Montelukast Lek-am

Leaflet attached to the packaging: patient information

Montelukast LEK-AM, 4 mg, chewable tablets

Montelukast

Read the leaflet carefully before giving this medicine to a child, as it contains important information for the patient.

• 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Montelukast LEK-AM and what is it used for
• 2. Important information before giving Montelukast LEK-AM to a child
• 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 is Montelukast LEK-AM and what is it used for

What is Montelukast LEK-AM

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

The doctor has prescribed Montelukast LEK-AM to treat asthma in a child, to prevent asthma symptoms from occurring during the day and at night.

• Montelukast LEK-AM is used to treat patients aged 2 to 5 years who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Montelukast LEK-AM may also be used as an alternative to inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Montelukast LEK-AM also helps prevent narrowing of the airways caused by physical exertion in patients aged 2 years and older.

The doctor will determine how to take Montelukast LEK-AM, depending on the symptoms and severity of asthma in the child.

What is asthma?

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

• breathing difficulties caused by narrowing of the airways. This narrowing worsens and improves in response to various factors;
• sensitivity of the airways, which react to many factors, such as cigarette smoke, plant pollen, cold air, or physical exertion;
• swelling (inflammation) of the lining of the airways. Asthma symptoms include coughing, wheezing, and a feeling of pressure in the chest.

2. Important information before giving Montelukast LEK-AM to a child

Tell the doctor about any current or past illnesses or allergies in the child.

When not to give Montelukast LEK-AM to a child:

Warnings and precautions

Discuss with your doctor or pharmacist before giving Montelukast LEK-AM to a child.

• If the child's asthma symptoms worsen or breathing difficulties occur, seek medical attention immediately.
• Orally administered Montelukast LEK-AM is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always have a rescue inhaler with you in case of an asthma attack in the child.
• It is essential that the child takes all asthma medications prescribed by the doctor. Do not use Montelukast LEK-AM instead of other asthma medications prescribed by the doctor.
• Remember that if the child taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening of respiratory symptoms, and/or rash, seek medical attention.
• Do not give the child aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen the child's asthma symptoms.

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 such symptoms occur while taking montelukast, contact your doctor.

While taking montelukast, contact your doctor if such symptoms occur.

Children and adolescents

Do not use this medicine in children under 2 years of age.
For children and adolescents under 18 years of age, other forms and doses of this medicine are available, tailored to the patient's age.

Montelukast LEK-AM and other medicines

Tell your doctor or pharmacist about all medicines the child is taking or has recently taken, including those obtained without a prescription.
Some medicines may affect the action of Montelukast LEK-AM or Montelukast LEK-AM may affect the action of other medicines taken by the child.
Before taking Montelukast LEK-AM, tell your doctor if the child is taking:

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections).

Montelukast LEK-AM with food and drink

Montelukast LEK-AM, 4 mg chewable tablets, should not be taken with food; take the medicine at least 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding

This section does not apply to Montelukast LEK-AM 4 mg chewable tablets, as this medicine is intended for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Montelukast LEK-AM 4 mg chewable tablets, as this medicine is intended for use in children aged 2 to 5 years. However, the following information is relevant to the active substance - montelukast.
It is not expected that Montelukast LEK-AM will affect the ability to drive and use machines. However, individual responses to the medicine may vary. Some side effects (such as dizziness and drowsiness) reported during montelukast treatment may affect the ability to drive and use machines.

Montelukast LEK-AM contains aspartame, sodium, and mannitol

Montelukast LEK-AM, 4 mg, in the form of chewable tablets, contains 0.84 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful to children with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.
Montelukast LEK-AM contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
Montelukast LEK-AM in the form of chewable tablets also contains mannitol. The medicine may have a mild laxative effect.

3. How to take Montelukast LEK-AM

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• This medicine should be given to the child under adult supervision.
• Give the child only one Montelukast LEK-AM 4 mg tablet once daily, as recommended by the doctor.
• Give the medicine even when the child does not have asthma symptoms, as well as in the event of an acute asthma attack.

Use in children aged 2 to 5 years

The recommended dose is one 4 mg chewable tablet once daily, in the evening.
Make sure the child taking Montelukast LEK-AM does not take other medicines containing the same active substance - montelukast.
Take the medicine orally.
Chew the tablet before swallowing.
Montelukast LEK-AM, 4 mg chewable tablets, should not be taken with food; take the medicine at least 1 hour before or 2 hours after a meal.

Taking a higher dose of Montelukast LEK-AM than recommended

Contact your doctor immediately.
In most cases of overdose, no side effects have been observed.
In cases of overdose in children and adults, the most commonly observed symptoms were abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a dose of Montelukast LEK-AM

Take Montelukast LEK-AM as recommended by your doctor. However, if the child misses a dose, return to the usual dosing schedule - one tablet once daily.
Do not take a double dose to make up for the missed dose.

Stopping Montelukast LEK-AM treatment

Montelukast LEK-AM, 4 mg, is effective in treating asthma in a child only when taken regularly.
It is essential to continue taking Montelukast LEK-AM in the child as long as the doctor recommends. This will help keep the child's asthma under control.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Montelukast LEK-AM can cause side effects, although not everybody gets them.
During clinical trials with montelukast 4 mg chewable tablets, the most commonly reported side effects (which may occur in less than 1 in 10 people) considered related to the medicine were:

• abdominal pain,
• excessive thirst. Additionally, in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets, the following were reported:
• headache. These symptoms were usually mild and occurred more frequently in patients taking montelukast than in patients taking a placebo (a tablet that does not contain any medicine).

Severe side effects

Contact your doctor immediatelyif the child experiences any of the following side effects, which may be severe and require immediate medical attention.
Uncommon (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 (may occur in less than 1 in 1,000 people):

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

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

• a syndrome of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening of respiratory symptoms, and/or rash (Churg-Strauss syndrome) (see section 2);
• decreased 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 montelukast was made available

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

• upper respiratory tract infection.

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

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

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

• changes in behavior and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness;
• dizziness, drowsiness, tingling and numbness;
• nosebleeds;
• dry mouth, indigestion;
• bruising, itching, hives;
• muscle or joint pain, muscle spasms;
• bedwetting in children;
• weakness and/or fatigue, malaise, swelling.

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

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

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

• painful, red, subcutaneous nodules, most commonly occurring 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Montelukast LEK-AM

Keep this medicine out of the 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 after EXP.
The expiry date refers to the last day of the month.
Medicines should 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 Montelukast LEK-AM contains

• The active substance is montelukast. Each chewable tablet contains 4 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, raspberry flavor, aspartame, and magnesium stearate.

What Montelukast LEK-AM looks like and contents of the pack

Montelukast LEK-AM 4 mg chewable tablets are white or almost white, round, 8 mm in diameter, biconvex, and uncoated.
The tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters, and then in a cardboard box. The pack contains 28 tablets (2 blisters of 14 tablets).

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Date of last revision of the leaflet: