Promonta 5 mg

Package leaflet: Information for the user

Promonta 5 mg
5 mg, chewable tablets
Montelukast
For children aged 6 to 14 years
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

Promonta 5 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 5 mg relieves asthma symptoms and helps control asthma.
Your doctor has prescribed Promonta 5 mg for the treatment of asthma in the child to prevent daytime and nighttime asthma symptoms.

• Promonta 5 mg is used in the treatment of patients aged 6 to 14 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Promonta 5 mg may also be used instead of inhaled glucocorticosteroids in children aged 6 to 14 years who have not recently taken oral glucocorticosteroids for asthma treatment and who are unable to use inhaled glucocorticosteroids.
• Promonta 5 mg also helps prevent exercise-induced narrowing of the airways.

Your doctor will determine how to use Promonta 5 mg depending on the patient's symptoms and 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 hyperresponsiveness, in which the airways react 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 tightness in the chest.
1/6

2. Important information before using Promonta 5 mg

You should inform your doctor about any medical conditions and allergies currently present or experienced in the past.

When not to use Promonta 5 mg

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

Warnings and precautions

• If asthma symptoms worsen or breathing difficulties occur, contact your doctor immediately.
• Promonta 5 mg oral tablets are not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep a rescue inhaler available for immediate use in case of an asthma attack.
• It is important that the patient takes all anti-asthma medications prescribed by the doctor. Promonta 5 mg should not be used instead of other anti-asthma medications prescribed by the doctor.
• Remember that if a patient taking anti-asthma medications develops additional symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening respiratory symptoms and/or rash, medical advice should be sought.
• The patient should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if these worsen asthma symptoms.

Neuropsychiatric events (e.g. changes in behaviour and mood, 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 your doctor immediately.

Children and adolescents
Promonta 4 mg chewable tablets are available for children aged 2 to 5 years.
Promonta 10 mg film-coated tablets are available for patients aged 15 years and older.

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 the patient is taking.
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Before starting Promonta 5 mg, inform your doctor if the patient 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). 2/6

Taking Promonta 5 mg with food and drink
Promonta 5 mg chewable tablets should not be taken during meals; the medicine should be taken 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding
Use during pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before using Promonta 5 mg. The doctor will assess whether it is safe to take Promonta 5 mg during pregnancy.

Use during breastfeeding
It is not known whether Promonta 5 mg passes into breast milk. Therefore, if the patient is breastfeeding or planning to breastfeed, she should consult her doctor before using Promonta 5 mg.

Driving and operating machinery
Promonta 5 mg is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse reactions (such as dizziness and drowsiness), although very rare with Promonta 5 mg, may affect the ability to drive or operate machinery.

Promonta 5 mg contains aspartame
The medicine contains 6 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 5 mg contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Promonta 5 mg

Take only one tablet of Promonta 5 mg once daily, as directed by the physician.
The medicine should be taken even when the patient does not have asthma symptoms, as well as during an acute asthma attack.
Promonta 5 mg should always be taken as directed by the physician. In case of doubt, consult a physician or pharmacist.
The medicine should be taken orally.
Children aged 6 to 14 years:
The recommended dose is one chewable tablet of Promonta 5 mg once daily in the evening. Promonta 5 mg chewable tablets should not be taken 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 patient is not taking any other medicine containing the same active substance, montelukast.
Taking more Promonta 5 mg than recommended
Contact a physician immediately for advice. In most cases of overdose, no adverse effects have been reported. The most commonly reported symptoms of overdose in adults and children include: abdominal pain, drowsiness, increased thirst, headache, vomiting, and hyperactivity.
3/6
Missed dose of Promonta 5 mg
Take Promonta 5 mg as directed by the physician. However, if a dose is missed, resume the regular dosing schedule—one tablet once daily. Do not take a double dose to make up for the missed dose.
Stopping Promonta 5 mg
Promonta 5 mg is effective in treating asthma only when taken regularly. It is important that the patient continues taking Promonta 5 mg for as long as directed by the physician. This will help keep the patient's asthma under control.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
In clinical trials using montelukast 5 mg chewable tablets, the most commonly reported adverse reactions (occurring in at least 1 in 100 but less than 1 in 10 treated patients), considered to be related to montelukast administration, were:
headache.
Additionally, in clinical trials using montelukast 10 mg coated tablets, the following were reported:

• abdominal pain.

These symptoms were usually mild and occurred more frequently in patients taking montelukast than in patients taking placebo (a tablet containing no active drug).
Furthermore, after the medicine was placed on the market, 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):
diarrhoea, 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, anxious feeling, restlessness, agitation, including aggressive behaviour or hostility, depression
• dizziness, drowsiness, tingling and (or) numbness, seizures
• nosebleeds
• dryness of the mouth, dyspepsia
• bruising, itching, urticaria
• weakness / fatigue, malaise, oedema
• joint and muscle pain, muscle cramps

Rare (may affect up to 1 in 1,000 people):
increased tendency to bleed

• tremor, attention disorders, memory disorders, palpitations 4/6

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

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

In patients with asthma treated with montelukast, very rare cases of a syndrome characterised by symptoms such as: influenza-like symptoms, tingling or numbness in the 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, a doctor should be contacted immediately.
For more detailed information on adverse reactions, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Promonta 5 mg

Keep the medicine out of the 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Promonta 5 mg contains
The active substance is montelukast (in the form of montelukast sodium).
One chewable tablet contains 5 mg of montelukast in the form of montelukast sodium.
Other components are:
5/6
Microcrystalline cellulose, mannitol, crospovidone, iron oxide red (E172),
hydroxypropylcellulose, disodium edetate, cherry flavour, 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 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 under the following names:
Poland: Promonta 5 mg
6/6