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MONTELUKAST OPKO 10 mg TABLETS

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About the medicine

How to use MONTELUKAST OPKO 10 mg 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 Patient

Montelukast OPKO 10 mg Tablets EFG

Read all of this leaflet carefully before you start taking this 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 signs of illness are the same as yours.
  • If you get 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 is Montelukast OPKO and what is it used for
  2. What you need to know before you take Montelukast OPKO
  3. How to take Montelukast OPKO
  4. Possible side effects
  5. Storage of Montelukast OPKO
  6. Contents of the pack and other information

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

What is Montelukast OPKO

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

How Montelukast OPKO works

Leukotrienes cause the airways in the lungs to narrow and become inflamed, which can cause asthma symptoms. By blocking the leukotrienes, montelukast improves asthma symptoms, helps control asthma, and reduces symptoms of seasonal allergies (also known as hay fever or allergic rhinitis).

When to take Montelukast OPKO

Your doctor has prescribed montelukast to treat asthma, to prevent asthma symptoms during the day and night.

  • Montelukast is used to treat adults and adolescents 15 years of age and older who are not adequately controlled with their asthma medication and need additional treatment.
  • Montelukast also helps prevent narrowing of the airways caused by exercise.
  • In patients with asthma who are indicated for montelukast, it may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use this medication.

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.

The symptoms of asthma include: Coughing, wheezing, and chest congestion.

What are seasonal allergies?

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

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Montelukast OPKO

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

DO NOT TAKEMontelukast OPKO

  • If you 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 starting this medication.

  • If your asthma or breathing gets worse, tell your doctor immediately.
  • Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks.
  • It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast should not replace other asthma medications that your doctor has prescribed.
  • Any patient being treated with asthma medications 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 pulmonary symptoms, and/or skin rash, they should consult their doctor.
  • Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

Several neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood-related, depression, and suicidal thoughts) in patients of all ages (see section 4). If you develop these symptoms while taking montelukast, you should consult your doctor.

Children and adolescents

Do not give this medicine to children under 15 years 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 OPKO

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines work.

Before taking montelukast, tell your doctor if you are taking the following medicines:

  • Phenobarbital (used to treat epilepsy).
  • Phenytoin (used to treat epilepsy).
  • Rifampicin (used to treat tuberculosis and some other infections).
  • Gemfibrozil (used to treat high plasma lipid levels).

Taking Montelukast OPKO with food and drinks

Montelukast 10 mg tablets can be taken with or without food.

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 taking this medicine.

Pregnancy

Your doctor will assess whether you can take montelukast during this period.

Breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine.

Driving and using machines

Montelukast is not expected to affect your 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 may affect the patient's ability to drive or operate machinery.

Montelukast OPKO contains aspartame and sodium

Montelukast OPKO contains 0.75 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Montelukast OPKO

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.

  • You should only take one tablet of montelukast once a day, as prescribed by your doctor.
  • It should be taken even when you do not have symptoms or when you have an acute asthma attack.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet once daily, in the evening.

If you are taking montelukast, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medicine is taken orally.

You can take montelukast with or without food.

If you take more Montelukast OPKO than you should

Contact your 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast OPKO

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

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

If you stop taking Montelukast OPKO

Montelukast may only treat your asthma if you continue to take it.

It is important that you continue to take montelukast for as long as your doctor prescribes it. It will help control your asthma.

If you have any further questions on the use of this medicine, ask 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.

In clinical trials with montelukast 10 mg tablets, the side effects related to the administration of the medicine and most frequently reported (may affect up to 1 in 10 people) were:

  • abdominal pain
  • headache

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 notice any of the following side effects, which may be serious and may require 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 may cause difficulty breathing or swallowing
  • 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 pulmonary symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
  • low platelet count
  • mood-related changes: hallucinations, disorientation, suicidal thoughts and actions
  • inflammation (inflammation) of the lungs
  • severe skin reactions (erythema multiforme) that can occur without warning
  • inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the medicine

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

  • upper respiratory infection

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

  • diarrhea, nausea, vomiting
  • skin rash
  • fever
  • elevated liver enzymes

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

  • 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):

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

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

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

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 Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast OPKO

  • 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 blister after “EXP”. 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.
  • Store in the original package to protect from light and moisture. This medicine does not require any special storage temperature.
  • Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Contents of the pack and other information

Composition ofMontelukast OPKO

  • The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
  • The other ingredients (excipients) are: mannitol (E421), microcrystalline cellulose (E460i), sodium croscarmellose (E468), aspartame (E951), cherry flavor, red iron oxide (E172), yellow iron oxide (E172), and magnesium stearate (E470b).

Appearance of the product and contents of the pack

Montelukast OPKO 10 mg are uncoated, round, biconvex tablets, light brown in color, with score lines on both sides, measuring 9.4 mm to 9.8 mm. The score lines are only to facilitate breaking for easier swallowing and not to divide into equal doses.

Montelukast OPKO 10 mg is available in a cardboard box containing 2 Al/Al blisters with 14 tablets each.

Marketing authorization holder and manufacturer

Marketing authorization holder:

OPKO Health Spain S.L.U

Plaza Europa 13-15, 08908

L`Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer:

Laboratori Fundació Dau

Calle C De La Zona Franca 12-14

Polígono Industrial de la Zona Franca De Barcelona,

08040, Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Montelukast OPKO

Spain: Montelukast OPKO 10 mg tablets EFG

Date of last revision of this leaflet: June 2024

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 MONTELUKAST OPKO 10 mg TABLETS

Discuss questions about MONTELUKAST OPKO 10 mg 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.

Camera Book a video appointment
€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 OPKO 10 mg TABLETS?
MONTELUKAST OPKO 10 mg 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 OPKO 10 mg TABLETS?
The active ingredient in MONTELUKAST OPKO 10 mg TABLETS is montelukast. This information helps identify medicines with the same composition but different brand names.
Who manufactures MONTELUKAST OPKO 10 mg TABLETS?
MONTELUKAST OPKO 10 mg TABLETS is manufactured by Opko Health Spain S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MONTELUKAST OPKO 10 mg 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 OPKO 10 mg 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 OPKO 10 mg 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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