Package Insert: Information for the User

Montelukast Alter 5 mg

Chewable Tablets EFG

What isMontelukast Alter

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

How it worksMontelukast Alter

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

When to useMontelukast Alter

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 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 Alter

•if you or your child areallergic to montelukast or to any of the other components ofthis 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.

•Montelukastoralis 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 the asthma medications prescribed by your doctor.Montelukastshould not be used in place of other asthma medications prescribed by your doctor for you or your child.

•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 Alter

Inform your doctor or pharmacist if you or your child are taking or have recently taken, or may need to take any other medication, including those obtained 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 Alterwith food and beverages

Montelukast5 mgchewable tablets should not be taken with meals; they 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, or plan to become 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 plan 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) that have been reported rarely withmontelukastmay affect the patient's ability to drive or operate machinery.

Montelukast Alter5 mgchewable tablets contain aspartame and sodium

This medication contains 3.0 mg of aspartame in each 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 23 mg of sodium (1mmol) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as 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 you or your child do not have symptoms or when they have an acute asthma attack.

For children aged6 to14 years:

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

If you or your child are takingmontelukast, make sure neither you nor your child 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 withmeals; it should be taken at least 1 hour before or 2 hours after eating.

If you or your child take moreMontelukast Alterthan they should

Seek help from your doctor immediately.

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, thirst, 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 Alteror forgot to giveMontelukast Alterto 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 Alter

Montelukastmay only treat your asthma or your child's asthma if you or your child continue to take 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 medicine can cause side effects, although not everyone will experience them.

In clinical trials conducted with montelukast 5 mg chewable tablets, the side effects related to the administration of the drug and reported most frequently (may affect up to 1 in 10 people), were:

•headache

Additionally, 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 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 mood changes: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of bleeding
• tremors
• 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 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 mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, 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 disturbances, memory disturbances, involuntary 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 face (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 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 5 mg:

•The active ingredient is: montelukast.Eachtablet contains montelukast sodium equivalent to 5 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 content of the packaging

The chewable tablets of 5 mg are pink, round, biconvexand with the inscription “5” on one face.

Sit is presented in packaging of 28 tablets.

Holder of the marketing authorization

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

Revision date of this leaflet:April 2024

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