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AXALHIS 1 mg/ml NASAL SPRAY SOLUTION

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About the medicine

How to use AXALHIS 1 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 the User

AXALHIS 1 mg/ml nasal spray solution

azelastine hydrochloride

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

  • Keep this package 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, as 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 package leaflet.

Contents of the package leaflet:

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

1. What AXALHIS is and what it is used for

AXALHIS contains azelastine, which belongs to a group of medicines that prevent the effects of histamine (antihistamines) and other substances that the body produces as part of an allergic reaction, which cause symptoms of sneezing, runny nose, itching or nasal congestion. Azelastine also has an additional anti-inflammatory effect.

This medicine is used to treat the symptoms of seasonal allergic rhinitis and acute exacerbations (attacks) of perennial allergic rhinitis.

AXALHIS nasal spray solution is intended for use by adults, adolescents, and children over 6 years of age.

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 AXALHIS

Do not useAXALHIS

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

This medicine must not be used in children under 6 years of age. The instructions for adolescents are the same as for adults (see also section 3 "Use in children and adolescents").

Warnings and precautions

The spray must be used with the head in an upright position.

Consult your doctor or pharmacist before you start using this medicine.

Children and adolescents

This product must not be used in children under 6 years of age.

.

Using AXALHIS with other medicines.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No specific interactions have been studied.

Blank space with thin horizontal lines above and below

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There are no or limited data on the use of azelastine in pregnant women. Therefore, this medicine should only be used during pregnancy if recommended by a doctor.

Due to the lack of data, AXALHIS nasal spray solution must not be used during breastfeeding.

Driving and using machines

You may rarely experience fatigue, tiredness, exhaustion, dizziness, or weakness due to the same condition or when using the nasal spray. In these cases, do not drive or operate machinery.

Note that the consumption of alcohol or other medicines may increase these effects.

3. How to use AXALHIS

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

Adults, adolescents, and children over 6 years of age

The recommended dose is one spray (0.14 ml) into each nostril, twice a day (0.56 mg of azelastine hydrochloride).

Instructions for the correct administration of the medicine

  1. Blow your nose
  2. Before the first use, remove the plastic cap from the nozzle (Diagram 1)
  3. Remove the protective cap (Diagram 2)
  4. Before the first use, press the pump several times until a uniform spray comes out (3-4 times) (Diagram 3)
  5. Spray once into each nostril keeping your head in an upright position. Do not tilt your head back(Diagram 4).
  6. Clean the pump nozzle and replace the protective cap

Four diagrams showing the use of the nasal spray, holding the bottle, tilting the head, and spraying into the nostril

When the product has not been used for 6 days or more, reactivate the pump by pressing down and releasing a sufficient number of times until a fine mist comes out.

Use in children and adolescents

This medicine must not be used in children under 6 years of age due to the lack of safety and efficacy data.

If you use more AXALHISthan you should

If you have sprayed too much of this medicine, contact your doctor or pharmacist. With nasal administration, overdose reactions are not expected. Studies conducted in animals have revealed that toxic doses can produce symptoms in the central nervous system (excitement, tremors, convulsions). If this occurs in humans, symptomatic and supportive treatment should be initiated. If the overdose is recent, gastric lavage is recommended.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested Blank space with thin horizontal lines above and below

If you forget to use AXALHIS

Do not use a double dose to make up for forgotten doses.

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

If you stop using AXALHIS

Treatment with azelastine should be done regularly until the symptoms are relieved.

If you stop treatment with azelastine nasal spray, the symptoms of your allergy may recur. Follow the instructions and do not exceed the recommended duration of use indicated by your doctor.

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Medicine questions

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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.

Common side effects (may affect up to 1 in 10 people): you may experience an unpleasant taste after administration (often due to incorrect application, for example, tilting the head too far back during administration), which may rarely cause nausea.

Uncommon side effects (may affect up to 1 in 100 people): nasal discomfort due to inflammation of the nasal tissue (itching, burning), sneezing, nasal bleeding.

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

Very rare side effects (may affect up to 1 in 10,000 people): fatigue (tiredness, exhaustion), dizziness or weakness (may be caused by the condition itself), hypersensitivity reactions, rash, itching, urticaria (nettle rash).

If any of the side effects gets serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

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 package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System www.notificaram.es.

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

5. Storage of AXALHIS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Do not refrigerate or freeze.

Do not store 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 no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of AXALHIS

  • Blank space with thin horizontal lines above and below The active substance is azelastine hydrochloride 1 mg/ml
  • The other ingredients (excipients) are: hypromellose 2910, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride, and purified water

Appearance of AXALHIS and contents of the pack

AXALHIS is a clear, colorless, and particle-free solution.

AXALHIS nasal spray solution is filled in a multidose plastic container (high-density polyethylene) equipped with a dosing pump. Each bottle contains 10 ml of solution.

Marketing authorisation holder

Zentiva, k.s.

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Manufacturer

SAG Manufacturing S.L.U.

Carretera N-I, Km 36

28750 San Agustín de Guadalix – Madrid

Spain

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Date of last revision of this package leaflet: March 2023

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

Online doctors for AXALHIS 1 mg/ml NASAL SPRAY SOLUTION

Discuss questions about AXALHIS 1 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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€80
5.0 (2)
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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€55
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 AXALHIS 1 mg/ml NASAL SPRAY SOLUTION?
AXALHIS 1 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 AXALHIS 1 mg/ml NASAL SPRAY SOLUTION?
The active ingredient in AXALHIS 1 mg/ml NASAL SPRAY SOLUTION is azelastine. This information helps identify medicines with the same composition but different brand names.
Who manufactures AXALHIS 1 mg/ml NASAL SPRAY SOLUTION?
AXALHIS 1 mg/ml NASAL SPRAY SOLUTION is manufactured by Zentiva K.S.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of AXALHIS 1 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 AXALHIS 1 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 AXALHIS 1 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, ASTEPRO 1.5 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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