Asmenol

Package Leaflet: Information for the Patient

Asmenol

10 mg, coated tablets

Montelukast

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Asmenol and what is it 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 is Asmenol and what is it used for

The active substance of Asmenol is montelukast, which is a leukotriene receptor antagonist.
It blocks the action of substances that occur naturally in the lungs, called leukotrienes. These substances
cause narrowing of the airways and inflammation in the lungs, which can lead to the occurrence of
asthma symptoms.
Leukotrienes also contribute to the occurrence of allergy symptoms. Blocking the action of leukotrienes
relieves the symptoms of seasonal allergies (also known as seasonal allergic rhinitis or hay fever).
Asmenol, when taken regularly, relieves asthma symptoms, such as shortness of breath, and prevents
asthma attacks.
Asmenol is prescribed in the following cases

• if it is not possible to provide adequate asthma treatment with other medicines and additional treatment is necessary.
• to prevent bronchospasm caused by physical exertion.
• to treat asthma and hay fever (seasonal allergic rhinitis) simultaneously in patients with asthma over 15 years of age.

What is asthma?
Asthma is a chronic disease.
In asthma, there are:

• breathing difficulties caused by narrowing of the airways. This narrowing 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 a feeling of chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions of the body, often caused by airborne tree, grass, and weed pollen. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose; sneezing; tearing, swelling, redness, and itching of the eyes

2. Important information before taking Asmenol

When not to take Asmenol

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

Warnings and precautions

Before starting to take Asmenol, discuss it with your doctor or pharmacist.
If asthma symptoms worsen or breathing difficulties occur, inform your doctor immediately.
Remember that Asmenol is not intended for the treatment of acute asthma attacks. In such a case, the medicine will not be helpful and should never be used for this purpose. In the event of an asthma attack, take the medicine intended for use in such emergencies and follow the doctor's instructions exactly. It is very important to always have the medicine needed for an asthma attack (i.e., a short-acting beta-agonist in the form of an inhaler, also known as a bronchodilator) readily available.
If it is necessary to use a beta-agonist inhaler more frequently than usual, consult your doctor as soon as possible.
It is important to take all asthma medicines prescribed by your doctor.
Do not replace steroid medicines (inhalers or tablets) with Asmenol.
Also, inform your doctor if you experience any of the following symptoms while taking Asmenol: flu-like symptoms, sensory disturbances such as tingling or numbness of the limbs, worsening of respiratory symptoms, and (or) skin rash. The doctor will decide on further action.
The patient should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma symptoms in the patient.
Inform your doctor about any current or past illnesses and allergies.

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If the patient experiences such symptoms while taking montelukast, they should consult a doctor.

If the patient experiences such symptoms while taking montelukast, they should consult a doctor.

Children and adolescents

For children from 6 months to 5 years of age, a 4 mg granule formulation is available.
For children from 2 to 5 years of age, a 4 mg chewable tablet formulation is available.
For children from 6 to 14 years of age, a 5 mg chewable tablet formulation is intended.

Asmenol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Asmenol can be taken with other medicines used to treat asthma.
However, some medicines may affect the action of Asmenol, and Asmenol may affect the action of some other medicines. It is especially important to inform your doctor about taking phenobarbital or phenytoin (medicines used to treat epilepsy), rifampicin (a medicine used to treat tuberculosis and some other infections), or gemfibrozil (a medicine used to treat high lipid levels in the blood). In such cases, caution is advised, especially in children.

Asmenol with food and drink

Asmenol 10 mg coated tablets can be taken with or without food.

Pregnancy and breastfeeding

Limited data on the use of the medicine during pregnancy do not indicate a causal relationship between montelukast and the occurrence of congenital malformations (e.g., limb malformations), which are rarely observed worldwide after the medicine has been marketed.
Pregnancy
If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult a doctor before taking this medicine. The doctor will assess whether Asmenol can be taken during this period.
Breastfeeding
It is not known whether the medicine passes into breast milk. Therefore, if a woman is breastfeeding or plans to breastfeed, she should consult a doctor before taking this medicine.
The doctor will discuss further action with the patient.

