Asmenol

Package leaflet: Information for the patient

Asmenol
5 mg, chewable tablets
Montelukastum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

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

Table of contents

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

1. What Asmenol is and what it is used for

The active substance in Asmenol is montelukast, which is a leukotriene receptor antagonist.
It blocks the action of naturally occurring substances in the lungs called leukotrienes. These
substances cause narrowing of the airways and inflammation in the lungs, which may lead to
asthma symptoms.
Regular use of Asmenol helps relieve asthma symptoms, such as shortness of breath, and prevents asthma attacks.
Asmenol is prescribed in the following cases:

• when adequate asthma control cannot be achieved with other medications and additional treatment is required;
• for the prevention of exercise-induced bronchoconstriction;
• as an alternative treatment in children aged 6 to 14 years who are unable to use inhaled corticosteroid aerosols.

What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing increases and decreases in response to various triggers.
• Airway hyperresponsiveness, where 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.

2. Important information before taking Asmenol
When not to take Asmenol

• if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Asmenol, discuss it with your doctor or pharmacist.
If your child's asthma worsens or breathing difficulties increase, inform your doctor immediately.
Please remember that Asmenol is not intended for the treatment of acute asthma attacks. It will not help in such cases and should never be used for this purpose. In the event of an asthma attack, give your child the medicine prescribed for such emergencies and follow your doctor's instructions precisely. It is very important that the medicine needed during an asthma attack (i.e., a short-acting inhaled beta-agonist, also known as a bronchodilator, in an inhaler) is always readily available.
If your child needs to use the inhaled beta-agonist more frequently than usual, consult your doctor as soon as possible.
It is important that your child takes all asthma medications prescribed by the doctor. Asmenol should not replace any inhaled or oral steroid medications your child is currently taking.
You should also inform your doctor if, during treatment with Asmenol, your child develops any of the following symptoms: flu-like symptoms, sensory disturbances such as tingling or numbness in the limbs, worsening respiratory symptoms, and/or skin rash.
Your doctor will decide on further management.
You should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your asthma symptoms.
Inform your doctor about any current or past medical conditions and allergies your child may have.

Children and adolescents
For children aged 6 months to 5 years, Asmenol Mini 4 mg granules are available.
For children aged 2 to 5 years, 4 mg chewable tablets are available.
For children aged 6 to 14 years, 5 mg chewable tablets are available.
For patients aged 15 years and older, 10 mg coated tablets are available.

Asmenol and other medicines
Tell your doctor or pharmacist about any other medicines your child is currently taking, has recently taken, or might take in the future.
Asmenol can be taken together with other medicines used in asthma treatment.
However, some medicines may affect the action of Asmenol, and conversely, Asmenol may affect the action of certain other medicines.
It is especially important to inform your doctor if your child is taking phenobarbital or phenytoin (medicines used to treat epilepsy) or rifampicin (a medicine used to treat tuberculosis and certain other infections) or gemfibrozil (a medicine used to treat high plasma lipid levels). In such cases, caution should be exercised, particularly in children.

Asmenol with food and drink
Asmenol 5 mg chewable tablets should be taken 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding
This section does not apply to Asmenol 5 mg chewable tablets, as this dosage form is indicated for children aged 6 to 14 years. However, the following information refers to the active substance, montelukast.
Limited data on the use of the medicine during pregnancy do not indicate a causal relationship between montelukast use and congenital malformations (such as limb defects), which have been rarely reported worldwide since the medicine was introduced.
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will assess whether Asmenol can be used during this period.
Breastfeeding
It is not known whether the medicine passes into human milk. Therefore, if you are breastfeeding or intend to breastfeed, consult your doctor before using this medicine.
Your doctor will discuss further management with you.

Driving and operating machinery
Asmenol generally does not impair the ability to drive or operate machinery. However, the effect of the medicine may vary between individuals. In very rare cases, dizziness and drowsiness have been reported, which may affect reaction ability.

Asmenol contains aspartame
This medicine contains a source of phenylalanine. It may be harmful to patients with phenylketonuria.
Each 5 mg tablet contains phenylalanine equivalent to 3.37 mg of phenylalanine per dose.

