Leaflet: information for the user

Montelukast Qualigen 4 mg chewable tablets 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.
• If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMontelukast Qualigenand what it is used for

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

3. How to takeMontelukast Qualigen

4. Possible side effects

5. Storage ofMontelukast Qualigen

6. Contents of the pack and additional information

What is montelukast

Montelukastis 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,montelukastimproves asthma symptoms and helps control asthma.

When to use montelukast

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

•Montelukastis used for the treatment of patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.

•Montelukastis 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 the treatment of their asthma and who have demonstrated that they are unable to use inhaled corticosteroids.

•Montelukastalso helps prevent airway constriction caused by exercise in patients 2 years of age and older.

Depending on the symptoms and severity of your child's asthma, your doctor will determine how to usemontelukast.

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 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 giveMontelukast Qualigen 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 doctor or pharmacist before giving montelukast to your child.

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

• Montelukast oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your 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 doctor. Montelukast should not be used in place of other asthma medications prescribed by your doctor for your child.

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

Children and adolescents

Do not give this medication to children under 2 years 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 Qualigen

Inform your 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 doctor if your child is 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)

TakingMontelukast Qualigen with food and drinks

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

Pregnancy and breastfeeding

This subsection does not apply to montelukast 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years.

Driving and operating machinery

This subsection does not apply to montelukast 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, 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 machinery. 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 machinery.

Montelukast Qualigen contains aspartame and sodium

This medication contains 2.40 mg of aspartame in each 10 mg/g chewable tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases 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 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

•This medication must be administered to children under the supervision of an adult. For children who have problems taking a chewable tablet, an oral granule formulation is available.

•Your child should only take one chewable tablet ofmontelukastonce a day, as prescribed by your child's doctor.

•It should be taken even when your child does not have symptoms or when having an acute asthma attack.

For children aged2 to5 years:

The recommended dose is a chewable tablet of 4 mg daily at night.

If your child is takingthis medication, make sure they do not take any other medication that contains the same active ingredient, montelukast.

This medication is taken orally.

The tablets must be chewed before swallowing.

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

If your child takes moreMontelukast Qualigenthan they should

Seek help from your child's doctor immediately.

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in overdose in adults and children were abdominal pain, drowsiness, sedation, 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 giveMontelukast Qualigento your child

Try to givemontelukastas prescribed. However, if your child forgets a dose, limit yourself to resuming the usual regimen of one chewable tablet once a day.

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

If your child interrupts treatment withMontelukast Qualigen

Montelukastmay treat your child's asthma only if they continue taking it.

It is essential that your child continues to takemontelukastfor 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 chewable tablets of 4 mg, the side effects related to the administration of the drug and reported most frequently (may affect up to 1 in 10 people), were:

•abdominal pain

•thirst

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

•headache

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

Severe side effects:

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

Uncommon (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 emotional changes: excitement including aggressive or hostile behavior, depression

•seizures;

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

•increased risk of bleeding

•tremor

•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 rash (Churg-Strauss syndrome) (see section 2).

•low platelet count

•behavioral and emotional changes: hallucinations, disorientation, suicidal thoughts and actions

•lung inflammation

•severe skin reactions (erythema multiforme) that may occur without warning

•inflammation of the liver (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 rash

•fever

•elevated liver enzymes

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

•behavioral and emotional changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness

•dizziness, somnolence, 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 emotional changes: attention alteration, memory alteration, uncontrolled muscle movements

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

• red, painful lumps under the skin that more frequently appear on the acne (erythema nodosum)

• behavioral and emotional 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 about the safety of this medicine.

•Keep this medication out of the sight and reach of children.

•Do not use this medication after the expiration date that appears on the blister pack after CAD. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date is the last day of the month indicated.

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

•Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Montelukast Qualigen

•The active ingredient 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 content of the packaging

Montelukast Qualigen 4 mg: chewable tablets of 4 mg of pink color, oval, biconvex, and with the inscription "4" on one face.

It is presented in packaging of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

Last review date of this leaflet::April 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/