Patient Information Leaflet: Package Insert

Montelukast Alter 4 mg

Orally Disintegrating Tablets EFG

What is Montelukast Alter

Montelukastis a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How Montelukast Alter works

Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes,montelukast4 mg improves asthma symptoms and helps control asthma.

When to use Montelukast Alter

Your doctor has prescribedmontelukast4 mg to 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 symptoms and the 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 diseases.

•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 Alterto 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 4 mg to your child.

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

•Montelukast oralis 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 for asthma attacks available.

•It is essential that your child uses all medications for asthma prescribed by their doctor. Montelukastshould not be used in place of other asthma medications prescribed by your child's doctor.

•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 other 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 Monteluakst Alter

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 4 mg, or montelukast 4 mg 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)

Montelukast Alter4 mgwith food and beverages

Montelukast 4 mgchewable 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 is not applicable tomontelukast4 mg chewable tablets since its use is indicated in children between 2 and 5 years of age.

Driving and operating machinery

This subsection is not applicable to montelukast 4 mg chewable tablets, as its use is indicated in children between 2 and 5 years of age, however, the following information is important for the active ingredient, montelukast.

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 drowsiness) that have been reported with montelukastmay affect the patient's ability to drive or operate machinery.

Montelukast Alter4 mgchewable tablets contain aspartame and sodium

Each tablet contains 2.40 mg of aspartame.

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.

Each tablet contains less than 23 mg of sodium (1mmol), which is essentially "sodium-free".

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

•This medication 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 only take one chewable montelukast tablet once a day, as prescribed by their doctor.

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

For children aged 2 to 5 years:

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

If your child is taking montelukast, ensure they do not take any other medication containing the same active ingredient, montelukast.

This medication is taken orally.

The tablets should 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 more Montelukast Alter 4 than they should:

Seek immediate help from your child's doctor.

In most cases of overdose, no adverse effects were reported. The symptoms that occurred 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 ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to give Montelukast Alter to your child:

Try to give montelukast 4 mg as prescribed. However, if your child forgets a dose, limit yourself to resuming the usual daily intake of one tablet.

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

If your child interrupts treatment with Montelukast Alter:

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

It is essential that your child continues taking montelukast for the time their doctor prescribes. It will help control your child's asthma.

If you have any other doubts about the use of this product, 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 withmontelukast 4 mgchewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people), were:

•abdominal pain

•sedation

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 tablet that does not contain a medicine).

Severe side effects

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

Not common (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

• convulsions

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

Not common (may affect up to 1 in 100 people):

• behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nasal bleeding
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle 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 (may affect up to 1 in 10,000 people):

• red, painful bumps under the skin that more frequently appear on the face (erythema nodosum)
• behavioral and mood 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 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 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 packaging and medications you no longer need at the SIGRE collection point (or any other medication waste collection system) 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 of Montelukast Alter :

•The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.

•The other components are: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, iron oxide red (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951), and magnesium stearate.

Appearance of the product and contents of the packaging

The 4 mg chewable tablets are pink, oval, biconvex, and have the inscription “4” on one face.

They are presented in packs of 28 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A

C/ Mateo Inurria, 30

28036 Madrid-Spain

Responsible for Manufacturing

LaboratoriosNeuraxpharm Pharmaceuticals, S.L..

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

This leaflet has been approved in:March 2025

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