3. How to use Asmenol

This medicine should always be taken as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
The doctor will decide on the method of administration of Asmenol based on the child's
asthma symptoms and their severity.
It is important that the child takes Asmenol every evening as directed by the doctor.
The medicine should be taken even when the child has no symptoms and on days when
an asthma attack occurs.
The child should also continue taking all other asthma medications prescribed by the doctor.
Asmenol must not be used instead of other medicines.
This is an oral medicine.
The usual dose is:
Children aged 6 to 14 years:
1 chewable tablet of 5 mg Asmenol once daily in the evening. The child should take the tablet
at least 1 hour before or 2 hours after a meal.
If the patient is taking Asmenol, ensure they are not taking other medicines containing
the same active substance, montelukast.
Taking more Asmenol than recommended
Seek immediate medical advice.
In most reports of overdose, no adverse effects were observed.
The most commonly reported symptoms following overdose in adults and children were:
abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If a dose of Asmenol is missed
Try to give the medicine as directed by the doctor. However, if a dose is missed,
return to the regular dosing schedule—one tablet once daily. Do not take a double dose
to make up for the missed dose.
Stopping Asmenol treatment
It is important that the child continues taking Asmenol for as long as the doctor has instructed,
regardless of whether symptoms are present or not. Asmenol can be effective in treating asthma
only if treatment is continued.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

In clinical studies using montelukast at a dose of 5 mg, the following adverse reaction was most frequently reported (in less than 1 in 10 patients taking the medicine), probably related to the use of montelukast:

• headache.

Additionally, in clinical studies of montelukast at a dose of 10 mg, the following adverse reaction was reported:

• abdominal pain.

These were usually mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet containing no active ingredient).

The frequency of the possible adverse reactions listed below is defined using the following convention:

• very common (affects more than 1 in 10 patients)
• common (affects less than 1 in 10 patients)
• uncommon (affects less than 1 in 100 patients)
• rare (affects less than 1 in 1,000 patients)
• very rare (affects less than 1 in 10,000 patients).

Furthermore, since the medicine has been marketed, the following adverse reactions have been reported:

• upper respiratory tract infection (very common),
• increased tendency to bleeding (rare),
• allergic reactions, including swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing (uncommon),
• changes in behaviour and mood: sleep disorders, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling of anxiety, restlessness, especially motor restlessness, agitation, including aggressive behaviour or hostility, depression (uncommon); tremor, attention disorders, memory disorders (rare); hallucinations, disorientation, suicidal thoughts and behaviour (very rare),
• dizziness, drowsiness, tingling and (or) numbness, seizures (uncommon),
• palpitations (rare),
• nosebleeds (uncommon),
• diarrhoea, nausea, vomiting (common); dryness of the mouth, dyspepsia (uncommon),
• hepatitis (very rare),
• rash (common); bruising, itching, urticaria (uncommon); tender, red nodules under the skin, most commonly appearing on the lower legs (erythema nodosum), severe skin reactions (erythema multiforme), which may occur without warning (very rare),
• joint or muscle pain, muscle cramps (uncommon),
• fever (common); weakness, fatigue, malaise, oedema (uncommon).

Very rare cases of a syndrome involving symptoms such as influenza-like symptoms, tingling or numbness in the hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) have been observed in patients with asthma treated with montelukast. If your child develops one or more of these symptoms, contact your doctor immediately.

For detailed information about the medicine's 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 of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]

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 the medicine Asmenol

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.
The marking on the blister after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Asmenol contains

• The active substance is montelukast (as montelukast sodium). Each chewable tablet contains 5 mg of montelukast as montelukast sodium.
• The other ingredients are: microcrystalline cellulose, mannitol, crospovidone (type B), iron oxide red (E172), hydroxypropyl cellulose, disodium edetate, cherry flavour, aspartame (E951), talc, magnesium stearate.

What Asmenol looks like and contents of the pack
Asmenol 5 mg chewable tablets are pink, round tablets with "M5" embossed on one side.
Asmenol is available in aluminium/aluminium blisters containing 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works SA
Pelplińska Street 19
83-200 Starogard Gdanski
Poland

Manufacturer
POLPHARMA Pharmaceutical Works SA
Pelplińska Street 19
83-200 Starogard Gdanski
Poland
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia