Montelukast Lek-am

Package Leaflet: Information for the Patient

Montelukast LEK-AM, 10 mg, Film-Coated Tablets

Montelukast

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

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 narrow and cause asthma symptoms. By blocking the action of leukotrienes, Montelukast LEK-AM helps control asthma symptoms and helps control asthma, as well as relieving 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 to treat asthma, to prevent asthma symptoms during the day and at night.

• Montelukast LEK-AM is used to treat patients aged 15 and older who have not achieved adequate control of asthma with their current medications and need additional treatment.
• Montelukast LEK-AM also helps prevent narrowing of the airways caused by exercise.
• In patients with asthma, Montelukast LEK-AM may also relieve symptoms of seasonal allergic rhinitis.

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.

• difficulty breathing due to narrowing of the airways, 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 lining of the airways. Asthma symptoms include coughing, wheezing, and a feeling of tightness in the chest.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose; sneezing; tearing, swelling, redness, and itching of the eyes.

2. Important information before taking Montelukast LEK-AM

Tell your doctor about any illnesses and allergies you have now or have had in the past.

When not to take Montelukast LEK-AM:

Warnings and precautions

Discuss with your doctor before starting treatment with Montelukast LEK-AM.

• If your asthma symptoms worsen or you have difficulty breathing, seek medical attention immediately.
• Montelukast LEK-AM taken orally 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 important that you take all asthma medications prescribed by your doctor. Do not take Montelukast LEK-AM instead of 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 see a doctor.
• You should 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.

If you experience such symptoms while taking montelukast, contact your doctor.

Children and adolescents

Do not give this medicine to children under 15 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 taking, have recently taken, or might take, including those obtained without a prescription.

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections),
• gemfibrozil (used to treat high lipid levels in the blood).

Montelukast LEK-AM with food and drink

Montelukast LEK-AM, 10 mg, film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice 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 with montelukast, may affect your ability to drive or use machines.

If you experience these symptoms, do not drive or use machines.

Montelukast LEK-AM contains lactose and sodium

Montelukast LEK-AM, film-coated tablets contain lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Montelukast LEK-AM contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

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 10 mg tablet of Montelukast LEK-AM once daily, as advised by your doctor.
• Take the medicine even when you do not have asthma symptoms, as well as during an acute asthma attack.

Use in adults and adolescents aged 15 and over

The recommended dose is one 10 mg film-coated tablet once daily, in the evening. Make sure that you do not take other medicines that contain the same active substance - montelukast.

Take the medicine orally. Swallow the tablet with a sufficient amount of water.

Montelukast LEK-AM can be taken with or without food.

If you take more Montelukast LEK-AM than you should

Contact your 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 been most commonly observed: stomach pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If you forget to take Montelukast LEK-AM

Take Montelukast LEK-AM as advised by your doctor. However, if you miss a dose, return to your normal dosing schedule - one tablet once daily.

Do not take a double dose to make up for a missed dose.

If you stop taking 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 your doctor has prescribed. 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, this medicine can cause side effects, although not everybody gets them.

During clinical trials with montelukast 10 mg film-coated tablets, the most commonly reported side effects (which may occur in less than 1 in 10 people) considered to be related to montelukast were:

• stomach pain,
• headache. These symptoms were usually mild and occurred more frequently in patients taking montelukast than in patients taking placebo (a tablet that does not contain any medicine).

Severe side effects

Contact your doctor immediatelyif you experience any of the following severe side effects, which may require immediate medical attention.

Uncommon (may affect 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 affect less than 1 in 1,000 people):

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

Very rare (may affect 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 montelukast was marketed

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

• upper respiratory tract infection.

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

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

Uncommon (may affect 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 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 affect less than 1 in 1,000 people):

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

Very rare (may affect 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, tell your doctor or pharmacist. You can also report side effects 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

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

You can also report side effects to the marketing authorisation 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 this 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 that 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 film-coated tablet contains 10 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: tablet core:lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, magnesium stearate; tablet coating:hypromellose 6cP (E464), titanium dioxide (E171), macrogol 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, uncoated.

The tablets are packaged in blisters of OPA/Aluminium/PVC/Aluminium foil, and then in a cardboard box. The pack contains 28 tablets (4 blisters of 7 tablets).

Marketing authorisation holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.

ul. Ostrzykowizna 14A

05-170 Zakroczym

Poland

Tel.: +48 22 785 27 60

Fax: +48 22 785 27 60 ext. 106

Date of last revision of the leaflet: