Monkasta

Package Leaflet: Information for the Patient

Monkasta, 4 mg, Chewable Tablets

For Children Aged 2 to 5 Years

Montelukast

Read the Package Leaflet Carefully Before Giving the Medicine to the Child, as it Contains Important Information for the Patient.

• Keep this Package 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. It may Harm them, even if their Symptoms are the Same as the Child's.
• If the Child Experiences any Side Effects, including those not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Monkasta and what is it Used for
• 2. Important Information Before Giving Monkasta to the Child
• 3. How to Give Monkasta
• 4. Possible Side Effects
• 5. How to Store Monkasta
• 6. Contents of the Package and other Information

1. What is Monkasta and what is it Used for

What is Monkasta

Monkasta is a Leukotriene Receptor Antagonist, which Blocks the Action of Substances called Leukotrienes.

How Monkasta Works

Leukotrienes Cause the Airway to Narrow and Swell. By Blocking the Action of Leukotrienes, Monkasta Relieves the Symptoms of Asthma and Helps Control Asthma.

When to Use Monkasta

The Doctor has Prescribed Monkasta to Treat Asthma in the Child, to Prevent Asthma Symptoms from Occurring During the Day and at Night.

• Monkasta is Used to Treat Patients Aged 2 to 5 Years who have not Achieved Adequate Control of Asthma with their Current Medicines and Require Additional Treatment.
• Monkasta may also be Used as an Alternative to Inhaled Corticosteroids in Patients Aged 2 to 5 Years who have not Recently Taken Oral Corticosteroids for Asthma and are Unable to Use Inhaled Corticosteroids.
• Monkasta also Helps Prevent Exercise-Induced Narrowing of the Airways in Patients Aged 2 Years and Older.

The Doctor will Determine how to Give Monkasta to the Child, Depending on the Child's Symptoms and the Severity of their Asthma.

What is Asthma?

Asthma is a Chronic Disease.

In Asthma, there are:

• Difficulty Breathing Due to Narrowing of the Airways. This Narrowing can Worsen and Improve in Response to Various Factors.
• Sensitivity of the Airways, which React to Many Factors, such as Cigarette Smoke, Pollen, Cold Air, or Exercise.
• Swelling (Inflammation) of the Lining of the Airways. Asthma Symptoms include Coughing, Wheezing, and a Feeling of Tightness in the Chest.

2. Important Information Before Giving Monkasta to the Child

Tell the Doctor about any Health Problems and Allergies the Child has Now or has Had in the Past.

When not to Give Monkasta

• If the Child is Allergic to Montelukast or any of the other Ingredients of this Medicine (Listed in Section 6).

Warnings and Precautions

Before Giving Monkasta to the Child, Consult the Doctor or Pharmacist:

• If the Child's Asthma Worsens or they have Difficulty Breathing, Tell the Doctor Immediately.
• Monkasta is not Intended for the Treatment of Acute Asthma Attacks. If an Attack Occurs, Follow the Doctor's Advice. Always Carry a Relief Inhaler with you in Case of an Asthma Attack.
• It is Important to Give the Child all the Asthma Medicines Prescribed by the Doctor. Do not Give Monkasta Instead of other Asthma Medicines Prescribed by the Doctor.
• Remember to Consult the Doctor if the Child Experiences a Combination of Symptoms such as Flu-like Symptoms, Tingling or Numbness of the Hands or Feet, Worsening of Respiratory Symptoms, and/or Rash.
• Do not Give the Child Aspirin or other Non-Steroidal Anti-Inflammatory Medicines (also known as NSAIDs) if they Worsen the Child's Asthma Symptoms.

Various Neuropsychiatric Events (such as Changes in Behavior and Mood, Depression, and Suicidal Thoughts) have been Reported in Patients of all Ages Treated with Montelukast (See Section 4). If the Child Experiences any of these Symptoms while Taking Montelukast, Consult the Doctor.

Consult the Doctor if the Child Experiences any of these Symptoms while Taking Montelukast.

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 Child's Age.

Other Medicines and Monkasta

Tell the Doctor or Pharmacist about all Medicines the Child is Taking Now or has Taken Recently, including those Obtained without a Prescription.

Some Medicines may Affect the Action of Monkasta or Monkasta may Affect the Action of other Medicines.

Before Giving Monkasta, Tell the Doctor if the Child is Taking:

• Phenobarbital (Used to Treat Epilepsy),
• Phenytoin (Used to Treat Epilepsy),
• Rifampicin (Used to Treat Tuberculosis and some other Infections).

Monkasta with Food and Drink

Do not Give Monkasta 4 mg Chewable Tablets with Food; Give it at Least 1 Hour Before or 2 Hours After Food.

Pregnancy and Breast-Feeding

This Section does not Apply to Monkasta 4 mg Chewable Tablets, as they are Intended for Use in Children Aged 2 to 5 Years.

Driving and Using Machines

This Section does not Apply to Monkasta 4 mg Chewable Tablets, as they are Intended for Use in Children Aged 2 to 5 Years. However, the Following Information is Relevant to the Active Substance, Montelukast.

Monkasta is not Expected to Affect the Ability to Drive or Use Machines. However, Individual Reactions to the Medicine may Vary. Some Side Effects (such as Dizziness and Drowsiness) Reported with Monkasta may Affect the Ability to Drive or Use Machines in some Patients.

Monkasta Contains Aspartame and Sodium

This Medicine Contains 1.2 mg of Aspartame in each Chewable Tablet. Aspartame is a Source of Phenylalanine. It may be Harmful if the Child has Phenylketonuria, a Rare Genetic Disorder in which Phenylalanine Builds up in the Body due to its Impaired Elimination.

This Medicine Contains Less than 1 mmol (23 mg) of Sodium per Chewable Tablet, which means it is Essentially Sodium-Free.

3. How to Give Monkasta

Always Give this Medicine Exactly as the Doctor or Pharmacist has Told you. If you are not Sure, Check with the Doctor or Pharmacist.

• Give this Medicine to the Child Under Adult Supervision. For Children who have Difficulty with Chewable Tablets, a Granule Form is Available.
• Give the Child only one Monkasta Chewable Tablet Once a Day, as Advised by the Doctor.
• Give the Medicine Even when the Child does not have Asthma Symptoms, and also when an Acute Asthma Attack Occurs.

Use in Children Aged 2 to 5 Years

The Recommended Dose is one 4 mg Chewable Tablet Taken Once a Day, in the Evening.

If the Child is Taking this Medicine, Ensure they are not Taking any other Medicines that Contain the same Active Ingredient, Montelukast.

This Medicine is for Oral Use.

Chew the Tablet Before Swallowing.

Do not Give Monkasta 4 mg Chewable Tablets with Food; Give it 1 Hour Before or 2 Hours After Food.

Overdose of Monkasta

For Advice, Contact the Child's Doctor Immediately.

In Most Cases of Overdose, no Side Effects have been Observed.

The Most Commonly Reported Symptoms of Overdose in Adults and Children are: Abdominal Pain, Drowsiness, Increased Thirst, Headache, Vomiting, and Hyperactivity.

Missed Dose of Monkasta

Try to Give Monkasta as the Doctor has Prescribed. If the Child Misses a Dose, go Back to the Normal Dosing Schedule - one Chewable Tablet Once a Day.

Do not Give a Double Dose to Make up for a Missed Dose.

Stopping Monkasta

Monkasta is Effective in Treating Asthma in the Child only if it is Taken Regularly.

It is Important to Continue Giving the Medicine to the Child for as Long as the Doctor has Prescribed. This will Help Keep the Asthma Under Control.

If you have any Further Questions on the Use of this Medicine, Ask the Child's Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicines, this Medicine can Cause Side Effects, although not Everybody gets them.

During Clinical Trials with Montelukast 4 mg Chewable Tablets, the Most Commonly Reported Side Effects (which may Occur in up to 1 in 10 People) that were Considered to be Related to Montelukast were:

• Abdominal Pain,
• Increased Thirst.

