Montelukast lek-am

Package leaflet: Information for the patient

Montelukast LEK-AM, 10 mg, film-coated tablets
Montelukastum

Please read carefully the entire leaflet before taking the 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including those 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 package and other information

1. What Montelukast LEK-AM is and what it is 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 and also trigger allergy symptoms. By blocking the action of leukotrienes, Montelukast LEK-AM relieves asthma symptoms and helps control asthma, as well as alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When to use Montelukast LEK-AM
Your doctor has prescribed Montelukast LEK-AM for the treatment of asthma, to prevent asthma symptoms during the day and at night.

• Montelukast LEK-AM is used in the treatment of adult patients and adolescents aged 15 years and older whose asthma is not adequately controlled with previously used medications and who require additional therapy.
• Montelukast LEK-AM also helps prevent exercise-induced narrowing of the airways.
• In patients with asthma who are being treated with Montelukast LEK-AM, the medicine may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Montelukast LEK-AM based on your symptoms and the severity of your 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 hyperresponsiveness, meaning 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.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions commonly triggered by airborne allergens such as tree, grass, and weed pollens. Typical symptoms of seasonal allergies may include nasal congestion, runny nose, itchy nose, sneezing, watery eyes, eye swelling, redness, and itching.

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 to take Montelukast LEK-AM, discuss it with your doctor.

• If asthma symptoms worsen or you experience difficulty breathing, contact your doctor immediately.
• Orally administered Montelukast LEK-AM is not intended for the treatment of acute asthma attacks. If such an 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 take all anti-asthma medications prescribed by your doctor. Do not use Montelukast LEK-AM instead of other anti-asthma medications prescribed by your doctor.
• Be aware that if you experience symptoms such as flu-like illness, tingling or numbness in hands or feet, worsening respiratory symptoms and/or rash while taking anti-asthma medications, 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 (for example, changes in behaviour and mood,
depression, and suicidal tendencies) have been reported in patients of all ages
treated with montelukast (see section 4). If you experience such symptoms while
taking montelukast, contact your doctor.
Children and adolescents
Do not use this medicine in children under 15 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 your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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),
• gemfibrozil (used in the treatment of high plasma lipid levels).

Montelukast LEK-AM with food and drink
Montelukast LEK-AM 10 mg film-coated tablets can be taken regardless of meals.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Pregnancy
Your doctor will decide whether you can take Montelukast LEK-AM during this time.
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 lactose monohydrate and sodium
Montelukast LEK-AM in the form of film-coated tablets contains lactose. If you have been previously diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
Montelukast LEK-AM contains less than 1 mmol (23 mg) of sodium per tablet; this medicine is therefore considered "sodium-free".

3. How to use Montelukast LEK-AM

This medicine should always be taken as instructed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.

• Take only one Montelukast LEK-AM 10 mg tablet once daily, as directed by the doctor.
• The medicine should be taken even when the patient does not have asthma symptoms, and also during an acute asthma attack.

Use in adults and adolescents aged 15 years and older
The recommended dose is one 10 mg coated tablet once daily, taken in the evening. Ensure that
the patient taking Montelukast LEK-AM is not taking any other medicines containing the same
active substance – montelukast.
The medicine should be taken orally. Tablets should be swallowed with an adequate amount of water.
Montelukast LEK-AM may be taken with or without food.

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

If a dose of Montelukast LEK-AM is missed
Continue taking Montelukast LEK-AM as directed by the doctor. However, if a dose is missed,
return to the usual dosing schedule – one tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Montelukast LEK-AM
Montelukast LEK-AM 10 mg is effective in treating asthma only when taken regularly.
It is important to continue taking Montelukast LEK-AM for as long as directed by the treating doctor.
This will help keep the patient's asthma under control.
If there are any further doubts about the use of this medicine, consult the 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 with montelukast in 10 mg coated tablets,
the most commonly reported adverse reactions (which may occur in fewer than 1 in 10 people),
considered to be related to the use of this medicine, were:

• abdominal pain,
• headache. 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 medicine).

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 hostile thoughts, 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 and 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 suicide attempts;
• swelling (inflammation) of the lungs;
• severe skin reactions (erythema multiforme), which may occur without prior warning symptoms;
• hepatitis.

Other adverse reactions reported after montelukast became available on 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.

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

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness;
• dizziness, drowsiness, sensations of pricking and 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 adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 can 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 after EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system 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 package and other information

What Montelukast LEK-AM contains

• The active substance is montelukast. Each film-coated tablet contains 10 mg of montelukast in the form of montelukast sodium.
• Other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate; coating: hypromellose 6 cP (E464), titanium dioxide (E171), polyethylene glycol 3350, lactose monohydrate, triacetin.

What Montelukast LEK-AM looks like and contents of the pack
Montelukast LEK-AM 10 mg film-coated tablets are white or almost white, round, 9 mm in diameter, biconvex, without any marking.
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 (4 blisters with 7 tablets each).
Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106