Astmodil

PATIENT INFORMATION LEAFLET: USER INFORMATION

ASTMODIL, 10 mg, coated 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. 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 and alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Indications for use:

• Astmodil is used as an adjunctive treatment for mild or moderate chronic asthma in patients over 15 years of age who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Astmodil also helps prevent bronchospasm induced primarily by physical exertion.
• Astmodil used in the treatment of bronchial asthma also alleviates symptoms of hay fever (seasonal allergic rhinitis).

Astmodil, 10 mg is intended for use in adults and adolescents 15 years of age and older.

2. IMPORTANT INFORMATION BEFORE TAKING ASTMODIL

When not to take Astmodil

• If you are 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 any diseases or allergic reactions you have now or have had in the past.

• If your asthma symptoms worsen, see your doctor immediately.
• Astmodil is not intended for the treatment of acute asthma attacks. If an attack occurs, use an inhaler intended for use in asthma attacks or see your doctor as soon as possible.
• Do not take acetylsalicylic acid or anti-inflammatory drugs (so-called non-steroidal anti-inflammatory drugs - NSAIDs) if they worsen your asthma symptoms.
• If you experience symptoms such as fever, rash, weakness, malaise, tingling or numbness of hands or feet, worsening of respiratory symptoms, 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 the patient (including children) experiences such symptoms while taking Astmodil, consult a doctor (or pediatrician).

Taking other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription.
Some medicines may affect the action of Astmodil or Astmodil may affect the action of other medicines.
Before taking Astmodil, tell your doctor if you are 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).

Pregnancy and breastfeeding

Before taking any medicine, consult your 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

If you experience dizziness or drowsiness, do not drive or operate machinery.

Important information about some ingredients of Astmodil

The medicine contains lactose(one tablet contains 53.55 mg of lactose). This medicine contains 0.05355 g of lactose
(0.026775 g of glucose and 0.026775 g of galactose) in one tablet. This should be taken into account
in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars,
you should consult your doctor before taking the medicine.

Astmodil contains sodium

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

3. HOW TO TAKE ASTMODIL

Astmodil should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

The usual dose is:

Patients 15 years of age and older
1 coated tablet (10 mg) once daily, in the evening.
The medicine should be taken orally.
Astmodil can be taken with or without food.

Taking a higher dose of Astmodil than recommended

If you take more than the recommended dose of the medicine, contact your doctor immediately.
The following overdose symptoms may occur: drowsiness, headache, excessive thirst, abdominal pain, vomiting, and increased restlessness.

Missing a dose of Astmodil

If you forget to take a dose of Astmodil, but remember within 12 hours of the time you usually take it, take the tablet immediately, and then take the next tablet at the usual time.
If you forget for more than 12 hours, simply take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Astmodil

Astmodil is effective in treating asthma only when taken regularly.
Do not stop treatment without consulting your doctor. The doctor will decide when to stop treatment.
If you have any further questions about taking the medicine, consult your 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),
• flu-like symptoms, fever, weakness, malaise, worsening of respiratory symptoms, wheezing, cough, shortness of breath, persistent runny nose, tingling or numbness of hands or feet, and (or) rash (Churg-Strauss syndrome). These side effects are very rare.

Common side effects (occurring in 1 to 10 in 100 patients):

• headache,
• abdominal pain.

Very rare side effects (occurring in less than 1 in 10,000 patients):

• 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 hands and (or) feet,
• seizures,
• palpitations (irregular, rapid heartbeat),
• nasal bleeding,
• dry mouth, dyspepsia (belching, heartburn, bloating, abdominal pain), nausea, vomiting, diarrhea,
• abnormal liver function tests (elevated activity of liver enzymes 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
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. By reporting side effects, you can help provide 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 30°C.
Store in the original packaging to protect from light and moisture.
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 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 of the medicine is montelukast. Each coated tablet contains 10 mg of montelukast in the form of montelukast sodium.
• The medicine also contains: hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate, sodium carmellose, magnesium stearate. Tablet coating: hypromellose 6 cp, lactose monohydrate, macrogol 6000, titanium dioxide (E 171).

What Astmodil looks like and what the pack contains

Astmodil is a coated tablet. The tablets are white to cream-colored, round, biconvex, with the number "10" embossed on one side, without spots and damage.
The pack contains 28 tablets.

Marketing authorization holder and manufacturer

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

Date of approval of the leaflet: