Milukante

Package Leaflet: Information for the Patient

Milukante

10 mg, coated tablets

Montelukast

Read the package leaflet carefully before taking the medicine, 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

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

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 who have not achieved adequate control of asthma with their current medications and require additional medications.
• Milukante also helps prevent bronchospasm caused by physical exertion.
• Milukante is also used in the treatment of symptoms of seasonal allergic rhinitis.

Your doctor will determine how to take Milukante, depending on the symptoms and 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, pollen, cold air, or physical exertion.
• swelling (inflammation) of the lining of the airways.

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

What are Seasonal Allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose, itchy nose, sneezing, tearing, swelling, redness, and itching of the eyes.

2. Important information before taking Milukante

Inform your doctor about any current or past illnesses and allergies.

When not to take Milukante

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

Warnings and precautions

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

• If your asthma symptoms worsen or you experience breathing difficulties, seek medical attention immediately.
• Milukante is not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always carry a rescue inhaler with you in case of an asthma attack.
• It is essential to take all asthma medications prescribed by your doctor. Do not take Milukante instead of other asthma medications prescribed by your doctor.
• Remember that if you are taking asthma medications and experience symptoms such as flu-like symptoms, tingling or numbness in your hands or feet, worsening respiratory symptoms, and (or) rash, you should consult your doctor.
• Do not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your asthma symptoms.

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you experience such symptoms while taking montelukast, consult your doctor.

If you experience any of these symptoms while taking montelukast, consult your doctor.

Children and adolescents

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

For children aged 6 to 14 years, Milukante chewable tablets 5 mg are available.

Milukante and other medicines

Some medicines may affect the action of Milukante or Milukante may affect the action of other medicines you are taking.

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Milukante can be taken with other asthma medications.

Before taking Milukante, inform your doctor if you are taking any of the following medicines:

• 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 10 mg coated tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Women who are pregnant or planning 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 you are breastfeeding or plan to breastfeed, consult your doctor before taking Milukante.

Driving and using machines

It is unlikely that Milukante will affect your ability to drive or use machines. However, individual responses 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 your ability to drive or use machines.

Milukante contains lactose

Milukante 10 mg coated tablets contain lactose. If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

Milukante contains sodium

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

3. How to take Milukante

• Take only one Milukante tablet once a day, as directed by your doctor.
• Take the medicine even when you do not have asthma symptoms, as well as during an acute asthma attack.
• Always take Milukante as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• Take the medicine orally.

Use in adults and adolescents over 15 years of age

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

For patients with seasonal allergic rhinitis, take one 10 mg Milukante coated tablet once daily. The time of administration will be determined by your doctor, according to your individual needs.

The medicine can be taken with or without food.

Make sure that the patient taking Milukante does not take any other medicines containing the same active substance, montelukast.

Overdose of Milukante

Seek medical attention immediately.

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 reported: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missed dose of Milukante

Take Milukante as directed by your doctor. However, if you miss a dose, return to your 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 your doctor has prescribed it.

This will help keep your asthma under control.

If you have any further doubts about taking this medicine, consult 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 becomes serious or you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

During clinical trials with montelukast in the form of 4 mg chewable tablets, the most common side effects (occurring in at least 1 in 100 but less than 1 in 10 children) considered to be related to montelukast were:

• abdominal pain
• increased thirst. Additionally, in clinical trials with montelukast in the form of 10 mg 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 montelukast 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 (affecting at least 1 in 10 people)

Common (affecting 1 to 10 people in 100)

Uncommon (affecting 1 to 10 people in 1,000)

Rare (affecting 1 to 10 people in 10,000)

Very rare (affecting less than 1 in 10,000 people)

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 can 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 behavior or hostile attitude, depression (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 (hepatitis) (very rare);
• rash (common); bruising, itching, hives (uncommon); painful, red lumps under the skin, most often on the shins (erythema nodosum), severe skin reactions (erythema multiforme), 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 in the hands and feet, worsening respiratory symptoms, and (or) rash (Churg-Strauss syndrome) have been reported. If your child experiences any of these symptoms, inform your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Milukante

Keep the medicine out of the sight and reach of children.

No special precautions for storage are necessary.

Do not use Milukante after the expiry date stated on the blister pack 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 (in the form of montelukast sodium).

One coated tablet contains 10 mg of montelukast in the form of montelukast sodium.

Other ingredients of the medicine:

Tablet core:

microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, disodium edetate, magnesium stearate.

Tablet coating:

hypromellose 6cP, hydroxypropylcellulose, titanium dioxide, yellow iron oxide (E172), red iron oxide (E172).

What Milukante looks like and contents of the pack

Milukante 10 mg coated tablets are beige, round, coated 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 last revision of the leaflet:05.2024