Orilukast

Package Leaflet: Information for the User

Orilukast, 4 mg, Chewable Tablets

For children from 2 to 5 years old
montelukast

Read the package leaflet carefully before giving this medicine to a child, as it contains important information for the patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific child. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the child experiences any side effects, including any not listed in this leaflet, tell the doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Orilukast and what is it used for
• 2. Important information before giving Orilukast to a child
• 3. How to give Orilukast
• 4. Possible side effects
• 5. How to store Orilukast
• 6. Contents of the pack and other information

1. What is Orilukast and what is it used for

What is Orilukast

Orilukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Orilukast works

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Orilukast relieves asthma symptoms and helps control the condition.

When to use Orilukast

The doctor has prescribed Orilukast to treat asthma in the child, to prevent asthma symptoms from occurring during the day and at night.

• Orilukast is used to treat patients aged 2 to 5 years who have not achieved adequate asthma control with their current medications and require additional treatment.
• Orilukast may also be used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently used inhaled corticosteroids to treat asthma and in patients who are unable to use inhaled corticosteroids.
• Orilukast also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

The doctor will determine how to give Orilukast based on the child's symptoms and the severity of their asthma.

What is asthma?

Asthma is a chronic disease.
In asthma, there are:

• breathing difficulties due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various conditions.
• airway hypersensitivity, which reacts to many factors, such as cigarette smoke, plant pollen, cold air, or physical exertion.
• swelling (inflammation) of the lining of the airways.

Asthma symptoms include: coughing, wheezing, and a feeling of tightness in the chest.

2. Important information before giving Orilukast to a child

Tell the doctor if the child has or has had any diseases or allergies.

When not to give Orilukast to a child

• if the child is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before giving Orilukast to a child, discuss this with the doctor or pharmacist.

• If the child's asthma symptoms worsen or have difficulty breathing, tell the doctor immediately.
• Orilukast is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always have a rescue medication available for the child in case of an asthma attack.
• It is essential that the child takes all asthma medications prescribed by the doctor. Do not give Orilukast instead of other asthma medications prescribed by the doctor for the child.
• Remember to consult the doctor if the child taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms, and/or rash.
• Do not give the child aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen the child's asthma.

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If the patient experiences such symptoms while taking montelukast, consult a doctor.

Consult a doctor if the patient experiences such symptoms while taking montelukast.

Children and adolescents

Do not give this medicine to children under 2 years of age.
For children and adolescents under 18 years of age, other forms of this medicine are available, suitable for the patient's age.

Orilukast and other medicines

Tell the doctor or pharmacist about all medicines the child is taking or has recently taken, including those obtained without a prescription.
Some medicines may affect how Orilukast works or Orilukast may affect how other medicines work.
Before giving Orilukast, tell the doctor if the child is taking:

• phenobarbital (used to treat epilepsy);
• phenytoin (used to treat epilepsy);
• rifampicin (used to treat tuberculosis and some other infections).

Orilukast with food and drink

Do not give Orilukast 4 mg chewable tablets with food;
give the tablets at least 1 hour before a meal or 2 hours after a meal.

Pregnancy and breastfeeding

This section does not apply to Orilukast 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Orilukast 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years; however, the following information applies to the active substance, montelukast.
It is unlikely that Orilukast will affect the ability to drive or use machines. However, the reaction to the medicine may vary among individual patients.
Some side effects (such as dizziness and drowsiness) that occurred during Orilukast treatment may affect the ability to drive or use machines in some patients.

Orilukast contains aspartame

The medicine contains 0.3 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.
Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to give Orilukast

Always give this medicine to a child as directed by the doctor or pharmacist. If you are unsure, ask the doctor or pharmacist.

• Give this medicine to the child under adult supervision.
• Give the child only one Orilukast chewable tablet once daily as directed by the doctor.
• Give the medicine even if the child has no symptoms or if an acute asthma attack occurs.

For children from 2 to 5 years old

The recommended dose is one 4 mg chewable tablet per day, in the evening.
If the child is taking Orilukast, ensure they do not take any other medicines containing the same active substance, montelukast.
This medicine is for oral use only.
The tablet can be chewed or swallowed. If the tablet is to be swallowed, it should be taken with a sufficient amount of liquid (e.g., a glass of water).
Do not give Orilukast 4 mg chewable tablets with food; give the medicine at least 1 hour before a meal or 2 hours after a meal.

Using more Orilukast than recommended in a child

Immediately contact the child's doctor for advice.
In most reports of overdose, no side effects were reported. The most commonly reported symptoms of overdose in adults and children were: stomach pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a dose of Orilukast

Try to give Orilukast as directed by the doctor. However, if the child misses a dose, simply return to the usual dosing schedule - one chewable tablet once daily.
Do not give a double dose to make up for a missed dose.

Stopping Orilukast treatment

Orilukast will only treat the child's asthma if it is taken regularly.
It is essential that the child takes Orilukast regularly for as long as the doctor recommends. This will help keep the child's asthma under control.
If you have any further questions about this medicine, ask the doctor or pharmacist.

4. Possible side effects

Like all medicines, Orilukast can cause side effects, although not everybody gets them.
During clinical trials with montelukast 4 mg chewable tablets, the most commonly reported side effects (may affect up to 1 in 10 people)considered related to montelukast were:

• stomach pain
• excessive thirst.

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

• headache.

These symptoms were usually mild and occurred more frequently in patients taking montelukast than in patients taking a placebo (a tablet that does not contain any medicine).

Severe side effects

Immediately contact the doctorif the child experiences any of the following severe side effects, which may require immediate medical attention.
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 in behavior and mood: agitation, including aggressive behavior or hostility, depression
• seizures.

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

• increased tendency to bleed
• tremors
• heart palpitations.

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

• a syndrome of symptoms such as flu-like symptoms, tingling or numbness in the hands and feet, worsening respiratory symptoms, and/or rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and attempts
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior warning, inflammation of the liver.

Other side effects reported after the medicine was marketed

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
• rash
• fever
• increased liver enzyme activity.

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

• changes in behavior and mood: sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, restlessness, hyperactivity
• dizziness, drowsiness, tingling, and/or numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting in children
• weakness/fatigue, malaise, swelling.

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

• changes in behavior and mood: attention disturbances, memory disturbances, uncontrolled muscle movements.

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

• tender red lumps under the skin, most often on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without warning
• changes in behavior and mood: obsessive-compulsive symptoms, stuttering.

Reporting side effects

If the child experiences any side effects, including any not listed in this leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Orilukast

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicinal product.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Orilukast contains

• The active substance is montelukast. Each chewable tablet contains 4 mg of montelukast as 4.16 mg of montelukast sodium.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, aspartame (E951), iron oxide red (E172), mannitol (E421), cherry flavor.

What Orilukast looks like and contents of the pack

Orilukast 4 mg chewable tablets are pink, oval, biconvex, uncoated tablets with a score line on both sides. The tablet can be divided into equal doses.
The tablets are packaged in aluminum/aluminum blisters. The blisters are packaged in cardboard boxes.
Package sizes: 28, 56, 98 tablets.
Not all package sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Orilukast
Date of last revision of the leaflet: 26.02.2024