


Ask a doctor about a prescription for MONTELUKAST NORMON 10 mg FILM-COATED TABLETS
Package Leaflet: Information for the User
Montelukast Normon 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.
Contents of the pack:
What is Montelukast Normon
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Normon works
Leukotrienes cause the airways to narrow and swell, and can cause symptoms of asthma and allergy. By blocking the leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergy (also known as hay fever or allergic rhinitis).
When to use Montelukast Normon
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, red, and swollen eyes.
Tell your doctor about any allergy or medical problem you have now or have had.
Do not take Montelukast Normon
Warnings and precautions
Consult your doctor or pharmacist before starting to take montelukast
Several neuropsychiatric events (e.g., 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 Normon
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 how montelukast works, or montelukast may affect how other medicines work.
Before taking montelukast, tell your doctor if you are taking the following medicines:
Taking Montelukast Normon with food and drinks
Montelukast Normon 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.
Use during pregnancy
Your doctor will assess whether you can take montelukast during this period.
Use during 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 Normon 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 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of 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 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 Normon than you should
Ask your doctor for help 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 ingested. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.
If you forget to take Montelukast Normon
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 Normon
Montelukast Normon will 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 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 with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medicine).
Serious side effects
Tell 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):
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):
mood-related changes: obsessive-compulsive symptoms, stuttering
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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
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 refers to the last day of the month shown.
Store below 30°C.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicine to a pharmacy for proper disposal. This will help protect the environment.
Composition of Montelukast Normon
Core: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate (from potato), low-substituted hydroxypropylcellulose, hydroxypropylcellulose (E-464), magnesium stearate, Coating: hypromellose, macrogol 6000, titanium dioxide (E-171), talc, red iron oxide (E-172), and yellow iron oxide (E-172).
Appearance of the product and pack contents
Montelukast 10 mg tablets are cream-colored, round, biconvex, and engraved.
Montelukast 10 mg is available in blister packs of 28 tablets.
Marketing authorization holder and manufacturerLABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain
Date of last revision of this leaflet:May 2024
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/
You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75844/P_75844.html
The average price of MONTELUKAST NORMON 10 mg FILM-COATED TABLETS in October, 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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