Leaflet: information for the user

Montelukast Qualigen 5 mg chewable tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed only 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 or your child experience 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 starting to takeMontelukast 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 asthma and prevent asthma symptoms during the day and night.

•Montelukastis used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their medication and require additional treatment.

•Montelukastis 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 have demonstrated that they are unable to use inhaled corticosteroids.

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

Do not takeMontelukast Qualigenif you or your child

•are 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 you or your child start taking montelukast.

•If your asthma or breathing or 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 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 asthma medications prescribed by your doctor. Montelukast should not be used in place of other asthma medications prescribed 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 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.

Children and adolescents

Do not give this medication to children under 6 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 you or your child are taking, have taken recently, or may need to take any other medications, including those purchased without a prescription.

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

Before takingmontelukast, 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)

TakingMontelukast Qualigenwith food and beverages

Montelukast5 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 lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can takemontelukastduring this period.

Lactation

The presence ofmontelukastin breast milk is unknown. If you are breastfeeding or intend to breastfeed, you should consult your doctor before takingmontelukast.

Driving and operating machinery

Montelukastis 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) reported withmontelukastmay affect the patient's ability to drive or operate machinery.

Montelukast Qualigencontainsaspartame and sodium

This medication contains 3.00 mg of aspartame in each 10 mg/g 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 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

•You or your child should only take one chewable tablet ofmontelukastonce a day, as prescribed by your doctor.

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

For children aged 6 to 14 years:

The recommended dose is one chewable tablet of 5 mg daily at night.

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

This medication is taken orally.

The tablets should be chewed before swallowing.

Montelukast 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 take moreMontelukast Qualigenthan they should

Seek immediate help from your doctor.

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, 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 takeMontelukast Qualigenor give Montelukast Qualigen to your child

Try to takemontelukastas prescribed. However, if you or your child forget a dose, limit yourself to resuming the usual regimen of one chewable tablet once a day.

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

If you or your child interrupt treatment withMontelukast Qualigen

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

It is essential to continue takingmontelukastfor the time your doctor prescribes it. It will help control your asthma or your child's asthma.

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

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

In clinical trials conducted withchewable tablets of 5 mg, the side effects related to the administration of the drug and reported most frequently (may affect up to 1 in 10 people), 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 tablets than with placebo (a tablet that does not contain a medicine).

Severe side effects:

Consult your doctor immediatelyif you observe any of the following side effects, which may be severe and you or your child may need 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 mood 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 mood 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 medicine

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

• upper respiratory tract infection

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

• diarrhea
• skin rash
• fever
• elevated liver enzymes

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

• behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nasal bleeding
• dry mouth, urticaria
• muscle or joint pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, malaise, swelling

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

• behavioral and mood changes: attention disturbance, memory disturbance, uncontrolled muscle movements

Very rare

• red, painful lumps under the skin that more frequently appear on the skin (erythema nodosum)
• behavioral and mood changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you or your child 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 for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofMontelukast Qualigen

•The active ingredient is: montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.

•The other components are: mannitol (E 421), microcrystalline cellulose (E 460i), hydroxypropyl cellulose (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 packaging

Montelukast Qualigen 5 mg: chewable tablets of 5 mg, pink in color, round, biconvex, and with the inscription "5" on one face.

It is presented in packs 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 for Medicines and Medical Devices (AEMPS)http://www.aemps.es/