Astmodil

PATIENT INFORMATION LEAFLET: USER INFORMATION

Astmodil, 4 mg, chewable tablets

Montelukast

Read the leaflet carefully before taking the medicine.

• 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Astmodil and what is it 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 IS ASTMODIL AND WHAT IS IT USED FOR

Astmodil contains the active substance montelukast. The medicine blocks the action of substances called
leukotrienes. These substances cause swelling and narrowing of the airways, which triggers an
asthma attack.
By inhibiting the action of these substances, Astmodil alleviates asthma symptoms and helps control
asthma.
Indications for use:

• Astmodil is used as an adjunctive treatment for mild or moderate chronic asthma in patients aged 2 to 5 years who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Astmodil may also be used as a substitute for low-dose inhaled corticosteroids in patients aged 2 to 5 years with mild chronic asthma who have not experienced severe asthma attacks requiring oral corticosteroids in the recent period and are unable to use inhaled corticosteroids.
• Astmodil also helps prevent bronchospasm induced primarily by physical exertion in patients aged 2 years and older.

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

2. IMPORTANT INFORMATION BEFORE TAKING ASTMODIL

When not to take Astmodil

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

When to exercise special caution when taking Astmodil

Tell your doctor about all diseases or allergic reactions that your child is currently experiencing or has experienced in the past.

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

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

Taking other medicines

Tell your doctor or pharmacist about all medicines your child is currently taking or has taken recently, including those available 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, tell your doctor if your child 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 some other infections).

Taking Astmodil with food and drink

Do not take Astmodil during meals; take the medicine 1 hour before a meal 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 to the active substance, montelukast.
Before taking any medicine, consult a doctor or pharmacist.
Pregnant or breastfeeding women should consult their doctor before taking Astmodil. The doctor will assess whether they can take Astmodil during this period.

Driving and using machines

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 to the active substance, montelukast.
If dizziness or drowsiness occurs, do not drive or operate machinery.

Important information about some 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 to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medicine contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
The cherry flavor K, which is an ingredient of the medicine, contains:

• maltodextrin(a source of glucose) - if the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a 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 severe side effects, including respiratory disorders (so-called "gasping syndrome"). Do not give to small children (under 3 years) for more than a week without a doctor's recommendation. Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side 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 TAKE ASTMODIL

Astmodil should be given to the child under adult supervision.
Astmodil should always be taken by the child as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Astmodil should be taken daily, even when no asthma symptoms are present, as well as during periods of worsening asthma symptoms.

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.
Do not take Astmodil during meals; take the medicine 1 hour before a meal or 2 hours after a meal.
If your child is taking Astmodil, ensure they do not receive other medicines that contain the same active substance, montelukast.
Astmodil is not indicated for use in children under 2 years of age.

Taking a higher dose of Astmodil than recommended

If a higher dose of the medicine is taken than recommended, seek medical attention immediately.
The following overdose symptoms may occur: drowsiness, headache, excessive thirst, abdominal pain, vomiting, and increased restlessness.

Missing a 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 and then take the next tablet at the usual time.
If the patient forgets for more than 12 hours, they should simply take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Astmodil

Astmodil is effective in treating asthma only if taken regularly.
Do not stop treatment without consulting a doctor. The doctor will decide when to stop treatment.
If you have any further questions about taking the medicine, consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Astmodil can cause side effects, although not everybody gets them.

Stop taking the medicine and contact your doctor immediately if you experience any of the following side effects:

• allergic reactions (rash, swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing),
• symptoms like flu, fever, weakness, malaise, worsening of respiratory symptoms, wheezing, cough, shortness of breath, persistent runny nose, tingling or numbness of the hands or feet, and (or) rash (Churg-Strauss syndrome). These side effects are very rare.

Common side effects(affecting 1 to 10 in 100 people):

• abdominal pain,
• excessive thirst.

Rare side effects(may affect up to 1 in 10,000 people):

• stuttering.

Other side effects:

• upper respiratory tract infection,
• allergic reactions (rash, swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing),
• increased tendency to bleed,
• sleep disturbances, including nightmares, insomnia,
• somnambulism,
• hallucinations (perceiving non-existent objects or people),
• irritability, anxiety, restlessness, especially motor, agitation, including aggressive behavior or hostility,
• tremors,
• depression,
• suicidal thoughts and behaviors (suicidal tendencies),
• drowsiness, dizziness,
• tingling or numbness of the hands and (or) feet,
• seizures,
• palpitations (irregular, rapid heartbeat),
• nasal bleeding,
• dry mouth, nausea, vomiting, diarrhea,
• abnormal liver test results (elevated liver enzyme activity AspAT and AlAT),
• hepatitis (including cholestatic, hepatocellular, and mixed etiology - yellowing of the skin and whites of the eyes, itching),
• 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 (light red, itchy blisters on the skin).

If any of the side effects worsen or if you experience any side effects not listed in this leaflet, tell 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, or nurse. 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:
Jerozolimskie Avenue 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 ASTMODIL

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

What Astmodil contains

• The active substance of Astmodil is montelukast. Each chewable tablet, 4 mg contains 4 mg of montelukast in the form of montelukast sodium.
• The medicine also contains: hydroxypropylcellulose, microcrystalline cellulose, mannitol, sodium croscarmellose, aspartame (E 951), cherry flavor K (contains, among others, maltodextrin,

sorbic acid potassium (E 202), benzyl alcohol, ethanol, arabic gum (E 414), d-limonene),
magnesium stearate.

What Astmodil looks like and what the pack contains

Astmodil, 4 mg is a white to cream-colored, round, biconvex tablet with the number "4" embossed on one side, without spots or damage.
The pack contains 28 tablets.

Marketing authorization holder and manufacturer

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

Date of approval of the leaflet: