Milukante

Package leaflet: Information for the patient

Milukante
4 mg, chewable tablets
Montelukastum
Please read the entire leaflet carefully before giving this medicine to a child.

• Keep the leaflet, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist.

Table of contents:

1. What Milukante is and what it is 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 Milukante is and what it is 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 effects of leukotrienes, Milukante helps relieve asthma symptoms and helps control asthma.
Your doctor has prescribed Milukante for the treatment of asthma in your child to prevent asthma symptoms during both day and night.

• Milukante is used in the treatment of patients aged 2 to 5 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Milukante may also be used instead of inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who are unable to use inhaled corticosteroids.
• Milukante also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Milukante based on your child's symptoms and severity of asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing worsens and improves in response to various triggers.
• Hyperreactivity of the airways, which react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the lining of the airways.

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

2. Important information before taking Milukante
Please inform your doctor about any current or past medical conditions and allergies your child may have.

When not to use Milukante in a child:

• If your child is allergic (hypersensitive) to montelukast or to any of the other ingredients of Milukante (listed in section 6).

Warnings and precautions
Please discuss with your doctor or pharmacist before starting Milukante.

• If your child's asthma symptoms worsen or if breathing difficulties occur, seek immediate medical attention.
• Milukante tablets for oral use are not intended for the treatment of acute asthma attacks. If an asthma 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 your child takes all asthma medications prescribed by the doctor. Do not use Milukante instead of other asthma medications prescribed by your doctor.
• Be aware that if your child, while taking asthma medications, develops symptoms such as flu-like illness, tingling or numbness in the hands or feet, worsening respiratory symptoms, and/or rash, you should contact your doctor.
• Do not give your child acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if they worsen your 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 such symptoms occur while taking montelukast, consult your doctor.

Children
Milukante 4 mg chewable tablets are available for children aged 2 to 5 years.
Milukante 5 mg chewable tablets are available for children aged 6 to 14 years.

Milukante and other medicines
Some medicines may affect the action of Milukante or Milukante may affect the action of other medicines your child is taking.
Please inform your doctor about all medicines your child is currently taking, has recently taken, or plans to take.
Milukante may be used together with other medicines used in the treatment of asthma.
Please inform your doctor if your child is 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).

Milukante with food and drink
Milukante 4 mg chewable tablets should not be taken with food; the medicine should be taken at least one hour before a meal or two hours after a meal.

Pregnancy and breastfeeding
This section does not apply to Milukante 4 mg chewable tablets, as this formulation is indicated for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.

Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, please consult your doctor or pharmacist before using this medicine.
Your doctor will assess whether you can use Milukante during this period.

Breastfeeding
It is not known whether Milukante passes into human breast milk. If you are breastfeeding or planning to breastfeed, please consult your doctor before using Milukante.

Driving and operating machinery
This section does not apply to Milukante 4 mg chewable tablets, as this medicine is intended for use in children aged 2 to 5 years. However, the following information is relevant to the active substance, montelukast.
Milukante is not expected to affect the ability to drive or operate machinery. Nevertheless, individual responses to the medicine may vary. Some adverse reactions (such as dizziness and drowsiness), which have been very rarely reported during treatment with Milukante, may affect the ability to drive or operate machinery.

Milukante contains aspartame
The medicine contains 4.8 mg of aspartame per 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 improper excretion.

Milukante contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, meaning it is considered "sodium-free".

3. How to take Milukante

The child should take this medicine as directed by the doctor. Consult your doctor or
pharmacist if you have any doubts.

• This medicine should be administered to the child under the supervision of an adult.
• The child should be given only one Milukante tablet per day, as prescribed by the doctor.
• The medicine should be taken even when the child does not have asthma symptoms, as well as during an acute asthma attack.
• Milukante should always be used in the child as directed by the doctor. If in doubt, contact your doctor or pharmacist.
• The medicine should be taken orally.

Dosage for children aged 2 to 5 years:
One chewable and dispersible tablet of 4 mg should be taken once daily in the evening. Milukante 4 mg chewable and dispersible tablets should not be taken during meals; the medicine should be taken at least one hour before or two hours after a meal. The tablet should be chewed before swallowing.
Ensure that a child taking Milukante is not also taking other medicines containing the same active substance, montelukast.
Milukante 4 mg chewable and dispersible tablets are available for children aged 2 to 5 years.
Milukante 5 mg chewable and dispersible tablets are available for children aged 6 to 14 years.
Milukante 4 mg chewable and dispersible tablets are not recommended for children under 2 years of age.

