Allergodil sprint

Package leaflet: Information for the patient

Allergodil SPRINT, 1.5 mg/mL, nasal spray, solution
Azelastini hydrochloridum
Please read the entire leaflet carefully before use, 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 2 to 3 days, consult a physician.

Table of contents

1. What Allergodil SPRINT is and what it is 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 pack and other information

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

Allergodil SPRINT nasal spray contains azelastine hydrochloride, a substance belonging to the group of
antihistamine medicines. Antihistamines prevent the action of histamine produced by the body during
an allergic reaction.
Allergodil SPRINT nasal spray is used to treat symptoms of allergic rhinitis in adults, adolescents, and children aged 6 years and older. Allergic rhinitis is a type of allergic reaction to allergens such as pollen, house dust mites, or animal dander.
Allergodil SPRINT nasal spray reduces the severity of symptoms such as runny nose, sneezing, itching, or nasal congestion.
If there is no improvement or if the patient feels worse after 2 to 3 days of using the medicine, consult a physician. Do not use the medicine for longer than 4 weeks without consulting a physician.

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 treatment with Allergodil SPRINT, consult your doctor or pharmacist.
Children
Allergodil SPRINT must not be used in children under 6 years of age.
Allergodil SPRINT and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken,
as well as any medicines you plan to use.
No studies have been conducted on potential interactions between Allergodil SPRINT nasal spray and other
medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult her doctor or pharmacist before using this medicine.
There is limited data available on the effects of Allergodil SPRINT during pregnancy
and breastfeeding.
Driving and operating machinery
Allergodil SPRINT has minimal influence on the ability to drive and operate machinery.
Rarely, feelings of fatigue, tiredness, exhaustion, dizziness or weakness may occur, which
could be caused by the disease itself or by the use of Allergodil SPRINT. In such
cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

3. How to use Allergodil SPRINT

This medicine should always be used exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Allergodil SPRINT is intended for nasal use only.
Important:
If you have any doubts regarding the use of this medicine, consult your doctor or
pharmacist. If the patient is unsure about the dose to use or how to use this medicine, consult your
doctor or pharmacist.
The duration of treatment depends on the type, duration and severity of symptoms and should be determined by a doctor. Allergodil SPRINT nasal spray may only be used in patients diagnosed by a physician with allergic rhinitis and according to the physician's instructions.
Use beyond 4 weeks should be under medical supervision.
Adults and adolescents (aged 12 years and older):
The recommended dose is two sprays into each nostril once daily.
In some cases, two sprays into each nostril twice daily may be necessary. The maximum daily dose is two sprays into each nostril twice daily.
Children aged 6 to 11 years:
The recommended dose is one spray into each nostril twice daily.
Allergodil SPRINT is not recommended for use in children under 6 years of age due to lack of data on safety and/or efficacy in this age group.
If possible, Allergodil SPRINT should be used regularly until symptoms resolve. If treatment with Allergodil SPRINT is interrupted, symptoms may worsen.
Allergodil SPRINT nasal spray is intended for long-term use, but should not be used for longer than 4 weeks without consulting a doctor. If there is no improvement after 2 to 3 days of treatment, or if symptoms worsen, consult your doctor.
Use beyond 4 weeks is not recommended in children aged 6 to 11 years due to lack of clinical data.

Instructions for use

1. Clear the nose.
2. Remove the protective cap (Figure 1).
3. Before first use, prime the pump by pressing and releasing the nozzle six times (6 times) to release the dose 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 sufficiently until a fine mist is produced.
4. While holding the head upright, press the pump to administer a single spray into each nostril. Do not tilt the head backward (Figure 3).
5. Wipe the pump nozzle and replace the protective cap.

Figure 1 Figure 2 Figure 3

Accidental overdose of Allergodil SPRINT
If too much of the medicine is used nasally, the risk of complications is low. However, in case of overdose or accidental oral ingestion, central nervous system effects may occur (including drowsiness, confusion, coma, tachycardia, hypotension). If in doubt, consult a doctor. If anyone, especially a child, accidentally swallows Allergodil SPRINT, contact a doctor or the nearest hospital emergency department immediately.

Missed dose of Allergodil SPRINT
Use the nasal spray as soon as you remember, then continue with the next dose at the usual time. Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very rarely, an allergic reaction may occur after administration of this medicine, manifesting as
facial swelling, swelling of the tongue or throat, difficulty swallowing, urticaria, wheezing,
or breathing difficulties. In such a case, discontinue use of the medicine immediately and consult a doctor or go to hospital.

Common (may occur in fewer than 1 in 10 people):

• bitter taste in the mouth, particularly if the patient tilts the head backward during administration of the nasal spray. If a bitter taste in the mouth occurs after using Allergodil SPRINT nasal spray, it can be neutralized by drinking a non-alcoholic beverage (such as juice or milk).

Uncommon (may occur in fewer than 1 in 100 people):

• slight irritation inside the nose. This may cause a burning sensation, itching, nosebleeds, and sneezing.

Rare (may occur in fewer than 1 in 1,000 people):

• unpleasant taste, which may lead to nausea. A feeling of fatigue (tiredness, exhaustion), dizziness, weakness, or drowsiness may occur, which may also be caused by the underlying disease itself.

Very rare (may occur in fewer than 1 in 10,000 people):

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Allergodil SPRINT

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. The expiry date refers to the last day of the stated month.
Shelf-life after first opening the bottle: 6 months. After this period, any unused medicine should be discarded.
Do not store in the refrigerator or freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Allergodil SPRINT contains

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

What Allergodil SPRINT looks like and contents of the pack
Allergodil SPRINT, nasal spray, solution is a clear, colourless solution.
Allergodil SPRINT, nasal spray, solution is available in a brown glass bottle type III with a metering pump made of PP, PE, POM, elastomer and stainless steel, fitted with a protective cap, packed 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 Authorisation Holder:
Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
The Netherlands

Manufacturer:
Madaus GmbH
Lütticher Straße 5
53842 Troisdorf
Germany

For further information, please contact:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00