Leaflet: information for the user

Montelukast NORMON 4 mg granulated EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for your child and should not be given to other people, even if they have the same symptoms as your child, as it may harm them.

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

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

2. What you need to know before your child takesMontelukast NORMON

3. How to take Montelukast NORMON

4. Possible adverse effects

5. Storage of Montelukast NORMON

6. Contents of the pack and additional information

What is Montelukast

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

How Montelukast works

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

When to use Montelukast

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 asthma treatment and have shown that they are unable to use inhaled corticosteroids.

-Montelukast also helps prevent airway constriction 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 (swelling) of the inner layer of the airways.

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

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give Montelukast Normon to your child

- if your child is allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your child's doctor or pharmacist before giving montelukast to your child.

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

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

- It is essential that your child uses all medications for asthma prescribed by your child's doctor.

Montelukast should not be used in place of other asthma medications prescribed by your child's doctor.

- If your child is being treated with asthma medications, be aware that if your child develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening respiratory symptoms, and/or skin rash, consult your child's doctor.

- Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your child's 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 you develop these symptoms while taking montelukast, contact your child's doctor.

Children and adolescents

Do not give this medication to children under 6 months of age.

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

Other medications and Montelukast Normon

Inform your child's doctor or pharmacist if your child is taking, has recently taken, or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications your child is using.

Before taking montelukast, inform your child's doctor if your child is taking the following medications:

- phenobarbital (used for epilepsy treatment)

- phenytoin (used for epilepsy treatment)

- rifampicin (used for tuberculosis and other infections treatment)

Taking Montelukast Normon with food and beverages

Montelukast granules can be taken regardless of meal times.

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 operating 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 ingredient, montelukast.

Montelukast is not expected to affect your ability to drive a car or operate machines. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and drowsiness) reported with Montelukast may affect the patient's ability to drive or operate machines.

Montelukast Normon contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

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

- This medication should be administered to children under the supervision of an adult.

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

For children from 6 months to 5 years old:

The recommended dose is one packet of montelukast 4 mg granule orally every night.

If your child is taking montelukast, make sure they do not take any other product containing the same active ingredient, montelukast.

How should I give Montelukast NORMON granule to my child?

This medication is taken orally.

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

- Montelukast granule can be administered:

-directly in the mouth;

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

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

- Make sure to administer the entire spoonful with the food mixture to the child immediately (within 15 minutes).

IMPORTANT: Never keep leftovers of the food/granule mixture for later use.

- Montelukast granule is not intended to dissolve in liquids. However, your child can take liquids after swallowing Montelukast granule.

- Montelukast granule can be taken regardless of meal times.

If your child takes more Montelukast NORMON than they should

Seek help from your child's doctor immediately.

Most cases of overdose did not report adverse effects. The symptoms that were 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to give Montelukast NORMON to your child

Try to give montelukast as prescribed. However, if your child forgets a dose, limit yourself to resuming the usual regimen of one packet per day.

Do not give a double dose to compensate for missed doses.

If your child interrupts treatment with Montelukast NORMON

Montelukast can only treat your child's asthma if they continue to take it. It is essential that your child continues to take montelukast for the time their doctor prescribes. It will help control your child's asthma.

If you have any other doubts about the use of this medication, ask your child's doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

- diarrhea

- hyperactivity

- asthma

- skin with itching or scaly skin

- skin eruption

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

- drowsiness

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you observe any of the following side effects in your child, which may be severe and your child may require urgent medical treatment.

Not common (may affect up to 1 in 100 people):

• Allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• Behavioral 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
• Tremors
• 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 respiratory symptoms and/or skin eruption (Churg-Strauss syndrome) (see section 2)
• Low platelet count
• Behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• Pulmonary edema
• Severe skin reactions (erythema multiforme) that may occur without warning
• Liver inflammation (hepatitis)

Other side effects reported during the marketing of the drug

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 eruption
• Fever
• Elevated liver enzymes

Not common (may affect up to 1 in 100 people):

• Behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness
• Dizziness, drowsiness, tingling/numbness
• Nasal bleeding
• Dry mouth, indigestion
• Bruising, itching, urticaria
• Muscle or joint pain, muscle cramps
• Bedwetting (in children)
• Weakness/fatigue, discomfort, swelling

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

• Behavioral and mood changes: attention disturbances, memory disturbances, uncontrolled muscle movements

Very rare (may affect up to 1 in 10,000 people):

• Red, painful bumps under the skin that more frequently appear on the face (erythema nodosum)

Behavioral and mood changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects:

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep out of the sight and reach of children.
• Store in the original packaging to protect it from light and humidity.
• Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.
• Store below 30 °C.
• Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Montelukast NORMON

• The active ingredient is montelukast. Each blister pack contains montelukast sodium equivalent to 4 mg of montelukast.

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

Appearance of the product and content of the packaging

Montelukast 4 mg: white or almost white granules.

It is presented in packs of 28 blister packs.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain

Date of the last review of this leaflet:May 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/

You can access detailed and updated information about 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