Astmodil

ASTMODIL, 10 mg, film-coated tablets
(Montelukast)
Read the entire leaflet before taking this medicine.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any of the side effects worsen, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist immediately.

Leaflet Contents:

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

1. WHAT ASTMODIL IS AND WHAT IT IS USED FOR

Astmodil contains the active substance montelukast. It works by blocking substances called leukotrienes. These substances cause swelling and narrowing of the airways, leading to asthma attacks.
By inhibiting the action of leukotrienes, Astmodil relieves asthma symptoms and helps control asthma, as well as alleviating symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Indications:

• Astmodil is used as an add-on therapy in the treatment of mild to moderate persistent asthma in patients aged 15 years and older, in whom adequate asthma control has not been achieved with previously used medications and additional treatment is required.
• Astmodil also helps prevent exercise-induced bronchoconstriction.
• Astmodil, when used in the treatment of asthma, also relieves symptoms of hay fever (seasonal allergic rhinitis).

Astmodil 10 mg is intended for use in adults and adolescents aged 15 years and older.

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
Inform the doctor about all diseases or allergic reactions currently present or experienced in the past by the patient.

• 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.
• Do not use acetylsalicylic acid or anti-inflammatory medicines (so-called non-steroidal anti-inflammatory drugs - NSAIDs) if they worsen bronchial asthma symptoms in the patient.
• 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).

Use of other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, 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 in the treatment of epilepsy),
• phenytoin (a medicine used in the treatment of epilepsy),
• rifampicin (an antibiotic used in the treatment of tuberculosis or certain other infections).

Pregnancy and breastfeeding
Before using any medicine, consult a doctor or pharmacist.
Women who are pregnant or planning pregnancy, as well as women who are breastfeeding or planning to breastfeed, should consult their physician before using Astmodil. The doctor will assess whether they may take Astmodil during this period.

Driving and operating machinery
If dizziness or drowsiness occurs, do not drive or operate machinery.

Important information about certain 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 glucose and 0.026775 g galactose) per tablet. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

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

3. HOW TO USE ASTMODIL

Astmodil should always be used as directed by the physician. In case of doubts, contact your doctor or pharmacist.
Typically used dosage:
Patients aged 15 years and older
1 coated tablet (10 mg) once daily in the evening.
Astmodil should be taken orally.
Astmodil may be taken independently of meals.
Use of a higher than recommended dose of Astmodil
If a higher than recommended dose of Astmodil is taken, seek immediate medical advice.
The following symptoms of overdose may occur: drowsiness, headache, excessive thirst, abdominal pain, vomiting, and increased motor agitation.
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 and 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 treatment
Astmodil is effective in the treatment of asthma only when taken regularly.
Do not discontinue treatment without consulting your doctor. The decision to stop treatment will be made by the physician.
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 may 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, or throat causing difficulty in breathing or swallowing),
• flu-like symptoms, fever, weakness, malaise, worsening of respiratory symptoms, wheezing, cough, shortness of breath, persistent cold, tingling or numbness in the hands or feet, and (or) rash (Churg-Strauss syndrome). These adverse reactions are very rare.

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

• headache,
• abdominal pain.

Adverse reactions that are very rare (may occur in no more than 1 in 10,000 patients):

• stuttering.

Other adverse reactions:

• upper respiratory tract infection,
• allergic reactions (rash, swelling of the face, lips, tongue, or throat causing difficulty in breathing or swallowing),
• increased tendency to bleed,
• sleep disorders, including nightmares, insomnia,
• sleepwalking,
• hallucinations (perception of non-existent objects or people),
• irritability, anxiety, restlessness, especially motor restlessness, agitation, including aggressive behavior or hostility,
• tremor,
• depression,
• suicidal thoughts and behaviors (suicidal ideation),
• drowsiness, dizziness,
• tingling or numbness in hands and (or) feet,
• seizures,
• palpitations (irregular, rapid heartbeat),
• nosebleeds,
• dry mouth, dyspepsia (belching, 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 damage - 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 or pharmacist. 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 181 C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE ASTMODIL

Keep out of the reach and sight of children.
Store 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 specified month.
Period of use 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 the medicine Astmodil contains

• The active substance is montelukast. Each film-coated tablet contains 10 mg of montelukast in the form of montelukast sodium.
• Other ingredients: hydroxypropylcellulose, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.
  Coating of the tablet: hypromellose 6 cp, lactose monohydrate, macrogol 6000, titanium dioxide (E 171).

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

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]