Orilukast

Package leaflet: Information for the user

Orilukast, 10 mg, tablets
For adults and adolescents aged 15 years and older
montelukastum
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

• 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 individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Orilukast is and what it is used for
2. What you need to know 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 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, as well as allergy symptoms. By blocking leukotrienes, Orilukast relieves asthma symptoms, helps control asthma, and alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When to use Orilukast
Your doctor has prescribed Orilukast for the treatment of asthma to prevent daytime and nighttime asthma symptoms.

• Orilukast is used in the treatment of asthma in adults and adolescents aged 15 years and older who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Orilukast also helps prevent exercise-induced narrowing of the airways.
• In patients with asthma, Orilukast used for asthma treatment may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Orilukast based on your symptoms and severity of asthma.
What is asthma?
Asthma is a chronic disease.
In asthma:

• Breathing difficulties occur due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• The airways are hypersensitive and react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• There is swelling (inflammation) of the mucous lining of the airways.

Asthma symptoms include coughing, wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions commonly triggered by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include nasal congestion, runny nose, and itchy nose; sneezing; and watery, swollen, red, and itchy eyes.

2. Important information before using Orilukast

Tell your doctor if the patient has or has ever had any
diseases or allergies.
When not to use Orilukast

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Orilukast.

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

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 your doctor.
Children and adolescents
This medicine must not be used in children under 15 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
Some medicines may affect the way Orilukast works, or Orilukast may affect the action of other medicines.
Before starting Orilukast, tell your doctor if the patient 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);
• gemfibrozil (used to treat high plasma lipid levels).

Orilukast with food and drink
Orilukast may be taken with or without food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Your 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 intends to breastfeed, she should consult her doctor before using Orilukast.
Driving and operating machinery
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 or operate machinery in some patients.
Orilukast contains aspartame
The medicine contains 0.75 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, meaning the medicine is considered "sodium-free".

3. How to take Orilukast

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.

• Take only one Orilukast tablet once daily as directed by your doctor.
• The medicine should be taken even when the patient does not have any asthma symptoms or when an acute asthma attack occurs.

Adults and adolescents aged 15 years and above:
The recommended dose is one 10 mg tablet once daily in the evening.
If the patient is taking Orilukast, they should ensure they are not taking any other medicines
containing the same active substance, montelukast.
This medicine is for oral administration.
Orilukast 10 mg may be taken with or without food.

Taking more Orilukast than prescribed
Contact your 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.

If you forget to take Orilukast
Try to take Orilukast as prescribed by your doctor. However, if a dose is missed, return to the usual dosing schedule – one tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping Orilukast
Orilukast will only control asthma if taken regularly. It is important that the patient takes Orilukast regularly for as long as prescribed by the doctor. This will help keep the patient's asthma under control.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
During clinical studies with montelukast in 10 mg coated tablets, the most commonly reported adverse effects
(may occur in less than 1 in 10 people) considered to be related to montelukast treatment were:

• abdominal pain
• 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 medicine).

Serious adverse effects
Contact a doctor immediately if any of the following adverse effects occur, as they may be serious and the patient may require immediate medical attention.
Not very common ( 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 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 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 suicide attempts
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• hepatitis (inflammation of the liver).

Other adverse effects 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.

Not very common ( may occur in up to 1 in 100 people ):

• changes in behaviour 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 (hives)
• 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 behaviour 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)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Orilukast

Keep this medicine out of 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 package and other information

What Orilukast contains

• The active substance is montelukast. Each tablet contains 10 mg of montelukast in the form of 10.4 mg of montelukast sodium.
• The other ingredients are: mannitol (E 421), microcrystalline cellulose, sodium croscarmellose, magnesium stearate, aspartame (E 951), cherry flavour, yellow iron oxide (E 172), red iron oxide (E 172).

What Orilukast looks like and contents of the pack
Orilukast 10 mg tablets are light brown, round, biconvex, 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 European Economic Area countries under the following names:
Finland: Montelukast Orion
Poland: Orilukast