MONTELUKAST 4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Montelukast Aurovitas, 4 mg, Chewable Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Montelukast Aurovitas and what is it used for
   1. What is Montelukast Aurovitas
   2. How Montelukast Aurovitas works
   3. When to use Montelukast Aurovitas
   4. What is asthma?
4. Important information before taking Montelukast Aurovitas
   1. When not to take Montelukast Aurovitas:
   2. Warnings and precautions
   3. Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If the patient experiences such symptoms while taking montelukast, consult a doctor.
   4. Children and adolescents
   5. Other medicines and Montelukast Aurovitas
   6. Montelukast Aurovitas with food, drinks, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Montelukast Aurovitas contains sodium
5. How to take Montelukast Aurovitas
   1. Children aged 2 to 5 years:
   2. Taking a higher dose of Montelukast Aurovitas than recommended
   3. Missing a dose of Montelukast Aurovitas
   4. Stopping treatment with Montelukast Aurovitas
6. Possible side effects
   1. Severe side effects
   2. Other side effects reported after the medicine was marketed
   3. Reporting side effects
7. How to store Montelukast Aurovitas
8. Contents of the pack and other information
   1. What Montelukast Aurovitas contains
   2. What Montelukast Aurovitas looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. France
   7. Germany
   8. Italy
   9. Malta
   10. Poland
   11. Spain
   12. Date of last revision of the leaflet: 02/2024

Package Leaflet: Information for the User

Montelukast Aurovitas, 4 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Montelukast Aurovitas and what is it used for
• 2. Important information before taking Montelukast Aurovitas
• 3. How to take Montelukast Aurovitas
• 4. Possible side effects
• 5. How to store Montelukast Aurovitas
• 6. Contents of the pack and other information

1. What is Montelukast Aurovitas and what is it used for

What is Montelukast Aurovitas

Montelukast Aurovitas is a leukotriene receptor antagonist, which means it blocks the action of substances called leukotrienes.

How Montelukast Aurovitas works

Leukotrienes cause narrowing and swelling of the airways. By inhibiting the action of leukotrienes, Montelukast Aurovitas alleviates asthma symptoms and helps control asthma.

When to use Montelukast Aurovitas

Your doctor has prescribed Montelukast Aurovitas for the treatment of asthma in a child, to prevent asthma symptoms from occurring during the day and at night.

• Montelukast Aurovitas is used in the treatment of patients aged 2 to 5 years, whose previous treatment results are unsatisfactory and require additional medication.
• Montelukast Aurovitas may also be used as an alternative to inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids and are unable to use inhaled corticosteroids.
• Montelukast Aurovitas also helps prevent narrowing of the airways caused by physical exertion in patients aged 2 years and older.

The doctor will determine how to use Montelukast Aurovitas based on the child's symptoms and the severity of the asthma.

What is asthma?

Asthma is a chronic disease.

• Difficulty breathing due to narrowing of the airways. The airways narrow or widen in response to various factors.
• Sensitivity of the airways reacting to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• Inflammation (swelling) of the lining of the airways.

Asthma symptoms include coughing, wheezing, and a feeling of pressure in the chest.

2. Important information before taking Montelukast Aurovitas

Tell your doctor about all health problems or allergies that the patient has now or has had in the past.

When not to take Montelukast Aurovitas:

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 give montelukast to a child, discuss it with your doctor or pharmacist.

• If the child's asthma symptoms worsen or shortness of breath occurs, tell your doctor immediately.
• Oral Montelukast Aurovitas is not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always have a rescue inhaler with you.
• It is essential to give the child all asthma medications prescribed by the doctor. Montelukast Aurovitas should not be used as a replacement for other asthma medications prescribed by the doctor.
• Remember that if the child is taking asthma medications and experiences symptoms such as flu-like illness, tingling or numbness of the limbs, worsening shortness of breath, and/or rash, you should consult a doctor.
• A child who experiences asthma symptoms after taking acetylsalicylic acid (aspirin) should not take medications containing this substance or other anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs, NSAIDs).

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If the patient experiences such symptoms while taking montelukast, consult a doctor.

montelukast, consult a doctor.

Children and adolescents

Do not give this medicine to children under 2 years of age.

For children and adolescents under 18 years of age, other forms of this medicine are available, suitable for the patient's age.

Other medicines and Montelukast Aurovitas

Tell your doctor or pharmacist about all medicines the child is taking, has recently taken, or plans to take, including those obtained without a prescription.

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).

Montelukast Aurovitas with food, drinks, and alcohol

Montelukast Aurovitas chewable tablets 4 mg should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after food.

Pregnancy, breastfeeding, and fertility

This section does not apply to Montelukast Aurovitas chewable tablets 4 mg, as they are intended for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Montelukast Aurovitas chewable tablets 4 mg, as they are intended for use in children aged 2 to 5 years. However, the following information is relevant to the active substance of the medicine, montelukast.

It is not expected that Montelukast Aurovitas will affect the ability to drive or use machines. However, individual reactions to the medicine may vary. In very rare cases, during treatment with Montelukast Aurovitas, side effects such as dizziness and drowsiness have been reported, which may affect the ability to drive or use machines.

Montelukast Aurovitas contains aspartame, a source of phenylalanine. If the child taking the medicine has phenylketonuria (a rare, inherited disorder of metabolism), consider that each 4 mg chewable tablet contains phenylalanine (in an amount equivalent to 0.674 mg of phenylalanine per 4 mg chewable tablet).

Montelukast Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Montelukast Aurovitas

Montelukast Aurovitas should always be used in a child under the guidance of a doctor or pharmacist. If you are unsure, consult the child's doctor or pharmacist.

• This medicine should be given to the child under adult supervision.
• The child should take one Montelukast Aurovitas tablet once a day, as recommended by the doctor.
• The medicine should be taken even when the child does not have asthma symptoms, as well as in the event of an acute asthma attack.

Children aged 2 to 5 years:

The recommended dose is one 4 mg chewable tablet taken once daily, in the evening.

Ensure that the child taking Montelukast Aurovitas does not take other medicines that contain the same active substance, montelukast.

This medicine is intended for oral use.

The tablets should be chewed before swallowing.

Montelukast Aurovitas 4 mg chewable tablets should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after food.

Taking a higher dose of Montelukast Aurovitas than recommended

Contact the child's doctor immediately.

In most cases of overdose, no side effects have been observed. In cases of overdose in adults and children, the most common side effects observed were abdominal pain, drowsiness, increased thirst, headache, vomiting, and hyperactivity.

Missing a dose of Montelukast Aurovitas

Montelukast Aurovitas should be taken as recommended by the doctor. However, if a dose is missed, return to the usual schedule of taking one tablet once a day. Do not take a double dose to make up for the missed dose.

Stopping treatment with Montelukast Aurovitas

Montelukast Aurovitas is effective in treating asthma in a child only when taken regularly.

It is essential to continue using the medicine in the child as long as the doctor recommends.

This will help keep the asthma symptoms under control.

If you have any further questions about the use of this medicine in the child, ask the doctor or pharmacist.

4. Possible side effects

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

In clinical studies with montelukast 4 mg chewable tablets, the most common side effects (which may affect up to 1 in 10 people) considered to be related to Montelukast Aurovitas were:

• abdominal pain
• increased thirst.

Additionally, the following side effect was observed in clinical studies with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache.

These side effects were usually mild and occurred more frequently in patients treated with montelukast than in patients who received a placebo (a tablet that does not contain the medicine).

Severe side effects

Contact a doctor immediatelyif you experience any of the following side effects, which may be severe and require immediate medical attention.

Uncommon:may affect up to 1 in 100 people

• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing
• changes in behavior and mood: agitation, including aggressive behavior or hostility, depression
• seizures.

Rare:may affect up to 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations.

Very rare:may affect up to 1 in 10,000 people

• syndrome of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening respiratory symptoms, and/or rash (Churg-Strauss syndrome) (see section 2)
• decreased platelet count
• changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and attempts
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• liver inflammation.

Other side effects reported after the medicine was marketed

Very common:may affect more than 1 in 10 people

• upper respiratory tract infection.

Common:may affect up to 1 in 10 people

• diarrhea, nausea, vomiting
• rash
• fever
• increased liver enzyme levels.

Uncommon:may affect up to 1 in 100 people

• changes in behavior and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling or numbness
• nasal bleeding
• dry mouth, indigestion
• bruising, itching, hives
• muscle or joint pain, muscle cramps
• bedwetting in children
• weakness and/or fatigue, malaise, swelling.

Rare:may affect up to 1 in 1,000 people

• changes in behavior and mood: attention disorders, memory disorders, uncontrolled movements.

Very rare:may affect up to 1 in 10,000 people

• tender, red lumps under the skin, most often occurring on the shins (erythema nodosum)
• changes in behavior and mood: obsessive-compulsive symptoms, stuttering.

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, 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

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 this medicine.

5. How to store Montelukast Aurovitas

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date. The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Store in the original package to protect from light and moisture.

HDPE bottle containing 500 tablets.

Use within 12 months of first opening the HDPE bottle.

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. Contents of the pack and other information

What Montelukast Aurovitas contains

• The active substance is montelukast. Each chewable tablet contains montelukast sodium, which is equivalent to 4 mg of montelukast.
• The other ingredients are: Mannitol (E 421), microcrystalline cellulose (PH-101), hydroxypropylcellulose 2% (6 to 10 mPa·s), sodium croscarmellose, iron oxide red (E 172), microcrystalline cellulose (PH-102), aspartame (E 951), artificial cherry flavor [flavoring substances, modified starch] and magnesium stearate.

What Montelukast Aurovitas looks like and contents of the pack

Chewable tablets

Pink, speckled, oval, biconvex, uncoated tablets with 'X' engraved on one side and '52' on the other side.

Montelukast Aurovitas is available in chewable tablets packaged in PVC/Poliamid/Aluminum/PVC/Aluminum blisters and HDPE bottles with a PP closure containing a desiccant.

Package sizes:

Blisters: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, and 200 chewable tablets.

HDPE bottles: 30, 90, and 500 chewable tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France

MONTELUKAST ARROW LAB 4 mg, comprimé à croquer

Germany

Montelukast Aurobindo 4 mg Kautabletten

Italy

Montelukast Aurobindo Pharma Italia 4 mg Compressa masticabile

Malta

Montelukast Aurobindo 4 mg Chewable Tablets

Poland

Montelukast Aurovitas

Spain

Montelukast Aurovitas 4 mg comprimidos masticables EFG

Date of last revision of the leaflet: 02/2024