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MONKASTA 5 mg CHEWABLE TABLETS

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About the medicine

How to use MONKASTA 5 mg CHEWABLE TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Monkasta 5 mg Chewable Tablets EFG

For Children from 6 to 14 Years

montelukast

Read all of this leaflet carefully before you or your child start taking this medicine, because it contains important information for you or your child.

  • 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 or your child only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours or your child's.
  • If you or your child experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Monkasta and what is it used for

What is Monkasta

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

How Monkasta works

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

When Monkasta should be used

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

  • Monkasta is used for the treatment of pediatric patients between 6 and 14 years of age who are not adequately controlled with their medication and need additional treatment.
  • Monkasta is also used as an alternative treatment to inhaled corticosteroids in patients between 6 and 14 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.
  • Monkasta also helps prevent narrowing of the airways caused by exercise.

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

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 taking Monkasta

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

Do not take Monkasta

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

Warnings and precautions

Consult your doctor or pharmacist before you or your child start taking Monkasta:

  • If your or your child's asthma or breathing worsens, inform your doctor immediately.
  • Monkasta oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor to you or your child. Always have your asthma rescue medication with you.
  • It is essential that you or your child take all asthma medications prescribed by your doctor. Monkasta should not be used instead of other asthma medications prescribed by your doctor for you or your child.
  • Any patient 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 lung symptoms, and/or skin rash, they should consult their doctor.
  • You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they worsen your or your child's asthma.

Several neuropsychiatric events (such as changes in behavior and mood-related changes, 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, you should contact your doctor.

Children and adolescents

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

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

Taking Monkasta with other medicines

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

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

Before taking Monkasta, tell your doctor if you or your child are taking the following medicines:

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

Taking Monkasta with food

Monkasta 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

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

Monkasta contains aspartame and sodium

This medicine contains 1.5 mg of aspartame in each chewable tablet.

Aspartame is a source of phenylalanine, which may be harmful to you or your child if you or your child have 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 chewable tablet, which is essentially "sodium-free".

3. How to take Monkasta

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.

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

Use in children between 6 and 14 years of age

The recommended dose is one 5 mg chewable tablet at night.

If you or your child are taking Monkasta, make sure that neither you nor your child take any other medicine that contains the same active ingredient, montelukast.

This medicine should be taken orally.

The tablets should be chewed before swallowing.

Monkasta 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

If you or your child take more Monkasta than you should

Seek immediate medical attention from your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 652 04 20, indicating the medicine and the amount ingested.

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

If you or your child forget to take Monkasta

Try to take Monkasta as prescribed. However, if you or your child forget a dose, just resume your usual routine of one chewable tablet once a day.

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

If you or your child stop taking Monkasta

Monkasta can only treat your or your child's asthma if you continue to take it. It is essential to keep taking Monkasta for as long as your doctor prescribes it. It will help control your or your child's asthma.

If you have any further questions about 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 Monkasta 5 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 patients) were:

  • headache.

Additionally, the following side effect was reported in clinical trials with montelukast 10 mg film-coated tablets:

  • abdominal pain.

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).

Serious side effects

Talk to your doctor or your child's doctor immediatelyif you notice any of the following side effects, which may be serious and for which your child may need 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,
  • mood-related changes: agitation, including aggressive behavior or hostility, depression,
  • seizures.

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

  • increased tendency to 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 in blood,
  • mood-related changes: hallucinations, disorientation, suicidal thoughts and actions,
  • swelling (inflammation) of the lungs,
  • severe skin reactions (erythema multiforme) that can occur without warning,
  • inflammation of the liver (hepatitis).

Other side effects have been reported while the medicine has been on the market

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

  • 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

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

Reporting of side effects

If you or your child experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Monkasta

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 blister and on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

Composition of Monkasta

  • The active substance is montelukast.

Each chewable tablet contains 5 mg of montelukast (as montelukast sodium).

  • The other ingredients are mannitol (E421), microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, aspartame (E951), red iron oxide (E172), black cherry flavor (also contains glycerol triacetate (E1518)), and magnesium stearate (see section 2 "Monkasta 5 mg contains aspartame and sodium").

Appearance of the product and pack contents

The tablets are pink, speckled, round, slightly biconvex, with bisected edges and engraved with "5" on one side.

Available in boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140, or 200 chewable tablets in blisters.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warsaw, Poland

You can obtain further information about this medicine from the representative of the marketing authorization holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Member State

Medicine name

Austria

Montelukast Krka 5 mg Chewable Tablets

Belgium

Montelukast Krka 5 mg Chewable Tablets

Bulgaria

Монтелукаст Крка 5 mg жевателни таблетки

Cyprus

MONTELUKAST KRKA

Denmark

Montelukast Krka

Slovakia

Monkasta 5 mg žuvacie tablety

Spain

Monkasta 5 mg Chewable Tablets EFG

Estonia

MONKASTA

Finland

Montelukast Krka 5 mg Chewable Tablets

France

MONTELUKAST KRKA 5, comprimé à croquer

Hungary

Monalux 5 mg rágótabletta

Ireland

Montelukast 5 mg Chewable Tablets

Italy

Monkasta

Latvia

Monkasta 5 mg košlajamas tabletes

Lithuania

Monkasta 5 mg kramtomosios tabletes

Norway

Montelukast Krka 5 mg tyggetabletter

Netherlands

Montelukast Krka 5 mg Kauwtabletten

Poland

Monkasta

Portugal

Montelucaste KRKA 5 mg Comprimidos para mastigar

Czech Republic

MONKASTA

Romania

Monkasta 5 mg comprimate masticabile

Sweden

Montelukast Krka 5 mg tuggtablett

United Kingdom (Northern Ireland)

Montelukast 5 mg Chewable Tablets

Date of last revision of this leaflet: February 2024

“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.gob.es/”

Online doctors for MONKASTA 5 mg CHEWABLE TABLETS

Discuss questions about MONKASTA 5 mg CHEWABLE 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.

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  • headache, dizziness, migraine symptoms
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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.

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:

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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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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:

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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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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:

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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
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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
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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:

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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
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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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Frequently Asked Questions

Is a prescription required for MONKASTA 5 mg CHEWABLE TABLETS?
MONKASTA 5 mg CHEWABLE 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 MONKASTA 5 mg CHEWABLE TABLETS?
The active ingredient in MONKASTA 5 mg CHEWABLE TABLETS is montelukast. This information helps identify medicines with the same composition but different brand names.
How much does MONKASTA 5 mg CHEWABLE TABLETS cost in pharmacies?
The average pharmacy price for MONKASTA 5 mg CHEWABLE TABLETS is around 21.06 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures MONKASTA 5 mg CHEWABLE TABLETS?
MONKASTA 5 mg CHEWABLE TABLETS is manufactured by Krka D.D. Novo Mesto. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MONKASTA 5 mg CHEWABLE 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 MONKASTA 5 mg CHEWABLE 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 MONKASTA 5 mg CHEWABLE TABLETS?
Other medicines with the same active substance (montelukast) include MONKASTA 10 mg FILM-COATED TABLETS, MONKASTA 4 mg CHEWABLE TABLETS, MONTELUKAST ACCORD 10 mg FILM-COATED 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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