Leukast

Package leaflet: Information for the user

LEUKAST 10 mg film-coated tablets

Montelukast
“Generic medicine”
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What LEUKAST is and what it is used for
2. What you need to know before taking LEUKAST
3. How to take LEUKAST
4. Possible side effects
5. How to store LEUKAST
6. Contents of the pack and other information

1. What LEUKAST is and what it is used for

What LEUKAST is
LEUKAST is a leukotriene receptor antagonist that blocks substances known as leukotrienes.
How LEUKAST works
Leukotrienes cause narrowing and swelling of the airways in the lungs and also trigger allergic symptoms. By blocking leukotrienes, LEUKAST improves asthma symptoms and helps control the condition, as well as improving symptoms of seasonal allergies (also known as hay fever and seasonal allergic rhinitis).
When LEUKAST should be used
Your doctor has prescribed LEUKAST for the treatment of asthma, to prevent asthma symptoms both during the day and at night.

• LEUKAST is used to treat adults and adolescents aged 15 years and older whose asthma is not adequately controlled with their current medications and who require additional therapy.
• LEUKAST also prevents exercise-induced narrowing of the airways.
• In asthmatic patients for whom LEUKAST is indicated for asthma, LEUKAST may provide relief from symptoms of seasonal allergic rhinitis. Your doctor will determine how to use LEUKAST based on your symptoms and the severity of your asthma.

What is asthma?
Asthma is a long-term condition. Asthma involves:

• Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Airway sensitivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the airways.

Asthma symptoms include: coughing, shortness of breath, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: nasal congestion, runny nose, nasal itching, sneezing, red, swollen, itchy eyes, and tearing.

2. What you should know before taking LEUKAST

Inform your doctor of any medical conditions you currently have or have had in the past, and of any allergies.

Do not take LEUKAST

• if you are allergic (hypersensitive) 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 taking LEUKAST.

• If your asthma or breathing worsens, contact your doctor immediately.
• LEUKAST for oral use must not be used to treat acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep your emergency inhaled asthma medication with you.
• It is important that you take all asthma medications prescribed by your doctor. LEUKAST must not be used instead of other asthma medications prescribed for you.
• Patients taking asthma medications should be aware that a combination of symptoms such as flu-like illness, tingling or reduced sensation in the arms or legs, worsening of lung symptoms and/or skin redness may occur; if you experience these, consult your doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Patients should be aware that various neuropsychiatric events (e.g., changes in behaviour and mood) have been reported in adults, adolescents and children treated with LEUKAST (see section 4). If you develop these symptoms while taking LEUKAST, you should consult your doctor.

Children and adolescents

Do not give this medicine to children under 15 years of age.

Different formulations of this medicine are available for paediatric patients under 15 years of age, based on age group.

Other medicines and LEUKAST

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Some medicines may interfere with the action of LEUKAST, or LEUKAST may interfere with the action of other medicines.

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

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections)
• gemfibrozil (used to lower levels of fats – lipids – in the blood, such as triglycerides).

LEUKAST with food and drink

LEUKAST 10 mg film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking LEUKAST.

Pregnancy

Your doctor will decide whether you can take LEUKAST under these circumstances.

Breastfeeding

It is not known whether LEUKAST is excreted in human milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking LEUKAST.

Driving and using machines

No effects of LEUKAST on the ability to drive or operate machinery are expected. However, individual responses to medicines may vary.

Some adverse reactions (such as dizziness and drowsiness) have been reported very rarely with LEUKAST and may affect the ability to drive or use machinery.

LEUKAST 10 mg film-coated tablets contain lactose and sodium.

If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, i.e. essentially 'sodium-free'.

3. How to take LEUKAST

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, consult your doctor or pharmacist.

• Take only one LEUKAST tablet daily as prescribed by your doctor.
• Take the tablet even if you do not have symptoms or are experiencing an acute asthma attack.

For adults and adolescents aged 15 years and above:
The recommended dose is one 10 mg tablet taken once daily in the evening.
If you are taking LEUKAST, make sure you do not take other medicines containing the same active substance, montelukast.
This medicine is for oral use.
You may take LEUKAST 10 mg with food or without food.

If you take more LEUKAST than you should
Contact your doctor immediately.
In most reported cases of overdose, no adverse effects were observed. The most commonly reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take LEUKAST
Try to take LEUKAST as prescribed. However, if you forget to take a tablet, continue taking the medicine as normally scheduled. Do not take a double dose to make up for the forgotten tablet.

If you stop taking LEUKAST
Treatment with LEUKAST is effective against asthma only if you continue taking it. It is important to keep taking LEUKAST for as long as your doctor has prescribed it. It will help you control your asthma.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with LEUKAST 10 mg film-coated tablets, the side effects considered related to LEUKAST most commonly reported (may affect up to 1 in 10 people) were:

• abdominal pain
• headache

These side effects were usually mild and occurred more frequently in patients treated with LEUKAST than in those treated with placebo (a tablet containing no active substance).

Serious side effects
Talk to your doctor immediately if you notice any of the following side effects, which may be serious and for which you may need urgent medical treatment.

Uncommon: may affect up to 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 affect up to 1 in 1,000 people

• increased tendency to bleeding
• tremor
• palpitations

Very rare: may affect up to 1 in 10,000 people

• a group of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count in the blood
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) which may occur without warning
• inflammation of the liver (hepatitis)

Other side effects during commercial use of the medicine

Very common: may affect more than 1 in 10 people

• upper respiratory tract infection

Common: may affect up to 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• elevated liver enzymes

Uncommon: may affect up to 1 in 100 people

• changes in behaviour and mood: dream abnormalities, including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, digestive disturbances
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• involuntary loss of urine during sleep in children
• weakness/tiredness, malaise, swelling

Rare: may affect up to 1 in 1,000 people

• changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

Very rare: may affect up to 1 in 10,000 people

• painful red swellings under the skin, usually located on the front of the legs (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LEUKAST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after the word "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LEUKAST contains

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate. Tablet coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Description of the appearance of LEUKAST and contents of the pack
Box of 28 tablets: 4 blisters containing 7 tablets each.
Marketing Authorization Holder
Konpharma S.r.l. - Via Pietro della Valle 1 - 00193 Rome, Italy
Manufacturer
Adamed Pharma S.A., ul. Marszałka J. Piłsudskiego 59, 95-200 Pabianice, Poland