Promonta 10 mg

Package Leaflet: Information for the User

Promonta 10 mg

10 mg, coated tablets

Montelukast

For adults and adolescents 15 years and older

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.

Table of Contents of the Leaflet:

• 1. What is Promonta 10 mg and what is it used for
• 2. Important information before taking Promonta 10 mg
• 3. How to take Promonta 10 mg
• 4. Possible side effects
• 5. How to store Promonta 10 mg
• 6. Contents of the pack and other information

1. What is Promonta 10 mg and what is it used for

Promonta 10 mg is a leukotriene receptor antagonist, which blocks the action of substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways and cause allergy symptoms. By blocking the action of leukotrienes, Promonta 10 mg relieves symptoms of asthma and helps control asthma, as well as relieves symptoms of seasonal allergic rhinitis (also known as hay fever).

• Promonta 10 mg is used to treat patients who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Promonta 10 mg also helps prevent narrowing of the airways caused by physical exertion.
• In patients with asthma, Promonta 10 mg may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to take Promonta 10 mg, depending on your symptoms and the severity of your asthma.

What is asthma?

Asthma is a chronic disease.

• Difficulty breathing due to narrowing of the airways, which worsens and improves in response to various factors.

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• Sensitivity of the airways, which react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• Inflammation (swelling) of the lining of the airways.

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

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions to substances in the air, such as tree, grass, and weed pollen. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose, itching of the nose, sneezing, tearing, swelling, redness, and itching of the eyes.

2. Important information before taking Promonta 10 mg

Tell your doctor about any illnesses and allergies you have now or have had in the past.

When not to take Promonta 10 mg

Warnings and precautions

Before taking Promonta 10 mg, discuss it with your doctor or pharmacist.

• If your asthma symptoms worsen or you have difficulty breathing, seek medical attention immediately.
• Promonta 10 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 10 mg instead of other asthma medications prescribed by your doctor.
• If you are taking asthma medications and experience symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and/or rash, seek medical attention.
• 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 (such as 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

Children under 15 years of age should not take Promonta 10 mg.

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

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

Promonta 10 mg and other medicines

Some medicines may affect the action of Promonta 10 mg or Promonta 10 mg may affect the action of other medicines you are taking.

Tell your doctor or pharmacist about all medicines you are taking or plan to take.

Before taking Promonta 10 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),
• gemfibrozil (used to treat high lipid levels in the blood).

Taking Promonta 10 mg with food and drink

Promonta 10 mg can be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before taking Promonta 10 mg. The doctor will assess whether it is possible to take Promonta 10 mg during this period.

Use during breastfeeding

It is not known whether Promonta 10 mg passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Promonta 10 mg.

Driving and using machines

Promonta 10 mg is unlikely to affect your ability to drive or use machines. However, some side effects (such as dizziness and drowsiness), which have been reported very rarely, may affect your ability to drive or use machines.

Promonta 10 mg contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

Promonta 10 mg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be essentially sodium-free.

3. How to take Promonta 10 mg

Take only one tablet of Promonta 10 mg once daily, as directed by your doctor.

Take this medicine even when you do not have symptoms of asthma, and also when you have an acute asthma attack.

Always take this medicine exactly as your doctor has told you.

If you are unsure, consult your doctor or pharmacist.

Take the medicine orally.

Adults and adolescents 15 years and older:

The recommended dose is one 10 mg tablet once daily, in the evening.

Promonta 10 mg can be taken with or without food.

If you are taking Promonta 10 mg, make sure you are not taking any other medicine that contains the same active substance, montelukast.

What to do if you take more Promonta 10 mg than you should

Contact your doctor immediately.

In most cases of overdose, no adverse effects have been reported. The most common symptoms of overdose reported in adults and children are:

abdominal pain, drowsiness, increased thirst, headache, vomiting, and hyperactivity.

What to do if you forget to take Promonta 10 mg

Take Promonta 10 mg as directed by your doctor. However, if you forget to take a dose, return to your usual dosing schedule - one tablet once daily.

Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Promonta 10 mg

Promonta 10 mg is effective in treating asthma only when taken regularly.

It is essential to continue taking Promonta 10 mg for as long as your doctor has prescribed.

This will help keep your asthma under control.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Promonta 10 mg can cause side effects, although not everybody gets them.

In clinical trials with montelukast 10 mg tablets, the most common side effects (occurring in at least 1 in 100, but less than 1 in 10 patients) considered to be related to montelukast were:

abdominal pain,

headache.

These symptoms were usually mild and occurred more frequently in patients taking montelukast than in patients taking placebo (a tablet that does not contain any medicine).

Additionally, the following side effects have been reported after the marketing of the medicine:

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 activity of 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

• changes in behavior and mood, unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation, including aggressive behavior or hostility, 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 1,000 people)

increased tendency to bleed

• tremors, attention disturbances, memory disturbances, palpitations

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

• hallucinations, disorientation
• suicidal thoughts and attempts
• inflammation of the lungs (pneumonia) inflammation of the liver (hepatitis) red, lumpy rash (erythema multiforme), which can occur without warning
• severe skin reactions (Stevens-Johnson syndrome), which can occur without warning
• 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 respiratory symptoms, and/or rash (Churg-Strauss syndrome) have been reported. If you experience one or more of these symptoms, contact 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 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 to gather more information on the safety of this medicine.

5. How to store Promonta 10 mg

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

No special precautions for storage are necessary.

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Do not use this medicine 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 how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Promonta 10 mg contains

The active substance is montelukast (as montelukast sodium).

One coated tablet contains 10 mg of montelukast (as montelukast sodium).

The other ingredients are:

Core:

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

Coating:

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

What Promonta 10 mg looks like and contents of the pack

Promonta 10 mg coated tablets are beige, round, coated tablets.

Promonta 10 mg is available in OPA/Aluminum/PVC/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 10 mg

Date of last revision of the leaflet:June 2025

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