Astepro

Patient Information Leaflet

Astepro, 1.5 mg/mL, nasal spray, solution
Azelastini hydrochloridum
Please read this 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
a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 to 3 days, or if you feel worse, contact your doctor.

Table of contents

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

1. What Astepro is and what it is used for

Astepro nasal spray contains azelastine hydrochloride, a substance belonging to a group of medicines
called antihistamines. Antihistamines prevent the action of histamine, a substance produced by the
body during an allergic reaction.
Astepro nasal spray is used to treat symptoms of allergic rhinitis in adults, adolescents, and children
aged 6 years and older. Allergic rhinitis is an allergic reaction to allergens such as pollen, house dust
mites, or animal dander.
Astepro nasal spray helps reduce symptoms such as runny nose, sneezing, itching, or nasal congestion.
If there is no improvement after 2 to 3 days of treatment, or if you feel worse, consult your doctor.
Do not use this medicine for longer than 4 weeks without consulting a doctor.

2. Important information before using Astepro

When not to use Astepro

• 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 Astepro, discuss this with your doctor or pharmacist.
Children
Astepro must not be used in children under 6 years of age.
Astepro and other medicines
Tell your doctor about all medicines the patient is currently using or has recently used,
as well as any medicines the patient plans to use.
Studies on interactions between Astepro nasal spray and other medicines have not been conducted.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult her doctor or pharmacist before using this medicine.
There is limited data on the effects of using Astepro during pregnancy and breastfeeding.
Driving and operating machinery
Astepro has minimal influence on the ability to drive and operate machinery.
Rarely, feelings of fatigue, tiredness, exhaustion, dizziness or weakness may occur, which
may be caused by the disease itself or by the use of Astepro. In such cases,
driving and operating machinery should be avoided. Be aware that alcohol consumption may
exacerbate these effects.

3. How to use Astepro

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.
Astepro is intended for nasal use only.
Important:
If you have any doubts about how to use this medicine, consult your doctor or
pharmacist. If you are unsure about the dose 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 is determined by
your doctor. Astepro nasal spray may only be used in patients diagnosed by a doctor with allergic
rhinitis and as directed by a doctor.
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 in each nostril twice daily.
Children aged 6 to 11 years:
The recommended dose is one spray into each nostril twice daily.
Astepro nasal spray 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, Astepro should be used regularly until symptoms resolve. If treatment is interrupted, symptoms
may worsen.
Astepro 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 it six times (6 times) to release the medicine into the air (Figure 2). If Astepro nasal spray has not been used for 3 or more days, re-prime the pump by pressing and releasing it several times 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 nozzle and replace the protective cap.

Figure 1 Figure 2 Figure 3
If you use more Astepro than you should
When used nasally, overdose is unlikely to cause complications. However, after an overdose or if the
medicine is accidentally swallowed, adverse effects on the central nervous system may occur (including
drowsiness, confusion, coma, rapid heartbeat, and hypotension). If in doubt, consult your doctor. If
anyone, especially a child, accidentally swallows Astepro, contact a doctor or the nearest hospital
emergency department immediately.
If you forget to use Astepro
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 how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Very rarely, an allergic reaction may occur after using this medicine, manifesting as
swelling of the face, tongue or throat, difficulty in swallowing, hives, wheezing
or breathing difficulties. In such a case, treatment must be stopped immediately
and medical advice should be sought or the patient should go to hospital.
Common (may affect fewer than 1 in 10 people):

• bitter taste in the mouth, particularly if the patient tilts the head backwards when administering the nasal spray. If a bitter taste in the mouth occurs after using Astepro nasal spray, it can be neutralized by drinking a non-alcoholic beverage (such as juice or milk).

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

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

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

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

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Astepro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and cardboard box. The expiry date refers to the last day of the stated month.
Usable period after first opening the bottle: 6 months. After this time, any unused medicine should be discarded.
Do not store in a refrigerator or freeze.
Medicines should not be disposed of via sewage or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Astepro contains

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

What Astepro looks like and contents of the pack
Astepro nasal spray, solution is a clear, colourless solution.
Astepro nasal spray, solution is available in a brown type III glass bottle 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