Milukante

Patient Information Leaflet

Milukante
10 mg, film-coated tablets
Montelukastum
Please read the entire leaflet before using this medicine, as it contains
important information for the patient

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Leaflet 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 and trigger allergy symptoms. By blocking the action of leukotrienes, Milukante relieves asthma symptoms and helps control asthma, as well as alleviates symptoms of seasonal allergic rhinitis (also known as hay fever). Milukante is indicated for use in patients aged above 15 years.

Your doctor has prescribed Milukante for the treatment of asthma to prevent the occurrence of asthma symptoms during the day and night.

• Milukante is used in the treatment of patients in whom adequate asthma control has not been achieved with previously used medications and additional therapy is required.
• Milukante also helps prevent exercise-induced bronchoconstriction.
• Milukante is also used in the treatment of symptoms of seasonal allergic rhinitis.

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

What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing increases and decreases in response to various triggers.
• Airway hyperresponsiveness, meaning 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.

Symptoms of asthma include coughing, wheezing, and chest tightness.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions of the body, often triggered by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include nasal congestion, runny nose, nasal itching, sneezing, watery eyes, eye swelling, redness, and itching of the eyes.

2. Important information before using Milukante

Inform your doctor about any current or past medical conditions and allergies.

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 treatment with Milukante, discuss it with your doctor or pharmacist.

• If asthma symptoms worsen or breathing becomes difficult, contact your doctor immediately.
• 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 the patient continues to take all asthma medications prescribed by their doctor. Milukante should not be used as a substitute for other asthma medications prescribed by the doctor.
• Be aware 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 their 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 during treatment with montelukast, consult a doctor.

Children and adolescents

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 with other medicines

Some medicines may affect the action of Milukante or Milukante may affect the action of other medicines the patient is currently or recently taking, or plans to take.

Inform your doctor or pharmacist about all medicines the patient is currently or recently taking, or plans to take.

Milukante may be used together with other medicines used in the treatment of asthma. Inform your doctor before starting Milukante if the patient 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),
• gemfibrozil (used to lower blood triglyceride levels and increase levels of "good" cholesterol (HDL fraction)).

Milukante with food and drink

Milukante 10 mg film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, 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 planning to breastfeed, she should consult her doctor before using Milukante.

Driving and using machines

Milukante is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness), although very rare with Milukante, may affect the ability to drive or operate machinery.

Milukante contains lactose

Milukante 10 mg film-coated tablets contain lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Milukante contains sodium

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

3. How to use Milukante

• Take only one Milukante tablet once daily, as directed by your 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, consult your doctor or pharmacist.
• The medicine is taken orally.

Use in adults and adolescents aged 15 years and older

For patients with asthma or with asthma and seasonal allergic rhinitis, take 1 film-coated 10 mg tablet of Milukante once daily in the evening.

For patients with symptoms of seasonal allergic rhinitis, take 1 film-coated 10 mg tablet of Milukante once daily. The timing of administration will be determined individually by the doctor according to the patient's needs.

The medicine can be taken with or without food.

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 reported symptoms include: 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 a dose is missed, return to the regular 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 your 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them. If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

During clinical trials using montelukast in the form of chewable 4 mg tablets, the most commonly reported side effects considered to be 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 in the form of 10 mg film-coated tablets and 5 mg chewable tablets, the following were reported:

• headache

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

The frequency of the possible side 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)

Furthermore, after the medicine was placed on the market, the following side effects have been 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 in breathing or swallowing (Uncommon);
• changes in behaviour and mood [unusual dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, restlessness, hyperactivity, including aggressive behaviour or hostility, depression (Uncommon); tremor, attention disorders, memory disorders (Rare); hallucinations, disorientation, suicidal thoughts and suicide attempts (Very rare)];
• dizziness, drowsiness, tingling or 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, oedema (Uncommon);
• stuttering (Very rare).

In patients with asthma treated with montelukast, very rare cases of a group of symptoms known as Churg-Strauss syndrome have been reported, including flu-like symptoms, tingling or numbness in the hands and feet, worsening of respiratory symptoms, and (or) rash. If your child develops any of these symptoms, contact your doctor immediately.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side 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.
Side effects can also be reported to the marketing authorisation holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Milukante

Keep this medicine out of sight and reach of children.
No special precautions for storage are required.
Do not use Milukante 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 what to do with 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 (in the form of montelukast sodium).
Each film-coated tablet contains 10 mg of montelukast in the form of montelukast sodium.
Other components of the medicine:
Tablet core:
Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, disodium edetate,
magnesium stearate.
Tablet coating:
Hypromellose 6 cP, hydroxypropylcellulose, titanium dioxide, iron oxide yellow (E172), iron oxide red (E172).
What Milukante looks like and contents of the pack
Milukante 10 mg film-coated tablets are beige, round, coated 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}