Orilukast

Package Leaflet: Information for the User

Orilukast, 5 mg, Chewable Tablets

For children from 6 to 14 years old
montelukast

Read the package leaflet carefully before the patient takes this medicine, as it contains important information for the patient or the patient's child.

• Keep this 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 patient or child. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient or the patient's child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Orilukast and what is it used for
• 2. Important information before taking Orilukast
• 3. How to take 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 it.

When to use Orilukast

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

• Orilukast is used to treat children from 6 to 14 years old who have not achieved adequate asthma control with their current medications and need additional treatment.
• Orilukast may also be used instead of inhaled corticosteroids in patients from 6 to 14 years old who have not recently used inhaled corticosteroids to treat asthma and in patients who are unable to use inhaled corticosteroids.
• Orilukast also helps prevent narrowing of the airways caused by physical exertion.

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

What is asthma?

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

• breathing difficulties caused by 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 pressure in the chest.

2. Important information before taking Orilukast

Tell your doctor if the patient or the patient's child has or has had any diseases or allergies.

When not to take Orilukast

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

Warnings and precautions

Before starting to take Orilukast, discuss it with your doctor or pharmacist.

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

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

While taking montelukast, consult a doctor if such symptoms occur.

Children and adolescents

Do not give this medicine to children under 6 years old.
For children and adolescents under 18 years old, other forms of this medicine are available, suitable for the patient's age.

Orilukast and other medicines

Tell your doctor or pharmacist about all medicines the patient or the patient's 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 taking Orilukast, tell your doctor if the patient 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 take Orilukast 5 mg chewable tablets with food; take the tablets at least 1 hour before a meal or 2 hours after a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The doctor will assess whether the patient can take Orilukast during this period.
Breastfeeding
It is not known whether Orilukast passes into breast milk. If a woman is breastfeeding or plans to breastfeed, she should consult her doctor before taking Orilukast.

Driving and using machines

Do not expect Orilukast to affect the ability to drive or use machines. However, the reaction to the medicine may vary from patient to patient.
Some side effects (such as dizziness and drowsiness), which occurred during the use of Orilukast, may affect the ability to drive or use machines in some patients.

Orilukast contains aspartame

The medicine contains 0.375 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 take Orilukast

Always take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• The patient should take only one Orilukast chewable tablet once a day as recommended by the doctor.
• Take the medicine even if the patient does not have any symptoms or if an acute asthma attack occurs.

For children from 6 to 14 years old:

The recommended dose is one 5 mg chewable tablet per day, in the evening.
If the patient or the patient's child is taking Orilukast, make sure they do not take any other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
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 take Orilukast 5 mg chewable tablets with food; take the medicine at least 1 hour before a meal or 2 hours after a meal.

Using a higher dose of Orilukast than recommended

Immediately contact the 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: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and excessive restlessness.

Missing a dose of Orilukast

Try to take Orilukast as recommended by the doctor. However, if a dose is missed, simply return to the usual dosing schedule, one chewable tablet once a day.
Do not take a double dose to make up for a missed dose.

Stopping Orilukast treatment

Orilukast can only treat the patient's asthma if taken regularly.
It is essential to take Orilukast regularly for as long as the doctor recommends. This will help keep the patient's asthma under control.
If you have any further questions about the use of this medicine, ask your 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 5 mg chewable tablets, the most commonly reported side effects (which may occur in up to 1 in 10 people), considered to be related to montelukast, were:

• headache.

Additionally, in clinical trials with montelukast 10 mg film-coated tablets, the following were reported:

• abdominal pain.

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 a doctor if any of the following severe side effects occur, which may require immediate medical attention.
Uncommon (may occur in 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 occur in up to 1 in 1,000 people)

• increased tendency to bleed
• tremor
• palpitations.

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

• a syndrome of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening of lung 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 warning, liver inflammation.

Other side effects reported after the medicine was marketed

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

• upper respiratory tract infection.

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

• diarrhea, nausea, vomiting
• rash
• fever
• increased liver enzyme activity.

Uncommon (may occur in 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 occur in up to 1 in 1,000 people):

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

Very rare (may occur in 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 patient or the patient's child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, 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 5 mg of montelukast in the form of 5.2 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, 5 mg, chewable tablets are pink, round, uncoated tablets with a dividing 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:

Finland: Montelukast Orion
Poland: Orilukast
Date of last revision of the leaflet: 26.02.2024