Montelukast Qualigen 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Qualigen 4 mg chewable tablets EFG

Read the entire 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 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, as it may harm them.
• If your child experiences any adverse effects, consult your doctor or pharmacist, even if such adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

What is montelukast

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

How montelukast works

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, 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 2 to 5 years who are not adequately controlled with their current medication and require additional therapy.
• 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 Qualigen

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

Do not give Montelukast Qualigen 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 for your child.
• If your child is being treated with asthma medications, you should be aware that if he or she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary symptoms, and/or skin rash, you must 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 they cause his or her asthma to worsen.

Children and adolescents

Do not give this medicine to children under 2 years 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 Qualigen

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicine, 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 to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections)

Taking Montelukast Qualigen with food and drinks

Montelukast 4 mg chewable tablets should not be taken with food; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

This section does not apply to Montelukast 4 mg chewable tablets, as this formulation is indicated for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Montelukast 4 mg chewable tablets, as this formulation is indicated for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

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

Montelukast Qualigen contains aspartame and sodium

This medicine contains 2.40 mg of aspartame per tablet, equivalent to 10 mg/g.

Aspartame contains a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

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

3. How to take Montelukast Qualigeng

Follow exactly the instructions given by your child's doctor or pharmacist for administering this medicine. If in doubt, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under the supervision of an adult. For children who have difficulty taking a chewable tablet, an oral granule formulation is available.
• Your child should take only one montelukast chewable tablet once daily, as prescribed by the doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

For children aged 2 to 5 years:

The recommended dose is one 4 mg chewable tablet taken once daily in the evening.

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

This medicine is taken orally.

The tablets must be chewed before swallowing.

Montelukast 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.

If your child takes more Montelukast Qualigeng 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, drowsiness, 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 the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to give Montelukast Qualigeng to your child

Try to give montelukast as prescribed. However, if your child misses a dose, simply resume the usual regimen of one chewable tablet once daily.

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

If your child stops treatment with Montelukast Qualigeng

Montelukast can only treat your child's asthma if treatment is continued.

It is important that your child continues taking montelukast for the duration prescribed by the 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 experiences them.

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

• abdominal pain
• thirst

In addition, the following adverse effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast tablets than with placebo (a tablet containing no active medicine).

Serious adverse effects:

Consult your doctor immediately if you notice any of the following adverse effects, which may be serious and 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 in 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) which may occur without warning
• inflammation of the liver (hepatitis)

Other adverse effects reported during post-marketing surveillance 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):

• diarrhoea, nausea, vomiting
• 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, feeling anxious, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bed-wetting (in children)
• weakness/fatigue, malaise, swelling

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

• changes in behaviour and mood: attention disturbance, memory disturbance, 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 Qualigen

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister after EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the stated month.
• Store in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located at the pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Qualigen

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components are: mannitol (E 421), microcrystalline cellulose (E 460i), hydroxypropylcellulose (E 463), iron oxide red (E 172), sodium croscarmellose (E 468), strawberry flavor, aspartame (E 951) and magnesium stearate (E 470b).

Appearance of the product and contents of the container

Montelukast Qualigen 4 mg: 4 mg pink, oval, biconvex chewable tablets with the inscription "4" on one side.

Presented in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

Date of the most recent revision of this leaflet: April 2024

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