Montelukast Normon 4 mg granules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast NORMON 4 mg granules for oral suspension EFG

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

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

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

Contents of the leaflet:

1. What Montelukast NORMON is and what it is 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. How to store Montelukast NORMON
6. Contents of the pack and other information

1. What Montelukast is and what it is used for

What is Montelukast

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

How Montelukast works

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

When Montelukast should be used

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

• Montelukast is used for the treatment of patients aged 6 months to 5 years who are not adequately controlled with their current medication and require additional treatment.

• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.

• Montelukast also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how montelukast should be used.

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 triggers.

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

• Swelling (inflammation) of the inner lining of the airways.

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

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

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Montelukast Normon to your child

• if he or she is allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before giving montelukast to your child.

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

• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child’s rescue inhaled medication available for asthma attacks.

• It is important that your child uses all asthma medications prescribed by the 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, you should be aware that if your child develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen his or her asthma.

Various neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If these symptoms develop while taking montelukast, you must contact your 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 depending on the age range.

Other medicines and Montelukast Normon

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to 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 taking work.

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

• phenobarbital (used for the treatment of epilepsy)
• phenytoin (used for the treatment of epilepsy)
• rifampicin (used for the treatment of tuberculosis and certain other infections)

Taking Montelukast Normon with food and drinks

Montelukast granules may be taken regardless of meal times.

Pregnancy and breastfeeding

This section does not apply to Montelukast 4 mg granules, as this formulation is indicated for children aged between 6 months and 5 years.

Driving and using machines

This section does not apply to Montelukast 4 mg granules, as this formulation is indicated for children aged between 6 months and 5 years. However, the following information is important regarding the active substance, montelukast.

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

Montelukast Normon contains sodium

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

3. HOW TO TAKE Montelukast NORMON

Follow exactly the dosing instructions for this medicine as given by your child's doctor or pharmacist. If in 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. IDEMIt should be taken even when your child has no symptoms or during an acute asthma attack.

For children aged 6 months to 5 years:

The recommended dose is one 4 mg montelukast granule sachet taken orally once daily at night.

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

How should I give Montelukast NORMON granules to my child?

This medicine is taken by mouth.

• Do not open the sachet until ready to use.

• Montelukast granules can be administered:

  • directly into the mouth;

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

• Mix the entire contents of the montelukast granule sachet with one spoonful of cold or room-temperature soft food, taking care to ensure the full dose is mixed with the food.

• Make sure to administer the entire spoonful of the food/granule mixture to the child 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 may drink liquids after swallowing the montelukast granules.

• Montelukast granules may be taken regardless of meal times.

If your child takes more Montelukast NORMON than they should

Seek immediate help from your child's doctor.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and amount taken. It is recommended to bring the medicine packaging and leaflet 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, simply resume the usual regimen of one sachet once daily.

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

If your child stops taking Montelukast NORMON

Montelukast can only treat your child's asthma if it is taken continuously. It is important that your child continues taking montelukast for the duration prescribed by their doctor. 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 adverse effects

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

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

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

Additionally, the following adverse 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 adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a pill containing no active medicine).

Serious adverse effects

Contact your doctor immediately if you notice any of the following adverse effects in your child, as they may be serious and your child may 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, which may cause difficulty breathing or swallowing
• changes in behaviour and mood: excitation including aggressive behaviour or hostility, depression
• seizures

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

• increased tendency to 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 in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• inflammation of the liver (hepatitis)

Other adverse effects reported during the post-marketing period

Very common (may affect more than 1 in 10 people):

• upper respiratory tract infection

Common (may affect up to 1 in 10 people):

• diarrhoea, nausea, vomiting
• skin rash
• fever
• elevated liver enzymes

Uncommon (may affect up to 1 in 100 people):

• changes in behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

• changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

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

• painful red lumps under the skin, most commonly appearing on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects:

If your child experiences any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast NORMON

• Keep out of the sight and reach of children.
• Store in the original packaging to protect it from light and moisture.
• Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.
• Store below 30 °C.
• Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast NORMON

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

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

Appearance of the product and contents of the pack

Montelukast 4 mg: white or almost white granules.

It is 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 the most recent review of this leaflet: May 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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74176/P_74176.html