Montelukast Qualigen 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Qualigen 5 mg chewable tablets EFG

Read the entire leaflet carefully before you or your child start taking this medicine, because it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you or your child and must not be given to other people, even if they have the same symptoms as you or your child, since it could harm them.
• If you or your child experience 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 Qualigen is and what it is used for
2. What you need to know before taking 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 asthma and to prevent asthma symptoms during the day and night.

• Montelukast is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast is also used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast also helps prevent exercise-induced narrowing of the airways.

Depending on the symptoms and severity of your asthma or your child's 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 starting to take Montelukast Qualigen

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

Do not take Montelukast Qualigen if you or your child:

• are 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 you or your child start taking montelukast.

• If your asthma or breathing, or that of your child, 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 yourself or your child. Always keep your inhaled rescue medication for asthma attacks on hand.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications prescribed for you or your child by your doctor.
• 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.
• You or 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 your asthma to worsen.

Children and adolescents

Do not give this medicine to children under 6 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 you or your child are taking, have 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 work.

Before taking montelukast, inform your doctor if you or your child are 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 Qualigen with food and drink

Montelukast 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after eating.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will assess whether you can take montelukast during this period.

Breastfeeding

It is unknown whether montelukast is excreted in breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking montelukast.

Driving and using machines

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 drowsiness) that have been reported with montelukast may affect a patient's ability to drive or operate machinery.

Montelukast Qualigen contains aspartame and sodium

This medicine contains 3.00 mg of aspartame in each tablet, equivalent to 10 mg/g.

Aspartame is a source of phenylalanine, which may be harmful if you have 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; therefore, it is essentially “sodium-free”.

3. How to take Montelukast Qualigen

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

• You or your child should take only one montelukast chewable tablet once daily, as prescribed by your doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

For children aged 6 to 14 years:

The recommended dose is one 5 mg chewable tablet daily, taken in the evening.

If you or your child are taking this medicine, make sure that neither your child nor you take any other product containing the same active substance, montelukast.

This medicine is taken orally.

The tablets must be chewed before swallowing.

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

If you or your child take more Montelukast Qualigen than you should

Seek immediate medical help.

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’s packaging and leaflet to the healthcare professional.

If you or your child forget to take Montelukast Qualigen or forget to give it to your child

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

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

If you or your child stop taking Montelukast Qualigen

Montelukast can only control your asthma or your child’s asthma if you or your child continue taking it.

It is important to keep taking montelukast for as long as your doctor has prescribed it. It will help control your asthma or your child’s asthma.

If you have any further questions about the use of this medicine, ask your 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 5 mg chewable tablets, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• headache

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

• abdominal pain

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

Serious adverse effects:

Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and you or 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 related to behaviour and mood: agitation 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 pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)

• low platelet count

• changes related to 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 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
• rash
• fever
• elevated liver enzymes

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

• changes related to behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleed
• dry mouth, 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 related to behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

Very rare

• painful red lumps under the skin which most frequently appear on the shins (erythema nodosum)
• changes related to behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects

If you or your child experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 month indicated.
• 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 medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. 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 5 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 pack

Montelukast Qualigen 5 mg: 5 mg pink, round, chewable tablets, biconvex, with the imprint "5" 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 on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/