Montelukast Lek-am

Package Leaflet: Information for the Patient

Montelukast LEK-AM, 5 mg, Chewable Tablets

Montelukast

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

• Keep this package 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

What is Montelukast LEK-AM

Montelukast LEK-AM is a leukotriene receptor antagonist, which blocks the action of substances called leukotrienes.

How Montelukast LEK-AM works

Leukotrienes cause the airways to constrict and become inflamed. 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 asthma symptoms from occurring during the day and at night.

• Montelukast LEK-AM is used in the treatment of patients aged 6 to 14 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 patients aged 6 to 14 years, who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Montelukast LEK-AM also helps prevent bronchospasm caused by exercise.

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

What is asthma?

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

• breathing difficulties caused by airway constriction, which worsens and improves in response to various factors;
• airway hypersensitivity, which reacts to many factors, such as cigarette smoke, pollen, cold air, or physical exertion;
• inflammation (inflammation) of the airway lining. Asthma symptoms include coughing, wheezing, and a feeling of chest tightness.

2. Important information before taking Montelukast LEK-AM

Inform your doctor about any current or past illnesses and allergies.

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

Discuss the use of Montelukast LEK-AM with your doctor or pharmacist before starting treatment.

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

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages taking montelukast (see section 4). If you experience such symptoms while taking montelukast, contact your doctor.

During treatment with montelukast, contact your doctor if you experience any of these symptoms.

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 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 you are currently taking or have recently taken, as well as any medicines you plan to take, 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 you are taking.
Before starting treatment with Montelukast LEK-AM, inform 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).

Montelukast LEK-AM with food and drink

Montelukast LEK-AM, 5 mg chewable tablets, should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking 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 breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast LEK-AM.

Driving and using machines

Montelukast LEK-AM is not expected to affect your ability to drive or use machines. However, individual responses to the medicine may vary. Some side effects (such as dizziness and drowsiness), which have been reported during treatment with montelukast, may affect your ability to drive or use machines.
In case of such symptoms, do not drive or use machines.

Montelukast LEK-AM contains aspartame, sodium, and mannitol

Montelukast LEK-AM, 5 mg chewable tablets, contains 1.05 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.
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, 5 mg 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.

• Take only one 5 mg tablet of Montelukast LEK-AM once daily, as recommended by your doctor.
• Take the medicine even when you do not have asthma symptoms, as well as in case of 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 does not take any other medicines containing the same active substance - montelukast.
This medicine is intended for oral use.
The tablet should be chewed before swallowing.
Montelukast LEK-AM, 5 mg chewable tablets, should not be taken with food; the medicine should be taken 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 following symptoms have been most commonly reported: 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 you miss a dose, return to your usual dosing schedule - one tablet once daily.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Montelukast LEK-AM

Montelukast LEK-AM, 5 mg, is effective in treating asthma only when taken regularly.
It is essential to continue taking Montelukast LEK-AM as long as your doctor recommends. This will help keep your 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 5 mg chewable tablets, the most commonly reported side effect (which may occur in less than 1 in 10 people) considered to be related to the medicine was:

• headache. Additionally, in clinical trials with montelukast 10 mg film-coated tablets, the following side effects were reported:
• abdominal pain. 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 you experience 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;
• tremor;
• 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 in hands and feet, worsening 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 the marketing of montelukast

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 falling asleep, sleepwalking, irritability, feeling anxious, restlessness;
• dizziness, drowsiness, tingling or numbness;
• nosebleeds;
• dry mouth, indigestion;
• bruising, itching, hives;
• muscle or joint pain, muscle cramps;
• 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):

• 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 those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
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 Montelukast LEK-AM

Keep the medicine out of the sight and reach of children.
Store in the original package 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 5 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, strawberry flavor, 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, 9 mm in diameter, biconvex, with the number 5 engraved on one side.
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 each).

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: