
Ask a doctor about a prescription for MONTELUKAST QUALIGEN 10 mg FILM-COATED TABLETS
Package Leaflet: Information for the User
Montelukast Qualigen10 mg film-coated tablets EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the pack
What is montelukast
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How montelukast 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
Your doctor has prescribed montelukast to treat asthma and prevent asthma symptoms during the day and night.
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:
The symptoms of asthma include: coughing, wheezing, and congestion in the chest.
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. The symptoms of seasonal allergies typically include: congested nose, runny nose; sneezing; itchy, watery, swollen, red, and stinging eyes.
Tell your doctor about any allergy or medical problem you have now or have had.
Do not take Montelukast Qualigen
Warnings and precautions
Consult your doctor or pharmacist before starting to take montelukast 10 mg.
Several neuropsychiatric events (such as changes in behavior and mood-related, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, you should contact 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 presentations of this medicine are available based on the age range.
Other medicines and Montelukast Qualigen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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:
Taking Montelukast Qualigen with food and drinks
Montelukast 10 mg film-coated 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 this medicine 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 montelukast.
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 Qualigen contains lactose and sodium
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".
Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
For adults and adolescents 15 years of age and older:
The recommended dose is one 10 mg tablet daily in the evening.
If you are taking this medicine, 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 10 mg with or without food.
If you take more Montelukast Qualigen than you should
Seek help from 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, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.
If you forget to take Montelukast Qualigen
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 Qualigen
Montelukast may only treat your asthma if you continue to take it. It is important that you continue to take montelukast for the time your doctor prescribes it. It will help control your asthma.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
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 most frequently reported (may affect up to 1 in 10 people) were:
These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain medicine).
Serious side effects:
Consult your doctor immediatelyif you observe any of the following side effects, which may be serious and may require urgent medical treatment.
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Other side effects reported during the marketing of the medicine
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
Composition of Montelukast Qualigen
Lactose monohydrate, microcrystalline cellulose (E 460i), hydroxypropylcellulose (E 463), sodium croscarmellose (E 468), and magnesium stearate (E 470b).
Coating:polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soybean lecithin (E 322), xanthan gum (E 415), and yellow and red iron oxide (E 172).
Appearance of the product and contents of the pack
Montelukast Qualigen 10 mg: orange, round, biconvex, film-coated tablets with the inscription "10" on one side.
It is presented in packs of 28 tablets.
Marketing authorization holder and manufacturer
Marketing authorization holder:
Neuraxpharm Spain, S.L.U.
Avda. Barcelona 69
08970 Sant Joan Despí, Barcelona
Spain
Manufacturer:
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí, Barcelona
Spain
Date of last revision of this leaflet:April 2024
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/
The average price of MONTELUKAST QUALIGEN 10 mg FILM-COATED TABLETS in November, 2025 is around 21.06 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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