MONTELUKAST LEK-AM

Package leaflet: Information for the patient

Montelukast LEK-AM, 5 mg, chewable tablets
Montelukastum

Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Montelukast LEK-AM is and what it is used for
2. Important information before taking Montelukast LEK-AM
3. How to take Montelukast LEK-AM
4. Possible side effects
5. How to store Montelukast LEK-AM
6. Contents of the pack and other information

1. What Montelukast LEK-AM is and what it is used for

What Montelukast LEK-AM is
Montelukast LEK-AM is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes.
How Montelukast LEK-AM works
Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Montelukast LEK-AM relieves asthma symptoms and helps control asthma.
When to use Montelukast LEK-AM
Your doctor has prescribed Montelukast LEK-AM for the treatment of asthma to prevent daytime and nighttime asthma symptoms.

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

Your doctor will determine how to use Montelukast LEK-AM based on the 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 hyperresponsiveness, in which the airways react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion;
• Swelling (inflammation) of the mucous lining of the airways. Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before using Montelukast LEK-AM

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

When not to use Montelukast LEK-AM:

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

Warnings and precautions
Before starting Montelukast LEK-AM, discuss this with your doctor or
pharmacist.

• If your asthma symptoms worsen or you have difficulty breathing, contact your doctor immediately.
• Montelukast LEK-AM tablets for oral use are not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always keep a rescue inhaler available for immediate use in case of an asthma attack.
• It is important that you continue taking all asthma medications prescribed by your doctor. Do not replace other asthma medications prescribed by your doctor with Montelukast LEK-AM.
• Be aware that if you are taking asthma medications and experience symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms, and/or rash, you should contact your doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma symptoms.

Various neuropsychiatric events (e.g., behavioral changes and mood disturbances,
depression, and suicidal tendencies) have been reported in patients of all ages
treated with montelukast (see section 4). If such symptoms occur while taking
montelukast, contact your doctor.
Children and adolescents
Do not use this medicine in children under 6 years of age.
For children and adolescents under 18 years of age, other formulations and doses of this medicine
are available, adjusted to the patient's age.

Montelukast LEK-AM and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken,
as well as any medicines you plan to take, including over-the-counter medicines.
Some medicines may affect the action of Montelukast LEK-AM, or Montelukast LEK-AM may
affect the action of other medicines you are taking.
Before starting Montelukast LEK-AM, inform your doctor if you are taking any of the following
medicines:

• phenobarbital (used in the treatment of epilepsy),
• phenytoin (used in the treatment of epilepsy),
• rifampicin (used in the treatment of tuberculosis and certain other infections).

Montelukast LEK-AM with food and drink
Montelukast LEK-AM 5 mg chewable tablets should not be taken during meals; the medicine should be taken at least one hour before or two hours after a meal.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a
baby, consult your doctor before using this medicine.

Pregnancy
Your doctor will assess whether you can take Montelukast LEK-AM during this period.

Breastfeeding
It is not known whether montelukast passes into human milk. If you are breastfeeding or intend
to breastfeed, you should consult your doctor before using Montelukast LEK-AM.

Driving and operating machinery
Montelukast LEK-AM is not expected to affect your ability to drive or operate machinery.
However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported during treatment with montelukast may affect your ability to drive or operate machinery.
If you experience any of these symptoms, do not drive or operate machinery.

Montelukast LEK-AM contains aspartame, sodium, and mannitol
Montelukast LEK-AM 5 mg chewable tablets contain 1.05 mg of aspartame per 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 impaired excretion.

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

Montelukast LEK-AM chewable tablets also contain mannitol. The medicine may have a mild laxative effect.

3. How to use Montelukast LEK-AM

This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.

• Take only one Montelukast LEK-AM 5 mg tablet once daily, as directed by your doctor.
• This medicine should be taken even when the patient does not have asthma symptoms, and also during an acute asthma attack.

Use in children aged 6 to 14 years
The recommended dose is one 5 mg chewable tablet once daily in the evening.
Ensure that the patient taking Montelukast LEK-AM is not also taking other medicines containing the same active substance – montelukast.
This medicine is intended for oral use.
The tablet must be chewed before swallowing.
Do not take Montelukast LEK-AM 5 mg chewable tablets during meals; the medicine should be taken at least one hour before a meal or two hours after a meal.

Taking more Montelukast LEK-AM than prescribed
Contact your doctor immediately.
In most cases, no adverse effects have been observed following overdose.
In cases of overdose in children and adults, the most commonly observed symptoms were: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If you forget to take Montelukast LEK-AM
Montelukast LEK-AM should be taken as prescribed by your doctor. However, if a dose is missed, return to the regular dosing schedule – one tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping Montelukast LEK-AM
Montelukast LEK-AM 5 mg is effective in treating asthma only when taken regularly.
It is important to continue taking Montelukast LEK-AM for as long as your doctor has instructed. 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During clinical studies using montelukast chewable tablets at a dose of 5 mg, the most commonly reported adverse reaction (which may occur in fewer than 1 in 10 people) considered to be related to taking this medicine was:

• headache. Furthermore, in clinical studies using montelukast 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 ingredient).

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 fewer 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 fewer than 1 in 1,000 people):

• increased tendency to bleed;
• tremor;
• palpitations.

Very rare (may occur in fewer than 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);
• decreased 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 symptoms;
• hepatitis (inflammation of the liver).

Other adverse reactions reported after montelukast was marketed
Very common (may occur in more than 1 in 10 people):

• upper respiratory tract infection.

Common (may occur in fewer than 1 in 10 people):

• diarrhoea, nausea, vomiting;
• rash;
• fever;
• increased liver enzyme levels.

Uncommon (may occur in fewer than 1 in 100 people):

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness;
• dizziness, drowsiness, sensations of pricking, tingling or numbness;
• nosebleeds;
• dry mouth, dyspepsia;
• bruising, itching, urticaria;
• muscle or joint pain, muscle cramps;
• nocturnal enuresis in children;
• weakness and/or fatigue, malaise, oedema.

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

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

Very rare (may occur in fewer than 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 reactions
If any adverse reactions occur, 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 181C
02-222 Warsaw
Phone: +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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Montelukast LEK-AM

Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast LEK-AM contains

• The active substance is montelukast. Each chewable tablet contains 5 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, raspberry flavour, aspartame, and magnesium stearate.

What Montelukast LEK-AM looks like and contents of the pack
Montelukast LEK-AM 5 mg chewable tablets are white or almost white, round,
biconvex, with the number 5 engraved on one side, 9 mm in diameter.
The tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium foil and then placed in a cardboard box. The pack contains 28 tablets (2 blisters with 14 tablets each).
Marketing Authorisation Holder and Manufacturer
Pharmaceutical Company LEK-AM Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106