MILUKANTE 4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Milukante
3. 4 mg, Chewable Tablets
   1. Read the leaflet carefully before giving the medicine to a child.
   2. Table of Contents of the Leaflet:
4. What is Milukante and what is it used for
   1. What is Asthma?
5. Important Information Before Taking Milukante
   1. When Not to Give Milukante to a Child:
   2. Warnings and Precautions
   3. Various Neuropsychiatric Events (e.g., Changes in Behavior and Mood, Depression, and Suicidal Tendencies) Have Been Reported in Patients of All Ages Treated with Montelukast (see Section 4). If the Patient Experiences Such Symptoms While Taking Montelukast, Consult a Doctor.
   4. Children
   5. Milukante and Other Medicines
   6. Milukante with Food and Drink
   7. Pregnancy and Breastfeeding
   8. Driving and Using Machines
   9. Milukante Contains Aspartame
   10. Milukante Contains Sodium
6. How to Take Milukante
   1. Taking a Higher Dose of Milukante Than Recommended
   2. Missing a Dose of Milukante
   3. Stopping Treatment with Milukante
7. Possible Side Effects
   1. Reporting Side Effects
8. How to Store Milukante
9. Contents of the Pack and Other Information
   1. What Milukante Contains
   2. Milukante, 4 mg Chewable Tablets
   3. What Milukante Looks Like and Contents of the Pack
   4. Marketing Authorization Holder and Manufacturer
   5. This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Package Leaflet: Information for the Patient

Milukante

4 mg, Chewable Tablets

Montelukast

Read the leaflet carefully before giving the medicine to a child.

• -Keep the leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or pharmacist.

Table of Contents of the Leaflet:

• 1. What is Milukante and what is it used for
• 2. Important information before taking 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. The doctor has prescribed Milukante to treat asthma in the child, to prevent the occurrence of asthma symptoms during the day and night.

• Milukante is used to treat patients aged 2 to 5 years who have not achieved adequate control of asthma with their current medications and require additional medications.
• Milukante may also be used instead of inhaled glucocorticosteroids in children aged 2 to 5 years who have not recently taken oral glucocorticosteroids for asthma and are unable to use inhaled glucocorticosteroids.
• Milukante also helps prevent bronchospasm caused by physical exertion in patients aged 2 years and older.

The doctor will determine how to use Milukante based on the child's symptoms and the severity of asthma.

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, plant pollen, cold air, or physical exertion.
• inflammation (swelling) of the lining of the airways.

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

2. Important Information Before Taking Milukante

Inform the doctor about any current or past illnesses and allergies in the child.

When Not to Give Milukante to a Child:

• if the child has been diagnosed with hypersensitivity (allergy) to montelukast or any of the other ingredients of Milukante (listed in section 6).

Warnings and Precautions

Discuss the use of Milukante with a doctor or pharmacist before starting treatment.

• If the child's asthma symptoms worsen or breathing difficulties occur, seek medical attention immediately.
• Orally administered Milukante is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always have a rescue inhaler with you in case of an asthma attack in the child.
• It is essential for the child to take all asthma medications prescribed by the doctor. Do not use Milukante instead of other asthma medications prescribed by the doctor.
• Remember that if the child 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, seek medical attention.
• Do not give the child aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen the child's asthma symptoms.

Various Neuropsychiatric Events (e.g., Changes in Behavior and Mood, Depression, and Suicidal Tendencies) Have Been Reported in Patients of All Ages Treated with Montelukast (see Section 4). If the Patient Experiences Such Symptoms While Taking Montelukast, Consult a Doctor.

During treatment with montelukast, consult a doctor if such symptoms occur.

Children

For children aged 2 to 5 years, Milukante is available in 4 mg chewable tablets. For children aged 6 to 14 years, Milukante is available in 5 mg chewable tablets.

Milukante and Other Medicines

Some medicines may affect the action of Milukante or Milukante may affect the action of other medicines taken by the child. Inform the doctor about all medicines the child is currently taking or has recently taken, as well as any medicines the child plans to take. Milukante can be taken with other asthma medications. Before starting treatment with Milukante, inform the doctor if the child is taking:

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections).

Milukante with Food and Drink

Milukante 4 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

This section does not apply to Milukante 4 mg chewable tablets, as it is intended for use in children aged 2 to 5 years. However, the following information applies to the active substance, montelukast. PregnancyIf the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before taking the medicine. The doctor will assess whether the patient can take Milukante during this period. BreastfeedingIt 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

This section does not apply to Milukante 4 mg chewable tablets, as it is intended for use in children aged 2 to 5 years. However, the following information applies to the active substance, montelukast. It is not expected that Milukante will affect the ability to drive or use machines. However, individual responses to the medicine may vary. Some side effects (such as dizziness and drowsiness) that have been very rarely reported during treatment with Milukante may affect the ability to drive or use machines.

