Orilukast

Package Leaflet: Information for the User

Orilukast, 10 mg, Tablets

For adults and adolescents 15 years of age and older
montelukast

Read the package leaflet carefully before taking this medicine, as it contains important information for you.

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please 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, which blocks substances called leukotrienes.

How Orilukast works

Leukotrienes cause the airways in the lungs to narrow and swell, and cause allergy symptoms. By blocking leukotrienes, Orilukast relieves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to use Orilukast

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

• Orilukast is used to treat adults and adolescents 15 years of age and older who have not achieved adequate control of asthma with their current medications and need additional treatment.
• Orilukast also helps prevent narrowing of the airways caused by physical exertion.
• In patients with bronchial asthma, Orilukast used to treat asthma may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Orilukast based on your symptoms and the severity of your asthma.

What is asthma?

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

• breathing difficulties caused by narrowing of the airways. The narrowing of the airways worsens and improves in response to various conditions.
• airway hypersensitivity, which reacts 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 a feeling of tightness in the chest.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic reaction often caused by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose, and itchy nose; sneezing; tearing, swelling, redness, and itching of the eyes.

2. Important information before taking Orilukast

Tell your doctor if you have or have had any diseases or allergies.

When not to use Orilukast

Warnings and precautions

Discuss with your doctor or pharmacist before starting to take Orilukast.

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

During treatment with montelukast, if you experience such symptoms, consult your doctor.

Children and adolescents

This medicine must not be used in children under 15 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 your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those obtained without a prescription.
Some medicines may affect the way Orilukast works or Orilukast may affect the way other medicines work.
Before taking Orilukast, tell your doctor if you are taking any of the following medicines:

• phenobarbital (used to treat epilepsy);
• phenytoin (used to treat epilepsy);
• rifampicin (used to treat tuberculosis and some other infections);
• gemfibrozil (used to treat high lipid levels in the blood).

Orilukast with food and drink

Orilukast can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will assess whether you can take Orilukast during this period.
Breastfeeding
It is not known whether Orilukast passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Orilukast.

Driving and using machines

Orilukast is not expected to affect your ability to drive or use machines. However, individual reactions to the medicine may vary.
Some side effects (such as dizziness and drowsiness), which occurred during treatment with Orilukast, may affect the ability to drive or use machines in some patients.

Orilukast contains aspartame

The medicine contains 0.75 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 your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Take only one Orilukast tablet once daily as directed by your doctor.
• Take the medicine even when you do not have any asthma symptoms or when you have an acute asthma attack.

Adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet once daily, in the evening.
If you are taking Orilukast, make sure you do not take any other medicines containing the same active substance, montelukast.
This medicine is for oral use.
Orilukast 10 mg can be taken with or without food.

What to do if you take more Orilukast than you should

Contact your doctor immediately to get 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.

What to do if you forget to take Orilukast

Try to take Orilukast as directed by your doctor. However, if you miss a dose, return to your normal dosing schedule - one tablet once daily.
Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Orilukast

Orilukast can only treat your asthma if you take it regularly.
It is important that you take Orilukast regularly for as long as your doctor recommends. This will help keep your 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 10 mg film-coated tablets, the most commonly reported side effects (which may occur in less than 1 in 10 people)considered to be related to montelukast were:

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

Severe side effects

Seek medical help immediatelyif you experience any of the following side effects, which may be severe and require immediate medical attention.
Uncommon (which may occur in less 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 hostility, depression
• seizures.

Rare (which may occur in less than 1 in 1,000 people)

• increased tendency to bleed
• tremor
• palpitations.

Very rare (which may occur in less than 1 in 10,000 people)

• a syndrome of symptoms such as flu-like symptoms, tingling or numbness in the hands and feet, worsening of 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 symptoms
• hepatitis.

Other side effects reported after the medicine was marketed

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

• upper respiratory tract infection

Common (which may occur in less than 1 in 10 people):

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

Uncommon (which may occur in less than 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/tiredness, malaise, swelling.

Rare (which may occur in less than 1 in 1,000 people):

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

Very rare (which may occur in less than 1 in 10,000 people):

• tender red lumps under the skin, most often on the shins (erythema nodosum)
• changes in behavior and mood: obsessive-compulsive symptoms, stuttering.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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 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 month.
There are no special storage precautions 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. These measures will help protect the environment.

6. Contents of the pack 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 carmellose, magnesium stearate, aspartame (E 951), cherry flavor, 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 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.
Pack sizes: 28, 56, 98 tablets.
Not all pack 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