Driving and using machines

Asmenol generally does not affect the ability to drive or use machines. However, the action of the medicine may vary from patient to patient. In very rare cases, dizziness and drowsiness have been reported, which may affect the ability to react.

Asmenol contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact a doctor before taking the medicine.

Asmenol contains sodium

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

3. How to take Asmenol

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
The way to take Asmenol will be decided by your doctor, based on the symptoms and severity of asthma in the patient.
It is important to take Asmenol every evening, as prescribed by your doctor.
The patient should also take Asmenol even if no symptoms are present and on days when an asthma attack occurs.
The patient should also use all other asthma medicines prescribed by the doctor. Asmenol should not be used as a replacement for other medicines.
The medicine is for oral use.
Usually, the recommended dose is:
Adults and adolescents over 15 years of age:
1 coated tablet of 10 mg of Asmenol once a day, in the evening. The medicine can be taken with or without food.
If the patient is taking Asmenol, they should make sure they are not taking other medicines that contain the same active substance, montelukast.

Taking a higher dose of Asmenol than recommended

Seek medical advice immediately.
In most reports of overdose, no side effects were reported.
The most commonly reported symptoms after overdose in adults and children were:
abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

Missing a dose of Asmenol

Try to take the medicine as prescribed by your doctor. However, if one dose of the medicine is missed, return to the previous dosing schedule - one tablet once a day. Do not take a double dose to make up for the missed dose.

Stopping treatment with Asmenol

It is important to take Asmenol for as long as prescribed by your doctor, regardless of whether symptoms are present or not. Asmenol may only be effective in treating asthma if taken regularly.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Asmenol can cause side effects, although not everybody gets them.
In clinical trials with montelukast 10 mg, the following side effects were most commonly (in less than 1 in 10 patients taking the medicine) reported, probably related to montelukast:

• abdominal pain
• headache. They were usually mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain the medicine).

The frequency of possible side effects is defined using the following convention:

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

Additionally, after the medicine has been marketed, the following side effects have been reported:

• upper respiratory tract infection (very common),
• increased tendency to bleed (rare),
• allergic reactions, including swelling of the face, lips, tongue, and (or) throat, which may cause difficulty breathing or swallowing (uncommon),
• behavioral and mood changes: sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness, especially motor, agitation, including aggressive or hostile behavior, depression (uncommon); tremors, attention disturbances, memory disturbances (rare); hallucinations, disorientation, suicidal thoughts and behaviors, stuttering (very rare),
• dizziness, drowsiness, tingling, and (or) numbness (uncommon),
• palpitations (rare),
• nasal bleeding (uncommon),
• diarrhea, nausea, vomiting (common); dry mouth, indigestion (uncommon),
• hepatitis (very rare),
• rash (common); bruising, itching, hives (uncommon); tender, red lumps under the skin, most often occurring on the shins (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, swelling (uncommon).

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 and feet, worsening of respiratory symptoms, and (or) skin rash (Churg-Strauss syndrome) have been reported. If the patient experiences one or more of these symptoms, they should immediately inform their doctor.
For more detailed information on the side effects of the medicine, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the medicine.

5. How to store Asmenol

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the blister and outer packaging.
The expiry date stated on the blister after the abbreviation EXP and the batch number after the abbreviation Lot/LOT.
Medicines should not be disposed of 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 Asmenol contains

• The active substance of Asmenol is montelukast (in the form of montelukast sodium). Each coated tablet contains 10 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: Tablet core: Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, disodium edetate, magnesium stearate. Tablet coating: Hypromellose 6cP, hydroxypropylcellulose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What Asmenol looks like and contents of the pack

Asmenol 10 mg coated tablets are beige, round, coated tablets.
Asmenol is available in Aluminum/Aluminum blisters of 14, 28 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia
Saneca Pharmaceutical a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia
Date of last revision of the leaflet:August 2024