In Addition, in Clinical Trials with Montelukast 10 mg Film-Coated Tablets and 5 mg Chewable Tablets, the Following were Reported:

• Headache.

These Symptoms were Usually Mild and Occurred More Frequently in Patients Treated with Montelukast than in those Taking a Dummy Treatment (a Tablet that does not Contain any Medicine).

Severe Side Effects

Seek Medical Attention Immediatelyif the Child Experiences any of the Following Severe Side Effects, which may Require Urgent 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 Risk of Bleeding,
• Tremor,
• Palpitations.

Very Rare: may Affect up to 1 in 10,000 People

• Symptoms such as Flu-like Symptoms, Tingling or Numbness of the Hands and Feet, Worsening of 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 of the Lungs (Pneumonia),
• Severe Skin Reactions (Erythema Multiforme), which may Occur without Warning,
• Liver Inflammation (Hepatitis).

Other Side Effects Reported after the Medicine was Marked

Very Common: may Affect more than 1 in 10 People

• Upper Respiratory Tract Infections.

Common: may Affect up to 1 in 10 People

• Diarrhea, Nausea, Vomiting,
• Rash,
• Fever,
• Increased Liver Enzymes.

Uncommon: may Affect up to 1 in 100 People

• Changes in Behavior and Mood: Unusual Dreams, including Nightmares, Difficulty Falling Asleep, Sleepwalking, Irritability, Feeling Anxious, Restlessness,
• Dizziness, Drowsiness, Tingling and Numbness,
• Nosebleeds,
• Dry Mouth, Indigestion,
• Bruising, Itching, Hives,
• Muscle or Joint Pain, Muscle Cramps,
• Nocturnal Enuresis in Children,
• Weakness and/or Fatigue, Malaise, Swelling.

Rare: may Affect up to 1 in 1,000 People

• Changes in Behavior and Mood: Attention Disturbances, Memory Disturbances, Uncontrolled Movements.

Very Rare: may Affect up to 1 in 10,000 People

• Painful, Red Lumps under the Skin, usually on the Shins (Erythema Nodosum),
• Changes in Behavior and Mood: Obsessive-Compulsive Symptoms,
• Stuttering.

Reporting Side Effects

If you Get any Side Effects, Talk to your Doctor or Pharmacist. This includes any Possible Side Effects not Listed in this Package Leaflet. You can also Report Side Effects Directly via the National Reporting System:

Department for the Monitoring of Adverse Reactions to Medicinal Products,

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

You can also Report Side Effects 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 Monkasta

Keep this Medicine out of the Sight and Reach of Children.

Do not Use this Medicine after the Expiry Date Stated on the Blister and Carton after EXP.

The Expiry Date Refers to the Last Day of the Month.

Store in the Original Package to Protect from Light.

Do not Throw Away any Medicines via Wastewater or Household Waste. Ask your Pharmacist how to Throw Away Medicines you no Longer Use. These Measures will Help Protect the Environment.

6. Contents of the Package and other Information

What Monkasta Contains

• The Active Substance is Montelukast. Each Chewable Tablet Contains 4 mg of Montelukast (as Montelukast Sodium).
• The other Ingredients are Mannitol (E 421), Microcrystalline Cellulose, Sodium Carboxymethylcellulose, Hydroxypropylcellulose, Aspartame (E 951), Red Iron Oxide (E 172), Cherry Flavor (which also Contains Triacetin (E 1518)), and Magnesium Stearate. See Section 2 "Monkasta Contains Aspartame and Sodium".

What Monkasta Looks Like and Contents of the Package

Pink, Mottled, Round, Slightly Biconvex Tablets, with a Score Line and the Number 4 on one Side.

Package: 28 and 90 Chewable Tablets in Blisters, in a Carton.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more Information on the Names of the Medicine in other EU Member States and the UK (Northern Ireland), Contact the Local Representative of the Marketing Authorization Holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

Tel. 22 57 37 500

Date of Last Revision of the Package Leaflet:07.02.2024