Astmodil

Astmodil, 4 mg, chewable and chewable tablets
Montelukast
Read the entire leaflet before taking this medicine.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist.

Leaflet contents:

1. What Astmodil is and what it is used for
2. Important information before taking Astmodil
3. How to take Astmodil
4. Possible side effects
5. How to store Astmodil
6. Other information

1. WHAT ASTMODIL IS AND WHAT IT IS USED FOR

Astmodil contains the active substance montelukast. This medicine blocks the action of substances called leukotrienes. These substances cause swelling and narrowing of the airways, which leads to asthma attacks.
By inhibiting the action of these substances, Astmodil relieves asthma symptoms and helps control asthma.

Indications:

• Astmodil is used as an add-on treatment for mild to moderate persistent asthma in patients aged 2 to 5 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Astmodil may also be used as an alternative to low-dose inhaled corticosteroids in patients aged 2 to 5 years with mild persistent asthma who have not experienced severe asthma attacks requiring oral corticosteroids in the recent past and who are unable to use inhaled corticosteroids.
• Astmodil also helps prevent exercise-induced bronchoconstriction in patients aged 2 years and older.

Your doctor will determine how to use Astmodil based on your child's symptoms and the severity of asthma.
Astmodil 4 mg is intended for use in children aged 2 to 5 years.

2. IMPORTANT INFORMATION BEFORE USING ASTMODIL

When not to use Astmodil

• If the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of Astmodil (see section 6: Other information).

When to exercise special caution when using Astmodil
You should inform the doctor about any diseases or allergic reactions currently present or experienced
in the past by the child.

• If asthma symptoms worsen, contact a doctor immediately.
• Astmodil is not intended for the treatment of acute asthma attacks. If such an attack occurs, use an inhaled medicine intended for asthma attacks or seek medical advice as soon as possible.
• It is important that the child takes all anti-asthma medicines prescribed by the doctor. Astmodil should not be used instead of other anti-asthma medicines prescribed for the child.
• Do not give the child acetylsalicylic acid or anti-inflammatory medicines (so-called non-steroidal anti-inflammatory drugs - NSAIDs) if they worsen the child's asthma symptoms.
• If symptoms such as fever, rash, weakness, malaise, tingling or numbness in hands or feet, or worsening of respiratory symptoms occur during treatment, contact a doctor immediately (see section 4: Possible side effects).

Patients should be informed that various neuropsychiatric events (e.g. changes in behavior and mood) have been reported in adults, adolescents, and children treated with Astmodil (see section 4). If such symptoms occur in the patient (including in a child) during treatment with Astmodil, consult a doctor (or pediatrician).

Taking other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, including those
obtained without a prescription.
Some medicines may affect the action of Astmodil or Astmodil may affect the action of other medicines.
Before starting treatment with Astmodil, 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 (an antibiotic used to treat tuberculosis or certain other infections).

Taking Astmodil with food and drink
Do not take Astmodil during meals; the medicine should be taken 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding
This information does not apply to Astmodil 4 mg, as this medicine is intended for use in children aged 2 to 5 years. However, the following information is relevant regarding the active substance, montelukast.
Before taking any medicine, consult a doctor or pharmacist.
Women who are pregnant or planning pregnancy, and women who are breastfeeding or intend to breastfeed, should consult their physician before using Astmodil. The doctor will assess whether they can take Astmodil during this period.

Driving and operating machinery
This information does not apply to Astmodil 4 mg, as this medicine is intended for use in children aged 2 to 5 years. However, the following information is relevant regarding the active substance, montelukast.
If dizziness or drowsiness occurs, do not drive or operate machinery.

Important information about certain ingredients of Astmodil
The medicine contains 0.5 mg of aspartame (E 951) 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.

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

Cherry flavour K, an ingredient of the medicine, contains:

• maltodextrin (a source of glucose) – if the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine;
• benzyl alcohol – the medicine contains 0.065 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to small children is associated with a risk of serious adverse reactions including respiratory disorders (so-called "gasping syndrome"). Do not administer to small children (under 3 years of age) for longer than one week without medical advice. Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis);
• ethanol – this medicine contains 0.032 mg of alcohol (ethanol) per tablet. The amount of alcohol in one tablet of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects;
• d-limonene.

3. HOW TO USE ASTMODIL

Astmodil should be administered to a child under the supervision of an adult.
Astmodil should always be used in children according to the doctor's instructions. If in doubt,
contact a doctor or pharmacist.
Astmodil should be taken daily, even when there are no asthma symptoms, as well as during asthma exacerbations.
The usual dose is:
Children aged 2 to 5 years
1 chewable tablet, 4 mg once daily in the evening.
The medicine should be taken orally.
Astmodil should not be taken during meals; the medicine should be taken 1 hour before or 2 hours after a meal.
If a child is taking Astmodil, ensure they are not also receiving other medicines containing the same active substance, montelukast.
Astmodil is not indicated for use in children under 2 years of age.
Use of a higher than recommended dose of Astmodil
If a higher than recommended dose of the medicine is taken, consult a doctor immediately.
Symptoms of overdose may include: drowsiness, headache, excessive thirst, abdominal pain, vomiting, and increased motor activity.
Missed dose of Astmodil
If the patient forgets to take a dose of Astmodil but remembers within 12 hours of the usual time, they should take the tablet immediately, then take the next tablet at the usual time.
If the patient remembers more than 12 hours later, they should simply take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Discontinuation of Astmodil
Astmodil is effective in the treatment of asthma only when taken regularly.
Do not discontinue treatment without consulting a doctor. The decision to stop treatment should be made by a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Astmodil can cause adverse reactions, although not everyone experiences them.
Discontinue the medicine and contact your doctor immediately if any of the following adverse
reactions occur:

• allergic reactions (rash, swelling of the face, lips, tongue, and throat causing difficulty in breathing or swallowing),
• flu-like symptoms, fever, weakness, malaise, worsening of respiratory symptoms, wheezing, cough, dyspnea, persistent nasal congestion, tingling or numbness of the hands or feet, and (or) rash (Churg-Strauss syndrome). These adverse reactions are very rare.

Adverse reactions that are common (occurring in 1 to 10 out of 100 people):

• abdominal pain,
• excessive thirst.

Adverse reactions that are very rare (may occur in fewer than 1 in 10,000 people):

• stuttering.

Other adverse reactions:

• upper respiratory tract infection,
• allergic reactions (rash, swelling of the face, lips, tongue, and throat causing difficulty in breathing or swallowing),
• increased tendency to bleeding,
• sleep disorders, including nightmares, insomnia,
• sleepwalking,
• hallucinations (perception of non-existent objects or people),
• irritability, anxiety, restlessness, especially motor agitation, stimulation, including aggressive behavior or hostility,
• tremor,
• depression,
• suicidal thoughts and behaviors (suicidal tendencies),
• somnolence, dizziness,
• tingling or numbness of the hands and (or) feet,
• seizures,
• palpitations (irregular, rapid heartbeat),
• nosebleeds,
• dry mouth, dyspepsia (regurgitation, heartburn, bloating, abdominal pain), nausea, vomiting, diarrhea,
• abnormal liver function tests (increased activity of liver enzymes AspAT and AlAT),
• hepatitis (including cholestatic, hepatocellular, and mixed etiology liver injury - yellowing of the skin and whites of the eyes, itching of the skin),
• joint pain, muscle pain, muscle cramps,
• sudden swelling of the face, limbs, or joints without angioedema,
• erythema nodosum (red, painful nodules on the lower legs),
• urticaria (pinkish, itchy wheals on the skin).

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. HOW TO STORE ASTMODIL

Keep out of the reach and sight of children.
Store below 25°C in the original packaging.
Do not use after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Shelf life after first opening the container: 30 days.
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. OTHER INFORMATION

What Astmodil contains

• The active substance is montelukast. Each 4 mg chewable tablet contains 4 mg of montelukast as montelukast sodium.
• Other ingredients are: hydroxypropylcellulose, microcrystalline cellulose, mannitol, sodium croscarmellose, aspartame (E 951), cherry flavour K (containing, among others, maltodextrin,
  potassium sorbate (E 202), benzyl alcohol, ethanol, arabic gum (E 414), d-limonene),
  magnesium stearate.

What Astmodil looks like and contents of the pack

Astmodil 4 mg is a white to cream-coloured, round, biconvex uncoated tablet with the number "4" embossed on one side, free from spots and damage.
The pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
email: [email protected]