ORILUKAST

Package leaflet: Information for the user

Orilukast, 5 mg, chewable tablets
For children aged 6 to 14 years
montelukastum
Please read this leaflet carefully before the patient uses this medicine,
as it contains important information for the patient or the patient's child.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific patient or child. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient or the patient's child experiences any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Orilukast is and what it is 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 Orilukast is and what it is used for

What Orilukast is
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 disease.
When to take Orilukast
Your doctor has prescribed Orilukast for the treatment of asthma in the patient to prevent daytime and nighttime asthma symptoms.

• Orilukast is used in the treatment of children aged 6 to 14 years whose asthma is not adequately controlled with currently used medications and who require additional therapy.
• Orilukast may also be used instead of inhaled corticosteroids in patients aged 6 to 14 years who have not recently used inhaled corticosteroids for asthma treatment, or in patients who are unable to use inhaled corticosteroids.
• Orilukast also helps prevent exercise-induced narrowing of the airways.

Your doctor will determine how to use Orilukast based on the patient'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 worsens and improves in response to various triggers.
• Airway sensitivity, where 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 taking Orilukast

Tell your doctor if you or your child have ever had any medical conditions or allergies.

When not to take Orilukast

• Do not take Orilukast if you or your child are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Orilukast.

• If your asthma symptoms worsen or you experience breathing difficulties, contact your doctor immediately.
• Orilukast is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always keep a reliever medicine available for immediate use during an asthma attack.
• It is important that you continue taking all anti-asthma medicines prescribed by your doctor. Do not replace other anti-asthma medicines prescribed by your doctor with Orilukast.
• Consult your doctor if you or your child experience any of the following symptoms while taking anti-asthma medicines: flu-like symptoms, tingling or numbness in the hands or feet, worsening of lung symptoms and/or skin rash.
• Do not give acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (NSAIDs) to the patient if they worsen asthma symptoms.

Various neuropsychiatric events (such as behavioral and mood changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur while taking montelukast, consult your doctor.

Children and adolescents

Orilukast must not be used in children under 6 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 your doctor or pharmacist if you or your child are currently taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect how Orilukast works, or Orilukast may affect how other medicines work.

Tell your doctor if you are taking any of the following medicines before starting Orilukast:

• 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 5 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

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor or pharmacist before taking this medicine.

Pregnancy

Your doctor will decide whether you can take Orilukast during pregnancy.

Breastfeeding

It is not known whether Orilukast passes into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Orilukast.

Driving and using machines

Orilukast is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some side effects (such as dizziness and drowsiness) reported during treatment with Orilukast may affect the ability to drive or operate machinery in some patients.

Orilukast contains aspartame

This medicine contains 0.375 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 impaired excretion.

Other excipients

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Orilukast

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.

• The patient should be given only one Orilukast chewable tablet once daily, as directed by the doctor.
• The medicine should be taken even when the patient has no symptoms or during an acute asthma attack.

For children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet once daily in the evening.
If the patient or the patient's 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 swallowed, it should be taken with an adequate amount
of liquid (e.g. a glass of water).
Orilukast 5 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.

Overdose of Orilukast
Contact the 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 take Orilukast exactly as directed by the doctor. However, if a dose is missed, simply return to
the usual dosing schedule—one chewable tablet once daily.
Do not take a double dose to make up for the missed dose.

Stopping Orilukast
Orilukast can control the patient's asthma only if taken regularly.
It is important that the patient takes Orilukast regularly for as long as directed by the doctor. This will
help keep the patient'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 5 mg, the most frequently reported adverse reactions ( may occur in up to 1 in 10 people ), considered to be related to the use of montelukast, were:

• headache.

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

• abdominal pain.

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 your doctor immediately if any of the following adverse reactions occur, as they may be serious and the patient may 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 in breathing or swallowing
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures.

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

• increased tendency to bleeding
• tremor
• palpitations.

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

• a group of symptoms such as flu-like symptoms, sensation of pricking and tingling or numbness of hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour 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 behaviour and mood: sleep disorders, including nightmares, difficulty sleeping, sleepwalking, irritability, restlessness, motor restlessness
• dizziness, drowsiness, tingling and (or) numbness
• nosebleeds
• dryness of the mouth, dyspepsia
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• nocturnal enuresis in children
• weakness/fatigue, malaise, oedema.

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

• changes in behaviour and mood: attention disorders, memory disorders, 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 (nodular erythema), severe skin reactions (erythema multiforme), which may occur without warning
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of adverse reactions
If any adverse reactions occur in the patient or child, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of 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 authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 pack. 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 5 mg of montelukast as 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 flavour.

What Orilukast looks like and contents of the pack
Orilukast 5 mg chewable tablets are pink, round, uncoated tablets with a score line on both sides.
The tablet can be divided into equal doses.
The tablets are packed in aluminium/aluminium blisters. These blisters are packed into 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 about 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:
Finland: Montelukast Orion
Poland: Orilukast