Accidental overdose of Milukante
Contact your doctor immediately.
In most cases of overdose, no adverse effects have been observed. However, in cases of overdose in children and adults, the following symptoms have most commonly been reported: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missed dose of Milukante
Milukante should be taken as prescribed by the doctor. However, if the child forgets to take a dose, resume the regular dosing schedule—once daily, one tablet per day. Do not take a double dose to make up for the missed dose.

Stopping Milukante treatment
Milukante is effective in treating asthma in children only when taken regularly. It is important to continue using Milukante in the child for as long as directed by the doctor. This will help keep the child's asthma under control.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Milukante can cause adverse reactions, although not everyone experiences them.

In clinical trials using Milukante 4 mg chewable and dispersible tablets, the most commonly reported adverse reactions (occurring in at least 1 in 100 but less than 1 in 10 treated children), considered related to the use of Milukante, were:

• abdominal pain,
• excessive thirst.

Additionally, in clinical trials using Milukante 10 mg coated tablets and Milukante 5 mg chewable and dispersible tablets, the following were reported:

• headache.

These symptoms were usually mild in intensity and occurred more frequently in patients taking Milukante than in those receiving placebo (a tablet containing no active ingredient).

The frequency of the possible adverse reactions listed below is presented according to the following convention:

• Very common (affects at least 1 in 10 people)
• Common (affects 1 to 10 in 100 people)
• Uncommon (affects 1 to 10 in 1,000 people)
• Rare (affects 1 to 10 in 10,000 people)
• Very rare (affects less than 1 in 10,000 people)

Furthermore, since the medicine has been marketed, the following have been reported:

• upper respiratory tract infections (Very common);
• increased tendency to bleeding (Rare);
• allergic reactions, including swelling of the face, lips, tongue, and (or) throat, which may cause difficulty in breathing or swallowing (Uncommon);
• changes in behavior and mood [unusual dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness, agitation, including aggressive or hostile behavior, depression (Uncommon); tremor, attention disorders, memory disturbances (Rare); hallucinations, disorientation, suicidal thoughts and attempts (Very rare)];
• dizziness, drowsiness, tingling and numbness, seizures (Uncommon);
• palpitations (Rare);
• nosebleeds (Uncommon); lung inflammation (pneumonitis) (Very rare);
• diarrhoea, nausea, vomiting (Common); dry mouth, dyspepsia (Uncommon);
• hepatitis (liver inflammation) (Very rare);
• rash (Common); bruising, itching, urticaria (Uncommon); tender, red subcutaneous nodules most commonly appearing on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without prior symptoms (Very rare);
• muscle or joint pain, muscle cramps (Uncommon);
• fever (Common); weakness, fatigue, malaise, swelling (Uncommon).
• stuttering (Very rare).

In patients with asthma treated with montelukast, very rare cases of Churg-Strauss syndrome have been observed, characterized by symptoms such as flu-like symptoms, tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash. If any of these symptoms occur in a child, the treating physician should be informed immediately.

For detailed information about the medicine's adverse reactions, consult a doctor or pharmacist. If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform the doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Adverse Drug Reactions, 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 authorization holder.

Reporting adverse reactions helps to provide 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 must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Milukante contains
The active substance is montelukast (in the form of montelukast sodium).
One chewable and dispersible tablet contains 4 mg of montelukast in the form of montelukast
sodium.
The other ingredients are:
Milukante, chewable and dispersible tablets 4 mg
Microcrystalline cellulose, mannitol, crospovidone, ferric oxide red (E 172),
hydroxypropyl cellulose, disodium edetate, cherry flavour, aspartame (E 951), talc, magnesium
stearate.
What Milukante looks like and contents of the pack
Milukante 4 mg chewable and dispersible tablets are light pink, oval, biconvex tablets.
Milukante is available in aluminium/aluminium blisters containing 28 tablets.
Marketing Authorisation Holder and Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
{Poland} {Milukante}