Promonta 4 mg

Package leaflet: Information for the user

Promonta 4 mg
4 mg, chewable tablets
Montelukastum
For children aged 2 to 5 years
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents:

1. What Promonta 4 mg is and what it is used for
2. What you need to know 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 pack and other information

1. What Promonta 4 mg is and what it is 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 effects of leukotrienes, Promonta 4 mg helps relieve asthma symptoms and helps control asthma.
Your doctor has prescribed Promonta 4 mg for the treatment of asthma in the child, to prevent asthma symptoms during the day and at night.

• Promonta 4 mg is used in the treatment of patients aged 2 to 5 years in whom adequate asthma control has not been achieved with previously used medications and additional therapy is required.
• Promonta 4 mg may also be used as an alternative to inhaled glucocorticosteroids in children aged 2 to 5 years who have not recently received oral glucocorticosteroids for asthma treatment and who are unable to use inhaled glucocorticosteroids.
• Promonta 4 mg also helps prevent exercise-induced narrowing of the airways in children aged 2 years and older.

Your doctor will determine how to use Promonta 4 mg in the child, depending on the symptoms present and the 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 sensitivity, whereby the airways react to many factors, such as cigarette smoke, 1/6

pollen, cold air, or physical exertion.

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

Symptoms of asthma include coughing, wheezing, and a feeling of tightness in the chest.

2. Information before using Promonta 4 mg

You should inform the doctor about any health conditions and allergies currently present or previously experienced by the child.

When not to use Promonta 4 mg

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

Warnings and precautions

Before starting treatment with Promonta 4 mg, discuss it with the doctor or pharmacist.

• If the child's asthma symptoms worsen or if breathing difficulties occur, contact the doctor immediately.
• Promonta 4 mg tablets for chewing and sucking are intended for oral use and are not meant for treating acute asthma attacks. If an asthma attack occurs, follow the doctor's instructions. Always keep a rescue inhaler available for immediate use in case of an asthma attack.
• It is important that the child takes all asthma medications prescribed by the doctor. Promonta 4 mg should not be used instead of other asthma medications prescribed by the doctor.
• Be aware that if a child taking asthma medications develops symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms, and/or rash, medical advice should be sought.
• Do not give the child acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma symptoms in the child.

Neuropsychiatric events (e.g. behavioral and mood changes, depression, suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur during treatment with montelukast, contact the doctor.

Children and adolescents

Promonta 4 mg, chewable and suckable tablets, are not recommended for use in children under 2 years of age.

For children aged 6 to 14 years, Promonta 5 mg chewable and suckable tablets are available.

For adults and adolescents aged 15 years and older, Promonta 10 mg 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.

Tell the doctor or pharmacist about all medicines currently used or recently used by the child, as well as any medicines the child plans to take.

Before starting treatment with Promonta 4 mg, inform the 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 certain other infections).

Taking Promonta 4 mg with food and drink

Promonta 4 mg chewable and suckable tablets should not be taken during meals. The medicine should be taken at least one hour before a meal or two hours after a meal.

Pregnancy and breastfeeding

This section of the leaflet does not apply to Promonta 4 mg chewable and suckable tablets, as they are intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.

Use during pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before using Promonta 4 mg. The doctor will assess whether it is safe to take Promonta 4 mg during pregnancy.

Use during breastfeeding

It is not known whether Promonta 4 mg passes into breast milk. Therefore, if a woman is breastfeeding or planning to breastfeed, she should consult her doctor before using Promonta 4 mg.

Driving and using machines

This section of the leaflet does not apply to Promonta 4 mg chewable and suckable tablets, as they are intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.

Promonta 4 mg 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), which have been reported very rarely with Promonta 4 mg, may affect the ability to drive or operate machinery.

Promonta 4 mg contains aspartame

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

Promonta 4 mg contains sodium

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

3. How to use Promonta 4 mg

This medicine should be given to a child under the supervision of an adult.
The child should be given only one tablet of Promonta 4 mg once daily, as directed by the doctor.
The medicine should be used even when the child does not have asthma symptoms, as well as during an acute asthma attack.
Promonta 4 mg should always be used in the child exactly as prescribed by the doctor. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally.
Children aged 2 to 5 years:
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The recommended dose is one chewable tablet of Promonta 4 mg once daily in the evening. Promonta 4 mg chewable tablets should not be given 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 child is not taking any other medicine containing the same active substance, montelukast.
Use of a higher than recommended dose of Promonta 4 mg
Contact a doctor immediately for advice. In most cases, no adverse effects have been reported following overdose. The most commonly reported symptoms of overdose in adults and children include: abdominal pain, drowsiness, increased thirst, headache, vomiting, and hyperkinesia.
Missed dose of Promonta 4 mg
Promonta 4 mg should be used as directed by the doctor. However, if the child forgets to take a dose, resume the usual dosing schedule—one tablet once daily. Do not take a double dose to make up for the missed dose.
Stopping treatment with Promonta 4 mg
Promonta 4 mg is effective in treating asthma only when taken regularly. It is important that the child continues taking Promonta 4 mg for as long as prescribed by the doctor. This will help keep the child's asthma under control.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
In clinical trials using montelukast 4 mg in the form of chewable tablets, the most commonly reported adverse reactions (occurring in at least 1 in 100, but less than 1 in 10 patients treated), considered to be related to montelukast administration, were:
abdominal pain,
excessive thirst.

Additionally, in clinical trials using montelukast in 10 mg film-coated tablets and 5 mg chewable tablets, the following were reported:

• headache.

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

Furthermore, since the medicine has been marketed, the following adverse reactions 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 enzyme activity

Uncommon (may affect up to 1 in 100 people):
allergic reactions, including facial, lip, tongue, and (or) throat swelling, which may cause difficulty in breathing or swallowing

• changes in behaviour and mood, unusual dreams including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation, including aggressive behaviour or hostility, depression
• dizziness, drowsiness, tingling and (or) numbness, seizures
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• weakness/fatigue, malaise, oedema
• joint and muscle pain, muscle twitching

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

• tremor, attention disorders, memory impairment, palpitations

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

• hallucinations, disorientation
• suicidal thoughts and suicide attempts
• swelling (inflammation) of the lungs, hepatitis, tender red subcutaneous nodules, most commonly appearing on the shins (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without prior symptoms, stuttering.

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

For more detailed information about adverse reactions, consult your doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C
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 responsible entity.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Promonta 4 mg

Keep this 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.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. This will help protect the environment.

6. Contents of the pack and other information

What Promonta 4 mg contains
The active substance is montelukast (as montelukast sodium).
Each chewable tablet contains 4 mg of montelukast as montelukast sodium.
The other ingredients are:
Microcrystalline cellulose, mannitol, crospovidone, iron oxide red (E172), hydroxypropylcellulose, disodium edetate, cherry flavour, aspartame (E951), talc, magnesium stearate.

What Promonta 4 mg looks like and contents of the pack
Promonta 4 mg chewable tablets are pink, oval-shaped tablets with "M4" embossed on one side.
Promonta 4 mg is available in aluminium/aluminium blisters containing 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +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 medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Promonta 4 mg
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