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MONTELUKAST UR 10 mg FILM-COATED TABLETS

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About the medicine

How to use MONTELUKAST UR 10 mg FILM-COATED TABLETS

Translated with AI

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

Montelukast UR 10 mg film-coated tablets EFG

Read the package leaflet carefully before your child starts taking 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, pharmacist, or nurse.
  • This medicine has been prescribed to your child, 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 side effects, consult your doctor or pharmacist, even if they are side effects not mentioned in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Montelukast UR and what is it used for

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Montelukast UR improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed Montelukast UR to treat asthma and prevent asthma symptoms during the day and night.

  • Montelukast UR is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.
  • Montelukast UR also helps prevent narrowing of the airways caused by exercise.
  • In asthmatic patients with Montelukast UR indicated for the treatment of asthma, Montelukast UR 10 mg may also provide relief from symptoms of seasonal allergic rhinitis.

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

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 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.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: Stuffy nose, runny nose, itchy nose, sneezing; watery, swollen, red, and itchy eyes.

Doctor consultation

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2. What you need to know before taking Montelukast UR

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast UR if:

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

Warnings and precautions:

  • If your child's asthma or breathing worsens, tell your doctor immediately.
  • Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always have your child's rescue inhaler medication for asthma attacks.
  • It is essential to use all asthma medications prescribed by your doctor. Montelukast UR should not replace other asthma medications your doctor has prescribed.
  • If you are being treated with asthma medications, be aware that if you 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, you should consult your doctor.
  • Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Use in children:

Montelukast UR is indicated for patients 15 years of age and older.

For children 6 to 14 years old, Montelukast UR 5 mg chewable tablets are available. For children 2 to 5 years old, Montelukast UR 4 mg chewable tablets are available.

Use of other medications:

Some medications may affect the functioning of Montelukast UR, or Montelukast UR may affect the functioning of other medications you are taking.

Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including those obtained without a prescription.

Before taking Montelukast UR, tell your doctor if you are taking the following medications:

  • phenobarbital (used to treat epilepsy)
  • phenytoin (used to treat epilepsy)
  • rifampicin (used to treat tuberculosis and some other infections)

Taking Montelukast UR with food and drinks:

Montelukast UR can be taken with or without food.

Pregnancy and breastfeeding:

Pregnancy:

Women who are pregnant or plan to become pregnant should consult their doctor before taking Montelukast UR. Your doctor will assess whether you can take Montelukast UR during this period.

Breastfeeding:

It is unknown whether Montelukast is excreted in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast UR.

Driving and using machines:

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

Important information about some of the ingredients of Montelukast UR:

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Montelukast UR

  • Always take Montelukast UR exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
  • The usual dose is one Montelukast UR tablet once daily as prescribed by your doctor.
  • It should be taken even when your child does not have symptoms or during an acute asthma attack.
  • It should be taken orally.

For children 15 years of age and older:

One Montelukast UR tablet at night. The film-coated tablet should be swallowed with a sufficient amount of liquid (e.g., water). Montelukast UR can be taken with or without food.

If you are taking Montelukast UR, make sure you do not take any other medication that contains the same active ingredient, Montelukast.

If you take more Montelukast UR than you should:

Seek immediate medical attention from your child's doctor.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently 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 taken.

If you forget to take Montelukast UR:

Try to take Montelukast UR as prescribed. However, if you miss a dose, just resume your regular schedule of one tablet once daily.

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

If you stop taking Montelukast UR:

Montelukast UR can only treat asthma if you continue taking it.

It is essential to continue taking Montelukast UR for as long as your doctor prescribes it. It will help control your child's asthma.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

Medicine questions

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4. Possible side effects

Like all medicines, Montelukast UR can cause side effects, although not everybody gets them.

Possible side effects are listed according to the following categories:

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

Common side effects (may affect up to 1 in 10 people)

Uncommon side effects (may affect up to 1 in 100 people)

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

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

Side effects of unknown frequency (cannot be estimated from the available data)

In clinical trials with Montelukast, the side effects related to the administration of the medicine and most frequently reported (occurring in at least 1 in 100 patients and less than 1 in 10 patients treated) were:

  • abdominal pain
  • headache

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

Additionally, since the medicine has been marketed, the following side effects have been reported:

  • upper respiratory tract infection
  • increased risk of bleeding
  • allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
  • behavioral and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, feeling anxious, restlessness, including aggressive or hostile behavior, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions (in very rare cases)]
  • dizziness, drowsiness, tingling/numbness, seizures
  • palpitations
  • nasal bleeding
  • diarrhea, dry mouth, indigestion, nausea, vomiting
  • hepatitis (inflammation of the liver)
  • bruises, itching, hives, painful red lumps under the skin that most frequently appear on the shins (erythema nodosum)
  • joint or muscle pain, muscle cramps
  • fatigue, discomfort, swelling, fever

In asthmatic patients treated with Montelukast, very rare cases of 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) have been reported. You should immediately inform your doctor if your child has one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you experience any side effect that is severe or if you notice any side effects not mentioned in this package leaflet, inform your child's doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not mentioned in this package leaflet. You can also report them directly through the national reporting system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast UR 10 mg

  • 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 after EXP. The expiry date is the last day of the month shown.
  • Store in the original package to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your usual pharmacy. 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:

  • The active ingredient is Montelukast.

Each tablet contains 10.4 mg of Montelukast sodium, which is equivalent to 10 mg of Montelukast.

  • The other ingredients are:

Lactose monohydrate (130.6 mg), microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and anhydrous colloidal silica.

Coating: hypromellose, hypromellose (E-463), titanium dioxide (E-171), red and yellow iron oxide (E-172).

Appearance of the product and contents of the pack:

Montelukast UR 10 mg film-coated tablets are pale pink-yellow, round, biconvex with "M10" engraved on one side.

Montelukast UR 10 mg is available in packs of 28 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

c/ Solana, 26

28850 – Torrejon de Ardoz. (Madrid) Spain

Manufacturer:

Siegfried Generics Malta Ltd.

HHF070 Hal Far Industrial Estate, (PO Box 14), BBG 3000 Hal Far

Malta

Or

Laboratorios de Medicamentos Internacionales, S.A.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This package leaflet was approved in April 2011.

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

Online doctors for MONTELUKAST UR 10 mg FILM-COATED TABLETS

Discuss questions about MONTELUKAST UR 10 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

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:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
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.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
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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€58
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 (25)
Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
5.0 (760)
Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55

Frequently Asked Questions

Is a prescription required for MONTELUKAST UR 10 mg FILM-COATED TABLETS?
MONTELUKAST UR 10 mg FILM-COATED TABLETS 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 MONTELUKAST UR 10 mg FILM-COATED TABLETS?
The active ingredient in MONTELUKAST UR 10 mg FILM-COATED TABLETS is montelukast. This information helps identify medicines with the same composition but different brand names.
How much does MONTELUKAST UR 10 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for MONTELUKAST UR 10 mg FILM-COATED TABLETS is around 21.06 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures MONTELUKAST UR 10 mg FILM-COATED TABLETS?
MONTELUKAST UR 10 mg FILM-COATED TABLETS is manufactured by Aristo Pharma Iberia S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MONTELUKAST UR 10 mg FILM-COATED TABLETS 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 MONTELUKAST UR 10 mg FILM-COATED TABLETS 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 MONTELUKAST UR 10 mg FILM-COATED TABLETS?
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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