Promonta 4 mg

Leaflet accompanying the packaging: information for the user

Promonta 4 mg

4 mg, chewable tablets

Montelukast

For children from 2 to 5 years old

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Promonta 4 mg and what is it used for
• 2. Important information before taking Promonta 4 mg
• 3. How to take Promonta 4 mg
• 4. Possible side effects
• 5. How to store Promonta 4 mg
• 6. Contents of the packaging and other information

1. What is Promonta 4 mg and what is it used for

Promonta 4 mg is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Promonta 4 mg alleviates the symptoms of asthma and helps control asthma.
The doctor has prescribed Promonta 4 mg for the treatment of asthma in the child, in order to prevent the occurrence of asthma symptoms during the day and at night.

• Promonta 4 mg is used in the treatment of patients from 2 to 5 years old, in whom adequate control of asthma has not been achieved with the medicines used so far, and additional medicines are necessary.
• Promonta 4 mg may also be used as a substitute for inhaled glucocorticosteroids in children from 2 to 5 years old, who have not recently taken glucocorticosteroids orally for the treatment of asthma and who are unable to use inhaled glucocorticosteroids.
• Promonta 4 mg also helps prevent narrowing of the airways caused by physical exertion in children from 2 years old and older.

The doctor will determine how to take Promonta 4 mg in the child, depending on the symptoms and severity of asthma in the patient.

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.
• sensitivity of the airways, which react to many factors, such as cigarette smoke, 1/6

plant pollen, cold air, or physical exertion.

• swelling (inflammation) of the lining of the airways.

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

2. Important information before taking Promonta 4 mg

You should inform the doctor about any complaints and allergies that the child is currently experiencing or has experienced in the past.

When not to take Promonta 4 mg

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

Warnings and precautions

Before starting to take Promonta 4 mg, you should discuss it with your doctor or pharmacist.

• If the child's asthma symptoms worsen or if they experience breathing difficulties, they should immediately consult their doctor.
• Orally administered Promonta 4 mg is not intended for the treatment of acute asthma attacks. If such an attack occurs, you should follow the doctor's instructions. You should always have a rescue inhaler with you in case of an asthma attack in the child.
• It is important for the child to take all asthma medicines prescribed by their doctor. Promonta 4 mg should not be taken as a substitute for other asthma medicines prescribed by the doctor.
• You should remember that if the child taking asthma medicines experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening of respiratory symptoms, and (or) rash, they should consult their doctor.
• The child should not be given acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen the child's asthma symptoms.

In patients of any age treated with montelukast, various neuropsychiatric events (e.g., changes in behavior and mood, depression, suicidal thoughts) have been reported (see section 4). If such symptoms occur during treatment with montelukast, you should

contact your doctor.

Children and adolescents

Promonta 4 mg, chewable tablets, are not recommended for use in children under 2 years old.
For children from 6 to 14 years old, Promonta 5 mg, chewable tablets, are available.
For adults and adolescents from 15 years old, Promonta 10 mg, film-coated tablets, are available.

Promonta 4 mg and other medicines

Some medicines may affect the action of Promonta 4 mg, or Promonta 4 mg may affect the action of other medicines taken by the child.
You should tell your doctor or pharmacist about all medicines that the child is currently taking or has recently taken, as well as any medicines that the child plans to take.
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Before starting to take Promonta 4 mg, you should inform your doctor if the child is taking any of the following medicines:

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

Taking Promonta 4 mg with food and drink

Promonta 4 mg, chewable tablets, should not be taken during meals; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.

Pregnancy and breastfeeding

This section of the leaflet does not apply to Promonta 4 mg, chewable tablets, as it is intended for use in children from 2 to 5 years old, but the following information applies to the active substance, montelukast.
Use during pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before taking Promonta 4 mg. The doctor will assess whether it is possible to take Promonta 4 mg during this period .
Use during breastfeeding
It is not known whether Promonta 4 mg passes into breast milk. Therefore, if the patient is breastfeeding or plans to breastfeed, they should consult their doctor before taking Promonta 4 mg.

Driving and using machines

This section of the leaflet does not apply to Promonta 4 mg, chewable tablets, as it is intended for use in children from 2 to 5 years old, but the following information applies to the active substance, montelukast.
It should not be expected that Promonta 4 mg will affect the ability to drive and use machines. However, the reaction to the medicine may vary from patient to patient.
Some side effects (such as dizziness and drowsiness), which have been very rarely reported during treatment with Promonta 4 mg, may affect the ability to drive and use machines.

Promonta 4 mg contains aspartame

The medicine contains 4.8 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Promonta 4 mg contains sodium

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

3. How to take Promonta 4 mg

This medicine should be given to the child under adult supervision.
The child should be given only one tablet of Promonta 4 mg once a day, as recommended by the doctor.
The medicine should be taken even when the child does not experience asthma symptoms, as well as when they experience an acute asthma attack.
Promonta 4 mg should always be taken in the child as recommended by the doctor. If there are any doubts, you should consult the doctor or pharmacist.
The medicine should be taken orally.

Children from 2 to 5 years old:

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The recommended dose is one chewable tablet of Promonta 4 mg once a day, in the evening. Promonta 4 mg, chewable tablets, should not be taken during meals; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.
The tablet should be chewed before swallowing.
You should ensure that the child does not take any other medicine containing the same active substance, montelukast.

Taking a higher dose of Promonta 4 mg than recommended

You should immediately consult a doctor for advice. In most cases of overdose, no side effects have been reported. The most commonly reported symptoms of overdose, occurring in adults and children, are: abdominal pain, drowsiness, increased thirst, headache, vomiting, and hyperactivity.

Missing a dose of Promonta 4 mg

Promonta 4 mg should be taken as recommended by the doctor. However, if the child forgets to take a dose, they should return to their usual dosing schedule - one tablet once a day.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Promonta 4 mg

Promonta 4 mg is effective in treating asthma only if it is taken regularly.
It is important for the child to take Promonta 4 mg for as long as the doctor recommends. This will help keep the child's asthma under control.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical trials with montelukast, 4 mg in chewable tablets, the most commonly reported side effects (occurring in at least 1 in 100, but less than 1 in 10 treated patients), which were considered to be related to montelukast, were:
abdominal pain,
increased thirst.
Additionally, in clinical trials with montelukast in 10 mg film-coated tablets and 5 mg chewable tablets, the following have been 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).
Additionally, after the medicine was placed on the market, the following side effects have been reported:

Very common (may affect more than 1 in 10 people):

upper respiratory tract infection

Common (may affect up to 1 in 10 people):

diarrhea, nausea, vomiting
fever
rash
increased liver enzymes

Uncommon (may affect up to 1 in 100 people):

allergic reactions, including swelling of the face, lips, tongue, and (or) throat, which may cause difficulty breathing or swallowing
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• changes in behavior and mood, unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness, hyperactivity, including aggressive or hostile behavior, depression
• dizziness, drowsiness, tingling and (or) numbness, seizures
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• weakness/tiredness, malaise, swelling
• joint and muscle pain, muscle tremors

Rare (may affect up to 1 in 1000 people):

increased tendency to bleeding

• tremors, attention disorders, memory disorders, heart palpitations

Very rare (may affect up to 1 in 10,000 people):

• hallucinations, disorientation
• suicidal thoughts and attempts
• inflammation (inflammation) of the lungs, liver inflammation, tender, red, subcutaneous nodules, most often occurring on the shins (erythema nodosum), severe skin reactions (Stevens-Johnson syndrome), which may occur without prior symptoms, stuttering.

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 or feet, worsening of respiratory symptoms, and (or) rash (Churg-Strauss syndrome) have been reported. You should immediately inform your doctor if one or more of the above symptoms occur.
To obtain more detailed information on side effects, you should consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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 to gather more information on the safety of the medicine.

5. How to store Promonta 4 mg

The medicine should be stored 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.
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Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Promonta 4 mg contains

The active substance of the medicine is montelukast (in the form of montelukast sodium).
One chewable tablet contains 4 mg of montelukast in the form of montelukast sodium.
The other ingredients of the medicine are:
microcrystalline cellulose, mannitol, crospovidone, red iron oxide (E172),
hydroxypropylcellulose, disodium edetate, cherry flavor, aspartame (E951), talc, magnesium stearate.

What Promonta 4 mg looks like and contents of the packaging

Promonta 4 mg chewable tablets are pink, oval tablets with "M4" embossed on one side.
Promonta 4 mg is available in aluminum/aluminum blisters of 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer

HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia
Saneca Pharmaceutical a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Promonta 4 mg
Date of last revision of the leaflet:June 2025
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