unsure about the dose to use or how to use the medicine, they should consult their doctor or pharmacist.

The duration of treatment depends on the type, duration, and course of symptoms and is determined by the doctor. Allergodil SPRINT, nasal spray may only be used in patients with allergic rhinitis diagnosed by a doctor and according to the principles determined by the doctor.
Using the medicine for more than 4 weeks should be done under medical supervision.

Adults and adolescents (12 years and older):

It is recommended to use two doses in each nostril once a day.
In some cases, it may be necessary to administer two doses in each nostril twice a day. The maximum daily dose is two sprays in each nostril twice a day.

Children aged 6 to 11:

It is recommended to use one dose in each nostril twice a day.
Allergodil SPRINT is not recommended for use in children under 6 years of age due to the lack of data on safety and/or efficacy in this age group.
If possible, the medicine should be used regularly until the symptoms disappear.
If the use of Allergodil SPRINT is interrupted, the symptoms of the disease may worsen.
Allergodil SPRINT, nasal spray is intended for long-term use, but without consulting a doctor, the medicine should not be used for more than 4 weeks. If there is no improvement or the patient feels worse after 2 to 3 days of using the medicine, a doctor should be consulted.
Using the medicine for more than 4 weeks is not recommended in children aged 6 to 11 due to the lack of clinical data.

Method of administration

• 1. Clean the nose.
• 2. Remove the protective cap (Figure 1).
• 3. Before the first use, prime the pump by pressing and releasing it six times (6 times) to release a dose of the medicine into the air (Figure 2). If Allergodil SPRINT nasal spray has not been used for 3 or more days, re-prime the pump by pressing and releasing it until a fine spray appears.
• 4. While pressing the pump, spray a single dose of the medicine into each nostril, keeping the head in an upright position. Do not tilt the head back (Figure 3).
• 5. Wipe the tip of the pump with a clean tissue and replace the protective cap.

Figure 1 Figure 2 Figure 3

Using a higher dose of Allergodil SPRINT than recommended

In the event of using too much of the medicine, there is a small likelihood of complications. After an overdose or accidental ingestion, central nervous system disorders (including drowsiness, disorientation, coma, rapid heartbeat, low blood pressure) may occur. In case of doubt, a doctor should be consulted. If someone, especially a child, accidentally ingests Allergodil SPRINT, they should immediately contact a doctor or the nearest hospital emergency department.

Missing a dose of Allergodil SPRINT

The nasal spray should be used as soon as possible, and the next dose should be used at the usual time. A double dose should not be used to make up for a missed dose.
In case of further doubts about using this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using this medicine, a very rare allergic reaction may occur, characterized by swelling of the face, tongue, or throat, difficulty swallowing, hives, wheezing, or shortness of breath. In such a case, the use of the medicine should be stopped immediately, and a doctor or hospital should be consulted.
Common(may affect up to 1 in 10 people):

• bitter taste in the mouth, especially if the patient tilts their head back while administering the nasal spray. If a bitter taste in the mouth occurs after using Allergodil SPRINT, a non-alcoholic drink (such as juice or milk) can be consumed to neutralize it.

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

• mild irritation inside the nose. This may cause a burning sensation, itching, bleeding from the nose, and sneezing.

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

• unpleasant taste, which may cause nausea. Fatigue (tiredness, exhaustion), dizziness, weakness, or drowsiness may occur, which may also be caused by the disease itself.

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

• allergic reactions (hypersensitivity), rash, itching, or hives.

Reporting side effects

If side effects occur, including any possible side effects not listed in this package leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 allow for more information to be collected on the safety of this medicine.

5. How to store Allergodil SPRINT

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 6 months. After this period, any unused medicine should be discarded.
The medicine should not be stored in the refrigerator or frozen.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked 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 Allergodil SPRINT contains

• The active substance of the medicine is azelastine hydrochloride. 1 mL of the solution contains 1.5 mg of azelastine hydrochloride. 1 dose, i.e., a single actuation of the pump (0.14 mL), delivers 0.21 mg of azelastine hydrochloride, equivalent to 0.19 mg of azelastine.
• The other ingredients are: hypromellose, sucralose, liquid sorbitol, crystallizing, disodium edetate, sodium citrate, purified water.

What Allergodil SPRINT looks like and contents of the package

Allergodil SPRINT, nasal spray, solution is a clear, colorless solution.
Allergodil SPRINT, nasal spray, solution is available in a brown glass bottle with a pump dispenser made of PP, PE, POM, elastomer, and stainless steel with a protective cap, in a cardboard box.
Bottle containing 5 mL of solution.
Bottle containing 10 mL of solution.
Bottle containing 17 mL of solution.
Bottle containing 20 mL of solution.
Bottle containing 22 mL of solution.
Not all pack sizes may be marketed.

Marketing authorization holder:

Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
Netherlands

Manufacturer:

Madaus GmbH
Lütticher Straße 5
53842 Troisdorf
Germany

For further information, please contact:

Viatris Healthcare Sp. z o.o.
phone: 22 546 64 00

Date of last revision of the package leaflet: