Asmenol

Package Leaflet: Information for the Patient

Asmenol

5 mg, Chewable 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.
Asmenol, when taken regularly, alleviates asthma symptoms, such as shortness of breath, and prevents asthma attacks.
Asmenol is prescribed in the following cases:

• if a child cannot be provided with adequate asthma treatment with other medicines and additional treatment is necessary.
• to prevent bronchospasm caused by physical exertion.
• as an alternative treatment for children aged 6 to 14 years who are unable to use inhalers containing corticosteroids.

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.
• sensitivity of the airways, which 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 pressure in the chest.

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 a child's asthma worsens or has difficulty breathing, you should immediately inform
the doctor.
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, the child should be given a medicine intended for use in such emergency situations and follow the doctor's instructions exactly. It is very important that 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) is always easily accessible.
If a child needs to use a beta-agonist inhaler more frequently than usual, you should consult the attending physician as soon as possible.
It is important that the child takes all asthma medicines prescribed by the attending physician. Asmenol should not be used to replace steroids (inhalers or oral) that the child is taking.
You should also inform the doctor if the child experiences 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 drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen the patient's asthma symptoms.
You should inform the doctor about any current or past illnesses and allergies in the child.

Children and adolescents

For children aged 6 months to 5 years, Asmenol Mini is available in the form of 4 mg granules.
For children aged 2 to 5 years, the medicine is available in the form of 4 mg chewable tablets.
For children aged 6 to 14 years, the medicine is available in the form of 5 mg chewable tablets.
For patients aged 15 and over, the medicine is available in the form of 10 mg film-coated tablets.

Asmenol and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans 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 the doctor about the child taking phenobarbital or phenytoin (medicines used to treat epilepsy) or 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 a case, caution should be exercised,
especially in children.

Asmenol with food and drink

Asmenol 5 mg chewable tablets should be taken 1 hour before meals or 2 hours after meals.

Pregnancy and breastfeeding

This section does not apply to Asmenol 5 mg chewable tablets, as this dose is intended for children aged 6 to 14 years. However, the following information applies to the active substance, montelukast.
Limited data on the use of the medicine during pregnancy do not indicate a causal relationship between montelukast intake and the occurrence of congenital malformations (e.g., limb defects), 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 used during this period.
Breastfeeding
It is not known whether the medicine passes into breast milk. Therefore, if the patient 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 aspartame

The medicine contains a source of phenylalanine. It may be harmful to patients with phenylketonuria.
Each 5 mg tablet contains phenylalanine in an amount equivalent to 3.37 mg of phenylalanine per dose.

3. How to take Asmenol

This medicine should always be taken exactly as prescribed by your doctor. If you are not sure, ask 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 child.
It is important that the child takes Asmenol every evening, as prescribed by the doctor. The medicine should also be taken when the child has no symptoms and on days when an asthma attack occurs.
The child should also take all other asthma medicines prescribed by the doctor. Asmenol should not be used instead of other medicines.
The medicine is for oral use.
Usual dose:
Children aged 6 to 14 years:
1 chewable tablet of 5 mg Asmenol once a day, in the evening. The child should take the tablet at least 1 hour before meals or 2 hours after meals.
If the patient is taking Asmenol, make sure they do not take 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 give the child the medicine as prescribed by the 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 Asmenol treatment

It is important that the child takes Asmenol for as long as the doctor has prescribed, regardless of whether symptoms are present or not. Asmenol may only be effective in treating asthma if its use is continued.
If you have any further questions about the use of 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 5 mg, the following side effect was most frequently (in less than 1 in 10 patients taking the medicine) reported, probably related to montelukast:

• headache. Additionally, in clinical trials with montelukast 10 mg, the following side effect was reported:
• abdominal pain. 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 (occurs in more than 1 in 10 patients)
• common (occurs in less than 1 in 10 patients)
• uncommon (occurs in less than 1 in 100 patients)
• rare (occurs in less than 1 in 1,000 patients)
• very rare (occurs 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 (very rare),
  • dizziness, drowsiness, tingling, and (or) numbness, seizures (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 spasms (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 child experiences one or more of these symptoms, you should immediately inform the attending physician.
  For 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 Drug Safety Monitoring of the Office for Registration 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
  e-mail: ndl@urpl.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 the medicine.

  5. How to store Asmenol

  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 pack and outer packaging.
  The expiry date stated on the blister pack 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 chewable tablet contains 5 mg of montelukast in the form of montelukast sodium.
  • The other ingredients are: microcrystalline cellulose, mannitol, crospovidone (type B), red iron oxide (E172), hydroxypropyl cellulose, disodium edetate, cherry flavor, 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 aluminum/aluminum blisters of 14, 28 tablets.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Polpharma S.A.
  Pelplińska 19
  83-200 Starogard Gdański

  Manufacturer

  Polpharma S.A.
  Pelplińska 19
  83-200 Starogard Gdański
  HBM Pharma s.r.o.
  Sklabinská 30
  036 80 Martin
  Slovakia

  Date of last revision of the leaflet: