Promonta 5 mg

Package Leaflet: Information for the User

Promonta 5 mg

5 mg, chewable tablets

Montelukast

For children from 6 to 14 years of age

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• 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.

Contents of the pack:

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

1. What is Promonta 5 mg and what is it used for

Promonta 5 mg is a leukotriene receptor antagonist, which blocks the action of substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Promonta 5 mg relieves asthma symptoms and helps control asthma.

Your doctor has prescribed Promonta 5 mg for the treatment of asthma in your child, to prevent asthma symptoms during the day and night.

• Promonta 5 mg is used for the treatment of patients from 6 to 14 years of age who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Promonta 5 mg may also be used instead of inhaled corticosteroids in children from 6 to 14 years of age who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Promonta 5 mg also helps prevent narrowing of the airways caused by physical exertion.

Your doctor will determine how to take Promonta 5 mg, depending on the symptoms and severity of asthma in your child.

What is asthma?

Asthma is a chronic disease.

In asthma, there are:

• breathing difficulties caused by narrowing of the airways, which 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.
• inflammation (swelling) of the lining of the airways.

Asthma symptoms include: coughing, wheezing, and feeling of chest tightness.

2. Important information before taking Promonta 5 mg

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

When not to take Promonta 5 mg

Warnings and precautions

• Promonta 5 mg 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 Promonta 5 mg instead of other asthma medications prescribed by your doctor.
• Do not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your 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 while taking montelukast,

contact your doctor immediately.

Children and adolescents

For children from 2 to 5 years of age, Promonta 4 mg chewable tablets are available.

For patients from 15 years of age, Promonta 10 mg film-coated tablets are available.

Promonta 5 mg and other medicines

Some medicines may affect the action of Promonta 5 mg or Promonta 5 mg 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.

Before taking Promonta 5 mg, inform your doctor if you are 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 5 mg with food and drink

Do not take Promonta 5 mg chewable tablets during meals; take the medicine 1 hour before a meal or 2 hours after a meal.

Pregnancy and breastfeeding

Pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before taking Promonta 5 mg. The doctor will assess whether it is possible to take Promonta 5 mg during this period.

Breastfeeding

It is not known whether Promonta 5 mg passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Promonta 5 mg.

Driving and using machines

It is unlikely that Promonta 5 mg will affect your ability to drive or use machines. However, the reaction to the medicine may vary from person to person.

Some side effects (such as dizziness and drowsiness), which have been very rarely reported during treatment with Promonta 5 mg, may affect your ability to drive or use machines.

Promonta 5 mg contains aspartame

The medicine contains 6 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 elimination.

Promonta 5 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 5 mg

Take only one Promonta 5 mg tablet once daily, as directed by your doctor.

Take the medicine even if your child does not have asthma symptoms, as well as when they experience an acute asthma attack.

Always take Promonta 5 mg as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Take the medicine orally.

Children from 6 to 14 years of age:

The recommended dose is one Promonta 5 mg chewable tablet once daily, in the evening.

Do not take Promonta 5 mg chewable tablets during meals; take the medicine at least 1 hour before a meal or 2 hours after a meal.

Chew the tablet before swallowing.

Make sure your child does not take any other medicine containing the same active substance, montelukast.

Taking a higher dose of Promonta 5 mg than recommended

Consult your doctor immediately 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 5 mg

Take Promonta 5 mg 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 Promonta 5 mg

Promonta 5 mg is effective in treating asthma only if taken regularly.

It is essential to take Promonta 5 mg for as long as your doctor recommends. This will help keep your child's 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, Promonta 5 mg can cause side effects, although not everybody gets them.

In clinical trials with montelukast, 5 mg 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:

headache.

In addition, in clinical trials with montelukast, 10 mg film-coated tablets, the following side effects were reported:

• abdominal pain.

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 marketed, the following side effects were 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 face, lip, tongue, and (or) throat swelling, which may cause difficulty breathing or swallowing

• 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 / fatigue, 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
• lung inflammation (pneumonia), liver inflammation (hepatitis), tender, red, purple spots on the skin, usually 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 syndrome of symptoms such as flu-like symptoms, tingling or numbness of hands or feet, worsening of respiratory symptoms, and (or) rash (Churg-Strauss syndrome) have been reported. If you experience one or more of these symptoms, inform your doctor immediately.

For more detailed information on side effects, consult your doctor or pharmacist.

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 Monitoring, 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. Side effects can also be reported to the marketing authorization holder.

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

5. How to store Promonta 5 mg

Keep the 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Promonta 5 mg contains

The active substance is montelukast (as montelukast sodium).

One chewable tablet contains 5 mg of montelukast (as montelukast sodium).

The other ingredients are:

microcrystalline cellulose, mannitol, crospovidone, red iron oxide (E172), hydroxypropylcellulose, disodium edetate, cherry flavor, aspartame (E951), talc, magnesium stearate.

What Promonta 5 mg looks like and contents of the pack

Promonta 5 mg chewable tablets are pink, round tablets with "M5" embossed on one side.

Promonta 5 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, 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Promonta 5 mg

Date of last revision of the leaflet:June 2025