Orilukast

Package leaflet: Information for the user

Orilukast, 4 mg, chewable tablets
For children aged 2 to 5 years
montelukastum
Please read this leaflet carefully before giving this medicine to your child, because it
contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific child only. Do not pass it on to others. It may harm other people, even if their symptoms are similar.
• If your child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Orilukast is and what it is used for
2. Important information before using Orilukast in your child
3. How to take Orilukast
4. Possible side effects
5. How to store Orilukast
6. Contents of the pack and other information

1. What Orilukast is and what it is 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 helps relieve asthma symptoms and aids in asthma control.
When to use Orilukast
Your doctor has prescribed Orilukast for the treatment of asthma in your child to prevent asthma symptoms during the day and at night.

• Orilukast is used in the treatment of patients aged 2 to 5 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Orilukast may also be used instead of inhaled corticosteroids in patients aged 2 to 5 years who have not recently used inhaled corticosteroids for asthma treatment 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.

Your doctor will determine how to use Orilukast based on your child's symptoms and severity of asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
• Airway sensitivity, where the airways react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the lining of the airways.

Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before using Orilukast in a child

Tell the doctor if the child has or has ever had any
diseases or allergies.
When not to use Orilukast in 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
Talk to the doctor or pharmacist before giving Orilukast to a child.

• If the child's asthma symptoms worsen or breathing difficulties increase, contact the doctor immediately.
• Orilukast is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always keep a reliever medicine available for the child in case of an asthma attack.
• It is important that the child takes all anti-asthma medicines prescribed by the doctor. Orilukast should not be used as a substitute for other anti-asthma medicines prescribed for the child.
• Remember to consult the doctor if a child taking asthma medicines develops symptoms such as: flu-like symptoms, tingling or numbness in hands or feet, worsening of lung symptoms and/or rash.
• Do not give the child acetylsalicylic acid (aspirin) or anti-inflammatory medicines (so-called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma in the child.

Various neuropsychiatric events (for example, changes in behaviour and
mood, depression and suicidal tendencies) have been reported in patients of all ages
treated with montelukast (see section 4). If such symptoms occur during treatment with
montelukast, consult a doctor.
Children and adolescents
This medicine must not be used in children under 2 years of age.
Other formulations of this medicine, appropriate for the patient's age, are available for children and adolescents under 18 years of age.
Orilukast and other medicines
Tell the doctor or pharmacist about all medicines the child is currently taking, has recently taken, or plans to take, including medicines available without a prescription.
Some medicines may affect how Orilukast works, or Orilukast may affect how other medicines work.
Before starting Orilukast, tell the doctor if the child is taking any of the following medicines:

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

Orilukast with food and drink
Orilukast 4 mg chewable tablets must not be taken with food; the tablets should be taken at least 1 hour before or 2 hours after a meal.
Pregnancy and breastfeeding
This section does not apply to Orilukast 4 mg chewable tablets, as this medicine is 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 this medicine is intended for use in children aged 2 to 5 years; however, the following information refers to the active substance, montelukast.
Orilukast is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary.
Some adverse effects (such as dizziness and drowsiness) that have occurred during treatment with Orilukast may affect the ability to drive and operate machinery in some patients.
Orilukast contains aspartame
The medicine contains 0.3 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to take Orilukast

This medicine should always be given to the child as directed by the doctor or pharmacist. If in
doubt, consult the doctor or pharmacist.

• This medicine should be given to the child under the supervision of an adult.
• The child should be given only one Orilukast chewable tablet once daily as directed by the doctor.
• The medicine should be given even when the child has no symptoms or during an acute asthma attack.

For children aged 2 to 5 years
The recommended dose is one 4 mg chewable tablet once daily, taken in the evening.
If the child is taking Orilukast, ensure that they are not taking any other medicines
containing the same active substance, montelukast.
This medicine is intended for oral use.
The tablet may be chewed or swallowed. If the tablet is swallowed, it should be taken with an adequate amount
of liquid (e.g. a glass of water).
Orilukast 4 mg chewable tablets should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.
Accidental overdose of Orilukast in children
Contact the child's doctor immediately for advice.
In most reports of overdose, no adverse effects were reported. The most commonly reported symptoms of overdose in adults and children were: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.
Missed 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
Orilukast will only control asthma in the child if taken regularly.
It is important that the child takes Orilukast regularly for as long as directed by the doctor. This will help keep the child's asthma under control.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During clinical trials using montelukast in the form of chewable tablets with a strength of 4 mg, the most frequently reported adverse reactions (may occur in up to 1 in 10 people) considered to be related to montelukast use were:

• abdominal pain
• excessive thirst.

Additionally, in clinical trials using montelukast in the form of 10 mg coated tablets and 5 mg chewable tablets, the following were reported:

• headache.

These symptoms were usually mild in intensity and occurred more frequently in patients taking montelukast than in patients taking placebo (a tablet containing no active drug).

Serious adverse reactions
Contact a doctor immediately if your child experiences any of the following adverse reactions, which may be serious and require immediate medical attention.

Uncommon ( may occur in more than 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 hostile attitude, 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 group of symptoms such as flu-like symptoms, sensations of pricking, tingling or numbness in 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
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior signs of liver inflammation.

Other adverse reactions reported after marketing of the medicine
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 ):

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

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

• changes in behavior and mood: sleep disorders, including nightmares, difficulty falling asleep, sleepwalking, irritability, restlessness, motor restlessness
• dizziness, drowsiness, tingling and/or numbness
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• nocturnal enuresis in children
• weakness/fatigue, malaise, swelling.

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

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

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

• tender red nodules under the skin, most commonly appearing 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 of adverse reactions
If your child experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Orilukast

Keep this 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 stated month.
There are no special requirements regarding the storage temperature of the medicinal product.
Store in the original packaging to protect from light and moisture.
Medicines must 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 in the form of 4.16 mg of montelukast sodium.
• 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.
Tablets are packed in aluminium/aluminium blisters. These blisters are placed in cardboard boxes.
Pack sizes: 28, 56, 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Orilukast