Milukante

Package Leaflet: Information for the Patient

Milukante

5 mg, Chewable Tablets

Montelukast

Read the package leaflet carefully before giving the 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 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 Milukante and what is it used for
• 2. Before you take Milukante
• 3. How to take Milukante
• 4. Possible side effects
• 5. How to store Milukante
• 6. Contents of the pack and other information

1. What is Milukante and what is it used for

Milukante is a leukotriene receptor antagonist. It blocks the action of substances called leukotrienes. These substances cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Milukante relieves the symptoms of asthma and helps control asthma. Your doctor has prescribed Milukante for the treatment of asthma, to prevent asthma symptoms from occurring during the day and night.

• Milukante is used to treat patients aged 6 to 14 years who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Milukante may also be used instead of 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.
• Milukante also helps prevent narrowing of the airways caused by physical exercise in patients aged 6 to 14 years.
• Milukante is also used to treat symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Milukante, depending on the symptoms and severity of asthma in the patient.

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.
• airway hypersensitivity, which reacts to many factors, such as cigarette smoke, pollen, cold air, or physical exercise.
• swelling (inflammation) of the lining of the airways.

Asthma symptoms include: coughing, wheezing, and a feeling of pressure in the chest.

2. Before you take Milukante

When not to take Milukante

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

Warnings and precautions

Before taking Milukante, discuss it with your doctor or pharmacist.

• If asthma symptoms worsen or breathing difficulties occur, seek medical attention immediately.
• Oral Milukante is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always carry a rescue inhaler with you in case of an asthma attack.
• It is essential that the patient takes all asthma medications prescribed by the doctor. Milukante should not be taken instead of other asthma medications prescribed by the doctor.
• Remember that if the patient 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, they should see a doctor.
• The patient should not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen 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 the patient experiences such symptoms while taking montelukast, they should consult a doctor.

While taking montelukast, consult a doctor if such symptoms occur.

Children

For children aged 2 to 5 years, Milukante chewable tablets 4 mg are available.

Milukante and other medicines

Some medicines may affect the action of Milukante or Milukante may affect the action of other medicines taken by the patient. Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take. Milukante can be taken with other asthma medications. Before taking Milukante, inform your doctor if the patient is taking:

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections),
• gemfibrozil (used to reduce triglyceride levels and increase "good" cholesterol (HDL) levels in the blood).

Milukante with food and drink

Milukante chewable tablets 5 mg should not be taken with food; take the medicine at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine. Pregnancy Women who are pregnant or plan to become pregnant should consult their doctor before taking Milukante. The doctor will assess whether they can take Milukante during this period. Breastfeeding It is not known whether Milukante passes into breast milk. If a woman is breastfeeding or plans to breastfeed, she should consult a doctor before taking Milukante.

Driving and using machines

It is unlikely that Milukante will affect the ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness), which have been very rarely reported during treatment with Milukante, may affect the ability to drive or use machines.

Milukante contains aspartame

The medicine contains 6.0 mg of aspartame in each chewable tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

Milukante contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, which means it is essentially "sodium-free".

3. How to take Milukante

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

• This medicine should be given to the child under adult supervision.
• Take only one Milukante tablet once daily, as prescribed by your doctor.
• Take the medicine even when the patient does not have asthma symptoms, as well as during an acute asthma attack.
• Always take Milukante as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• Take the medicine orally.

Use in children aged 6 to 14 years:

For patients with asthma or asthma and seasonal allergic rhinitis, take one 5 mg chewable tablet once daily, in the evening. For patients with seasonal allergic rhinitis, take one 5 mg chewable tablet once daily. The doctor will determine the timing of administration individually for each patient. Do not take Milukante during meals. Take the medicine at least 1 hour before or 2 hours after meals. Chew the tablet before swallowing. Ensure that the patient taking Milukante does not take other medicines containing the same active substance, montelukast.

Overdose of Milukante

Immediately consult your doctor for advice. 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 observed: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missed dose of Milukante

Take Milukante as prescribed by your 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 Milukante

Milukante is effective in treating asthma only when taken regularly. It is essential to continue taking Milukante as long as prescribed by your doctor. This will help keep the patient'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, Milukante can cause side effects, although not everybody gets them. If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. During clinical trials with montelukast chewable tablets 5 mg, the most commonly reported side effects (occurring in at least 1 in 100 but less than 1 in 10 treated children), which were considered to be related to montelukast, were:

• abdominal pain
• excessive thirst
• Additionally, in clinical trials with montelukast film-coated tablets 10 mg, the following side effects 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).

The frequency of possible side effects listed below is defined as follows: Very common (affects at least 1 in 10 people) Common (affects 1 to 10 people in 100) Uncommon (affects 1 to 10 people in 1,000) Rare (affects 1 to 10 people in 10,000) Very rare (affects less than 1 in 10,000 people)

Additionally, after the medicine was marketed, the following side effects were reported:

• upper respiratory tract infections (Very common);
• increased tendency to bleed (Rare);
• allergic reactions, including face, lip, tongue, and/or throat swelling, which can cause breathing or swallowing difficulties (Uncommon);
• changes in behavior and mood [unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness, hyperactivity, including aggressive behavior or hostility] (Uncommon); tremors, attention disorders, memory disorders (Rare); hallucinations, disorientation, suicidal thoughts and attempts (Very rare);
• dizziness, drowsiness, tingling, and numbness (Uncommon);
• palpitations (Rare);
• nosebleeds (Uncommon); lung inflammation (pneumonia) (Very rare);
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon);
• liver inflammation (Very rare);
• rash (Common); bruising, itching, hives (Uncommon); painful, red, lumps under the skin, most commonly on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which can occur without prior symptoms (Very rare);
• muscle or joint pain, muscle spasms (Uncommon);
• fever (Common); weakness, fatigue, malaise, swelling (Uncommon);
• stuttering (Very rare).

In patients with asthma treated with montelukast, very rare cases of 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) have been reported. If the child experiences one or more of these symptoms, they should immediately inform their doctor.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Drug Safety, 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 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 Milukante

Keep the medicine out of the sight and reach of children. Store in the original package to protect from light. Do not use this medicine after the expiry date stated on the blister and outer packaging. 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 Milukante contains

The active substance is montelukast (as montelukast sodium). One chewable tablet contains 5 mg of montelukast as montelukast sodium. The other ingredients are:

Milukante, chewable tablets 5 mg

Microcrystalline cellulose, mannitol, crospovidone, red iron oxide (E 172), hydroxypropylcellulose, disodium edetate, cherry flavor, aspartame (E 951), talc, magnesium stearate.

What Milukante looks like and contents of the pack

Milukante 5 mg chewable tablets are pink, round, biconvex tablets with "M5" engraved on one side. Milukante is available in aluminum/aluminum blisters containing 28 tablets.

Marketing authorization holder and manufacturer

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

{Poland} {Milukante} Date of last revision of the leaflet:05.2024