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ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION

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About the medicine

How to use ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for theuser

Astepro 1.5 mg/ml nasal spray solution

azelastine hydrochloride

Read all of this leaflet carefully before you start usingthis medicine, because it contains important information for you.

  • Keep this leaflet, you may need to read it again
  • If you have any further questions, ask your doctor or pharmacist
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What Astepro is and what it is used for
  2. What you need to know before you use Astepro
  3. How to use Astepro
  4. Possible side effects
  5. Storage of Astepro
  6. Contents of the pack and further information

1. What Astepro is and what it is used for

Astepro contains azelastine hydrochloride, which belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of histamine, which is produced by the body as part of an allergic reaction.

Astepro is used for the treatment of seasonal allergic rhinitis (hay fever) in adults, adolescents, and children aged 6 years and older. Allergic rhinitis is an allergic reaction to substances such as pollen.

It usually causes runny nose, sneezing, itching, or nasal congestion. Astepro can help you control these symptoms.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Astepro

Do not use Astepro

  • If you are allergic to azelastine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start using Astepro.

Children

Astepro is not recommended for children under 6 years of age.

Using Astepro with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

There is only limited information about the effects of Astepro on the fetus or baby.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Astepro has a negligible influence on the ability to drive and use machines.

You may rarely experience fatigue or dizziness due to the disease itself or when using Astepro. In these cases, do not drive or use machines. Consuming alcohol may intensify these effects.

3. How to use Astepro

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults and adolescents over 12 years

  • The recommended dose is two sprays in each nostril once a day. In some cases, two sprays in each nostril twice a day may be required.
  • The maximum daily dose is two sprays in each nostril twice a day.

Use in children from 6 to 11 years

The recommended dose is one spray in each nostril twice a day.

Clinical experience over 4 weeks showed good efficacy and safety in children. There is no experience in children for longer than this; however, clinical trials of up to one year's duration using twice the daily dose showed good safety in adults and adolescents.

This medicine is not recommended for use in children under 6 years of age due to the lack of safety and/or efficacy data.

Duration of treatmentIf possible, use this medicine regularly until your symptoms have disappeared. If you stop using Astepro, it is likely that your symptoms will return.

This medicine is suitable for long-term use.

It is not recommended to use it for more than 4 weeks in children from 6-11 years due to the lack of clinical data.

Method of administration

For nasal use.

How to use the spray

  1. Blow your nose first.
  2. Remove the protective cap (Figure 1).
  3. Before using for the first time, the pump must be pressed six times until a constant spray is produced (Figure 2). When Astepro has not been used for three or more days, the pump must be pressed a sufficient number of times until a fine spray appears.
  4. Spray once in each nostril, keeping your head upright. Do not tilt your head back (Figure 3).
  5. Clean and replace the protective cap.

Nasal medication bottle with white applicator and thin nozzle for nasal administrationHand holding an auto-injector with a black arrow indicating the direction of injection into the skinHand holding a vial with liquid and a syringe prepared to extract the medication

Figure 1 Figure 2 Figure 3

If you use more Astepro than you should

If you apply too much Astepro to your nose, you are unlikely to have any problems. If you are concerned, talk to your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Astepro

If you forget to use your medicine, use it as soon as you remember, then apply the next dose at your usual time. Do not use a double dose to make up for forgotten doses.

If you have any questions about using this medicine, talk to your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These effects include:

Common (may affect up to 1 in 10 people):

  • Unpleasant taste in your mouth (especially if you tilt your head too far back during administration of the nasal spray).

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

  • Mild irritation inside the nose (itching, pruritus), sneezing, and blood in the nose.

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

  • The unpleasant taste may make you feel unwell. Fatigue (tiredness, exhaustion), dizziness, weakness, or a feeling of drowsiness that may appear may also be caused by the disease itself.

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

  • An allergic reaction, skin rash, itching, or hives.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Astepro

Keep out of the sight and reach of children.

Do not use your spray after the expiry date stated on the carton and label after "EXP". The expiry date is the last day of the month stated.

Discard any remaining medicine 6 months after opening the nasal spray.

Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Astepro

  • The active substance is azelastine hydrochloride. 1 ml of solution contains 1.5 mg of azelastine hydrochloride. Each spray (0.14 ml) contains 0.21 mg of azelastine hydrochloride, equivalent to 0.19 mg of azelastine.
  • The other ingredients are: hypromellose, sucralose, sorbitol liquid (crystallizable), disodium edetate, sodium citrate, purified water.

Appearance and pack contents

Astepro is a clear, colorless solution.

It is available in a brown glass bottle with a metering pump. The 10 ml bottle contains 5 or 10 ml of nasal spray solution. The 20 ml bottle contains 17, 20, or 22 ml of nasal spray solution.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

Madaus GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5ª planta

08011 - Barcelona

Spain

This medicine is authorised in the Member States of the EEA under the following names:

Austria: Astepro 1.5 mg/ml Nasenspray

Denmark: Astepro

Finland: Astepro 0.19 mg/annos nenäsumute, liuos

Germany: Astepro 1,5 mg/ml Nasenspray, Lösung

Ireland: Astepro 1.5 mg/ml Nasal Spray, Solution

Spain: Astepro 1,5 mg/ml solución para pulverización nasal

Italy: Afluon

Netherlands: Astepro 0.15 %

Sweden: Astepro 0.19 mg/dos nässpray, lösning

United Kingdom: Astepro 0.15 % Nasal Spray

Date of last revision of thisleaflet:January 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

Online doctors for ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION

Discuss questions about ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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0.0 (0)
Doctor

Marta Reguero Capilla

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

  • allergic rhinitis, seasonal allergies, and perennial allergy symptoms;
  • allergic conditions in adults and children;
  • bronchial asthma and allergy-related respiratory symptoms;
  • urticaria (acute and chronic) and angioedema;
  • food allergies and reactions to foods, additives, or medications;
  • atopic dermatitis, allergic rashes, and persistent itching;
  • unexplained or recurrent allergic reactions;
  • interpretation of laboratory tests, allergy testing, and immunology results;
  • immune system concerns, frequent infections, and reduced immune response;
  • ongoing medical follow-up and treatment adjustment.
Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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€60

Frequently Asked Questions

Is a prescription required for ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION?
ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION?
The active ingredient in ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION is azelastine. This information helps identify medicines with the same composition but different brand names.
Who manufactures ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION?
ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION is manufactured by Cooper Consumer Health B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ASTEPRO 1.5 mg/ml NASAL SPRAY SOLUTION?
Other medicines with the same active substance (azelastine) include AFLUON 1 mg/ml NASAL SPRAY SOLUTION, AFLUON SUCRALOSE 1.5 mg/mL NASAL SPRAY SOLUTION, AXALHIS 1 mg/ml NASAL SPRAY SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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