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About the medicine

How to use MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES

Contents of the leaflet

  1. Introduction
  2. What is Montelukast Aurovitas Spain and what is it used for
  3. What you need to know before your child takes Montelukast Aurovitas Spain
  4. How to take Montelukast Aurovitas Spain
  5. Possible side effects
  6. Storage of Montelukast Aurovitas Spain
  7. Contents of the pack and further information

Introduction

Package Leaflet: Information for the User

Montelukast Aurovitas Spain 4 mg Granules

Read all of this leaflet carefully before giving this medicine to your child, 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 your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
  • If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Montelukast Aurovitas Spain and what is it used for
  2. What you need to know before your child takes Montelukast Aurovitas Spain
  3. How to take Montelukast Aurovitas Spain
  4. Possible side effects
  5. Storage of Montelukast Aurovitas Spain

Contents of the pack and further information

1. What is Montelukast Aurovitas Spain and what is it used for

What isMontelukast Aurovitas Spain

Montelukast Aurovitas Spain is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How it worksMontelukast Aurovitas Spain

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.

When to useMontelukast Aurovitas Spain

Your doctor has prescribed this medicine to treat your child's asthma and prevent asthma symptoms during the day and night.

  • Montelukast Aurovitas Spain is used for the treatment of patients between 6 months and 5 years of age who are not adequately controlled with their medication and need additional treatment.
  • Montelukast Aurovitas Spain is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
  • Montelukast Aurovitas Spain also helps prevent narrowing of the airways caused by exercise in patients 2 years of age and older.

Depending on your child's symptoms and the severity of their asthma, their doctor will determine how to use Montelukast Aurovitas Spain.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

  • Difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various diseases.
  • Airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
  • Swelling (inflammation) of the inner layer of the airways.

Asthma symptoms include: Coughing, wheezing, and chest congestion.

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 your child takes Montelukast Aurovitas Spain

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not give Montelukast Aurovitas Spain to your child:

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

Warnings and precautions

Consult your doctor or pharmacist before giving Montelukast Aurovitas Spain to your child:

  • If your child's asthma or breathing worsens, inform their doctor immediately.
  • Montelukast Aurovitas Spain oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for your child. Always have your child's rescue inhaler medication for asthma attacks.
  • It is essential that your child uses all asthma medications prescribed by their doctor. Montelukast Aurovitas Spain should not be used in place of other asthma medications prescribed by their doctor.
  • If your child is being treated with asthma medications, they should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
  • Your child should not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make their asthma worse.

Several neuropsychiatric events (e.g., changes in behavior and mood-related, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If your child develops these symptoms while taking montelukast, they should contact their doctor.

Children and adolescents

Do not give this medicine to children under 6 months of age.

For pediatric patients under 18 years of age, other formulations of this medicine are available based on the age range.

Other medicines and Montelukast Aurovitas Spain

Tell your child's doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect how montelukast works, or montelukast may affect how other medicines your child is using work.

Before taking Montelukast Aurovitas Spain, tell your doctor if your child is taking the following medicines:

  • Phenobarbital (used to treat epilepsy).
  • Phenytoin (used to treat epilepsy).
  • Rifampicin (used to treat tuberculosis and some other infections).

Taking Montelukast Aurovitas Spain with food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

This subsection is not applicable to Montelukast Aurovitas Spain 4 mg granules, as its use is indicated in children between 6 months and 5 years of age.

Driving and using machines

This subsection is not applicable to Montelukast Aurovitas Spain 4 mg granules, as its use is indicated in children between 6 months and 5 years of age. However, the following information is important for the active substance, montelukast.

Montelukast is not expected to affect your child's ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported with Montelukast Aurovitas Spain may affect your child's ability to drive or operate machinery.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

3. How to take Montelukast Aurovitas Spain

Follow the instructions for administration of this medicine indicated by your child's doctor or pharmacist. If in doubt, consult your child's doctor or pharmacist again.

  • This medicine should be administered to children under adult supervision.
  • Your child should take Montelukast Aurovitas Spain every night.
  • It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

For children from 6 months to 5 years of age:

The recommended dose is one sachet of Montelukast Aurovitas Spain 4 mg granules orally every night.

If your child is taking Montelukast Aurovitas Spain, ensure they do not take any other medicine that contains the same active substance, montelukast.

How should I give Montelukast Aurovitas Spain granules to my child?

This medicine is taken orally.

  • Do not open the sachet until the time of use.
  • Montelukast Aurovitas Spain granules can be administered:
  • directly into the mouth;
  • or mixed with a spoonful of soft cold or room temperature food (e.g., apple sauce, ice cream, carrots, and rice).
  • Mix the entire contents of Montelukast Aurovitas Spain granules in a spoonful of soft cold or room temperature food, taking care to observe that the full dose is mixed with the food.
  • Ensure the entire spoonful of the food/granule mixture is given to the child immediately (within 15 minutes). IMPORTANT: Never save any leftover food/granule mixture for later use.
  • Montelukast Aurovitas Spain granules are not intended to be dissolved in liquids. However, your child can drink liquids after swallowing Montelukast Aurovitas Spain granules.
  • Montelukast Aurovitas Spain granules can be taken with or without food.

If your child takes more Montelukast Aurovitas Spain than they should

Seek help from your child's doctor immediately.

In most cases of overdose, no adverse effects were reported. The symptoms that occurred most frequently reported in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

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

If you forget to give Montelukast Aurovitas Spain to your child

Try to give Montelukast Aurovitas Spain as prescribed. However, if you forget to give a dose to your child, just resume the regular schedule of one sachet once a day.

Do not give a double dose to make up for missed doses.

If your child stops taking Montelukast Aurovitas Spain

Montelukast Aurovitas Spain may only treat your child's asthma if they continue taking it. It is essential that your child continues taking this medicine for the time their doctor prescribes it. It will help control your child's asthma.

If you have any other questions about the use of this medicine, ask your child's 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.

In clinical trials conducted with Montelukast Aurovitas Spain 4 mg granules, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

  • Diarrhea.
  • Hyperactivity.
  • Asthma.
  • Itchy or scaly skin.
  • Rash.

Additionally, the following side effects were reported in clinical trials with Montelukast Aurovitas Spain 10 mg film-coated tablets and Montelukast Aurovitas Spain 5 mg or 4 mg chewable tablets:

  • Abdominal pain.
  • Headache.
  • Thirst.

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious side effects

Consult your doctor immediatelyif you observe any of the following side effects in your child, as they may be serious and your child may need urgent medical treatment.

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

  • Allergic reactions including swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing.
  • Behavior and mood-related changes: excitement including aggressive or hostile behavior, depression.
  • Seizures.

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

  • Increased risk of bleeding.
  • Tremor.
  • Palpitations.

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

  • A combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2).
  • Low platelet count.
  • Behavior and mood-related changes: hallucinations, disorientation, suicidal thoughts and actions.
  • Inflammation (inflammation) of the lungs.
  • Severe skin reactions (erythema multiforme) that can occur without warning.
  • Liver inflammation (hepatitis).

Other side effects reported during the marketing of the medicine:

Very common (may affect more than 1 in 10 people):

  • Upper respiratory tract infection

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

  • Diarrhea, nausea, vomiting.
  • Rash.
  • Fever.
  • Elevated liver enzymes.

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

  • Behavior and mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness.
  • Dizziness, drowsiness, tingling/numbness.
  • Nosebleeds.
  • Dry mouth, indigestion.
  • Bruising, itching, hives.
  • Joint or muscle pain, muscle cramps.
  • Bedwetting (in children).
  • Weakness/tiredness, malaise, swelling.

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

  • Behavior and mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements.

