Milukante

Package leaflet: Information for the patient

Milukante
5 mg, chewable tablets
Montelukastum
Please read this leaflet carefully before giving the medicine to your child,
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. This medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 action of leukotrienes, Milukante relieves asthma symptoms and helps control asthma. Your doctor has prescribed Milukante for the treatment of asthma to prevent daytime and nighttime asthma symptoms.

• Milukante is used in the treatment of patients aged 6 to 14 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Milukante may also be used instead of inhaled glucocorticosteroids in patients aged 6 to 14 years who have not recently taken oral glucocorticosteroids for asthma treatment and who are unable to use inhaled glucocorticosteroids.
• Milukante also helps prevent exercise-induced narrowing of the airways in patients aged 6 to 14 years.
• Milukante is also used in the treatment of symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Milukante depending on the patient'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 factors.
• Airway hypersensitivity, in which the airways react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous membrane lining the airways.

Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before using Milukante

When not to use Milukante

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

Warnings and precautions
Before starting to take Milukante, discuss this with your doctor or pharmacist.

• If asthma symptoms worsen or breathing difficulties occur, contact your doctor immediately.
• Milukante tablets for oral use are not intended for treating acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always keep a rescue inhaler available for immediate use during an asthma attack.
• It is important that the patient continues taking all asthma medications prescribed by their doctor. Milukante should not be used instead of other asthma medications prescribed by the doctor.
• Remember that if a patient taking asthma medications develops symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening respiratory symptoms and/or rash, medical advice should be sought.
• The patient should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if these worsen asthma symptoms.

Various neuropsychiatric events (e.g. changes in behaviour and mood, depression and suicidal thoughts) 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 with other medicines
Some medicines may affect the action of Milukante or Milukante may affect the action of other medicines the patient is taking.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Milukante can be used together with other medicines used in the treatment of asthma.
Before starting Milukante, inform your doctor if the patient is taking any of the following medicines:

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

Milukante with food and drink
Milukante 5 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
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Women who are pregnant or planning pregnancy should consult their doctor before using Milukante. The doctor will assess whether the patient can take Milukante during this period.

Breastfeeding
It is not known whether Milukante passes into breast milk. If a woman is breastfeeding or intends to breastfeed, she should consult her doctor before using Milukante.

Driving and operating machinery
Milukante is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse reactions (such as dizziness and drowsiness), which have been reported very rarely during treatment with Milukante, may affect the ability to drive or operate machinery.

Milukante contains aspartame
The medicine contains 6.0 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 impaired excretion.

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

3. How to take Milukante
This medicine should always be taken exactly as directed by the doctor. If in doubt, consult your doctor or pharmacist.

• This medicine should be administered to a child under the supervision of an adult.
• Take only one Milukante tablet once daily, as directed by the doctor.
• The medicine should be taken even when the patient has no asthma symptoms and also during an acute asthma attack.
• Milukante should always be taken as directed by the doctor. If in doubt, contact your doctor or pharmacist.
• The medicine should be taken by mouth.

Use in children aged 6 to 14 years:
In patients with asthma or asthma with concomitant seasonal allergic rhinitis, take 1 chewable tablet of 5 mg once daily in the evening.
In patients with symptoms of seasonal allergic rhinitis, take 1 chewable tablet of 5 mg once daily. The timing of administration will be individually adjusted by the doctor according to the patient's needs.
Milukante should not be taken during meals. 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 patient taking Milukante is not also taking other medicines containing the same active substance, montelukast.

Taking more Milukante than recommended
Contact your doctor immediately for advice.
In most cases of overdose, no adverse effects have been observed.
In cases of overdose in children and adults, the most commonly observed symptoms have been: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If a dose of Milukante is missed
Take Milukante as directed by your doctor. However, if the patient forgets to take a dose, resume the usual dosing schedule—take one tablet once daily.
Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

In clinical trials using montelukast 5 mg chewable tablets, the most frequently reported adverse effects considered related to montelukast use (occurring in at least 1 in 100 but less than 1 in 10 treated children) were:

• abdominal pain
• excessive thirst

Additionally, in clinical trials using montelukast 10 mg coated tablets, the following were reported:

• headache

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

The frequency of possible adverse effects 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)

Additionally, since the medicine has been marketed, the following adverse effects 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 behaviour and mood [unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, restlessness, hyperkinesia, agitation, including aggressive behaviour or hostile attitude, depression (Uncommon); tremor, attention disorders, memory disorders (Rare); hallucinations, disorientation, suicidal thoughts and attempts (Very rare)];
• dizziness, drowsiness, tingling and numbness, seizures (Uncommon);
• palpitations (Rare);
• nosebleeds (Uncommon); lung inflammation (Very rare);
• diarrhoea, nausea, vomiting (Common); dry mouth, dyspepsia (Uncommon);
• hepatitis (Very rare);
• rash (Common); bruising, itching, urticaria (Uncommon); painful, 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, oedema (Uncommon);
• stuttering (Very rare).

In patients with asthma treated with montelukast, very rare cases of a syndrome characterised by symptoms such as influenza-like illness, tingling or numbness in the hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) have been reported. If your child develops one or more of these symptoms, contact your doctor immediately.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to 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 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. This practice will help protect the environment.

6. Contents of the package and other information

What Milukante contains
The active substance is montelukast (in the form of montelukast sodium).
One chewable and dispersible tablet contains 5 mg of montelukast as montelukast sodium.
Other components of the medicine:
Milukante 5 mg chewable and dispersible tablets
Microcrystalline cellulose, mannitol, crospovidone, iron oxide red (E 172), hydroxypropylcellulose, disodium edetate, cherry flavour, aspartame (E 951), talc, magnesium stearate.
What Milukante looks like and contents of the pack
Milukante 5 mg chewable and dispersible tablets are pink, round, biconvex tablets with "M5" embossed on one side.
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 European Economic Area countries under the following names:
{Poland} {Milukante}