Leaflet: information for the user

Montelukast Normon 5 mg chewable tablets EFG

Read this leaflet carefully before you or your child start taking the medicine.

• 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 for you or your child and should not be given to others, even if they have the same symptoms as you or your child, as it may harm them.
• If you experience any side 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 starting to take Montelukast Normon

3. How to take Montelukast Normon

4. Possible side effects

5. Storage of Montelukast Normon

6. Contents of the pack and additional information

Montelukast Normon is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Normon improves asthma symptoms and helps control asthma.

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

-Montelukast Normon is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.

-Montelukast Normon is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated that they are unable to use inhaled corticosteroids.

-Montelukast Normon also helps prevent airway constriction caused by exercise.

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

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 conditions.

-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 doctor about any allergy or medical condition you or your child have now or have had.

Do not take Montelukast Normonif you or your child

-are allergic to montelukast or to any of the other components of this medication (including in section 6).

Be especially careful with Montelukast Normon

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

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

-It is essential that you or your child use all medications for asthma prescribed by your doctor. Montelukast Normon should not be used in place of other asthma medications prescribed by your doctor for you or your child.

-Any patient being 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 respiratory 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 nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

Patients should be aware that several neuropsychiatric events have been reported with Montelukast Normon (for example, changes in behavior and mood-related changes) in adults, adolescents, and children (see section 4). If you or your child develop these symptoms while taking Montelukast Normon, you should consult your doctor or your child's doctor.

Use in children

For children aged 2 to 5 years, Montelukast Normon 4 mg chewable tablets and Montelukast Normon 4 mg granules are available.

For children aged 6 to 14 years, Montelukast Normon 5 mg chewable tablets are available.

Other medications and Montelukast Normon

Some medications may affect the functioning of Montelukast Normon, or Montelukast Normon may affect the functioning of other medications you are using.

Inform your doctor or pharmacist if you or your child are using or have recently used other medications, including those obtained without a prescription.

Before taking Montelukast Normon, inform your doctor if you or your child are taking the following medications:

-phenobarbital (used for the treatment of epilepsy)

-phenytoin (used for the treatment of epilepsy)

-rifampicin (used for the treatment of tuberculosis and some other infections)

Taking Montelukast Normon with food and beverages

Montelukast Normon 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

Pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast Normon. Your doctor will evaluate whether you can take Montelukast Normon during this period.

Breastfeeding

The safety of Montelukast Normon in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast Normon.

Driving and operating machinery

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

Montelukast Normon contains aspartame and sodium

This medication contains 1.5 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

- You or your child should only take one Montelukast Normon 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 they have an acute asthma attack.

- Take Montelukast Normon as instructed by your doctor. Consult your doctor or pharmacist if you have any doubts.

- It should be taken orally.

For children aged 6 to 14 years:

Take one chewable tablet of 5 mg daily at night. Montelukast Normon 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

If you or your child are taking Montelukast Normon, make sure that neither you nor your child take any other product containing the same active ingredient, montelukast.

If you or your child take more Montelukast Normon than you should:

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Montelukast Normon or forget to give Montelukast Normon to your child:

Try to take Montelukast Normon as prescribed. However, if you or your child forget a dose, simply resume the usual regimen of one tablet once a day.

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

If you or your child interrupt treatment with Montelukast Normon:

Montelukast Normon can only treat your asthma or your child's asthma if you or your child continue to take it. It is essential to continue taking Montelukast Normon for the time your doctor prescribes. It will help control your asthma or your child's asthma.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

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

In clinical trials conducted with montelukast 5 mg chewable tablets, the side effects related to the administration of the drug and reported most frequently (occurring in at least 1 in 100 patients and less than 1 in 10 patients treated), were:

-headache

In addition, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets:

-abdominal pain

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

In addition, since the drug has been marketed, the following side effects have been reported:

-upper respiratory tract infection

-increased risk of bleeding

-allergic reactions that include skin rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing

-behavioral and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, anxiety sensation, restlessness, excitement including aggressive or hostile behavior, tremor, depression, sleep problems, somnambulism, suicidal thoughts and actions (in very rare cases)]

-dizziness, drowsiness, tingling/numbness, seizures

-palpitations

-nasal bleeding

-diarrhea, dry mouth, indigestion, nausea, vomiting

-hepatitis (inflammation of the liver)

-hematomas, itching, urticaria, painful red bumps under the skin that more frequently appear on the skin (erythema nodosum)

-joint or muscle pain, muscle cramps

-fatigue, discomfort, swelling, fever

-stuttering (very rare, may affect up to 1 in 10,000 people)

In patients with asthma treated with montelukast, rare cases of a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of respiratory symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported. Inform your doctor immediately if you experience one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, report it to your doctor or pharmacist.

Reporting of side effects:

If you experience 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 of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of the sight and reach of children.

Store below 30°C.

Store in the original packaging to protect it from light and humidity.

Do not use Montelukast Normon after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Montelukast Normon

• The active ingredient is montelukast. This tablet contains montelukast sodium corresponding to 5 mg of montelukast.
• The other components are:

Microcrystalline cellulose, mannitol (E-421), sodium carboxymethyl starch (from potato), aspartame (E-951), magnesium stearate, cherry aroma, and iron oxide red (E-172).

Appearance of the product and contents of the packaging

The 5 mg chewable tablets are reddish, round, biconvex, and printed.

Blister packs in packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was revised in January 2022

Detailed and updated 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 mobile phone (smartphone). You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74237/P_74237.html