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

  • Painful red lumps under the skin that most frequently appear on the shins (erythema nodosum).
  • Behavior and mood-related changes: obsessive-compulsive symptoms, stuttering.

Reporting of side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Aurovitas Spain

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 carton and sachet. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Montelukast Aurovitas Spain

  • The active substance is montelukast. Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.
  • The other ingredients (excipients) are: mannitol, hypromellose (low substituted), and magnesium stearate.

Appearance of the product and pack contents

Montelukast Aurovitas Spain 4 mg granules are a white to yellow granule.

Pack sizes: 28 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Generis Farmacêutica, S.A.

Rua Joao de Deus, 19

2700-487 Amadora

Portugal

Date of last revision of this leaflet: April 2024

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 MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES

Discuss questions about MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES, including use, safety considerations and whether a prescription is appropriate, subject to medical assessment and local regulations.

Doctor
5.0(6)

Jorge Correa Bellido

General medicine7 years of experience
Licence no. 464626297

Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

Throughout his career, he has participated in various medical and academic projects, including a research fellowship in Spain, where he contributed to evidence-based studies in the field of family medicine. This experience allowed him to broaden his global perspective on healthcare and comprehensive patient care.

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Dr. Correa Bellido provides comprehensive care for a wide variety of medical conditions, including:

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His services include virtual consultations, diagnosis and management of acute and chronic diseases, prescription renewals, and personalized medical advice.

With a patient-centered approach and a strong commitment to continuous learning, Dr. Correa Bellido provides accessible and high-quality healthcare to patients both in Spain and around the world.

Book a video appointment
€86
Doctor

Chikeluo Okeke

General medicine4 years of experience

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

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€66
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Nuno Tavares Lopes

General medicine18 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies

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  • Sick leave (Baixa médica) connected to Segurança Social in Portugal

  • IMT medical certificates for driving licence exchange

Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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€70
Doctor

Hocine Lokchiri

General medicine21 years of experience

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€64
Doctor
4.7(11)

Anastasiia Shalko

General medicine13 years of experience
Licence no. 52891

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
  • viral illnesses such as colds and seasonal infections
  • gastrointestinal complaints (nausea, diarrhoea, abdominal pain, gastroenteritis)
  • sudden changes in how a child or adult feels
  • questions about existing treatment and whether adjustments are needed
  • renewal of prescriptions when clinically appropriate

Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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€56
Doctor
5.0(8)

Lizaveta Trafimchuk Takhvaniuk

DermatologyGeneral medicine10 years of experience
Licence no. 58788

Dr. Lizaveta Trafimchuk Takhvaniuk graduated in Medicine and subsequently specialized in Dermatology and Venereology. She has more than 10 years of clinical experience and is licensed to practice in Spain, where she focuses on the comprehensive diagnosis and treatment of dermatological conditions.

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With a strong interest in a comprehensive approach to skin health, she also treats scars, post-procedural skin changes, and conditions related to hormonal factors and aging, including those associated with pregnancy, menopause, and age-related skin changes.

Thanks to her experience and continuous professional development, Dr. Trafimchuk provides high-quality medical care that is professional, confidential, and aligned with modern dermatology standards.

Book a video appointment
€72

Frequently Asked Questions

MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES is montelukast. This information helps identify medicines with the same composition but different brand names.

The average pharmacy price for MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES is around 16.84 EUR. Prices may vary depending on the manufacturer and dosage form.

MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES is manufactured by Aurovitas Spain, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Family doctors, Pulmonologists, Allergists, ENT doctors, General medicine doctors, Anaesthesiologists may assess whether MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, MONTELUKAST AUROVITAS SPAIN 4 mg GRANULES is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (montelukast) include MONKASTA 10 mg FILM-COATED TABLETS, MONKASTA 4 mg CHEWABLE TABLETS, MONKASTA 5 mg CHEWABLE TABLETS. 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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