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MONTELUKAST ACCORD 10 mg FILM-COATED TABLETS

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About the medicine

How to use MONTELUKAST ACCORD 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 Patient

Montelukast Accord 10 mg Film-Coated 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 Accord and what is it used for
  2. What you need to know before you take Montelukast Accord
  3. How to take Montelukast Accord
  4. Possible side effects
  5. Storage of Montelukast Accord
  6. Contents of the pack and other information

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

What is Montelukast Accord

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

How Montelukast Accord works

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

When to use Montelukast Accord

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

  • Montelukast is used for the treatment of adults and adolescents 15 years and older who are not adequately controlled with their medication and need additional treatment.
  • Montelukast also helps prevent exercise-induced narrowing of the airways.
  • In patients with asthma who are indicated for montelukast for asthma, montelukast 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 montelukast.

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.

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. Seasonal allergy symptoms typically include: stuffy nose, runny nose; sneezing; itchy, watery, swollen, red, and scratchy 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 Accord

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

Do not take Montelukast Accord:

  • 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 Montelukast Accord

  • If your asthma or breathing worsens, tell your doctor immediately.
  • Montelukast Accord 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 inhalation medication for asthma attacks.
  • It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Accord should not replace other asthma medications prescribed by your doctor.
  • 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 and legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
  • Do not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make your asthma worse.

Neuropsychiatric effects have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you should contact your doctor.

Consult your doctor or pharmacist before starting Montelukast Accord.

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.

Taking Montelukast Accord with other medicines

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

Before taking Montelukast Accord, 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 Accord with food and drinks

Montelukast Accord 10 mg 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 10 mg film-coated tablets during this time.

Breastfeeding

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

Driving and using machines

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

Montelukast Accord 10 mg contains lactose.If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Montelukast 10 mg film-coated tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Montelukast Accord

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of 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.

Use in adults and adolescents 15 years and older:

The recommended dose is one 10 mg tablet per night.

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

This medicine is for oral use.

Montelukast 10 mg can be taken with or without food.

If you take more Montelukast Accord than you should

In most cases of overdose, no adverse 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 ingested.

If you forget to take Montelukast Accord

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 forgotten doses.

If you stop taking Montelukast Accord

Montelukast may only treat your asthma if you continue taking it.

It is important that you continue taking 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 conducted with montelukast 10 mg film-coated tablets, the side effects related to the administration of the medicine and reported most frequently (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, as they may be serious and may require urgent medical treatment.

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

  • Allergic reactions that include swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing.
  • Behavior and mood 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):

  • 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 changes: hallucinations, disorientation, suicidal thoughts and actions
  • Lung inflammation (inflammation)
  • Severe skin reactions (erythema multiforme) that may 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.
  • Skin rash.
  • Fever.
  • Elevated liver enzymes.

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

  • Behavior and mood 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, discomfort, swelling.

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

  • Behavior and mood 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 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Accord

  • Keep 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 refers to the last day of that month.
  • This medicine does not require any special storage conditions. Store in the original package to protect from light and moisture.
  • Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Accord

  • The active substance is montelukast.
  • The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose (LH-11) (E 463), sodium croscarmellose, and magnesium stearate.

Coating: hydroxypropylcellulose (LF) (E 463), hypromellose 6 CPS (A), titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and pack contents

Montelukast Accord 10 mg tablets are beige, square-shaped with rounded edges, biconvex, film-coated, with "M10" engraved on one side and smooth on the other side.

Montelukast Accord 10 mg tablets are available in OPA-Al-PVC/Al blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, and 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est 6ª planta

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Member StateMedicine name

Austria

Denmark

Bulgaria Montelukast Accord 10 mg ?????????

????????

Estonia Montelukast Accord

Finland Montelukast Accord 10 mg Kalvopäävysteinen

Tabletti/filmdragerade tabletter

France MONTELUKAST ACCORD HEALTHCARE

10 mg comprimés pelliculés

Ireland Montelukast 10 mg Film-coated Tablets

Italy Montelukast Accord 10 mg compresse rivestite

con film

Latvia Montelukast Accord 10 mg apvalkotas tabletes

Malta Montelukast 10 mg Film-coated Tablets

Norway Montelukast Accord 10 mg Filmdrasjerte

tabletter

Portugal Montelucaste Accord, 10 mg, Comprimido

revestido por película

Spain Montelukast Accord 10 mg comprimidos

recubiertos con película EFG

Sweden Montelukast Accord 10 mg filmdragerade

tabletter

Netherlands Montelukast 10 mg Filmomhulde tabletten

United Kingdom (NI) Montelukast 10 mg Film-coated Tablets

Date of last revision of this leaflet:December 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 MONTELUKAST ACCORD 10 mg FILM-COATED TABLETS

Discuss questions about MONTELUKAST ACCORD 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 ACCORD 10 mg FILM-COATED TABLETS?
MONTELUKAST ACCORD 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 ACCORD 10 mg FILM-COATED TABLETS?
The active ingredient in MONTELUKAST ACCORD 10 mg FILM-COATED TABLETS is montelukast. This information helps identify medicines with the same composition but different brand names.
Who manufactures MONTELUKAST ACCORD 10 mg FILM-COATED TABLETS?
MONTELUKAST ACCORD 10 mg FILM-COATED TABLETS is manufactured by Accord Healthcare S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MONTELUKAST ACCORD 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 ACCORD 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 ACCORD 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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