Milukante Contains Aspartame

The medicine contains 4.8 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 the medicine is considered "sodium-free".

3. How to Take Milukante

The child should take this medicine as directed by the doctor. Consult a doctor or pharmacist if there are any doubts.

• This medicine should be given to the child under adult supervision.
• The child should take only one Milukante tablet once a day, as directed by the doctor.
• The medicine should be taken even if the child does not have asthma symptoms, as well as in the event of an acute asthma attack.
• Milukante should always be taken by the child as directed by the doctor. If there are any doubts, consult a doctor or pharmacist.
• The medicine should be taken orally.

Dose used in children aged 2 to 5 years: Take one 4 mg chewable tablet once a day, in the evening. Milukante 4 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. The tablet should be chewed before swallowing. Ensure that the child taking Milukante does not take other medicines containing the same active substance, montelukast. For children aged 2 to 5 years, Milukante is available in 4 mg chewable tablets. For children aged 6 to 14 years, Milukante is available in 5 mg chewable tablets. Milukante 4 mg chewable tablets are not indicated for use in children under 2 years of age.

Taking a Higher Dose of Milukante Than Recommended

Consult a doctor immediately. In most cases of overdose, no side effects have been observed. In cases of overdose in children and adults, the most commonly observed symptoms were: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a Dose of Milukante

Give Milukante as directed by the doctor. However, if the child misses a dose, return to the usual dosing schedule - one tablet once a day. Do not take a double dose to make up for the missed dose.

Stopping Treatment with Milukante

Milukante is effective in treating asthma in the child only if taken regularly. It is essential to continue taking Milukante as directed by the doctor. This will help keep the child's asthma under control. If there are any doubts about taking the medicine, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Milukante can cause side effects, although not everybody gets them. During clinical trials with Milukante 4 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 in 100 but less than 1 in 10 children) considered related to Milukante were:

• abdominal pain,
• excessive thirst. Additionally, in clinical trials with Milukante 10 mg film-coated tablets and 5 mg chewable tablets, the following side effects were reported:
• headache. These symptoms were usually mild and occurred more frequently in patients taking Milukante than in patients taking a placebo (a tablet that does not contain any medicine).

The frequency of possible side effects listed below is presented according to the following convention: Very common (occurring in at least 1 in 10 patients) Common (occurring in 1 to 10 patients in 100) Uncommon (occurring in 1 to 10 patients in 1000) Rare (occurring in 1 to 10 patients in 10,000) Very rare (occurring in less than 1 patient in 10,000) Additionally, after the medicine was placed on the market, the following side effects were reported:

• upper respiratory tract infections (Very common);
• increased tendency to bleed (Rare);
• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (Uncommon);
• changes in behavior and mood [unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness, hyperactivity, including aggressive or hostile behavior, depression (Uncommon); tremors, attention disorders, memory disorders (Rare); hallucinations, disorientation, suicidal thoughts and attempts (Very rare)];
• dizziness, drowsiness, tingling, and numbness, seizures (Uncommon);
• palpitations (Rare);
• nasal bleeding (Uncommon); pulmonary inflammation (swelling) (Very rare);
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon);
• hepatitis (Very rare);
• rash (Common); bruising, itching, hives (Uncommon); painful, red, subcutaneous nodules, most commonly on the shins (erythema nodosum), severe skin reactions (Stevens-Johnson syndrome), which may 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, seek medical attention immediately. For more information on side effects, consult a doctor or pharmacist. If the child's side effects worsen or if any side effects not listed in this leaflet occur, tell the doctor or pharmacist.

Reporting Side Effects

If side effects occur, including any side effects not listed in this leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reactions of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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. Reporting side effects will help gather more information on the safety of the medicine.

5. How to Store Milukante

Keep the medicine out of sight and reach of children. Store in the original packaging 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 a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Milukante Contains

The active substance of the medicine is montelukast (as montelukast sodium). One chewable tablet contains 4 mg of montelukast as montelukast sodium. The other ingredients of the medicine are:

Milukante, 4 mg Chewable Tablets

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 4 mg chewable tablets are light pink, oval, biconvex tablets. 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 Approval of the Leaflet:05.2024