Montelukast lek-am

Patient Information Leaflet

Montelukast LEK-AM, 4 mg, chewable tablets
Montelukastum

Please read this leaflet carefully before giving this medicine to your child, as it contains important information for you.

• 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 share it with others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions 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 giving Montelukast LEK-AM to your 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 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 Montelukast LEK-AM should be used
Your doctor has prescribed Montelukast LEK-AM for the treatment of asthma in your child to prevent asthma symptoms during the day and at night.

• Montelukast LEK-AM is used in the treatment of patients aged 2 to 5 years who have not achieved adequate asthma control with previously used medications and who require additional therapy.
• Montelukast LEK-AM may also be used as an alternative to inhaled corticosteroids in children aged 2 to 5 years who have not recently received oral corticosteroids for asthma treatment and who are unable to use inhaled corticosteroids.
• Montelukast LEK-AM also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Montelukast LEK-AM based on your child's symptoms and the 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 increases and decreases in response to various triggers;
• Airway sensitivity, where the airways react to many factors such as cigarette smoke, pollen, cold air, or physical exertion;
• Swelling (inflammation) of the mucous membrane lining the airways.

Asthma symptoms include coughing, wheezing, and chest tightness.

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

Inform the attending physician about any current or past medical conditions and allergies in the child.

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

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

Warnings and precautions

Before starting to give Montelukast LEK-AM to a child, discuss this with the doctor or pharmacist.

• If the child's asthma symptoms worsen or if breathing difficulties occur, contact the attending physician immediately.
• The orally administered medicine Montelukast LEK-AM is not intended for the treatment of acute asthma attacks. In case of such an attack, follow the doctor's instructions. Always keep a reliever inhaler available for immediate use in case of an asthma attack in the child.
• It is important that the child takes all asthma medications prescribed by the attending physician. Montelukast LEK-AM should not be used as a substitute for other asthma medications prescribed by the doctor.
• Remember that if a child taking asthma medications develops symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening respiratory symptoms and/or rash, medical advice should be sought.
• Do not give the child acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma symptoms in the child.

Neuropsychiatric events (e.g. behavioral and mood changes, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur in a patient during treatment with montelukast, contact a doctor.

Children and adolescents

Do not use this medicine in children under 2 years of age.

Other formulations and doses of this medicine, appropriate for the patient's age, are available for children and adolescents under 18 years of age.

Montelukast LEK-AM and other medicines

Tell the doctor or pharmacist about all medicines currently or recently taken by the child, as well as any medicines that may be given to the child, including those available 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 starting treatment with Montelukast LEK-AM, inform the doctor if the child is 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 4 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

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 operating machinery

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 regarding the active substance – montelukast.

Montelukast LEK-AM is not expected to affect the ability to drive or operate machinery. Nevertheless, individual responses to the medicine may vary. Some adverse reactions (such as dizziness and drowsiness) reported during treatment with montelukast may affect the ability to drive and operate machinery.

Montelukast LEK-AM contains aspartame, sodium, and mannitol

Montelukast LEK-AM 4 mg chewable tablets contain 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 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 in the form of chewable tablets also contains mannitol. The medicine may have a mild laxative effect.

3. How to use Montelukast LEK-AM

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt,
consult your doctor or pharmacist.

• This medicine should be administered to a child under the supervision of an adult.
• The child should be given only one tablet of Montelukast LEK-AM, 4 mg, once daily, as directed by the doctor.
• The medicine should be taken even when the child does not have asthma symptoms, and also during 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.
Ensure that the child taking Montelukast LEK-AM is not also taking other medicines containing the same active substance – montelukast.
The medicine should be taken orally.
The tablet must be chewed before swallowing.
Montelukast LEK-AM 4 mg chewable tablets should not be taken 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 recommended
Contact your doctor immediately.
In most cases of overdose, no adverse effects have been observed.
In cases of overdose in children and adults, the most commonly observed symptoms have been:
abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If a dose of Montelukast LEK-AM is missed
Montelukast LEK-AM should be taken as directed by the doctor. However, if the child forgets to take a dose, resume the usual 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, 4 mg, is effective in treating asthma in children only when taken regularly.
It is important to continue giving Montelukast LEK-AM to the child for as long as directed by the doctor.
This will help keep the child'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.
In clinical trials using montelukast in the form of chewable tablets at a dose of 4 mg, the most commonly reported adverse reactions (may occur in fewer than 1 in 10 people), considered to be related to taking this medicine, were:

• abdominal pain,
• excessive thirst.

Additionally, in clinical trials using montelukast in the form of 10 mg coated tablets and 5 mg chewable tablets, the following were reported:

• headache.

These symptoms were usually mild in severity and occurred more frequently in patients taking montelukast than in patients taking placebo (a tablet containing no active ingredient).

Serious adverse reactions
Contact a doctor immediately if your child experiences any of the following adverse reactions, which may be serious and require immediate medical attention.

Not very common (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 breathing or swallowing;
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression;
• seizures.

Rare (may occur in fewer than 1 in 1000 people):

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

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

• a syndrome of symptoms such as flu-like symptoms, 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 (liver inflammation).

Other adverse reactions reported after montelukast was introduced to the market
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.

Not very common (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, tingling and numbness;
• nosebleeds;
• dryness in the mouth, dyspepsia;
• bruising, itching, urticaria (hives);
• muscle or joint pain, muscle cramps;
• nocturnal enuresis (bedwetting) in children;
• weakness and (or) fatigue, malaise, swelling.

Rare (may occur in fewer than 1 in 1000 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 Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Montelukast LEK-AM

Keep the 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 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 no longer required. These measures 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, hydroxypropyl cellulose, sodium croscarmellose, raspberry flavour, 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,
biconvex, 8 mm in diameter, without any markings.
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
LEK-AM Pharmaceutical Company Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106