MONTELUKAST NORMON 4 mg GRANULES

Introduction

Package Leaflet: Information for the User

Montelukast NORMON 4 mg Granules

Read all of this leaflet carefully before giving this medicine to your child, because it contains important information.

• 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 your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.

If your child experiences side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

What is Montelukast NORMON

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

How Montelukast NORMON works

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

When to use Montelukast NORMON

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

Montelukast is used to treat patients between 6 months and 5 years of age who are not adequately controlled with their medication and need additional treatment.

Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age who have not recently taken oral corticosteroids for their asthma and have demonstrated that they are unable to use inhaled corticosteroids.

Montelukast also helps prevent narrowing of the airways caused by exercise in patients 2 years of age and older.

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

-Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.

-Inflammation of the inner layer of the airways.

Asthma symptoms include: coughing, wheezing, and chest congestion.

2. What you need to know before your child takes Montelukast NORMON

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not give Montelukast NORMON to your child

-if they 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 giving montelukast to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.

-Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given your child. Always have your child's rescue inhaler medication for asthma attacks.

• It is essential that your child uses all asthma medications prescribed by their doctor.

Montelukast should not be used instead of other asthma medications prescribed by your doctor for your child.

• If your child is being treated with asthma medications, they 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.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.

Several neuropsychiatric events (e.g., changes in behavior and mood, 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, they should contact their doctor.

Children and adolescents

Do not give this medicine to children under 6 months 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 NORMON

Tell your doctor or pharmacist if your child is taking, has 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 your child is using work.

Before taking montelukast, tell your doctor if your child is taking the following medicines:

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

Taking Montelukast NORMON with food and drinks

Montelukast granules can be taken without regard to meals.

Pregnancy and breastfeeding

This subsection is not applicable to Montelukast 4 mg granules, as its use is indicated in children between 6 months and 5 years of age.

Driving and using machines

This subsection is not applicable to Montelukast 4 mg granules, as its use is indicated in children between 6 months and 5 years of age. However, the following information is important for the active substance, montelukast.

Montelukast is not expected to affect your child's 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 your child's ability to drive or operate machinery.

Montelukast NORMON contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

3. How to take Montelukast NORMON

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist for your child. In case of doubt, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under adult supervision.

-Your child should take montelukast every night. It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

For children from 6 months to 5 years of age:

The recommended dose is one sachet of montelukast 4 mg granules orally every night.

If your child is taking montelukast, ensure they do not take any other product containing the same active substance, montelukast.

How to give Montelukast NORMON granules to your child

This medicine is taken orally.

-Do not open the sachet until the time of use.

-Montelukast granules can be administered:

-directly into the mouth;

-or mixed with a spoonful of soft cold or room-temperature food (e.g., apple sauce, ice cream, carrots, and rice).

-Mix the entire contents of Montelukast granules in a spoonful of soft cold or room-temperature food, taking care to observe that the full dose is mixed with the food.

• Ensure the child is given the entire spoonful of the food/granule mixture immediately (within 15 minutes).

IMPORTANT: never save any leftover food/granule mixture for later use.

-Montelukast granules are not intended to be dissolved in liquids. However, your child can take liquids after swallowing Montelukast granules.

-Montelukast granules can be taken without regard to meals.

If your child takes more Montelukast NORMON than they should

Seek help from your child's doctor immediately.

In most cases of overdose, no side 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, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to give Montelukast NORMON to your child

Try to give montelukast as prescribed. However, if your child misses a dose, just resume the usual routine of one sachet once a day.

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

If your child stops taking Montelukast NORMON

Montelukast may only treat your child's asthma if they continue taking it. It is essential that your child continues taking montelukast for as long as their doctor prescribes it. It will help control your child's asthma.

If you have any further questions about the use of this medicine, ask your child's doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials conducted with montelukast 4 mg granules, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• diarrhea
• hyperactivity
• asthma
• itchy or scaly skin
• skin rash

Additionally, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets and montelukast 5 mg or 4 mg chewable tablets:

• abdominal pain
• headache
• thirst

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

Consult your doctor immediatelyif you observe any of the following side effects in your child, which may be serious and 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 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
• inflammation of the lungs (pneumonitis)
• 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 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, malaise, 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 your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's 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 NORMON

• Keep out of sight and reach of children.
• Store in the original packaging to protect from light and moisture.
• Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.
• Store below 30°C.
• Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Montelukast NORMON

• The active substance is montelukast. Each sachet contains montelukast sodium equivalent to 4 mg of montelukast.

• The other ingredients are: mannitol (E-421), hypromellose (E-464), and magnesium stearate.

Appearance and packaging of the product

Montelukast 4 mg: white or almost white granules.

Available in packs of 28 sachets.

Marketing authorization holder and manufacturer

LABORATORIOS 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.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74176/P_74176.html